12 unchanged sentences
In June 2024, we reported updated interim data from the monotherapy dose-escalation arms of the Phase 1/1b clinical trial, selected a recommended dose for expansion, initiated monotherapy dose expansion arms, and reported initial data from the combination dose escalation cohorts of the Phase 1/1b clinical trial.
−Removed: All expansion arms are actively enrolling patients in the ongoing Phase 1/1b clinical trial at a recommended dose of 18 mg administered intravenously every two weeks.
−Removed: During the second half of 2025, we plan to present interim data from the monotherapy and combination expansion arms, including tolerability, response rate, and durability, and to engage with regulatory authorities to discuss potential registrational pathways for WTX-124, including strategies for accelerated approval.
+Added: All expansion arms are either actively enrolling patients or fully enrolled in the ongoing Phase 1/1b clinical trial at a recommended dose of 18 mg administered intravenously every two weeks.
+Added: During the fourth quarter of 2025, we plan to release interim data from the monotherapy and combination expansion arms and to provide feedback from the Company’s End of Phase 1 meeting with regulatory authorities.
We evaluated WTX-330 in a first-in-human Phase 1 clinical trial for the treatment of immunotherapy resistant advanced or metastatic solid tumors or lymphoma.
1 unchanged sentence
We reported initial data from the Phase 1 clinical trial in June 2024 and presented updated interim safety and efficacy data from the Phase 1 clinical trial at the Society for Immunotherapy of Cancer Annual Meeting in November 2024, highlighting the tolerability profile and monotherapy efficacy signals of WTX-330.
−Removed: Guided by these data, we initiated a Phase 1b/2 clinical trial of WTX-330 in the first quarter of 2025 in patients with selected advanced or metastatic solid tumors and dosed our first patient in the second quarter of 2025.
+Added: Guided by these data, we initiated a Phase 1b/2 clinical trial of WTX-330 in the first quarter of 2025 in patients with selected advanced or metastatic solid tumors and are actively enrolling.
+Added: An update on the clinical trial is expected to be released in the fourth quarter of 2025, with guidance on potential further development plans.
We continue to build our PREDATOR platform to generate a pipeline of innovative therapeutics that cover a diversity of immune stimulating mechanisms with the potential to address significant unmet medical need in therapeutic areas including new immuno-oncology, autoimmune, and inflammatory diseases.
7 unchanged sentences
After tissue specific cleavage, the half-life extension domain is removed, and the payload is released to modulate the activity of immune cells.
−Removed: We select the proprietary protease-cleavable linker to enable conditional release of the immunomodulating agent
−Removed: of the INDUKINE or INDUCER molecule within disease-specific tissue.
−Removed: This selection is based on our extensive screening in preclinical studies to identify protease-cleavable linkers that are efficiently cleaved by a broad array of disease-specific tissues (e.g., human tumor tissues) with minimal cleavage in non-diseased tissues.
−Removed: We continue to further the development of our INDUKINE preclinical product candidates, WTX-712, WTX-518, and WTX-921.
+Added: We select the proprietary protease-cleavable linker to enable conditional release of the immunomodulating agent of the INDUKINE or INDUCER molecule within disease-specific tissue.
+Added: This selection is based on our extensive screening in
+Added: preclinical studies to identify protease-cleavable linkers that are efficiently cleaved by a broad array of disease-specific tissues (e.g., human tumor tissues) with minimal cleavage in non-diseased tissues.
+Added: We have previously announced additional INDUKINE preclinical development candidates available for partnering, including WTX-712, WTX-518, and WTX-921.
WTX-712 is a systemically delivered, conditionally activated Interleukin-21 (IL-21) INDUKINE molecule that is being developed to minimize the severe toxicities that have been observed with recombinant IL-21 therapy and maximize clinical benefit when administered as monotherapy or in combination with checkpoint inhibitors in refractory and/or immunologically unresponsive tumors.
16 unchanged sentences
The execution of this Transfer Agreement was the last material performance obligation required of us under the Collaboration Agreement.
