KALA BIO, Inc.
For the period ended Jun 30, 2025. Filed Aug 8, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 8, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0001558370-25-007763
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-08.
0001558370-25-010853
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 105 previous paragraphs and 119 current paragraphs.
72 unchanged; 30 reworded; 12 added; 0 removed; 3 previous and 5 current paragraphs rearranged.
Tables are not compared: 31 previous and 33 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
Loss (gain) on Fair Value Remeasurement of Contingent Consideration
Current report
Research and development expenses were $6.2 million for the three months ended June 30, 2025, compared to $5.3 million for the three months ended June 30, 2024, an increase of $0.9 million. The increase was primarily due toa $0.7 million increase in employee-related costs and $0.3 million increase in KPI-012 development costs, as we advance the clinical development of KPI-012, partially offset by $0.1 million decrease inother research and development costs.
Current report
Loss (gain) on fair value remeasurement of contingent consideration
Current report
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report
General and administrative expenses
Current report
General and administrative expenses were $9.2 million for the six months ended June 30, 2025, compared to $9.7 million for the six months ended June 30, 2024, which was a decrease of $0.5 million. The decrease in general and administrative expenses for the six months ended June 30, 2025 was primarily due to a $0.6 million decrease in
Current report
employee-related costs, a $0.1 million decrease in administrative and professional service fees, partially offset by a $0.2 million increase in stock-based compensation costs.
Current report
Research and development expenses
Current report
Interest income
Current report
Interest income was $0.9 million for the six months ended June 30, 2025 and was $1.0 million for the six months ended June 30, 2024. Interest income consists of interest earned on our cash, cash equivalents and short-term investments, if any. The decrease was attributable to the quantity and mix of investments and lower interest rates during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024.
Current report
Interest expense
Reworded paragraphs (30)
Previous wording
The CHASE trial is comprised of two patient cohorts. On March 27, 2023, we announced positive safety data from the first cohort of the CHASE trial, which is an open-label study to evaluate the safety of the high dose of KPI-012 ophthalmic solution (3 U/mL) dosed topically four times per day, or QID, in two patients. Both patients in the first cohort successfully completed eight weeks of dosing with no safety issues observed. We have initiated the second and final patient cohort of the CHASE trial in the United States, which is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group trial to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) versus vehicle dosed topically QID for 56 days in approximately 90 adult patients. To date, we have opened 45 trial sites for the CHASE trial in the United States. We have also initiated several clinical trial sites in Argentina, Peru, Brazil and Colombia for the CHASE trial and we are in the process of initiating additional clinical trial sites in Latin America.
Current wording
The CHASE trial is comprised of two patient cohorts. On March 27, 2023, we announced positive safety data from the first cohort of the CHASE trial, which is an open-label study to evaluate the safety of the high dose of KPI-012 ophthalmic solution (3 U/mL) dosed topically four times per day, or QID, in two patients. Both patients in the first cohort successfully completed eight weeks of dosing with no safety issues observed. In July 2025, we completed patient enrollment in the second and final patient cohort of the CHASE trial, which is a multicenter, randomized, double-masked, vehicle-controlled, parallel-group trial to evaluate the safety and efficacy of two doses of KPI-012 ophthalmic solution (3 U/mL and 1 U/mL) versus vehicle dosed topically QID for 56 days. The CHASE trial randomized 79 patients across 37 sites in the United States and Latin America with verified PCEDs at baseline that will be eligible for inclusion in the primary efficacy analysis.
Previous wording
The primary endpoint of the CHASE trial is the complete healing of the PCED as measured by corneal fluorescein staining. We are targeting reporting topline safety and efficacy data from the CHASE trial in the third quarter of 2025. If the results are positive, and subject to discussion with regulatory authorities, we believe this trial could serve as the first of two pivotal trials required to support the submission of a Biologics License Application, or BLA, for KPI-012 to the FDA.
Current wording
The primary endpoint of the CHASE trial is the complete healing of the PCED as measured by corneal fluorescein staining photographs analyzed by a masked central reading center. We expect to report topline safety and efficacy data from the CHASE trial at the end of September 2025. Contingent on positive results and subject to discussion with regulatory authorities, we believe the CHASE trial could potentially serve as a pivotal trial required to support the submission of a Biologics License Application, or BLA, for KPI-012 to the FDA.
