0001117480-24-000035 | 10-Q | XBRL Viewer

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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

The Business and Summary of Significant Accounting Policies - Narrative (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) segment	Sep. 30, 2023 USD ($)	Dec. 31, 2019 USD ($)
Business and Summary of Significant Accounting Policies
Contract and grant revenue	$ 26,000	$ 11,000	$ 155,000	$ 320,000
Number of segment \| segment			1
Grant \| Oncoceutics, Inc.
Business and Summary of Significant Accounting Policies
Deferred revenue	100,000		$ 100,000
Contract and grant revenue	24,000	0	200,000	30,000
Licensing
Business and Summary of Significant Accounting Policies
Contract and grant revenue	0	0	0	49,000
Emergent Biodefense Operations Lansing LLC
Business and Summary of Significant Accounting Policies
Revenue recognized	2,000	11,000	2,000	200,000
Ohara Pharmaceutical Co., Ltd.
Business and Summary of Significant Accounting Policies
License agreement, nonrefundable regulatory milestone payment to be received					$ 2,500,000
Ohara Pharmaceutical Co., Ltd. \| Licensing
Business and Summary of Significant Accounting Policies
Contract and grant revenue	$ 0	$ 0	$ 0	$ 100,000

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (65,433)	$ (63,934)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment	67	68
Amortization of debt issuance costs	220	201
Amortization of discount/premium on investments	(3,172)	(5,655)
Share-based compensation	7,331	15,204
Gain on redemption of investments	(5)	0
Gain on sale of property and equipment	0	(5)
Lease-related amortization	(83)	(66)
Changes in operating assets and liabilities:
Accounts receivable	(151)	1,029
Prepaid expenses and other assets	1,773	3,616
Accounts payable and accrued liabilities	3,744	(4,958)
Net cash used in operating activities	(55,709)	(54,500)
Cash flows from investing activities:
Purchases of property and equipment	(124)	(89)
Proceeds from sale of property and equipment	0	5
Purchases of short-term investments	(45,569)	(72,224)
Purchases of long-term investments	(49,580)	(24,592)
Proceeds from redemptions/maturities of short-term investments	143,597	139,430
Proceeds from redemptions of long-term investments	3,025	0
Net cash provided by investing activities	51,349	42,530
Cash flows from financing activities:
Proceeds from exercise of stock options	2	0
Proceeds from employee stock purchase plan	600	465
Payments of debt issuance costs	(258)	(219)
Net cash provided by financing activities	344	246
Net decrease in cash and cash equivalents	(4,016)	(11,724)
Cash and cash equivalents:
Beginning of period	27,661	25,842
End of period	$ 23,645	$ 14,118

The Business and Summary of Significant Accounting Policies - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value, Separate Account Investment
Short-term investments	$ 112,585	$ 155,174
Long-term investments	16,201	21,657
Fair value, Measurements, Recurring
Fair Value, Separate Account Investment
Cash equivalents	19,558	24,102
Short-term investments	112,585	155,174
Long-term investments	16,201	21,657
Total	148,344	200,933
Fair value, Measurements, Recurring \| U.S. treasury securities
Fair Value, Separate Account Investment
Short-term investments	73,283	99,779
Long-term investments	16,201	21,657
Fair value, Measurements, Recurring \| Commercial paper
Fair Value, Separate Account Investment
Short-term investments	10,213	44,319
Fair value, Measurements, Recurring \| Corporate bonds
Fair Value, Separate Account Investment
Short-term investments	29,089	11,076
Fair value, Measurements, Recurring \| Money market funds
Fair Value, Separate Account Investment
Cash equivalents	19,558	24,102
Fair value, Measurements, Recurring \| Quoted Prices in Active Markets for Identical Assets (Level 1)
Fair Value, Separate Account Investment
Cash equivalents	19,558	24,102
Short-term investments	32,562	40,336
Long-term investments	0	3,975
Total	52,120	68,413
Fair value, Measurements, Recurring \| Quoted Prices in Active Markets for Identical Assets (Level 1) \| U.S. treasury securities
Fair Value, Separate Account Investment
Short-term investments	32,562	40,336
Long-term investments	0	3,975
Fair value, Measurements, Recurring \| Quoted Prices in Active Markets for Identical Assets (Level 1) \| Commercial paper
Fair Value, Separate Account Investment
Short-term investments	0	0
Fair value, Measurements, Recurring \| Quoted Prices in Active Markets for Identical Assets (Level 1) \| Corporate bonds
Fair Value, Separate Account Investment
Short-term investments	0	0
Fair value, Measurements, Recurring \| Quoted Prices in Active Markets for Identical Assets (Level 1) \| Money market funds
Fair Value, Separate Account Investment
Cash equivalents	19,558	24,102
Fair value, Measurements, Recurring \| Significant Other Observable Inputs (Level 2)
Fair Value, Separate Account Investment
Cash equivalents	0	0
Short-term investments	80,023	114,838
Long-term investments	16,201	17,682
Total	96,224	132,520
Fair value, Measurements, Recurring \| Significant Other Observable Inputs (Level 2) \| U.S. treasury securities
Fair Value, Separate Account Investment
Short-term investments	40,721	59,443
Long-term investments	16,201	17,682
Fair value, Measurements, Recurring \| Significant Other Observable Inputs (Level 2) \| Commercial paper
Fair Value, Separate Account Investment
Short-term investments	10,213	44,319
Fair value, Measurements, Recurring \| Significant Other Observable Inputs (Level 2) \| Corporate bonds
Fair Value, Separate Account Investment
Short-term investments	29,089	11,076
Fair value, Measurements, Recurring \| Significant Other Observable Inputs (Level 2) \| Money market funds
Fair Value, Separate Account Investment
Cash equivalents	0	0
Fair value, Measurements, Recurring \| Significant Unobservable Inputs (Level 3)
Fair Value, Separate Account Investment
Cash equivalents	0	0
Short-term investments	0	0
Long-term investments	0	0
Total	0	0
Fair value, Measurements, Recurring \| Significant Unobservable Inputs (Level 3) \| U.S. treasury securities
Fair Value, Separate Account Investment
Short-term investments	0	0
Long-term investments	0	0
Fair value, Measurements, Recurring \| Significant Unobservable Inputs (Level 3) \| Commercial paper
Fair Value, Separate Account Investment
Short-term investments	0	0
Fair value, Measurements, Recurring \| Significant Unobservable Inputs (Level 3) \| Corporate bonds
Fair Value, Separate Account Investment
Short-term investments	0	0
Fair value, Measurements, Recurring \| Significant Unobservable Inputs (Level 3) \| Money market funds
Fair Value, Separate Account Investment
Cash equivalents	$ 0	$ 0

Significant Agreements (Details)		1 Months Ended	3 Months Ended		9 Months Ended
Significant Agreements (Details)	Sep. 26, 2022 USD ($) treatment	Sep. 30, 2024 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
BARDA \| Emergent
Schedule of Investments
Proceed from the contract amendment		$ 67,400,000	$ 67,400,000		$ 67,400,000
Emergent \| TEMBEXA \| Base Period
Schedule of Investments
Up-front cash payment	$ 238,000,000
Quantity royalty rate, trigger (treatments) \| treatment	1,700,000
Emergent \| TEMBEXA \| Base Period \| Non- United States
Schedule of Investments
Gross profit royalty rate (as a percent)	15.00%
Emergent \| TEMBEXA \| Base Period \| United States
Schedule of Investments
Gross profit royalty rate (as a percent)	20.00%
Emergent \| BARDA
Schedule of Investments
Payment to be received upon achievement of milestones		2,700,000	2,700,000		2,700,000
Emergent \| BARDA \| Base Period
Schedule of Investments
Maximum milestone proceeds upon the exercise of options	$ 124,000,000
SymBio Pharmaceuticals \| Scenario, Plan
Schedule of Investments
Deferred revenue	$ 12,500,000
Emergent Biodefense Operations Lansing LLC
Schedule of Investments
Revenue recognized			2,000	$ 11,000	2,000	$ 200,000
Ohara Pharmaceutical Co., Ltd.
Schedule of Investments
License agreement, nonrefundable regulatory milestone payment to be received								$ 2,500,000
License agreement, fixed overhead reimbursement		$ 3,300,000
Ohara Pharmaceutical Co., Ltd. \| Scenario, Adjustment
Schedule of Investments
Research and development expenses			$ (500,000)		$ (500,000)
CR Sanjui \| Oncoceutics, Inc.
Schedule of Investments
Payment to be received upon achievement of milestones							$ 5,000,000