+Added: We believe that there is substantial doubt about our ability to continue as a going concern for at least twelve months from the date these condensed consolidated financial statements are issued in this Form 10-Q.
+Added: The conditions which raise substantial doubt about our ability to continue as a going concern, as well as our plan to mitigate these conditions are discussed in the section below titled “Liquidity and Capital Resources.”
Financial Operations Overview
2 unchanged sentences
The Collaboration Agreement includes multiple development and regulatory and sales-based milestones, which were excluded from the transaction price at inception of the Collaboration Agreement based on our assessment that there was a high level of uncertainty of achieving the milestones.
−Removed: During the six months ended June 30, 2025, we re-evaluated this assessment as it pertains to any milestones that continue to be excluded from the transaction price, and concluded no adjustment to the transaction price associated with variable consideration previously excluded from the transaction price should be recognized.
+Added: During the nine months ended September 30, 2025, we re-evaluated this assessment as it pertains to any milestones that continue to be excluded from the transaction price, and concluded no adjustment to the transaction price associated with variable consideration previously excluded from the transaction price should be recognized.
As of the execution of the Transfer Agreement, we no longer have any material performance obligations under the Collaboration Agreement, and all remaining deferred revenue related to the Collaboration Agreement was recognized upon execution of the Transfer Agreement.
−Removed: Accordingly, we recognized no revenue related to the Collaboration Agreement during the six months ended June 30, 2025.
+Added: Accordingly, we recognized no revenue related to the Collaboration Agreement during the nine months ended September 30, 2025.
In the future, our ability to generate revenue from the Collaboration Agreement will depend on successfully achieving the various development and regulatory and sales-based milestones.
We may also generate revenue from product sales or other collaboration agreements, strategic alliances and licensing arrangements.
−Removed: We expect that potential future revenue, if any, will
−Removed: fluctuate from quarter-to-quarter and year-to-year based upon our ability to successfully meet the criteria for payment of the remaining development and regulatory milestones, and the timing and amount of other payments and product sales, to the extent any are successfully commercialized.
+Added: We expect that potential future revenue, if any, will fluctuate from quarter-to-quarter and year-to-year based upon our ability to successfully meet the criteria for payment of the remaining development and regulatory milestones, and the timing and amount of other payments and product sales, to the extent any are successfully commercialized.
If we fail to complete the development of our product candidates in a timely manner or obtain regulatory approval for them, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected.
14 unchanged sentences
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
2025 2024 2025 2024
5 unchanged sentences
WTX-921 31 — 71 —
+Added: WTX-518 50 68 52 251
JZP898 — 14 — 538
3 unchanged sentences
Research and development activities are central to our business model.
−Removed: We expect that our research and development expenses will continue to be substantial for the foreseeable future as we progress our clinical trials of WTX-124 and WTX-330, continue preclinical development of WTX-712 and WTX-518, begin preclinical development of WTX-1011, and continue to discover and develop additional product candidates.
+Added: We expect that our research and development expenses will continue to be substantial for the foreseeable future as we progress our clinical trials of WTX-124 and WTX-330, continue preclinical development of WTX-712, WTX-518, WTX-921, and WTX-1011, and continue to discover and develop additional product candidates.
As a result of our entry into the Collaboration Agreement, which commenced in April 2022, our external preclinical development costs for JZP898 were generally reimbursed by Jazz until we completed all material performance obligations in June 2024.
The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming.
−Removed: We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete
−Removed: development of our current or future product candidates.
+Added: We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete development of our current or future product candidates.
The actual probability of success for our product candidates will depend on a variety of factors, including:
28 unchanged sentences
Results of Operations
−Removed: Comparison of the Three Months Ended June 30, 2025 and 2024
+Added: Comparison of the Three Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations:
Three Months Ended
−Removed: June 30, $ Change
+Added: September 30, $ Change
(in thousands)
−Removed: Collaboration revenue $ — $ 1,143 $ (1,143)
Operating expenses:
10 unchanged sentences
Interest expense (1,341) (1,244) (97)
−Removed: Loss on extinguishment of debt — (553) 553
Other income, net — 97 (97)
1 unchanged sentence
$ (16,370) $ (16,673) $ 303
−Removed: No revenue was recognized during the three months ended June 30, 2025.