Previous wording
We believe the multifactorial mechanism of action of KPI-012 also makes our MSC-S a platform technology. We are evaluating the potential development of KPI-012 for additional rare front-of-the-eye diseases, such as for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision. In addition, we have
Current wording
We believe the multifactorial mechanism of action of KPI-012 also makes our MSC-S a platform technology. We are evaluating the potential development of KPI-012 for additional rare front-of-the-eye diseases, such as for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision. In addition, we have initiated preclinical studies under our KPI-014 program to evaluate the utility of our MSC-S platform for inherited
Previous wording
initiated preclinical studies under our KPI-014 program to evaluate the utility of our MSC-S platform for inherited retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. We expect to commercialize in the United States any of our product candidates that receive marketing approval.
Current wording
retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. We expect to commercialize in the United States any of our product candidates that receive marketing approval.
Previous wording
Since inception, we have incurred significant losses from operations and negative cash flows from operations. Our net loss was $8.9 million and $11.8 million for the three months ended March 31, 2025 and 2024, respectively, and $38.5 million for the year ended December 31, 2024. As of March 31, 2025, we had an accumulated deficit of $676.9 million. We generated only limited revenues from product sales of EYSUVIS and INVELTYS prior to the sale of the Commercial Business to Alcon in July 2022. We have financed our operations primarily through proceeds from the sale of our Commercial Business to Alcon, our initial public offering, or IPO, follow-on public common stock offerings and sales of our common stock under our sales agreement with Jefferies, LLC, or Jefferies, in at-the-market offerings, private placements of common stock and/or preferred stock (including our most recent private placement resulting in gross proceeds of approximately $10.8 million in December 2024), borrowings under credit facilities and our Loan Agreement with Oxford Finance, or the Loan Agreement, disbursements under a grant from California Institute for Regenerative Medicine, or CIRM (including our most recent disbursement of $2.3 million from CIRM in April 2025 upon the achievement of a specified milestone), convertible promissory notes and warrants.
Current wording
Since inception, we have incurred significant losses from operations and negative cash flows from operations. Our net loss was $11.2 million and $20.1 million for the three and six months ended June 30, 2025, respectively, and $38.5 million for the year ended December 31, 2024. As of June 30, 2025, we had an accumulated deficit of $688.0 million. We generated only limited revenues from product sales of EYSUVIS and INVELTYS prior to the sale of the Commercial Business to Alcon in July 2022. We have financed our operations primarily through proceeds from the sale of our Commercial Business to Alcon, our initial public offering, or IPO, follow-on public common stock offerings and sales of our common stock under our sales agreement with Jefferies, LLC, or Jefferies, in at-the-market offerings, private placements of common stock and/or preferred stock (including our most recent private placement resulting in gross proceeds of approximately $10.8 million in December 2024), borrowings under credit facilities and our Loan Agreement with Oxford Finance, or the Loan Agreement, disbursements under a grant from California Institute for Regenerative Medicine, or CIRM (including our most recent disbursement of $2.3 million from CIRM in April 2025 upon the achievement of a specified milestone), convertible promissory notes and warrants.
Previous wording
General and administrative expenses consist primarily of salaries, benefits, stock-based compensation and travel expenses related to our executive, finance, human resources, legal, compliance, information technology and
Current wording
General and administrative expenses consist primarily of salaries, benefits, stock-based compensation and travel expenses related to our executive, finance, human resources, legal, compliance, information technology and business development functions. General and administrative expenses also include professional fees for auditing, tax,
Previous wording
business development functions. General and administrative expenses also include professional fees for auditing, tax, information technology, consultants, legal services and allocated facility-related costs not otherwise included in research and development expenses.
Current wording
information technology, consultants, legal services and allocated facility-related costs not otherwise included in research and development expenses.
Previous wording
We expect that our research and development costs for 2025 will be comparable to such expenses for the year ended December 31, 2024 as we continue to advance the clinical development of KPI-012, including conducting our ongoing CHASE trial from which we anticipate reporting topline safety and efficacy data in the third quarter of 2025, and as we conduct any necessary preclinical studies and clinical trials and other development activities for any other product candidate we may develop in the future, including our planned preclinical studies under our KPI-014 program. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming. We may never succeed in obtaining marketing approval for any of our product candidates. The probability of success for each product candidate may be affected by numerous factors, including preclinical data, clinical data, competition, manufacturing capability and commercial viability.