Investments (Tables)

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Schedule of Short-Term and Long-Term Investments

The following tables summarize the Company’s debt investments (in thousands):


	September 30, 2024
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Corporate bonds	$	29,017	$	80	$	(8)	$	29,089

Commercial paper	10,185		28		—		10,213
U.S. treasury securities	89,326		171		(13)		89,484

Total investments	$	128,528	$	279	$	(21)	$	128,786

	December 31, 2023
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Corporate bonds	$	11,079	$	4	$	(7)	$	11,076
Commercial paper	44,271		52		(4)		44,319

U.S. treasury securities	121,474		126		(164)		121,436

Total investments	$	176,824	$	182	$	(175)	$	176,831

Schedule of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time

The following tables summarize the Company’s debt investments with unrealized losses, aggregated by investment type and the length of time that individual investments have been in a continuous unrealized loss position (in thousands, except number of securities):


	September 30, 2024
	Less than 12 Months				Greater than 12 Months				Total
	Fair Value		Unrealized Loss		Fair Value		Unrealized Loss		Fair Value		Unrealized Loss
Corporate bonds	$	7,391	$	(8)	$	—	$	—	$	7,391	$	(8)

U.S. treasury securities	12,697		(8)		12,440		(5)		25,137		(13)

Total	$	20,088	$	(16)	$	12,440	$	(5)	$	32,528	$	(21)
Number of securities with unrealized losses			8				3				11

	December 31, 2023
	Less than 12 Months				Greater than 12 Months				Total
	Fair Value		Unrealized Loss		Fair Value		Unrealized Loss		Fair Value		Unrealized Loss

Corporate bonds	$	6,365	$	(7)	$	—	$	—	$	6,365	$	(7)
Commercial paper	5,464		(4)		—		—		5,464		(4)
U.S. treasury securities	$	64,531	$	(120)	$	14,937	$	(44)	$	79,468	$	(164)

Total	$	76,360	$	(131)	$	14,937	$	(44)	$	91,297	$	(175)
Number of securities with unrealized losses			24				4				28

Schedule of the Scheduled Maturity of Company Investments

The following table summarizes the scheduled maturity for the Company’s debt investments at September 30, 2024 (in thousands):


Maturing in one year or less	$	112,585
Maturing after one year through two years	16,201
Total debt investments	$	128,786

- Definition

Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

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+ Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net loss	$ (22,879)	$ (20,685)	$ (21,869)	$ (23,986)	$ (18,576)	$ (21,372)	$ (65,433)	$ (63,934)

- Definition

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

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-Subparagraph (SX 210.13-02(a)(4)(iv))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 31: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(5))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 32: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 60B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482689/260-10-45-60B

Reference 33: http://www.xbrl.org/2003/role/disclosureRef
-Topic 205
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483499/205-20-50-7

Reference 34: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
-Section 45
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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
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-Section 45
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Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
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-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

Commitments and Contingencies - Schedule of Maturity Analysis of Operating Lease Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Lessee, Operating Lease, Liability, Payment, Due
Remainder of fiscal year	$ 191
Year one	781	$ 759
Year two	467	781
Year three		467
Total future minimum rental payments	1,439	2,007
Less amount of lease payments representing interest	95	188
Total present value of lease payments	$ 1,344	$ 1,819

Investments - Schedule of Investment Maturity (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Debt Securities, Available-for-sale, Maturity, Allocated and Single Maturity Date, Fair Value
Maturing in one year or less	$ 112,585
Maturing after one year through two years	16,201
Total debt investments	$ 128,786	$ 176,831

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Leases

The Company leases its facilities under long-term operating leases that expire at various dates through 2026. The Company generally has options to renew lease terms on its facilities, which may be exercised at the Company’s sole discretion. In addition, certain lease arrangements may be terminated prior to their original expiration date at the Company’s discretion. The Company evaluates renewal and termination options at the lease commencement date to determine if it is reasonably certain to exercise the option and has concluded on all operating leases that it is not reasonably certain that any options will be exercised. The weighted-average remaining lease term for the Company’s operating leases as of September 30, 2024 was 1.83 years.

Expense related to leases is recorded on a straight-line basis over the lease term. Lease expense under operating leases, including common area maintenance fees, totaled approximately $0.2 million for the three months ended September 30, 2024 and 2023 and $0.5 million for the nine months ended September 30, 2024 and 2023.

The discount rate implicit within the Company’s leases is generally not determinable and therefore the Company determines the discount rate based on its incremental borrowing rate based on the information available at commencement date. As of September 30, 2024, the operating lease liabilities reflect a weighted-average discount rate of 7.89%.

The following table sets forth the operating lease right-of-use assets and liabilities as of September 30, 2024 (in thousands):


Assets
Operating lease right-of-use assets	$	1,089

Liabilities
Operating lease short-term liabilities (recorded within Accrued liabilities)	$	700
Operating lease long-term liabilities (recorded within Lease-related obligations)	644
Total operating lease liabilities	$	1,344

Operating lease payments over the remainder of the lease terms are as follows (in thousands):


Years Ending December 31,	As of September 30, 2024



2024	$	191
2025	781
2026	467
Total future minimum rental payments	$	1,439
Less amount of lease payments representing interest	95
Total present value of lease payments	$	1,344

As of December 31, 2023, operating lease payments over the remainder of the lease terms were as follows (in thousands):


Years Ending December 31,	As of December 31, 2023




2024	$	759
2025	781
2026	467
Total future minimum rental payments	$	2,007
Less amount of lease payments representing interest	188
Total present value of lease payments	$	1,819

For the three months ended September 30, 2024 and 2023, the Company made lease payments of approximately $0.2 million and for the nine months ended September 30, 2024 and 2023, the Company made lease payments of approximately $0.6 million and $0.5 million, respectively.