−Removed: Following the execution of the Transfer Agreement with Jazz in June 2024, the only significant sources of revenue expected to be generated from the Collaboration Agreement are the remaining development and regulatory and sales-based milestones.
−Removed: Based on our assessment that there continues to be a high level of uncertainty of achieving these milestones, no revenue from the remaining milestones has been recognized during the three months ended June 30, 2025.
−Removed: Comparatively, we recognized $1.1 million during the three months ended June 30, 2024 related to the Collaboration Agreement with Jazz prior to the execution of the Transfer Agreement.
Research and Development Expenses
1 unchanged sentence
Three Months Ended
−Removed: June 30, $ Change
+Added: September 30, $ Change
(in thousands)
1 unchanged sentence
Personnel 3,318 3,642 (324)
−Removed: Manufacturing 2,052 3,899 (1,847)
Contract research organization 1,413 1,366 47
1 unchanged sentence
Facility costs 770 886 (116)
+Added: Manufacturing 675 2,392 (1,717)
Other 128 175 (47)
Total research and development expenses $ 11,634 $ 12,528 $ (894)
−Removed: Research and development expenses for the three months ended June 30, 2025 were $13.1 million compared to $15.3 million for the three months ended June 30, 2024.
+Added: Research and development expenses for the three months ended September 30, 2025 were $11.6 million compared to $12.5 million for the three months ended September 30, 2024.
The decrease of $0.9 million was primarily due to:
−Removed: • $0.4 million of decreased clinical trial costs driven primarily by a decrease in costs associated with the Phase 1/1b clinical trial for WTX-124, which incurred higher patient and site monitoring costs during three months ended June 30, 2024 compared to the three months ended June 30, 2025;
• $0.3 million of decreased personnel costs, driven primarily by the timing and valuation of stock-based awards granted to employees;
−Removed: • $1.8 million of decreased manufacturing costs driven primarily by a decrease in costs associated with WTX-330, which were higher during the three months ended June 30, 2024 in preparation for our Phase 1b/2 clinical trial for WTX-330 that was initiated during the first quarter of 2025.
+Added: • $1.7 million of decreased manufacturing costs driven primarily by a decrease in costs associated with WTX-330, which were higher during the three months ended September 30, 2024 in preparation for our Phase 1b/2 clinical trial for WTX-330 that was initiated during the first quarter of 2025.
These decreases were partially offset by:
−Removed: • $0.4 million of increased contract research organization costs and $0.3 million of increased lab consumables, both driven primarily by costs associated with furthering the development of our preclinical candidates.
+Added: • $1.5 million of increased clinical trial costs, driven by costs associated with the continued enrollment in our Phase 1/1b clinical trial for WTX-124.
General and Administrative Expenses
1 unchanged sentence
Three Months Ended
−Removed: June 30, $ Change
+Added: September 30, $ Change
(in thousands)
7 unchanged sentences
$ 4,092 $ 4,596 $ (504)
−Removed: General and administrative expenses were $4.4 million for the three months ended June 30, 2025 compared to $4.8 million for three months ended June 30, 2024.
−Removed: The decrease of $0.4 million was primarily due to a decrease in personnel costs of $0.3 million driven primarily by the timing and valuation of stock-based awards granted to employees.
+Added: General and administrative expenses were $4.1 million for the three months ended September 30, 2025 compared to $4.6 million for three months ended September 30, 2024.
+Added: The decrease of $0.5 million was primarily due to:
+Added: • $0.3 million of decreased personnel costs, driven primarily by the timing and valuation of stock-based awards granted to employees;
+Added: • $0.2 million of decreased professional services fees due to decreased used of external consultants during the period.
Interest Income
−Removed: Interest income was $0.9 million for the three months ended June 30, 2025 compared to $1.8 million for the three months ended June 30, 2024.
−Removed: This decrease in interest income was primarily a result of lower balances in money market accounts during the three months ended June 30, 2025 compared to the three months ended June 30, 2024.
+Added: Interest income was $0.7 million for the three months ended September 30, 2025 compared to $1.6 million for the three months ended September 30, 2024.
+Added: This decrease in interest income was primarily a result of lower balances in money market accounts during the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Interest Expense
−Removed: Interest expense was $1.3 million for the three months ended June 30, 2025, compared to $1.1 million for the three months ended June 30, 2024.
+Added: Interest expense was $1.3 million for the three months ended September 30, 2025, compared to $1.2 million for the three months ended September 30, 2024.
This increase in interest expense was primarily the result of a higher effective interest rate under the K2HV Loan Agreement, compared to the effective interest rate associated with our previous term loan with PWB.
−Removed: Loss on Extinguishment of Debt
−Removed: The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the three months ended June 30, 2024.
−Removed: As no corresponding finance activity occurred for the three months ended June 30, 2025, we did not incur any gain or loss on a debt extinguishment during the current period.
Other Income, Net
−Removed: Other income, net for the three months ended June 30, 2025 and 2024 primarily consists of the gains recognized for the change in fair value of the derivative liability associated with the K2HV Loan Agreement during each period.
+Added: Other income, net for the three months ended September 30, 2025 and 2024 primarily consists of the gains recognized for the change in fair value of the derivative liability associated with the K2HV Loan Agreement, as well as foreign currency gains and losses related to services performed by foreign vendors during each period.
Results of Operations
−Removed: Comparison of the Six Months Ended June 30, 2025 and 2024
+Added: Comparison of the Nine Months Ended September 30, 2025 and 2024
The following table summarizes our results of operations:
−Removed: Six Months Ended
−Removed: June 30, $ Change
+Added: Nine Months Ended
+Added: September 30, $ Change
(in thousands)
16 unchanged sentences
$ (52,441) $ (50,115) $ (2,326)
−Removed: No revenue was recognized during the six months ended June 30, 2025.
+Added: No revenue was recognized during the nine months ended September 30, 2025.
Following the execution of the Transfer Agreement with Jazz in June 2024, the only significant sources of revenue expected to be generated from the Collaboration Agreement are the remaining development and regulatory and sales-based milestones.
−Removed: Based on our assessment that there continues to be a high level of uncertainty of achieving these milestones, no revenue from the remaining milestones has been recognized during the six months ended June 30, 2025.
−Removed: Comparatively, we recognized $1.9 million during the six months ended June 30, 2024 related to the Collaboration Agreement with Jazz prior to the execution of the Transfer Agreement.
+Added: Based on our assessment that there continues to be a high level of uncertainty of achieving these milestones, no revenue from the remaining milestones has been recognized during the nine months ended September 30, 2025.
+Added: Comparatively, we recognized $1.9 million during the nine months ended September 30, 2024 related to the Collaboration Agreement with Jazz prior to the execution of the Transfer Agreement.
Research and Development Expenses
The following table summarizes our research and development expenses:
−Removed: Six Months Ended
−Removed: June 30, $ Change
+Added: Nine Months Ended
+Added: September 30, $ Change
(in thousands)
−Removed: Personnel $ 8,081 $ 8,765 $ (684)
Clinical trial costs $ 11,515 $ 9,321 $ 2,194
+Added: Personnel 11,399 12,407 (1,008)
Manufacturing 6,190 10,100 (3,910)
−Removed: Lab consumables 1,987 1,486 501
Contract research organization 3,275 3,188 87
+Added: Lab consumables 2,795 2,567 228
Facility costs 2,351 2,550 (199)
1 unchanged sentence
Total research and development expenses $ 37,897 $ 40,707 $ (2,810)
−Removed: Research and development expenses for the six months ended June 30, 2025 were $26.3 million compared to $28.2 million for the six months ended June 30, 2024.
+Added: Research and development expenses for the nine months ended September 30, 2025 were $37.9 million compared to $40.7 million for the nine months ended September 30, 2024.
The decrease of $2.8 million was primarily due to:
1 unchanged sentence
• $3.9 million of decreased manufacturing costs, driven by a decrease of costs associated with WTX-330 and JZP898 of $6.0 million and $0.5 million, respectively.
−Removed: Costs associated with WTX-330 were higher during the six months ended June 30, 2024 in preparation for our Phase 1b/2 clinical trial for WTX-330 that was initiated during the first quarter of 2025, and costs associated with JZP898 were higher during the six months ended June 30, 2024 prior to the execution of the Transfer Agreement with Jazz.
+Added: Costs associated with WTX-330 were higher during the nine months ended September 30, 2024 in preparation for our Phase 1b/2 clinical trial for WTX-330 that was
+Added: initiated during the first quarter of 2025, and costs associated with JZP898 were higher during the nine months ended September 30, 2024 prior to the execution of the Transfer Agreement with Jazz.
These decreases were partially offset by an increase in costs associated with WTX-124 of $3.0 million due to our manufacturing efforts to continue to support our ongoing Phase 1/1b clinical trial for WTX-124.
1 unchanged sentence
• $2.2 million of increased clinical trial costs, driven by costs associated with the continued enrollment in our ongoing Phase 1/1b clinical trial for WTX-124 and the initiation of our Phase 1b/2 clinical trial for WTX-330.
−Removed: • $0.5 million of increased lab consumables for supplies procured in our efforts to further the development of our preclinical candidates.
General and Administrative Expenses
The following table summarizes our general and administrative expenses:
−Removed: Six Months Ended
−Removed: June 30, $ Change
+Added: Nine Months Ended
+Added: September 30, $ Change
(in thousands)
1 unchanged sentence
Professional services 3,540 3,852 (312)
−Removed: Facilities 657 696 (39)
+Added: Facility costs
+Added: 984 1,084 (100)
Corporate insurance 803 880 (77)
2 unchanged sentences
Total general and administrative expenses $ 13,362 $ 14,424 $ (1,062)
−Removed: General and administrative expenses were $9.3 million for the six months ended June 30, 2025 compared to $9.8 million for the six months ended June 30, 2024.
−Removed: The decrease of $0.6 million was due to moderate decreases across all general and administrative expenses, including a decrease in personnel costs of $0.3 million driven primarily by the timing and valuation of stock-based awards granted to employees.
+Added: General and administrative expenses were $13.4 million for the nine months ended September 30, 2025 compared to $14.4 million for the nine months ended September 30, 2024.
+Added: The decrease of $1.1 million was primarily due to:
+Added: • $0.5 million of decreased personnel costs, driven primarily by the timing and valuation of stock-based awards granted to employees;
+Added: • $0.3 million of decreased professional services fees due to decreased used of external consultants during the period.
Interest Income
−Removed: Interest income was $1.8 million for the six months ended June 30, 2025 compared to $3.8 million for the six months ended June 30, 2024.
−Removed: This decrease in interest income was primarily a result of lower balances in money market accounts during the six months ended June 30, 2025 compared to the six months ended June 30, 2024.
+Added: Interest income was $2.5 million for the nine months ended September 30, 2025 compared to $5.4 million for the nine months ended September 30, 2024.
+Added: This decrease in interest income was primarily a result of lower balances in money market accounts during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024.
Interest Expense
−Removed: Interest expense was $2.6 million for the six months ended June 30, 2025 compared to $2.1 million for the six months ended June 30, 2024.
+Added: Interest expense was $3.9 million for the nine months ended September 30, 2025 compared to $3.4 million for the nine months ended September 30, 2024.
This increase in interest expense was primarily the result of a higher effective interest rate under the K2HV Loan Agreement, compared to the effective interest rate associated with our previous term loan with PWB.
Loss on Extinguishment of Debt
−Removed: The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the six months ended June 30, 2024.
−Removed: As no corresponding finance activity occurred for the six months ended June 30, 2025, we did not incur any gain or loss on a debt extinguishment during the current period.
+Added: The extinguishment of the PWB term loan resulted in a one-time loss of $0.6 million for the nine months ended September 30, 2024.
+Added: As no corresponding finance activity occurred for the nine months ended September 30, 2025, we did not incur any gain or loss on a debt extinguishment during the current period.
Other Income, Net
−Removed: Other income, net for the six months ended June 30, 2025 and 2024 primarily consists of the gains recognized for the change in fair value of the derivative liability associated with the K2HV Loan Agreement during each period.
+Added: Other income, net for the nine months ended September 30, 2025 and 2024 primarily consists of the gains recognized for the change in fair value of the derivative liability associated with the K2HV Loan Agreement, as well as foreign currency gains and losses related to services performed by foreign vendors during each period.
Liquidity and Capital Resources
8 unchanged sentences
and enabling manufacturing for our development programs.
−Removed: Our net loss was $18.0 million and $36.1 million the three and six months ended June 30, 2025, respectively.
−Removed: As of June 30, 2025, we had an accumulated deficit of $450.7 million.
+Added: Our net loss was $16.4 million and $52.4 million the three and nine months ended September 30, 2025, respectively.
+Added: As of September 30, 2025, we had an accumulated deficit of $467.0 million.
As we have no products that are approved for sale, we have not generated any revenue from product sales to date, and we do not expect to generate any such revenue for the foreseeable future, if at all.
1 unchanged sentence
Because our product candidates are in clinical development and the outcome of our efforts is uncertain, we cannot estimate the actual costs necessary to successfully complete the development and commercialization of our product candidates, or when we may achieve profitability, if at all.
−Removed: We expect to continue to incur substantial and increasing expenses and net losses for the foreseeable future, as we continue to advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual
−Removed: property portfolio, hire additional research and development and business personnel and operate as a public company.
+Added: We expect to continue to incur substantial and increasing expenses and net losses for the foreseeable future, as we continue to advance our current and future product candidates through preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public company.
As a result, we expect that our accumulated deficit will also increase significantly.
−Removed: As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.
+Added: These conditions raise substantial doubt about our ability to continue as a going concern for at least twelve months from the date these condensed consolidated financial statements are issued in this Form 10-Q.
+Added: We will need substantial additional funding to support our continuing operations and pursue our growth strategy.
Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings or other sources, such as potential collaboration agreements, strategic alliances and licensing arrangements.
22 unchanged sentences
The term loan bears a variable interest rate equal to the greater of (i) 10.3%, and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) and (B) 1.8%.
−Removed: We may prepay, at our option, all, but not less than all, of the outstanding principal balance and all accrued and unpaid interest with respect to the principal balance being prepaid of the term loans, subject to a prepayment premium to which the Lenders are entitled and certain notice requirements.
+Added: We may prepay, at our option, all, but not less than all, of the outstanding principal balance and all accrued and unpaid interest with respect to the principal balance being prepaid of the term loans, subject to a prepayment premium to which the Lenders are entitled and certain notice
+Added: requirements.
We are obligated to pay a final fee equal to 6.95% of the aggregate amount of the term loans funded, or the Final Fee, to occur upon the earliest of (i) the maturity date, (ii) the acceleration of the term loans, and (iii) the prepayment of the term loans.
6 unchanged sentences
Upon the occurrence of an event of default, a default interest rate of an additional 5.0% per annum may be applied to the outstanding loan balances, and the Lenders may declare all outstanding obligations immediately due and payable and exercise all of its rights and remedies as set forth in the K2HV Loan Agreement and under applicable law.
−Removed: As of June 30, 2025, we are in compliance with all covenants.
+Added: As of September 30, 2025, we are in compliance with all covenants.
Subject to certain conditions, we granted the Lenders the right, prior to repayment of the term loans, to invest up to $5.0 million in the aggregate in future offerings of capital stock, at market terms, subject to certain exceptions and conditions.
4 unchanged sentences
We were initially entitled to offer and sell shares of our common stock having an aggregate offering price of up to $50.0 million in the ATM Offering, which was subsequently increased in February 2024 to $75.0 million.
−Removed: On May 8, 2025, we filed a new Registration Statement on Form S-3 and filed a new prospectus covering the ATM Offering, or the Prospectus.
−Removed: As a result of becoming subject to General Instruction I.B.6 of Form S-3, which is referred to as the Baby Shelf Limitation, we are entitled to offer and sell shares of our common stock with an aggregate offering price of up to $12.5 million in the ATM Offering.
−Removed: As of June 30, 2025, we remain subject to the Baby Shelf Limitation.
−Removed: During the six months ended June 30, 2025, we sold 421,766 shares of our common stock at an average price of $1.33 per share for net proceeds of $0.3 million after deducting sales commissions and offering expenses.
+Added: On May 8, 2025, we filed a new Registration Statement on Form S-3 and filed a new prospectus covering the ATM Offering, or the Prospectus, with an aggregate offering price of up to $12.5 million in the ATM Offering.
+Added: During the nine months ended September 30, 2025, we sold 2,360,186 shares of our common stock at an average price of $1.71 per share for net proceeds of $3.6 million after deducting sales commissions and offering expenses.
Jazz Collaboration
−Removed: As of June 30, 2025, we have received $20.0 million in payments from Jazz, excluding payments for reimbursed costs, under the terms of the Collaboration Agreement.
+Added: As of September 30, 2025, we have received $20.0 million in payments from Jazz, excluding payments for reimbursed costs, under the terms of the Collaboration Agreement.
We are eligible to receive up to an additional $515.0 million in development and regulatory milestones, and up to $740.0 million in sales-based milestones for all Licensed Products.
1 unchanged sentence
Plan of Operation and Future Funding Requirements
−Removed: As of June 30, 2025, we had cash and cash equivalents of $77.6 million.
−Removed: We also had restricted cash and cash equivalents of $0.9 million as of June 30, 2025.
−Removed: We believe that our existing cash and cash equivalents at June 30, 2025, will be sufficient to fund our operational expenses and capital expenditure requirements into the fourth quarter of 2026.
−Removed: We have based this estimate on assumptions that may prove to be wrong, however, and we could use our capital resources sooner than we expect.
−Removed: Our need to raise additional funds may be accelerated if our research and development expenses exceed our current expectations, if we acquire a third party, or if we acquire or license rights to additional product candidates or new technologies from one or more third parties.
+Added: As of September 30, 2025, we had cash and cash equivalents of $65.7 million.
+Added: We also had restricted cash and cash equivalents of $0.9 million as of September 30, 2025.
+Added: Based on our current operating plan, we expect that our cash and cash equivalents will be insufficient to allow us to fund our current operating plan through at least twelve months from the date these condensed consolidated financial statements are issued in this Form 10-Q.
+Added: We are currently evaluating plans to mitigate the conditions which raise substantial doubt about our ability to continue as a going concern.
+Added: We will be required to raise additional funds through an additional public equity financing, establish collaborations with or license our technology to other companies, or seek alternative means of financial support in order to continue to fund our operations in the future.
+Added: There can be no assurance, however, that additional fundraising will be successful and available on terms acceptable to us, or at all.
+Added: If we are unable to
+Added: raise capital when needed or on acceptable terms, we may be forced to delay, reduce, or eliminate certain costs related to our operations and research and development programs.
The timing and amount of our operating expenditures will depend largely on:
19 unchanged sentences
If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
−Removed: If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs.
−Removed: Any of these actions could materially and adversely affect our business, financial condition, results of operations, cash flows and prospects.
+Added: If we are unable to raise capital when needed or on acceptable terms, we may be forced to delay, reduce, or eliminate certain costs related to our operations and research and development programs.
The following table provides information regarding our cash flows:
−Removed: Six Months Ended
+Added: Nine Months Ended
+Added: September 30,
(in thousands)
7 unchanged sentences
Operating Activities
−Removed: Net cash used in operating activities for the six months ended June 30, 2025 was $34.1 million compared to $29.5 million for the six months ended June 30, 2024.
−Removed: The increase in cash used for operating activities of $4.6 million is driven by several factors, including a decrease in interest income recognized during the six months ended June 30, 2025 of $1.9 million compared to the six months ended June 30, 2024.
−Removed: Additionally, we recognized no collaboration revenue during the six months ended June 30, 2025 following the execution of the Transfer Agreement in June 2024;
−Removed: a decrease of $0.5 million from the collaboration revenue recognized during the six months ended June 30, 2024, net of the change in deferred revenue for the same period.
−Removed: Finally, the cash used to pay down our current operating liabilities increased by $2.2 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 due to higher operating costs towards the end of 2024 and leading into the first quarter of 2025.
+Added: Net cash used in operating activities for the nine months ended September 30, 2025 was $49.3 million compared to $41.9 million for the nine months ended September 30, 2024.
+Added: The increase in cash used for operating activities of $7.3 million is driven by several factors, including a decrease in interest income recognized during the nine months ended September 30, 2025 of $2.8 million compared to the nine months ended September 30, 2024.
+Added: Additionally, as a result of the execution of the Transfer Agreement in June 2024, we recognized no collaboration revenue during the nine months ended September 30, 2025;
+Added: a decrease of $0.5 million from the collaboration revenue recognized during the nine months ended September 30, 2024, net of the change in deferred revenue for the same period.
+Added: Finally, the cash used to pay down our current operating liabilities increased by $4.3 million during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 due to higher operating costs towards the end of 2024 and leading into the first quarter of 2025.
Investing Activities
−Removed: Net cash used in investing activities for the six months ended June 30, 2024 was $0.1 million, which represents capital expenditures of property and equipment used in our operations during the period.
−Removed: No such expenditures occurred during the six months ended June 30, 2025.
+Added: Net cash used in investing activities for the nine months ended September 30, 2024 was $0.1 million, which represents capital expenditures of property and equipment used in our operations during the period.
+Added: No such expenditures occurred during the nine months ended September 30, 2025.
Financing Activities
−Removed: Net cash provided by financing activities for the six months ended June 30, 2025 was $0.4 million, compared to the $10.5 million for the six months ended June 30, 2024.
−Removed: Net proceeds from our ATM Offering were significantly higher for the six months ended June 30, 2024 due to significantly higher transaction volume combined with a higher average price per share of our common stock sold, which resulted in $21.1 million in net proceeds from our ATM Offering during the six months ended June 30, 2024.
+Added: Net cash provided by financing activities for the nine months ended September 30, 2025 was $3.7 million, compared to the $10.5 million for the nine months ended September 30, 2024.
+Added: Cash provided by financing activity for the nine months ended September 30, 2025 primarily consists of net proceeds of $3.6 million from our ATM Offering.
+Added: Net proceeds from our ATM Offering were significantly higher for the nine months ended September 30, 2024 due to significantly higher transaction volume combined with a higher average price per share of our common stock sold, which resulted in $21.1 million in net proceeds from our ATM Offering during the nine months ended September 30, 2024.
These proceeds were partially offset by the repayment of all amounts outstanding under the PWB Loan Agreement, which resulted in the repayment of $10.7 million in term loans, net of proceeds and debt issuance costs from the K2HV Loan Agreement.
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Our critical accounting policies are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Estimates” in our 2024 Annual Report, which was filed with the SEC on March 11, 2025.
−Removed: During the three and six months ended June 30, 2025, there were no material changes to our critical accounting policies from those previously disclosed.
+Added: During the three and nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those previously disclosed.
Quantitative and Qualitative Disclosures about Market Risk.
1 unchanged sentence
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.