Current wording
We expect that our research and development costs for 2025 will be comparable to such expenses for the year ended December 31, 2024 as we continue to advance the clinical development of KPI-012, including conducting our ongoing CHASE trial from which we expect to report topline safety and efficacy data at the end of September 2025, and as we conduct any necessary preclinical studies and clinical trials and other development activities for any other product candidate we may develop in the future, including our planned preclinical studies under our KPI-014 program. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming. We may never succeed in obtaining marketing approval for any of our product candidates. The probability of success for each product candidate may be affected by numerous factors, including preclinical data, clinical data, competition, manufacturing capability and commercial viability.
Previous wording
KPI-012 is in Phase 2b clinical development and all of our other research and development programs are in preclinical development. Successful development and completion of preclinical studies and clinical trials is uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each product candidate and future product candidate and are difficult to predict. We will continue to make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the scientific and clinical success of each product candidate as well as ongoing assessments as to the commercial potential of product candidates and our ability to enter into collaborations with respect to each product candidate. We will need to raise additional capital and may seek collaborations in the future to advance KPI-012 and any product
Current wording
KPI-012 is in Phase 2b clinical development and all of our other research and development programs are in preclinical development. Successful development and completion of preclinical studies and clinical trials is uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each product candidate and future product candidate and are difficult to predict. We will continue to make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the scientific and clinical success of each product candidate as well as ongoing assessments as to the commercial potential of product candidates and our ability to enter into collaborations with respect to each product candidate. We will need to raise additional capital and may seek collaborations in the future to advance KPI-012 and any product candidate we may develop. Additional private or public financings may not be available to us on acceptable terms, or at
Previous wording
candidate we may develop. Additional private or public financings may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a material adverse effect on our financial condition and our ability to pursue our business strategy.
Current wording
all. Our failure to raise capital as and when needed would have a material adverse effect on our financial condition and our ability to pursue our business strategy.
Previous wording
The CIRM Award is subject to a co-funding requirement under which Combangio is obligated to spend a specified minimum amount on the development of KPI-012 to obtain the full award amount. The remaining $1.1 million available under the CIRM Award is payable to Combangio only upon the achievement of specified milestones that are primarily related to Combangio’s progress in conducting the CHASE clinical trial. CIRM may permanently cease disbursements if the milestones are not met within four months of the scheduled completion dates or if the delay is not addressed to CIRM’s satisfaction, as determined by CIRM in its sole discretion. Additionally, if CIRM determines, in its sole discretion, that Combangio has not complied with the terms and conditions of the CIRM Award, CIRM may suspend or permanently cease disbursements. Under the terms of the CIRM Award, Combangio is obligated to pay a royalty on net sales of any product, service or approved drug resulting in whole or in part from the CIRM Award in the amount of 0.1% per $1.0 million of funds utilized by us until the earlier of ten years from the date of first commercial sale of such product, service or approved drug and such time as nine times the amount of funds awarded by CIRM has
Current wording
The CIRM Award is subject to a co-funding requirement under which Combangio is obligated to spend a specified minimum amount on the development of KPI-012 to obtain the full award amount. The remaining $1.1 million available under the CIRM Award is payable to Combangio only upon the achievement of specified milestones that are primarily related to Combangio’s progress in conducting the CHASE clinical trial. CIRM may permanently cease disbursements if the milestones are not met within four months of the scheduled completion dates or if the delay is not addressed to CIRM’s satisfaction, as determined by CIRM in its sole discretion. Additionally, if CIRM determines, in its sole discretion, that Combangio has not complied with the terms and conditions of the CIRM Award, CIRM may suspend or permanently cease disbursements. Under the terms of the CIRM Award, Combangio is obligated to pay a royalty on net sales of any product, service or approved drug resulting in whole or in part from the CIRM Award in the amount of 0.1% per $1.0 million of funds utilized by us until the earlier of ten years from the date of first commercial sale of such product, service or approved drug and such time as nine times the amount of funds awarded by CIRM has been paid in royalties, or the Base Royalty. In addition, following the satisfaction of the Base Royalty, Combangio is
Previous wording
been paid in royalties, or the Base Royalty. In addition, following the satisfaction of the Base Royalty, Combangio is obligated to pay a 1.0% royalty on net sales of any CIRM-funded invention in excess of $500 million per year until the last to expire patent covering such invention expires.