Commitments and Contingencies - Narrative (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Commitments and Contingencies Disclosure [Abstract]
Weighted average remaining lease term (in years)	1 year 9 months 29 days		1 year 9 months 29 days
Rent expense under non-cancelable operating leases	$ 0.2	$ 0.2	$ 0.5	$ 0.5
Weighted average discount rate (as a percent)	7.89%		7.89%
Lease payments	$ 0.2	$ 0.2	$ 0.6	$ 0.5

Significant Agreements	9 Months Ended
Significant Agreements	Sep. 30, 2024
Revenue Recognition [Abstract]
Significant Agreements	Significant Agreements We often enter into license agreements and collaborative arrangements to develop and commercialize drug candidates or sell the rights of a product. Our license agreements generally provide for nonrefundable upfront license fees, development and commercial-performance milestone payments, and royalties. See Note 1, The Business and Summary of Significant Accounting Policies, for additional discussion of revenues recognized under these types of arrangements. Collaborative arrangements may include research and development and manufacturing activities for which we may receive from collaboration partners expense reimbursements. Our collaboration arrangements are performed with no guarantee of either technological or commercial success, and each arrangement is unique in nature. Operating expenses for costs incurred pursuant to these arrangements are reported in their respective expense line items in the Consolidated Statements of Operations and Comprehensive Loss, net of any reimbursements due from our collaboration partners, with such reimbursements being recognized at the time the party becomes obligated to pay. We record payments received from our collaborative partners for their share of the development costs as a reduction of Research and development expenses. Emergent BioSolutions, Inc. On September 26, 2022, the Company completed the sale to Emergent of the Company’s exclusive worldwide rights to brincidofovir, including TEMBEXA and specified related assets (the Asset Sale). Emergent paid the Company an upfront cash payment of approximately $238 million upon the closing of the Asset Sale. In addition, pursuant to the Asset Purchase Agreement, the Company is eligible to receive from Emergent: (i) up to an aggregate of approximately $124 million in milestone payments payable upon the exercise of the options under the BARDA Agreement for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA to the U.S. government; (ii) royalty payments equal to 15% of the gross profits from the sales of TEMBEXA made outside of the United States; (iii) royalty payments equal to 20% of the gross profits from the sales of TEMBEXA made in the United States in excess of 1.7 million treatment courses; and (iv) up to an additional $12.5 million upon the achievement of certain other developmental milestones. The effects of recording certain adjustments associated with contingent consideration related to TEMBEXA have been excluded as the Company has made a policy election to account for these amounts when the contingency has been resolved in accordance with Accounting Standards Codification (ASC) 450, Contingencies. In September 2024, BARDA and Emergent agreed to amend the terms of the BARDA Agreement; in connection with that amendment, CLIN0004A and CLIN0005A were exercised for $67.4 million. The Company accounts for milestone payments due under ASC 450-30 - Contingencies - Gain Contingencies (ASC 450-30), and has calculated the milestone payment to be approximately $2.7 million related to the exercise of CLIN0004A and CLIN0005A. The Company would realize this amount upon receipt of the milestone payment. The period under which the Company was contracted to provide the majority of operational support services to Emergent in furtherance of its obligations under the Asset Purchase Agreement and the BARDA Agreement concluded on March 26, 2023, except for certain services which the parties agreed would continue until the occurrence of a specific event, or in some cases a predetermined end date. The BARDA Agreement was novated to Emergent in December 2022. The Company recognized $2,000 of contract revenue for support provided for the three and nine months ended September 30, 2024. The Company recognized $11,000 and $0.2 million of contract revenue for support provided to Emergent for the three and nine months ended September 30, 2023, respectively. Ohara Agreement In 2019, Oncoceutics, Inc., a Delaware corporation (Oncoceutics) which was subsequently acquired by the Company in January 2021, entered into a license, development and commercialization agreement with Ohara Pharmaceutical Co., Ltd. (Ohara) for dordaviprone in Japan (the “Ohara License Agreement”). The Company is entitled to receive up to $2.5 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all products, as defined in the agreement, in Japan. In September 2024, the Company entered into an addendum to its license, development and commercialization agreement with Ohara in which the parties agreed to collaboratively conduct development activities for dordaviprone in Japan, including expanding the ACTION Study into Japan (the “Ohara License Addendum”). Under the Ohara License Addendum, Ohara agreed to reimburse the Company for certain of its development costs incurred from its sponsorship of the ACTION Study in Japan, including fixed overhead payments totaling $3.3 million paid in quarterly installments through December 31, 2026, as well as site activation and subject enrollment-based payments. Amounts due under the Ohara License Addendum will be recognized in accordance with ASC 808 Collaborative Arrangements, as this agreement meets both requirements of a collaborative arrangement outlined in that guidance. During the three and nine months ended September 30, 2024, we recorded $0.5 million of reductions of Research and Development expenses for Ohara's share of development costs. CR Sanjiu Agreement In December 2020, Oncoceutics entered into a license, development and commercialization agreement with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (CR Sanjiu). Oncoceutics granted CR Sanjiu an exclusive royalty bearing license to develop and commercialize dordaviprone in China, Hong Kong, Macau and Taiwan (CR Sanjiu Territory). The Company is entitled to receive up to $5.0 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all licensed products, as defined in the agreement, in the CR Sanjiu Territory.

- Definition

The entire disclosure for long-term contracts or programs.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-SubTopic 35
-Topic 605
-Publisher FASB
-URI https://asc.fasb.org/605-35/tableOfContent

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(3)(c)(3))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(6)(d)(ii))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/912/tableOfContent

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
-SubTopic 275
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479072/912-275-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
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-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479072/912-275-50-3

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
-SubTopic 275
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479072/912-275-50-4

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
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-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479072/912-275-50-5

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
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-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479072/912-275-50-6

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
-SubTopic 310
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478685/912-310-50-1

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
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-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478685/912-310-50-4

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
-SubTopic 405
-Name Accounting Standards Codification
-Section 45
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478788/912-405-45-4

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
-SubTopic 405
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477623/912-405-50-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 912
-SubTopic 405
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477623/912-405-50-3

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 910
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482332/910-20-50-1

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02(3)(c)(2))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480566/210-10-S99-1

+ Details

Equity Transactions and Share-based Compensation - Narrative (Details) - USD ($)		1 Months Ended				3 Months Ended		9 Months Ended		12 Months Ended
	Jan. 01, 2023	Aug. 31, 2024	Jul. 31, 2024	Apr. 30, 2024	Nov. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2022	Feb. 29, 2024
Share-based Compensation Arrangement by Share-based Payment Award
Shares issued for restricted stock units (in shares)						6,000	187,000	287,000	408,000
One-time employee termination benefits									$ 600,000	$ 400,000
Share-based payment arrangement, expense						$ 2,389,000	$ 7,880,000	$ 7,331,000	15,204,000
Options granted (in shares)		150,000	120,000	223,000	950,000
Employee Stock Option
Share-based Compensation Arrangement by Share-based Payment Award
Expiration period								10 years
Vesting period								4 years
Independent Members Of Board
Share-based Compensation Arrangement by Share-based Payment Award
Share-based payment arrangement, expense									$ 300,000
The 2013 Plan
Share-based Compensation Arrangement by Share-based Payment Award
Number of shares reserved for future issuance (in shares)						10,200,000		10,200,000
Shares issued pursuant to the exercise of stock options (in shares)						0	0	2,000	0
The 2013 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award
Number of shares reserved for future issuance (in shares)						1,500,000		1,500,000
Number of shares authorized to be granted (in shares)						4,800,000		4,800,000
Additional shares authorized (in shares)	422,535
Participation term (in months)								24 months
Percentage of pay that employee can contribute, maximum (as a percent)						15.00%		15.00%
Discounted purchase price from market price, offering date (as a percent)								15.00%
Discounted purchase price from market price, purchase date (as a percent)								15.00%
Purchase interval (in months)								6 months
Shares issued pursuant to employee stock purchase plan (in shares)						297,000	121,000	717,000	429,000
Public Offering
Share-based Compensation Arrangement by Share-based Payment Award
Sale of common stock, amount authorized											$ 250,000,000
Public Offering \| Jeffries LLC
Share-based Compensation Arrangement by Share-based Payment Award
Sale of common stock, amount authorized											$ 75,000,000

