What changed in this filing

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Item 1. Financial Statements

2025-08-07 compared with 2025-05-07 · 67 added, 40 removed, 377 unchanged (22% of the section changed)

25 unchanged sentences

Preferred stock, $ 0.001 par value per share;

5,000,000 undesignated authorized shares as of March 31, 2025 (unaudited) and December 31, 2024, no shares issued or outstanding as of March 31, 2025 (unaudited) and December 31, 2024

5,000,000 undesignated authorized shares as of June 30, 2025 (unaudited) and December 31, 2024, no shares issued or outstanding as of June 30, 2025 (unaudited) and December 31, 2024

Common stock, $ 0.001 par value per share;

170,000,000 authorized shares as of March 31, 2025 (unaudited) and December 31, 2024, issued and outstanding shares – 89,002,825 as of March 31, 2025 (unaudited) and 84,038,922 as of December 31, 2024

170,000,000 authorized shares as of June 30, 2025 (unaudited) and December 31, 2024, issued and outstanding shares – 92,871,182 as of June 30, 2025 (unaudited) and 84,038,922 as of December 31, 2024

Additional paid-in capital

10 unchanged sentences

(in thousands, except share and per share data)

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

License and collaboration agreement revenues

15 unchanged sentences

(in thousands)

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Consolidated net loss

9 unchanged sentences

(in thousands, except share data)

Three Months Ended March 31, 2025 (unaudited)

Three and Six Months Ended June 30, 2025 (unaudited)

Comprehensive

8 unchanged sentences

Balance as of March 31, 2025

Three Months Ended March 31, 2024 (unaudited)

Issuance of common stock upon exercise of stock options

Issuance of common stock pursuant to employee stock purchase plan

Issuance of common stock from at-the-market offerings, net of offering costs

Stock-based compensation

Net unrealized loss on investments, net of tax

Balance as of June 30, 2025

Three and Six Months Ended June 30, 2024 (unaudited)

Comprehensive

8 unchanged sentences

Balance as of March 31, 2024

Issuance of common stock pursuant to employee stock purchase plan

Issuance of common stock from at-the-market offerings, net of offering costs

Stock-based compensation

Net unrealized loss on investments, net of tax

Balance as of June 30, 2024

See accompanying notes.

2 unchanged sentences

(in thousands)

Six Months Ended June 30,

Cash flows from operating activities:

15 unchanged sentences

Maturities of available-for-sale investment securities

Net cash used in investing activities

Net cash (used in) provided by investing activities

Cash flows from financing activities:

Proceeds from issuance of common stock through option exercises

Proceeds from issuance of common stock through employee stock purchase plan

Proceeds from issuance of common stock from at-the-market offerings, net of offering costs

33 unchanged sentences

Liquidity and Financial Condition

We have incurred net losses and negative cash flows from operations since our inception in 2005, including a consolidated net loss of $ 14.9 million for the three months ended March 31, 2025.

As of March 31, 2025, we had an accumulated deficit of $ 546.9 million.

We have incurred net losses and negative cash flows from operations since our inception in 2005, including a consolidated net loss of $ 19.5 million and $ 34.4 million for the three and six months ended June 30, 2025.

As of June 30, 2025, we had an accumulated deficit of $ 566.5 million.

We currently have an “at-the-market” offering program (the Jefferies ATM Offering Program) through an Open Market Sale Agreement SM with Jefferies LLC (Jefferies).

During the three months ended March 31, 2025, we sold an aggregate of 4,941,895 shares of common stock at a weighted-average price of $ 3.93 per share for proceeds of approximately $ 18.8 million under the Jefferies ATM Offering Program, net of offering costs.

During the six months ended June 30, 2025, we sold an aggregate of 8,771,725 shares of common stock at a weighted-average price of $ 4.32 per share for net proceeds of approximately $ 36.7 million under the Jefferies ATM Offering Program.

We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years at a minimum.

1 unchanged sentence

Accordingly, we will need to raise substantial additional capital to fund our operations.

The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our preclinical and clinical development efforts and the timing and nature of the regulatory approval process for our product candidates.

The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our preclinical, clinical and manufacturing development efforts and the timing and nature of the regulatory approval process for our product candidates, including pre-commercial activities.

We anticipate that we will seek to fund our operations through equity offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements, and when we are closer to commercialization of our product candidates potentially through debt financings.

1 unchanged sentence

Our failure to raise capital or enter into such arrangements when needed would have a negative impact on our financial condition and ability to develop our product candidates.

We believe that our existing cash, cash equivalents, restricted cash and available-for-sale investments of $ 78.8 million as of March 31, 2025 will be sufficient to meet our material cash requirements from known contractual and other obligations for a period of at least one year from the filing date of this Quarterly Report on Form 10-Q.