Current wording
obligated to pay a 1.0% royalty on net sales of any CIRM-funded invention in excess of $500 million per year until the last to expire patent covering such invention expires.
Previous wording
General and administrative expenses were $4.6 million for the three months ended March 31, 2025, compared to $5.4 million for the three months ended March 31, 2024, which was a decrease of $0.8 million. The decrease in general and administrative expenses for the three months ended March 31, 2025 was due to a decrease of $0.7 million in employee-related costs and a decrease of $0.1 million in stock-based compensation costs.
Current wording
General and administrative expenses were $4.6 million for the three months ended June 30, 2025, compared to $4.3 million for the three months ended June 30, 2024, which was an increase of $0.3 million. The increase in general and administrative expenses for the three months ended June 30, 2025 was due to a $0.3 million increase in stock-based compensation costs and $0.2 million increase in employee related costs, partially offset by a $0.2 million decrease inadministrative and professional service fees.
Previous wording
Loss on fair value remeasurement of contingent consideration for the three months ended March 31, 2025 was less than $0.1 million, as compared to $0.2 million for the three months ended March 31, 2024. The decrease wasprimarily due tochanges in discount rates, the passage of time and changes in the expected timing of the achievement of specified development, regulatory and commercialization milestones associated with the Combangio acquisition.
Current wording
Loss on fair value remeasurement of contingent consideration for the three months ended June 30, 2025 was $0.2 million as compared to a gain of less than $0.1 million for the three months ended June 30, 2024, primarily due tochanges in discount rates, the passage of time and changes in the expected timing.
Previous wording
Interest income was $0.5 million for both the three months ended March 31, 2025 and 2024. Interest income consists of interest earned on our cash, cash equivalents and short-term investments, if any.
Current wording
Interest income was $0.4 million for the three months ended June 30, 2025 and was $0.5 million for the three months ended June 30, 2024. Interest income consists of interest earned on our cash, cash equivalents and short-term investments, if any. The decrease was attributable to the quantity and mix of investments and lower interest rates during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024.
Previous wording
We incurred interest expense of $1.1 million for the three months ended March 31, 2025 and $1.5 million for the three months ended March 31, 2024. Interest expense for the three months ended March 31, 2025 and 2024 was comprised of the contractual coupon interest expense, the amortization of the debt discount and the accretion of the final payment fee associated with our Loan Agreement with Oxford Finance. During the three months ended March 31, 2025 and 2024, $29.3 million and $34.0 million, respectively, of indebtedness was outstanding under our Loan Agreement. On December 26, 2024, we madea partial prepayment of principal in the amount of $4.7 million.
Current wording
We incurred interest expense of $1.1 million for the three months ended June 30, 2025 and $1.5 million for the three months ended June 30, 2024. Interest expense for the three months ended June 30, 2025 and 2024 was comprised of the contractual coupon interest expense, the amortization of the debt discount and the accretion of the final payment fee associated with our Loan Agreement with Oxford Finance. During the three months ended June 30, 2025, $29.3 millionof indebtedness was outstanding under our Loan Agreement until $2.3 million was repaid on June 26, 2025 resulting in an outstanding indebtedness of $26.9 million as of June 30, 2025. During the three months ended June 30, 2024, $34.0 million of indebtedness was outstanding under our Loan Agreement.
Previous wording
Grant income for the three months ended March 31, 2025 and 2024 was $2.4 million and $1.1 million, respectively, related to the CIRM Award. The increase in grant income was due to the achievement of specified milestones under the CIRM Award and the timing of the associated costs related to the CHASE Phase 2b clinical trial.
Current wording
Grant income for the three months ended June 30, 2025 and 2024 was $0.5 million and $1.0 million, respectively, related to the CIRM Award. The decrease in grant income was due to the achievement of specified milestones under the CIRM Award and the timing of the associated costs related to the CHASE Phase 2b clinical trial.
Previous wording
Research and development expenses were $6.1 million for the three months ended March 31, 2025, compared to $6.4 million for the three months ended March 31, 2024, a decrease of $0.3 million. The decrease was primarily related to a $0.2 million decrease in medical affairs related KPI-012 development costs and a $0.1 million decrease in other research and development costs, which primarily included facility related costs.