The Business and Summary of Significant Accounting Policies - Deferred Loan Costs (Details) - Revolving Credit Facility	Nov. 21, 2023	Jan. 31, 2022 USD ($) installment	Sep. 30, 2024 USD ($)
Business and Summary of Significant Accounting Policies
Debt instrument, term (in years)		4 years
Aggregate principal amount		$ 50,000,000
Line of credit facility, unused capacity, commitment fee (as a percent)	0.35%	0.35%
Debt instrument, basis spread on variable rate (as a percent)		1.50%
Debt instrument, interest rate, stated (as a percent)		4.75%
Debt instrument, early termination fee (as a percent)		$ 500,000
Debt instrument, unused borrowing capacity, fee		$ 500,000
Number of installment payments (installment) \| installment		4
Current deferred loan costs			$ 100,000
Noncurrent deferred loan costs			100,000
Loan fee liability			$ 200,000

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	10,000,000	10,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	200,000,000	200,000,000
Common stock, shares issued (in shares)	89,936,053	88,929,300
Common stock, shares outstanding (in shares)	89,936,053	88,929,300

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenues:
Total revenues	$ 26	$ 11	$ 155	$ 320
Operating expenses:
Research and development	19,646	17,396	56,918	53,144
General and administrative	5,173	9,304	15,252	19,431
Total operating expenses	24,819	26,700	72,170	72,575
Loss from operations	(24,793)	(26,689)	(72,015)	(72,255)
Other income:
Interest income and other, net	1,914	2,703	6,582	8,321
Net loss	(22,879)	(23,986)	(65,433)	(63,934)
Other comprehensive loss:
Unrealized gain (loss) on debt investments, net	466	188	251	(288)
Comprehensive loss	$ (22,413)	$ (23,798)	$ (65,182)	$ (64,222)
Per share information:
Net loss, basic (in dollars per share)	$ (0.26)	$ (0.27)	$ (0.73)	$ (0.72)
Net loss, diluted (in dollars per share)	$ (0.26)	$ (0.27)	$ (0.73)	$ (0.72)
Weighted-average shares outstanding, basic (in shares)	89,701,117	88,620,666	89,531,017	88,500,813
Weighted-average shares outstanding, diluted (in shares)	89,701,117	88,620,666	89,531,017	88,500,813
Contract and grant revenue
Revenues:
Total revenues	$ 26	$ 11	$ 155	$ 271
Licensing revenue
Revenues:
Total revenues	$ 0	$ 0	$ 0	$ 49

Equity Transactions and Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based Payment Arrangement, Expensed and Capitalized, Amount
Total share-based compensation expense	$ 2,389	$ 7,880	$ 7,331	$ 15,204
Research and development expense
Share-based Payment Arrangement, Expensed and Capitalized, Amount
Total share-based compensation expense	1,350	1,739	4,636	5,619
General and administrative expense
Share-based Payment Arrangement, Expensed and Capitalized, Amount
Total share-based compensation expense	$ 1,039	$ 6,141	$ 2,695	$ 9,585

Cover Page - shares	9 Months Ended
Cover Page - shares	Sep. 30, 2024	Nov. 01, 2024
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-35867
Entity Registrant Name	CHIMERIX, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	33-0903395
Entity Address, Address Line One	2505 Meridian Parkway
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Durham
Entity Address, State or Province	NC
Entity Address, Postal Zip Code	27713
City Area Code	919
Local Phone Number	806-1074
Title of each class	Common Stock, par value $0.001 per share
Trading Symbol(s)	CMRX
Name of each exchange on which registered	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		89,936,053
Amendment Flag	false
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Entity Central Index Key	0001117480
Current Fiscal Year End Date	--12-31

Equity Transactions and Share-based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Schedule of Employee and Non-Employee Share-Based Compensation Expense Recognized Related to Stock Options, the ESPP and RSUs

Total share-based compensation expense recognized related to stock options, the ESPP and RSUs was as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development expense	$	1,350	$	1,739	$	4,636	$	5,619
General and administrative expense	1,039		6,141		2,695		9,585
Total share-based compensation expense	$	2,389	$	7,880	$	7,331	$	15,204

The Business and Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s audited financial statements and notes thereto included in its Annual Report on Form 10-K for the year ended December 31, 2023. In the opinion of the Company’s management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented have been included. Operating results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the full year, for any other interim period or for any future year.
Fair Value of Financial Instruments	Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. The determination of where an asset or liability falls in the hierarchy requires significant judgment. These levels are: •Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. •Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly. •Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement. There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. For additional information regarding the Company’s investments, please refer to Note 2, “Investments.”
Revenue Recognition	Revenue Recognition Policy The Company’s revenues generally consist of (i) contract and grant revenue—revenue generated under federal and private foundation grants and contracts and (ii) licensing revenue—revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements. Revenue is recognized in accordance with the criteria outlined in Accounting Standards Codification (ASC) 606 issued by the Financial Accounting Standards Board (FASB). Following this accounting pronouncement, a five-step approach is applied for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation.
Research and Development Expenses	Research and Development Expenses Research and development expenses are recorded when incurred and consist primarily of personnel costs including salaries, benefits and stock-based compensation expense, infrastructure, materials and supplies and other support costs, research and clinical studies performed by contract research organizations (“CROs”) and our collaboration partners and other outside services. From time to time, we enter into development and collaboration agreements in which we share expenses with a collaborative partner. We record payments received from our collaborative partners for their share of the development costs as a reduction of Research and development expenses.
Research and Development Prepaids and Accruals	Research and Development Prepaids and Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through September 30, 2024, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.
Basic and Diluted Net Loss Per Share of Common Stock	Basic and Diluted Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net loss per share of common stock is computed by dividing net loss by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during the periods of net loss, there was no difference between basic and diluted loss per share of common stock for the three and nine months ended September 30, 2024 and 2023.
Use of Estimates	Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. In addition to estimates discussed in other sections of this Quarterly Report on Form 10-Q, the most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.
Segments	Segments The Company operates in only one segment, pharmaceuticals.
Impact of Recently Issued Accounting Standards	Impact of Recently Issued Accounting Standards In November 2023, the FASB issued amended guidance for improvements to reportable segment disclosures, which requires that a public entity disclose significant segment expenses regularly reviewed by the chief operating decision maker (CODM), including public entities with a single reportable segment. This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We intend to adopt this standard in our Annual Report on Form 10-K for the year ending December 31, 2024. We are currently evaluating the potential impact of adopting this standard on our disclosures.

The Business and Summary of Significant Accounting Policies - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accounting Policies [Abstract]
Accrued research and development expenses	$ 9,889	$ 7,623
Accrued compensation	4,774	5,123
Other accrued liabilities	2,241	2,846
Total accrued liabilities	$ 16,904	$ 15,592

The Business and Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

The Business and Summary of Significant Accounting Policies

Description of Business

Chimerix is a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company is focused on developing imipridones as a potential new class of selective cancer therapies. The most advanced imipridone is dordaviprone (ONC201), which is in clinical-stage development for H3 K27M-mutant diffuse glioma as its lead indication. In addition, a second-generation imipridone (ONC206) is currently in dose escalating clinical trials for adult and pediatric patients with primary central nervous system tumors.

Basis of Presentation

The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s audited financial statements and notes thereto included in its Annual Report on Form 10-K for the year ended December 31, 2023. In the opinion of the Company’s management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented have been included. Operating results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the full year, for any other interim period or for any future year.

Fair Value of Financial Instruments

The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments.

For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures.

The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. The determination of where an asset or liability falls in the hierarchy requires significant judgment. These levels are:

•Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.

•Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly.

•Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. For additional information regarding the Company’s investments, please refer to Note 2, “Investments.”

Below are tables that present information about certain assets measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements
	September 30, 2024
	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash equivalents
Money market funds	$	19,558	$	19,558	$	—	$	—




Total cash equivalents	19,558		19,558		—		—
Short-term investments

U.S. treasury securities	73,283		32,562		40,721		—

Commercial paper	10,213		—		10,213		—
Corporate bonds	29,089		—		29,089		—
Total short-term investments	112,585		32,562		80,023		—
Long-term investments

U.S. treasury securities	16,201		—		16,201		—
Total long-term investments	16,201		—		16,201		—
Total	$	148,344	$	52,120	$	96,224	$	—

	Fair Value Measurements
	December 31, 2023
	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash equivalents
Money market funds	$	24,102	$	24,102	$	—	$	—



Total cash equivalents	24,102		24,102		—		—
Short-term investments

U.S. treasury securities	99,779		40,336		59,443		—

Commercial paper	44,319		—		44,319		—
Corporate bonds	11,076		—		11,076		—
Total short-term investments	155,174		40,336		114,838		—
Long-term investments

U.S. treasury securities	21,657		3,975		17,682		—

Total long-term investments	21,657		3,975		17,682		—
Total	$	200,933	$	68,413	$	132,520	$	—

Deferred Loan Costs

On January 31, 2022 (the Effective Date), the Company entered into a Loan and Security Agreement (the Loan Agreement), by and between the Company, as borrower, and Silicon Valley Bank, now a division of First-Citizens Bank & Trust Company, as the lender (the Lender). The Loan Agreement provides for a four-year secured revolving loan facility (the Credit Facility) in an aggregate principal amount of up to $50.0 million. Proceeds from the Credit Facility may be used for working capital and general corporate purposes. The Company has no obligation to draw down any amount under the Credit Facility, and has not drawn down any amount as of September 30, 2024.

On November 21, 2023, the Company entered into an Amendment to the Loan Agreement, which among other things, extended the term to September 30, 2026 and increased the unused line fee to 0.35% per annum on the unused portion of the Credit Facility, payable quarterly in arrears.

Borrowings under the Credit Facility accrue interest at a floating per annum rate of the greater of (i) 1.50% above the Prime Rate (as defined below) and (ii) 4.75%. Prime Rate is defined as the rate of interest per annum published in The Wall Street Journal or any successor publication thereto as the “Prime Rate”. If such rate of interest from The Wall Street Journal becomes unavailable, the “Prime Rate” shall mean the rate of interest per annum announced by the Lender as its prime rate in effect. In each case, in the event such prime rate is less than zero, such rate shall be deemed to be zero for purposes of the Loan Agreement. The Company must also pay an unused line fee equal to 0.35% per annum on the unused portion of the Credit Facility, payable quarterly in arrears. Upon the termination of the Loan Agreement for any reason prior to the Maturity Date, the Company will be required to pay to the Lender an early termination fee of $0.5 million. The Loan Agreement also requires the Company to pay the Lender a non-refundable commitment fee of $0.5 million, payable in four equal installments beginning on the Effective Date and each anniversary of the Effective Date thereafter until January 31, 2025. As of September 30, 2024, the Company has recorded current deferred loan costs of $0.1 million in prepaid expenses and other current assets and non-current deferred loan costs of $0.1 million in other long-term assets on the Consolidated Balance Sheets. As of September 30, 2024, the Company has recorded a current loan fee liability of $0.2 million in accrued liabilities.

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Accrued research and development expenses	$	9,889	$	7,623
Accrued compensation	4,774		5,123


Other accrued liabilities	2,241		2,846
Total accrued liabilities	$	16,904	$	15,592

Revenue Recognition

Policy

The Company’s revenues generally consist of (i) contract and grant revenue—revenue generated under federal and private foundation grants and contracts and (ii) licensing revenue—revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements. Revenue is recognized in accordance with the criteria outlined in Accounting Standards Codification (ASC) 606 issued by the Financial Accounting Standards Board (FASB). Following this accounting pronouncement, a five-step approach is applied for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation.

Emergent BioSolutions, Inc.

On September 26, 2022, the Company completed the sale to Emergent of the Company’s exclusive worldwide rights to brincidofovir, including TEMBEXA® and specified related assets. The Company recognized $2,000 of contract revenue for support provided to Emergent for the three and nine months ended September 30, 2024. The Company recognized $11,000 and $0.2 million of contract revenue for support provided to Emergent for the three and nine months ended September 30, 2023, respectively.

Grant Revenue

Grant revenue under cost-plus-fixed-fee grants from the federal government and private foundations is recognized as allowable costs are incurred and fees are earned. At September 30, 2024, the Company has a deferred revenue balance of $0.1 million related to these grants. For the three and nine months ended September 30, 2024, the Company recognized $24,000 and $0.2 million of grant revenue, respectively. For the three months ended September 30, 2023, the Company recognized no grant revenue and for the nine months ended September 30, 2023, the Company recognized $30,000 of grant revenue related to these grants.

Ohara Agreement

In 2019, Oncoceutics, Inc., a Delaware corporation (Oncoceutics) which was subsequently acquired by the Company in January 2021, entered into a license, development and commercialization agreement with Ohara Pharmaceutical Co., Ltd. (Ohara) for

dordaviprone in Japan. The Company is entitled to receive up to $2.5 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all products, as defined in the agreement, in Japan. For the three and nine months ended September 30, 2024, the Company recognized no license revenue related to this agreement. For the three months ended September 30, 2023, the Company recognized no license revenue related to this agreement and for the nine months ended September 30, 2023, the Company recognized approximately $0.1 million of license revenue related to this agreement.

Research and Development Expenses

Research and development expenses are recorded when incurred and consist primarily of personnel costs including salaries, benefits and stock-based compensation expense, infrastructure, materials and supplies and other support costs, research and clinical studies performed by contract research organizations (“CROs”) and our collaboration partners and other outside services. From time to time, we enter into development and collaboration agreements in which we share expenses with a collaborative partner. We record payments received from our collaborative partners for their share of the development costs as a reduction of Research and development expenses.

Research and Development Prepaids and Accruals

As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts.

The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through September 30, 2024, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.

Basic and Diluted Net Loss Per Share of Common Stock

Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net loss per share of common stock is computed by dividing net loss by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during the periods of net loss, there was no difference between basic and diluted loss per share of common stock for the three and nine months ended September 30, 2024 and 2023.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. In addition to estimates discussed in other sections of this Quarterly Report on Form 10-Q, the most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.

Segments

The Company operates in only one segment, pharmaceuticals.

Nasdaq Listing Rule Compliance

On June 27, 2024, the Company received a notice from The Nasdaq Global Market (Nasdaq) that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), as the minimum bid price of the Company’s common stock has been below $1.00 per share for 30 consecutive business days. The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Global Market.

The Company has 180 calendar days, or until December 24, 2024, to regain compliance with the minimum bid price requirement. To regain compliance, the minimum bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the minimum bid price requirement by December 24, 2024, the Company may be eligible for an additional 180-calendar day compliance period if it elects to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. The Company’s failure to regain compliance during this period could result in delisting of its common stock.

The Company intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the listing requirements. There can be no assurance that the Company will be able to regain compliance with Nasdaq’s Listing Rule 5450(a)(1) or will otherwise be in compliance with other Nasdaq listing criteria.

Impact of Recently Issued Accounting Standards

In November 2023, the FASB issued amended guidance for improvements to reportable segment disclosures, which requires that a public entity disclose significant segment expenses regularly reviewed by the chief operating decision maker (CODM), including public entities with a single reportable segment. This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We intend to adopt this standard in our Annual Report on Form 10-K for the year ending December 31, 2024. We are currently evaluating the potential impact of adopting this standard on our disclosures.

Income Taxes (Details) - USD ($)	12 Months Ended
Income Taxes (Details) - USD ($)	Dec. 31, 2024	Sep. 30, 2024
Income Tax Contingency
Unrecognized tax benefits		$ 0
Scenario, Forecast
Income Tax Contingency
Estimated annual effective tax rate (as a percent)	0.00%

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 23,645	$ 27,661
Short-term investments, available-for-sale	112,585	155,174
Accounts receivable	155	4
Prepaid expenses and other current assets	4,517	6,271
Total current assets	140,902	189,110
Long-term investments	16,201	21,657
Property and equipment, net of accumulated depreciation	281	224
Operating lease right-of-use assets	1,089	1,482
Other long-term assets	195	301
Total assets	158,668	212,774
Current liabilities:
Accounts payable	5,340	2,851
Accrued liabilities	16,904	15,592
Total current liabilities	22,244	18,443
Line of credit commitment fee	0	125
Lease-related obligations	644	1,177
Total liabilities	22,888	19,745
Stockholders’ equity:
Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding as of September 30, 2024 and December 31, 2023	0	0
Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2024 and December 31, 2023; 89,936,053 and 88,929,300 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively	90	89
Additional paid-in capital	996,389	988,457
Accumulated other comprehensive gain, net	258	7
Accumulated deficit	(860,957)	(795,524)
Total stockholders’ equity	135,780	193,029
Total liabilities and stockholders’ equity	$ 158,668	$ 212,774

Subsequent Events	9 Months Ended
Subsequent Events	Sep. 30, 2024
Subsequent Events [Abstract]
Subsequent Events	Subsequent Events The Company has evaluated subsequent events through the issuance date of these financial statements to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of September 30, 2024, and events which occurred subsequently but were not recognized in the financial statements.

Investments - Schedule of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time (Details) $ in Thousands	Sep. 30, 2024 USD ($) security	Dec. 31, 2023 USD ($) security
Debt Securities, Available-for-sale
Fair value, less than 12 months	$ 20,088	$ 76,360
Unrealized loss, less than 12 months	(16)	(131)
Fair value, greater than 12 months	12,440	14,937
Unrealized loss, greater than 12 months	(5)	(44)
Fair value, total	32,528	91,297
Unrealized loss, total	$ (21)	$ (175)
Number of securities with unrealized losses, less than 12 months \| security	8	24
Number of securities with unrealized losses, greater than 12 months \| security	3	4
Number of securities with unrealized losses, total \| security	11	28
Corporate bonds
Debt Securities, Available-for-sale
Fair value, less than 12 months	$ 7,391	$ 6,365
Unrealized loss, less than 12 months	(8)	(7)
Fair value, greater than 12 months	0	0
Unrealized loss, greater than 12 months	0	0
Fair value, total	7,391	6,365
Unrealized loss, total	(8)	(7)
U.S. treasury securities
Debt Securities, Available-for-sale
Fair value, less than 12 months	12,697	64,531
Unrealized loss, less than 12 months	(8)	(120)
Fair value, greater than 12 months	12,440	14,937
Unrealized loss, greater than 12 months	(5)	(44)
Fair value, total	25,137	79,468
Unrealized loss, total	$ (13)	(164)
Commercial paper
Debt Securities, Available-for-sale
Fair value, less than 12 months		5,464
Unrealized loss, less than 12 months		(4)
Fair value, greater than 12 months		0
Unrealized loss, greater than 12 months		0
Fair value, total		5,464
Unrealized loss, total		$ (4)

Investments

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Investments

The following tables summarize the Company’s debt investments (in thousands):


	September 30, 2024
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Corporate bonds	$	29,017	$	80	$	(8)	$	29,089

Commercial paper	10,185		28		—		10,213
U.S. treasury securities	89,326		171		(13)		89,484

Total investments	$	128,528	$	279	$	(21)	$	128,786

	December 31, 2023
	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Estimated Fair Value
Corporate bonds	$	11,079	$	4	$	(7)	$	11,076
Commercial paper	44,271		52		(4)		44,319

U.S. treasury securities	121,474		126		(164)		121,436

Total investments	$	176,824	$	182	$	(175)	$	176,831


	September 30, 2024
	Less than 12 Months				Greater than 12 Months				Total
	Fair Value		Unrealized Loss		Fair Value		Unrealized Loss		Fair Value		Unrealized Loss
Corporate bonds	$	7,391	$	(8)	$	—	$	—	$	7,391	$	(8)

U.S. treasury securities	12,697		(8)		12,440		(5)		25,137		(13)

Total	$	20,088	$	(16)	$	12,440	$	(5)	$	32,528	$	(21)
Number of securities with unrealized losses			8				3				11

	December 31, 2023
	Less than 12 Months				Greater than 12 Months				Total
	Fair Value		Unrealized Loss		Fair Value		Unrealized Loss		Fair Value		Unrealized Loss

Corporate bonds	$	6,365	$	(7)	$	—	$	—	$	6,365	$	(7)
Commercial paper	5,464		(4)		—		—		5,464		(4)
U.S. treasury securities	$	64,531	$	(120)	$	14,937	$	(44)	$	79,468	$	(164)

Total	$	76,360	$	(131)	$	14,937	$	(44)	$	91,297	$	(175)
Number of securities with unrealized losses			24				4				28

The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may consist of U.S. Government and government agency securities, money market and mutual fund investments, certificates of deposits, municipal and corporate notes and bonds, and commercial paper, among others. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of two years and requires an average portfolio maturity of no more than 12 months. Some of the securities in which the Company invests may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. Generally, the Company’s investments are not collateralized. The Company has not realized any significant losses from its investments.

The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates, among other things, the duration and extent to which the fair value of a security is less than its cost; the financial condition of the issuer and any changes thereto; and the Company’s intent to sell, or whether it will more likely than not be required to sell, the security before recovery of its cost basis. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Unrealized gains and losses on debt investments are recorded to unrealized gain (loss) on debt investments, net in the Consolidated Statements of Operations and Comprehensive Loss. Realized gains and losses on debt investments are recorded based on specific identification to interest income and other, net in the Consolidated Statements of Operations and Comprehensive Loss. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current investments. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term investments. At September 30, 2024, the Company believes that the cost of its investments is recoverable in all material respects. The Company recognizes interest income on an accrual basis in interest income in the Consolidated Statements of Operations and Comprehensive Loss.

The following table summarizes the scheduled maturity for the Company’s debt investments at September 30, 2024 (in thousands):


Maturing in one year or less	$	112,585
Maturing after one year through two years	16,201
Total debt investments	$	128,786

Investments - Schedule of Available-for-Sale securities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Schedule of Investments
Amortized Cost	$ 128,528	$ 176,824
Gross Unrealized Gains	279	182
Gross Unrealized Losses	(21)	(175)
Estimated Fair Value	128,786	176,831
Corporate bonds
Schedule of Investments
Amortized Cost	29,017	11,079
Gross Unrealized Gains	80	4
Gross Unrealized Losses	(8)	(7)
Estimated Fair Value	29,089	11,076
Commercial paper
Schedule of Investments
Amortized Cost	10,185	44,271
Gross Unrealized Gains	28	52
Gross Unrealized Losses	0	(4)
Estimated Fair Value	10,213	44,319
U.S. treasury securities
Schedule of Investments
Amortized Cost	89,326	121,474
Gross Unrealized Gains	171	126
Gross Unrealized Losses	(13)	(164)
Estimated Fair Value	$ 89,484	$ 121,436

- 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

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-Paragraph 6
-Subparagraph (SX 210.12-14(Column F)(Footnote 8))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477271/946-320-S99-6

Reference 63: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 6
-Subparagraph (SX 210.12-14(Column F)(Footnote 9))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477271/946-320-S99-6

Reference 64: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 19
-Subparagraph (1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477271/946-320-S99-19

Reference 65: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 19
-Subparagraph (3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477271/946-320-S99-19

+ Details

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Schedule of Operating Lease Right-of-Use Assets and Liabilities

The following table sets forth the operating lease right-of-use assets and liabilities as of September 30, 2024 (in thousands):


Assets
Operating lease right-of-use assets	$	1,089

Liabilities
Operating lease short-term liabilities (recorded within Accrued liabilities)	$	700
Operating lease long-term liabilities (recorded within Lease-related obligations)	644
Total operating lease liabilities	$	1,344

Schedule of Operating Lease Maturity

Operating lease payments over the remainder of the lease terms are as follows (in thousands):


Years Ending December 31,	As of September 30, 2024



2024	$	191
2025	781
2026	467
Total future minimum rental payments	$	1,439
Less amount of lease payments representing interest	95
Total present value of lease payments	$	1,344

As of December 31, 2023, operating lease payments over the remainder of the lease terms were as follows (in thousands):


Years Ending December 31,	As of December 31, 2023




2024	$	759
2025	781
2026	467
Total future minimum rental payments	$	2,007
Less amount of lease payments representing interest	188
Total present value of lease payments	$	1,819

Commitments and Contingencies - Schedule of Operating Lease Right-of-Use Assets and Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Assets
Operating lease right-of-use assets	$ 1,089	$ 1,482
Liabilities
Operating lease short-term liabilities (recorded within Accrued liabilities)	700
Operating lease long-term liabilities (recorded within Lease-related obligations)	644	1,177
Total operating lease liabilities	$ 1,344	$ 1,819
Operating lease, liability, current, statement of financial position [extensible list]	Accrued Liabilities, Current

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Gain (Loss)	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2022		88,054,127
Beginning balance at Dec. 31, 2022	$ 256,857	$ 88	$ 970,535	$ (337)	$ (713,429)
Increase (Decrease) in Stockholders' Equity
Share-based compensation	4,363		4,363
Employee stock purchase plan purchases (in shares)		308,000
Employee stock purchase plan purchases	357	$ 1	356
RSU stock issuance (in shares)		221,440
Comprehensive loss:
Unrealized loss (gain) on investments, net	106			106
Net loss	(21,372)				(21,372)
Comprehensive loss	(21,266)
Ending balance (in shares) at Mar. 31, 2023		88,583,567
Ending balance at Mar. 31, 2023	240,311	$ 89	975,254	(231)	(734,801)
Beginning balance (in shares) at Dec. 31, 2022		88,054,127
Beginning balance at Dec. 31, 2022	256,857	$ 88	970,535	(337)	(713,429)
Comprehensive loss:
Unrealized loss (gain) on investments, net	(288)
Net loss	(63,934)
Comprehensive loss	(64,222)
Ending balance (in shares) at Sep. 30, 2023		88,891,300
Ending balance at Sep. 30, 2023	208,303	$ 89	986,202	(625)	(777,363)
Beginning balance (in shares) at Mar. 31, 2023		88,583,567
Beginning balance at Mar. 31, 2023	240,311	$ 89	975,254	(231)	(734,801)
Increase (Decrease) in Stockholders' Equity
Share-based compensation	2,959		2,959
Comprehensive loss:
Unrealized loss (gain) on investments, net	(582)			(582)
Net loss	(18,576)				(18,576)
Comprehensive loss	(19,158)
Ending balance (in shares) at Jun. 30, 2023		88,583,567
Ending balance at Jun. 30, 2023	224,112	$ 89	978,213	(813)	(753,377)
Increase (Decrease) in Stockholders' Equity
Share-based compensation	7,880		7,880
Employee stock purchase plan purchases (in shares)		121,233
Employee stock purchase plan purchases	109		109
RSU stock issuance (in shares)		186,500
Comprehensive loss:
Unrealized loss (gain) on investments, net	188			188
Net loss	(23,986)				(23,986)
Comprehensive loss	(23,798)
Ending balance (in shares) at Sep. 30, 2023		88,891,300
Ending balance at Sep. 30, 2023	$ 208,303	$ 89	986,202	(625)	(777,363)
Beginning balance (in shares) at Dec. 31, 2023	88,929,300	88,929,300
Beginning balance at Dec. 31, 2023	$ 193,029	$ 89	988,457	7	(795,524)
Increase (Decrease) in Stockholders' Equity
Share-based compensation	2,749		2,749
Employee stock purchase plan purchases (in shares)		419,546
Employee stock purchase plan purchases	378	$ 1	377
RSU stock issuance (in shares)		281,056
Comprehensive loss:
Unrealized loss (gain) on investments, net	(185)			(185)
Net loss	(21,869)				(21,869)
Comprehensive loss	(22,054)
Ending balance (in shares) at Mar. 31, 2024		89,629,902
Ending balance at Mar. 31, 2024	$ 174,102	$ 90	991,583	(178)	(817,393)
Beginning balance (in shares) at Dec. 31, 2023	88,929,300	88,929,300
Beginning balance at Dec. 31, 2023	$ 193,029	$ 89	988,457	7	(795,524)
Comprehensive loss:
Unrealized loss (gain) on investments, net	251
Net loss	(65,433)
Comprehensive loss	$ (65,182)
Ending balance (in shares) at Sep. 30, 2024	89,936,053	89,936,053
Ending balance at Sep. 30, 2024	$ 135,780	$ 90	996,389	258	(860,957)
Beginning balance (in shares) at Mar. 31, 2024		89,629,902
Beginning balance at Mar. 31, 2024	174,102	$ 90	991,583	(178)	(817,393)
Increase (Decrease) in Stockholders' Equity
Share-based compensation	2,193		2,193
Exercise of stock options (in shares)		2,483
Exercise of stock options	2		2
Comprehensive loss:
Unrealized loss (gain) on investments, net	(30)			(30)
Net loss	(20,685)				(20,685)
Comprehensive loss	(20,715)
Ending balance (in shares) at Jun. 30, 2024		89,632,385
Ending balance at Jun. 30, 2024	155,582	$ 90	993,778	(208)	(838,078)
Increase (Decrease) in Stockholders' Equity
Share-based compensation	2,389		2,389
Employee stock purchase plan purchases (in shares)		297,418
Employee stock purchase plan purchases	222		222
RSU stock issuance (in shares)		6,250
Comprehensive loss:
Unrealized loss (gain) on investments, net	466			466
Net loss	(22,879)				(22,879)
Comprehensive loss	$ (22,413)
Ending balance (in shares) at Sep. 30, 2024	89,936,053	89,936,053
Ending balance at Sep. 30, 2024	$ 135,780	$ 90	$ 996,389	$ 258	$ (860,957)

Equity Transactions and Share-based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Equity Transactions and Share-based Compensation

At-The-Market Equity Offering; Shelf Registration Statement

On February 29, 2024, we entered into an Open Market Sale AgreementSM (Jefferies Sales Agreement) with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time through Jefferies, up to $75 million of shares of our common stock. On the same day, we filed a shelf registration statement on Form S-3 with the SEC, which contains a base prospectus, covering up to a total aggregate offering price of $250 million of our common stock, preferred stock, debt securities and warrants to purchase any of such securities, and a sales agreement prospectus, covering the offering, issuance and sale of up to a maximum aggregate offering price of $75 million of our common stock that may be issued and sold from time to time under the Jefferies Sales Agreement. The $75 million of shares that may be issued and sold from time to time under the Jefferies Sales Agreement is included in the $250 million of securities that may be offered, issued and sold by us pursuant to our shelf registration statement. As of September 30, 2024, no sales have been made under the shelf registration statement or the Jefferies Sales Agreement.

Stock Options

The Company maintains a 2024 Equity Incentive Plan (the 2024 Plan) and previously maintained a 2013 Equity Incentive Plan (the 2013 Plan). The 2024 Plan serves as the successor to and continuation of the 2013 Plan and provides for the grant of incentive stock options (ISOs), non-statutory stock options (NSOs), stock appreciation rights, restricted stock awards, restricted stock unit (RSU) awards, performance-based stock awards, and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company and its affiliates. Following shareholder approval in June 2024 of the 2024 Plan, any shares then available for future grants under the 2013 Plan were allocated to the 2024 Plan. No further grants will be made under the 2013 Plan. As of September 30, 2024, there was a total of 10.2 million shares reserved for future issuance under the 2024 Plan. The Company issued no shares and 2,000 shares of common stock pursuant to the exercise of stock options during the three and nine months ended September 30, 2024. The Company issued no shares of common stock pursuant to the exercise of stock options during the three and nine months ended September 30, 2023.

Employee Stock Purchase Plan

The Company maintains a 2013 Employee Stock Purchase Plan (ESPP), which provides for the issuance of shares of common stock pursuant to purchase rights granted to the Company’s employees or to employees of any of its designated affiliates. The Company has reserved a total of 4.8 million shares of common stock to be purchased under the ESPP, of which 1.5 million shares remained available for purchase as of September 30, 2024. The number of shares of common stock reserved for issuance automatically increased on January 1, 2023, by an additional 422,535 shares, pursuant to an “evergreen” provision contained in the ESPP commencing on January 1, 2014 and ending on (and including) January 1, 2023.

The ESPP provides for an automatic reset feature to start participants on a new twenty-four-month participation period in the event that the common stock market value on a purchase date is less than the common stock value on the first day of the twenty-four-month offering period. Eligible employees may authorize an amount up to 15% of their salary to purchase common stock at the lower of a 15% discount to the beginning price of their offering period or a 15% discount to the ending price of each six-month purchase interval. The Company issued approximately 297,000 and 717,000 shares of common stock pursuant to the ESPP during the three and nine months ended September 30, 2024, respectively. The Company issued approximately 121,000 and 429,000 shares of common stock pursuant to the ESPP during the three and nine months ended September 30, 2023, respectively. Compensation expense for shares purchased under the ESPP related to the purchase discount and the “look-back” option and were determined using a Black-Scholes option pricing model.

Restricted Stock Units (RSUs)

The Company has issued RSUs to certain employees which vest based on service criteria. When vested, the RSU represents the right to be issued the number of shares of the Company’s common stock that is equal to the number of RSUs granted. The grant date fair value for RSUs is based upon the market price of the Company’s common stock on the date of the grant. The fair value is then amortized to compensation expense over the requisite service period or vesting term. The Company issued approximately 6,000 and approximately 287,000 shares of common stock pursuant to the vesting of RSUs during the three and nine months ended September 30, 2024, respectively. The Company issued approximately 187,000 and approximately 408,000

shares of common stock pursuant to the vesting of RSUs during the three and nine months ended September 30, 2023, respectively.

Share-based Compensation

For awards with only service conditions and graded-vesting features, the Company recognizes compensation expense on a straight-line basis over the requisite service period. Total share-based compensation expense recognized related to stock options, the ESPP and RSUs was as follows (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development expense	$	1,350	$	1,739	$	4,636	$	5,619
General and administrative expense	1,039		6,141		2,695		9,585
Total share-based compensation expense	$	2,389	$	7,880	$	7,331	$	15,204

In December 2022, the Company announced a reduction in workforce. As a result, certain vested stock options were modified to extend their exercise period from 90 days to 12 months. In addition, certain outstanding stock option and RSU grants received accelerated vesting as if the service period of the terminated employee continued for up to an additional 12-month period. The Company recorded expense ratably from the announcement date through the date of termination with approximately $0.4 million being recognized during the twelve months ended December 31, 2022 and an additional $0.6 million being recognized during the nine months ended September 30, 2023.

In January 2023, the Company extended the post-termination exercise period from 90 days to three years for stock option grants made to non-employee members of our Board of Directors. This extension applies to all future grants as well as all then-outstanding grants. Related to this extension, the Company recorded approximately $0.3 million of expense during the nine months ended September 30, 2023.

In November 2023 and April 2024, the Company granted stock options covering up to a total of 950,000 and 223,000 shares, respectively, of our common stock in connection with the hiring of new employees. These stock options are subject to the terms of the Company's 2013 Plan, but were granted outside of the 2013 Plan, as they constituted inducement grants in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). In July and August 2024, the Company granted stock options covering up to a total of 120,000 and 150,000 shares, respectively, of our common stock in connection with the hiring of new employees. These stock options are subject to the terms of the 2024 Plan, but were granted outside of the 2024 Plan, as they constituted inducement grants in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The totality of these grants were non-statutory stock options, have a 10-year term and will vest over four years, with one-fourth vesting on the one-year anniversary of the date of hire and remaining three-fourths vesting over the following three years in equal monthly installments.

The Business and Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Schedule of Certain Assets Measured at Fair Value on a Recurring Basis

Below are tables that present information about certain assets measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements
	September 30, 2024
	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash equivalents
Money market funds	$	19,558	$	19,558	$	—	$	—




Total cash equivalents	19,558		19,558		—		—
Short-term investments

U.S. treasury securities	73,283		32,562		40,721		—

Commercial paper	10,213		—		10,213		—
Corporate bonds	29,089		—		29,089		—
Total short-term investments	112,585		32,562		80,023		—
Long-term investments

U.S. treasury securities	16,201		—		16,201		—
Total long-term investments	16,201		—		16,201		—
Total	$	148,344	$	52,120	$	96,224	$	—

	Fair Value Measurements
	December 31, 2023
	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash equivalents
Money market funds	$	24,102	$	24,102	$	—	$	—



Total cash equivalents	24,102		24,102		—		—
Short-term investments

U.S. treasury securities	99,779		40,336		59,443		—

Commercial paper	44,319		—		44,319		—
Corporate bonds	11,076		—		11,076		—
Total short-term investments	155,174		40,336		114,838		—
Long-term investments

U.S. treasury securities	21,657		3,975		17,682		—

Total long-term investments	21,657		3,975		17,682		—
Total	$	200,933	$	68,413	$	132,520	$	—

Schedule of Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):


	September 30, 2024		December 31, 2023
Accrued research and development expenses	$	9,889	$	7,623
Accrued compensation	4,774		5,123


Other accrued liabilities	2,241		2,846
Total accrued liabilities	$	16,904	$	15,592

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2024
Income Tax Disclosure [Abstract]
Income Taxes	Income Taxes The Company estimates an annual effective tax rate of 0% for the year ending December 31, 2024 as the Company incurred losses for the nine month period ended September 30, 2024 and is forecasting an estimated net loss for both financial statement and tax purposes for the year ending December 31, 2024. Therefore, no federal or state income taxes are expected and none have been recorded at this time. Income taxes have been accounted for using the liability method in accordance with FASB ASC 740. Due to the Company's history of losses since inception, there is not enough evidence at this time to support that the Company will generate future income of a sufficient amount and nature to utilize the benefits of its net deferred tax assets. Accordingly, the deferred tax assets have been reduced by a full valuation allowance, since the Company cannot currently support that realization of its deferred tax assets is more likely than not. However, the Company feels its deferred tax assets may be used upon the Company becoming profitable. At September 30, 2024, the Company had no unrecognized tax benefits that would reduce the Company’s effective tax rate if recognized.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
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-Section 50
-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12B
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-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details