We believe that our existing cash, cash equivalents, restricted cash and available-for-sale investments of $ 83.2 million as of June 30, 2025 will be sufficient to meet our material cash requirements from known contractual and other obligations for a period of at least one year from the filing date of this Quarterly Report on Form 10-Q.

Restricted Cash

As of March 31, 2025, restricted cash was approximately $ 2.4 million, which was held as a security deposit in conjunction with our corporate headquarters facility lease and financing leases as discussed further in Note 4 - Commitments and Contingencies.

As of June 30, 2025, restricted cash was approximately $ 2.9 million, of which $ 2.4 million was held as a security deposit in conjunction with our corporate headquarters facility lease and financing leases as discussed further in Note 4 - Commitments and Contingencies and $ 0.5 million was held as security deposit for our corporate credit card program.

Employee Retention Credit

2 unchanged sentences

The refund was recorded within the other receivables in our audited consolidated balance sheets, and as a $ 0.8 million reduction of research and development expenses and a $ 0.4 million reduction of general and administrative expenses in our audited consolidated statements of operations for the year ended December 31, 2023.

As of March 31, 2025, we have received $ 1.0 million of ERC benefits, and have $0.2 million in other receivables related to the remaining ERC benefits to be received.

As of June 30, 2025, we have fully received the ERC benefits refund.

Allowance of Credit Losses

55 unchanged sentences

Potentially dilutive securities not considered for the calculation of diluted net loss per share are as follows (in common stock equivalents):

Six Months Ended June 30,

Common stock warrants

5 unchanged sentences

Our CODM is our Chief Executive Officer , who reviews and evaluates consolidated research and development expenses, general and administrative expenses, net loss, net cash used in operating activities and our consolidated cash and cash equivalents for purposes of making operating decisions, allocating resources and planning and forecasting future periods.

The table below summarizes the significant expense categories regularly reviewed by our CODM for the three months ended March 31, 2025 and 2024.

The table below summarizes the significant expense categories regularly reviewed by our CODM for the three and six months ended June 30, 2025 and 2024.

Three Months Ended June 30,

Six Months Ended June 30,

License and collaboration agreement revenues

25 unchanged sentences

Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants.

As such, fair value is a market-based measurement that should be determined based on assumptions that market

participants would use in pricing an asset or liability.

As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

14 unchanged sentences

for Identical

As of March 31, 2025

As of June 30, 2025

Cash equivalents

17 unchanged sentences

Total assets measured at fair value

As of March 31, 2025 and December 31, 2024, available-for-sale investments are detailed as follows (in thousands):

March 31, 2025

As of June 30, 2025 and December 31, 2024, available-for-sale investments are detailed as follows (in thousands):

June 30, 2025

Contractual Maturity

19 unchanged sentences

When evaluating an investment for impairment, we review factors such as the severity of the impairment, changes in underlying credit ratings, our intent to sell or the likelihood that we would be required to sell the investment before its anticipated recovery in market value and the probability that the scheduled cash payments will continue to be made.

We recorded no allowance for credit losses in the unaudited condensed consolidated statements of operations and comprehensive loss during the three months ended March 31, 2025.

As of March 31, 2025, all available-for-sale investments had a variety of effective maturity dates of less than one year .

As of March 31, 2025, 16 out of 24 available-for-sale investments were in a gross unrealized loss position of which one available-for-sale investment with a market value of $ 1.0 million was in such position for greater than 12 months.

As of March 31, 2025 and December 31, 2024, accrued interest receivable on available-for-sale investments was $ 0.3 million and $ 0.2 million, respectively.

We recorded no allowance for credit losses in the unaudited condensed consolidated statements of operations and comprehensive loss during the three and six months ended June 30, 2025.

As of June 30, 2025, all available-for-sale investments had a variety of effective maturity dates of less than one year .

As of June 30, 2025, 21 out of 23 available-for-sale investments were in a gross unrealized loss position.

As of June 30, 2025 and December 31, 2024, accrued interest receivable on available-for-sale investments was $ 0.3 million and $ 0.2 million, respectively.

License, Collaboration and Other Agreements

11 unchanged sentences

We assessed our license and collaboration with Kyorin in accordance with Topic 606 which applies to delivered goods or services to a customer and concluded that Kyorin is a customer.

For the three months ended March 31, 2025 and 2024, we recognized $ 0 and

$ 0.2 million, respectively, in collaboration revenue from Kyorin for drug product material sold to Kyorin for the Japan portion of the EFZO-FIT study.

For the six months ended June 30, 2025 and 2024, we recognized $ 0 and $ 0.2 million, respectively, in collaboration revenue from Kyorin for drug product material sold to Kyorin for the Japan portion of the EFZO-FIT study.

The remaining milestones and royalty payments under the Kyorin Agreement are variable consideration.