Current wording
Research and development expenses were $12.3 million for the six months ended June 30, 2025, compared to $11.7 million for the six months ended June 30, 2024, which was an increase of $0.6 million. The increase was primarily due to a $0.8 million increase in employee-related costs and $0.1 million increase in KPI-012 development costs, as we advance the clinical development of KPI-012, partially offset by $0.2 million decrease in other research and development costs.
Previous wording
From entry into the Open Market Sale Agreement and as of March 31, 2025, we sold an aggregate of 784,196 shares of our common stock under the 2023 Shelf Registration for total net proceeds of $7.0 million, none of which were sold during the three months ended March 31, 2025 and 2024.
Current wording
From entry into the Open Market Sale Agreement and as of June 30, 2025, we sold an aggregate of 784,196 shares of our common stock under the 2023 Shelf Registration for total net proceeds of $7.0 million, none of which were sold during the three and six months ended June 30, 2025. During the six months ended June 30, 2024, we sold an aggregate of 387,500 shares of our common stock under the Open Market Sale Agreement under the 2023 Shelf Registration for total net proceeds of $2.5 million, all of which were sold during the three months ended June 30, 2024.
Previous wording
If we make an additional prepayment under the Loan Agreement equal to $2.5 million (inclusive of the final payment fee) on or prior to June 30, 2025, or the Second Extension Prepayment, the Amortization Date will be automatically changed to January 1, 2026, and the maturity date of the Loan Agreement will be automatically changed to May 1, 2027.
Current wording
If we made an additional prepayment under the Loan Agreement equal to $2.5 million (inclusive of the final payment fee) on or prior to June 30, 2025, or the Second Extension Prepayment, the Amortization Date would be automatically changed to January 1, 2026, and the maturity date of the Loan Agreement would be automatically changed to May 1, 2027. On June 26, 2025, the Company paid the Second Extension Prepayment, and as a result, the Amortization Data was automatically changed to January 1, 2026 and the maturity date was automatically changed to May 1, 2027.
Previous wording
We will be required to make a final payment fee of 7.00% of the original principal amount of any funded term loan payable on the earlier of (i) the prepayment of the term loan in full or (ii) the maturity date. At our option, we may elect to make partial repayments of the term loan to the Lender, subject to specified conditions, including the payment of
Current wording
We will be required to make a final payment fee of 7.00% of the original principal amount of any funded term loan payable on the earlier of (i) the prepayment of the term loan in full or (ii) the maturity date. At our option, we may elect to make partial repayments of the term loan to the Lender, subject to specified conditions, including the payment of applicable fees and accrued and unpaid interest on the principal amount of the term loan being repaid. For further information about the Loan Agreement, see Note 8, “Debt”, of our condensed consolidated financial statements.
Previous wording
As a result of the acquisition of Combangio, we may be required to pay additional contingent consideration to the former Combangio Equityholders. Former Combangio Equityholders are entitled to receive from us, subject to the terms and conditions of the merger agreement, contingent consideration, which would become payable upon our achievement of various development, regulatory and sales milestones and as a result of certain cash royalty payment obligations which are in the mid-to-high single digits. The total potential maximum payout for the milestone payments which are contingent upon the achievement of specified development, regulatory and commercialization milestones is $40.0 million and the total potential maximum payout for future sales-based milestone payments is an additional $65.0 million. To date, of the $40.0 million of contingent consideration payable upon achievement of specified development, regulatory and commercialization milestones, in March 2023 we paid to the former Combangio Equityholders an
Current wording
As a result of the acquisition of Combangio, we may be required to pay additional contingent consideration to the former Combangio Equityholders. Former Combangio Equityholders are entitled to receive from us, subject to the terms and conditions of the merger agreement, contingent consideration, which would become payable upon our achievement of various development, regulatory and sales milestones and as a result of certain cash royalty payment obligations which are in the mid-to-high single digits. The total potential maximum payout for the milestone payments which are contingent upon the achievement of specified development, regulatory and commercialization milestones is
Previous wording
aggregate of $2.5 million in cash and $2.4 million in shares of our common stock (representing an aggregate of 105,038 shares of our common stock) following dosing of the first patient in our CHASE trial in February 2023. The remaining amount of $0.1 million for this milestone was paid in cash in January 2024. For a full description of the consideration payable as a result of the Combangio Acquisition, see our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and Note 3, “Fair Value of Financial Instruments”, of our condensed consolidated financial statements.
Current wording
$40.0 million and the total potential maximum payout for future sales-based milestone payments is an additional $65.0 million. To date, of the $40.0 million of contingent consideration payable upon achievement of specified development, regulatory and commercialization milestones, in March 2023 we paid to the former Combangio Equityholders an aggregate of $2.5 million in cash and $2.4 million in shares of our common stock (representing an aggregate of 105,038 shares of our common stock) following dosing of the first patient in our CHASE trial in February 2023. The remaining amount of $0.1 million for this milestone was paid in cash in January 2024. For a full description of the consideration payable as a result of the Combangio Acquisition, see our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and Note 3, “Fair Value of Financial Instruments”, of our condensed consolidated financial statements.
Previous wording
As of March 31, 2025 and December 31, 2024, we had $42.2 million and $51.2 million in cash and cash equivalents, respectively. As of March 31, 2025 and December 31, 2024, we had $29.3 million in indebtedness, which represented the aggregate principal amount that was outstanding under the Loan Agreement with Oxford Finance.
Current wording
As of June 30, 2025 and December 31, 2024, we had $31.9 million and $51.2 million in cash and cash equivalents, respectively. As of June 30, 2025 and December 31, 2024, we had $26.9 million and $29.3 million, respectively, in indebtedness, which represented the aggregate principal amount that was outstanding under the Loan Agreement with Oxford Finance.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2025 was $8.8 million, compared to $10.8 million for the three months ended March 31, 2024, a decrease of $2.0 million, primarily due to a $2.5 million decrease in the net loss adjusted for non-cash charges, partially offset by the of $0.5 million increase due to the timing of working capital fluctuations. Notable working capital fluctuations included a $1.9 million increase in prepaid expenses and other current assets during the three months ended March 31, 2025, primarily as a result of a $2.3 million receivables recorded related to CIRM, which is included in prepaid expenses and other current assets as of March 31, 2025, as compared to a $0.4 million decrease during the three months ended March 31, 2024. This change in working capital during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 was partially offset by a change of $1.8 million in accounts payable and accrued expenses and other current liabilities fluctuations primarily due to the timing of payables.
Current wording
Net cash used in operating activities for the six months ended June 30, 2025 was $16.6 million, compared to $20.1 million for the six months ended June 30, 2024, a decrease of $3.5 million, primarily due to a $1.3 million decrease in the net loss adjusted for non-cash charges and a $2.2 million decrease in working capital. Notable working capital fluctuations included a $0.1 million increase in prepaid expenses and other current assets during the six months ended June 30, 2025, as compared to a $2.7 million increase during the six months ended June 30, 2024, primarily as a result of a disbursement of $3.2 million from CIRM in August 2024, which was included in prepaid expenses and other current assets as of June 30, 2024. This fluctuation in prepaid expenses and other current assets was partially offset by an increase of $0.3 million in accounts payable and accrued expenses and other current liabilities fluctuations primarily due to the timing of payables.
Previous wording
There was no cash used in or provided by investing activities for the three months ended March 31, 2025. Net cash used in investing activities for the three months ended March 31, 2024 of less than $0.1 million was related to purchases of property and equipment and other assets.
Current wording
Net cash used in investing activities for the six months ended June 30, 2025 and 2024 was less than $0.1 million in each period. Net cash used in investing activities, in both periods, was related to purchases of property and equipment and other assets.
Previous wording
Net cash used in financing activities for the three months ended March 31, 2025 was $0.1 million, primarily due to payment of issuance costs related tothe sale of common stock and shares of our Series I Preferred Stock in our December 2024 private placement.
Current wording
Net cash used in financing activities for the six months ended June 30, 2025 was $2.7 million, primarily due toa $2.5 million repayment of principal and payment fee on our Loan Agreement and $0.1 million payment of issuance costs related tothe sale of common stock and shares of our Series I Preferred Stock in our December 2024 private placement.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2024 was $8.4 million and consisted of $8.5 million of netproceeds from the sale of shares of our Series G Preferred Stock in our March 2024 private placement, partially offset by a $0.1 million payment for the First Dosing Milestone reflected in financing activities.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2024 was $23.4 million, largely consisted of $12.5 million of gross proceeds from the sale of common stock and shares of our Series H Preferred Stock in our June 2024 private placement, $8.5 million of net proceeds from the sale of shares of our Series G Preferred Stock in our March 2024 private placement and $2.5 million of net proceeds from the sale of shares of our common stock through Jefferies under our at-the-market equity offering, partially offset by a $0.1 million payment for the First Dosing Milestone reflected in financing activities.
Previous wording
We anticipate that our research and development expenses will increase substantially in the future as compared to prior periods as we advance the clinical development of KPI-012. Our research and development expenses will also increase in the future as we conduct any necessary preclinical studies and clinical trials and other development activities for any other product candidates we may develop in the future, including our planned preclinical studies under our KPI-014 program. If we obtain marketing approval for KPI-012 or any product candidates we may develop, we expect that our general and administrative expenses will increase substantially if and as we incur commercialization expenses related to product marketing, sales and distribution.
Current wording
We anticipate that our research and development expenses will increase substantially in the future as compared to prior periods as we advance the clinical development of KPI-012 and as we conduct any necessary preclinical studies and clinical trials and other development activities for any other product candidates we may develop in the future, including our planned preclinical studies under our KPI-014 program. If we obtain marketing approval for KPI-012 or any product candidates we may develop, we expect that our general and administrative expenses will increase substantially if and as we incur commercialization expenses related to product marketing, sales and distribution.
Previous wording
We will need to raise additional capital in the future to advance our business. Additional private or public financings may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a material adverse effect on our financial condition and our ability to pursue our business strategy. If we raise additional funds through collaborations, strategic alliances, licensing arrangements, royalty agreements, or marketing and distribution arrangements, 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. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or current or future commercialization efforts or grant rights to develop
Current wording
We will need to raise additional capital in the future to advance our business. Additional private or public financings may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a material adverse effect on our financial condition and our ability to pursue our business strategy. If we raise additional funds through collaborations, strategic alliances, licensing arrangements, royalty agreements, or marketing and distribution arrangements, 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. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or current or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves or cease operations and, potentially, wind down the company under the bankruptcy laws or otherwise. If we were to cease operations and wind down the company under the bankruptcy laws or otherwise, we cannot assure our stockholders or other stakeholders of any specific level of recovery, or any recovery at all on their specific claims or interest.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
The following table summarizes the results of our operations for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table summarizes the research and development expenses incurred during the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
Loss on fair value remeasurement of contingent consideration for the six months ended June 30, 2025 and 2024 was $0.2 million and $0.1 million, respectively, primarily due tochanges in discount rates, the passage of time and changes in the expected timing.
Current report — wording carried from elsewhere
We incurred interest expense of $2.2 million for the six months ended June 30, 2025 and $2.9 million for the six months ended June 30, 2024. Interest expense for the six months ended June 30, 2025 and 2024 was comprised of the contractual coupon interest expense, the amortization of the debt discount and the accretion of the final payment fee associated with our Loan Agreement with Oxford Finance. During the six months ended June 30, 2025, $29.3 millionof indebtedness was outstanding under our Loan Agreement until $2.3 million was repaid on June 26, 2025 resulting in an outstanding indebtedness of $26.9 million as of June 30, 2025. During the six months ended June 30, 2024, $34.0 million of indebtedness was outstanding under our Loan Agreement.
Current report — wording carried from elsewhere
Grant income for the six months ended June 30, 2025 and 2024 was $2.9 million and $2.1 million, respectively, related to the CIRM Award. The increase in grant income was due to the achievement of specified milestones under the CIRM Award and the timing of the associated costs related to the CHASE Phase 2b clinical trial.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Loss on fair value remeasurement of contingent consideration
Previous report — wording carried elsewhere
applicable fees and accrued and unpaid interest on the principal amount of the term loan being repaid. For further information about the Loan Agreement, see Note 8, “Debt”, of our condensed consolidated financial statements.
Previous report — wording carried elsewhere
and market products or product candidates that we would otherwise prefer to develop and market ourselves or cease operations and, potentially, wind down the company under the bankruptcy laws or otherwise. If we were to cease operations and wind down the company under the bankruptcy laws or otherwise, we cannot assure our stockholders or other stakeholders of any specific level of recovery, or any recovery at all on their specific claims or interest.