11 unchanged sentences

The amendment increased the total rentable square feet from 23,696 rentable square feet to 24,866 rentable square feet.

We provided a $ 0.7 million security deposit in the form of a letter of credit which is included in restricted cash as of March 31, 2025.

Future minimum payments under the facility lease and a reconciliation to the operating lease liability as of March 31, 2025 were as follows (in thousands):

We provided a $ 0.7 million security deposit in the form of a letter of credit which is included in restricted cash as of June 30, 2025.

Future minimum payments under the facility lease and a reconciliation to the operating lease liability as of June 30, 2025 were as follows (in thousands):

Operating Leases

4 unchanged sentences

Long-term operating lease liability, net of current portion

For each of the three months ended March 31, 2025 and 2024, we recorded an operating lease expense of $ 0.4 million and $ 0.3 million, respectively.

As of March 31, 2025, the weighted-average remaining lease term was 8.3 years and the weighted average discount rate was 8.8 %.

For each of the three months ended June 30, 2025 and 2024, we recorded an operating lease expense of $ 0.4 million.

For the six months ended June 30, 2025 and 2024, we recorded an operating lease expense of $ 0.8 million and $ 0.7 million, respectively.

As of June 30, 2025, the weighted-average remaining lease term was 8.1 years and the weighted average discount rate was 8.8 %.

Financing Leases

In April 2022, we entered into a master financing lease agreement to lease various research and development and information technology equipment over a 48-month term.

Future minimum payments under the financing lease and reconciliation to the financing lease liability as of March 31, 2025 were as follows (in thousands):

Future minimum payments under the financing lease and reconciliation to the financing lease liability as of June 30, 2025 were as follows (in thousands):

Financing Leases

3 unchanged sentences

Long-term financing lease liability, net of current portion

As of March 31, 2025, the weighted-average remaining lease term was 1.8 years and the weighted-average discount rate was 8.3 %.

As of March 31, 2025, we have a $ 1.7 million deposit held as collateral for the leased equipment, and this deposit is included in restricted cash.

As of June 30, 2025, the weighted-average remaining lease term was 1.6 years and the weighted-average discount rate was 8.3 %.

As of June 30, 2025, we have a $ 1.7 million deposit held as collateral for the leased equipment, and this deposit is included in restricted cash.

Stockholders’ Equity

4 unchanged sentences

Jefferies is entitled to a fixed commission rate of up to 3.0 % of the gross sales proceeds of shares sold under the Jefferies ATM Offering Program.

During the year ended December 31, 2024, we sold an aggregate of 20,653,450 shares of common stock at a weighted-average price of $ 2.02 per share for proceeds of approximately $ 40.3 million under the Jefferies ATM Offering Program, net of offering costs.

During the year ended December 31, 2024, we sold an aggregate of 20,653,450 shares of common stock at a weighted-average price of $ 2.02 per share for net proceeds of approximately $ 40.3 million under the Jefferies ATM Offering Program.

Common Stock Reserved for Future Issuance

Common stock reserved for future issuance was as follows:

March 31, 2025

June 30, 2025

Common stock options and restricted stock units

2 unchanged sentences

Shares available under the employee stock purchase plan

The following table summarizes our stock option activity under all equity incentive plans for the three months ended March 31, 2025:

The following table summarizes our stock option activity under all equity incentive plans for the six months ended June 30, 2025:

Stock Options

2 unchanged sentences

Canceled/forfeited/expired

Outstanding as of March 31, 2025

Outstanding as of June 30, 2025

The assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows:

Three Months Ended June 30,

Six Months Ended June 30,

Expected term (in years)

2 unchanged sentences

3.9 % – 4.5 %

3.8 % – 4.5 %

Expected volatility

1 unchanged sentence

76.7 % – 77.1 %

75.9 % – 77.5 %

76.7 % – 80.5 %

Expected dividend yield

The following table summarizes our restricted stock unit activity under all equity incentive plans for the three months ended March 31, 2025:

The following table summarizes our restricted stock unit activity under all equity incentive plans for the six months ended June 30, 2025:

Number of Outstanding

2 unchanged sentences

Balance as of December 31, 2024

Balance as of March 31, 2025

Balance as of June 30, 2025

Stock-based Compensation

The allocation of stock-based compensation for all options and restricted stock units and stock issued pursuant to our employee stock purchase plan is as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Research and development

1 unchanged sentence

Total stock-based compensation expense

Subsequent Events

Sales of Common Stock through the Jefferies ATM Offering Program

From July 1, 2025 through August 6, 2025, we sold an aggregate of 5,115,452 shares of common stock at a weighted-average price of $ 6.00 per share through the Jefferies ATM Offering Program for net proceeds of $ 29.8 million.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements