Quince Therapeutics Inc

Previous wording

We enrolled the first patient in the Phase 3 NEAT clinical trial of EryDex in A-T during the second quarter of 2024. We expect to report topline results from this trial in the fourth quarter of 2025, with a potential NDA submission in 2026, assuming positive study results.

Current wording

As of November 13, 2024, 32 patients have been enrolled in the Phase 3 NEAT clinical trial of EryDex in A-T. We expect to report topline results from this trial in the fourth quarter of 2025, with a potential NDA submission in 2026, assuming positive study results.

Previous wording

We updated an initial patient sizing project with further third-party analysis from IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics, which confirmed that there are approximately 4,600 diagnosed patients with A-T in the U.S. as of July 2024, an increase from previous estimates of approximately 3,400 diagnosed patients with A-T in the U.S. Currently, there are no approved treatments for A-T and the global market, based on our internal estimates and assumptions, represents a more than $1 billion peak commercial opportunity. We believe this could allow EryDex to demonstrate the clinical benefit and commercial potential of our AIDE technology.

Current wording

We also completed a patient sizing project with third-party analysis from IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics, which confirmed that there are approximately 4,600 diagnosed patients with A-T in the U.S. Currently, there are no approved treatments for A-T and the global market, based on our internal estimates and assumptions, represents a more than $1 billion peak commercial opportunity. We believe this could allow EryDex to demonstrate the clinical benefit and commercial potential of our AIDE technology.

Previous wording

We selected Duchenne muscular dystrophy (DMD) as our second development program. We consider DMD an ideal indication for EryDex as corticosteroids are the standard of care for this rare disease, but its utility is limited by significant chronic toxicity due to adrenal suppression. As a result, corticosteroid treatment in patients with DMD is commonly interrupted during adolescence due to interference with sexual maturation and delayed puberty. As a next step, we intend to focus on generating proof-of-concept clinical trial study designs to evaluate EryDex for the potential treatment of patients with DMD, including those with corticosteroid intolerance who represent the majority of the DMD population. We plan to initiate a DMD proof-of-concept study in 2025, which we plan to conduct utilizing capital efficient study approaches.

Current wording

We selected Duchenne muscular dystrophy (DMD) as our second development program. We consider DMD an ideal indication for EryDex as corticosteroids are the standard of care for this rare disease, but its utility is limited by significant chronic toxicity due to adrenal suppression. As a result, corticosteroid treatment in patients with DMD is commonly interrupted during adolescence due to interference with sexual maturation and delayed puberty. As a next step, we intend to focus on generating a Phase 2 clinical trial designed to evaluate EryDex for the potential treatment of patients with DMD, including those with corticosteroid intolerance who represent the majority of the DMD population. We plan to initiate a DMD Phase 2 study in 2025, which we plan to conduct utilizing capital efficient study approaches.

Previous wording

We intend to continue our investigation of other potential indications for EryDex where chronic corticosteroid treatment is – or has the potential to become – a standard of care if there were not corticosteroid-related safety concerns. This evaluation process spans across ataxia, neuromuscular, hematology, cancer, and autoimmune disease indications with a focus on rare diseases. To support our drug development pipeline expansion in a capital efficient structure, we would prioritize an investigator initiated clinical trial approach to evaluate EryDex for other potential rare disease indications. In addition, we intend to evaluate other potential applications of the AIDE technology platform using drugs and biologics targeted at rare and debilitating diseases to further expand our drug development pipeline.

Current wording

We also completed an initial assessment of other potential indications for EryDex where chronic corticosteroid treatment is – or has the potential to become – a standard of care if there were not corticosteroid-related safety concerns. This evaluation process spanned across ataxia, neuromuscular, hematology, cancer, and autoimmune disease indications with a focus on rare diseases. The prioritized list of other potential rare disease targets beyond A-T and DMD includes: 1) autoimmune hepatitis, 2) dermatomyositis, 3) pemphigus vulgaris, 4) Hashimoto's encephalopathy, 5) Becker muscular dystrophy, 6) pediatric lupus, 7) juvenile idiopathic arthritis, 8) myasthenia gravis, 9) limb-girdle muscular dystrophy, 10) chronic inflammatory demyelinating polyradiculoneuropathy, and 11) pulmonary sarcoidosis. To support our drug development pipeline expansion in a capital efficient structure, we would prioritize an investigator initiated clinical trial approach to evaluate EryDex for other potential rare disease indications. In addition, we intend to evaluate other potential applications of the AIDE technology platform using drugs and biologics targeted at rare and debilitating diseases to further expand our drug development pipeline.

Previous wording

We dosed the first patient with A-T in our Phase 3 NEAT clinical trial in the second quarter of 2024. NEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of EryDex in patients with A-T. To date, we have enrolled seven patients with A-T in the NEAT clinical trial across clinical sites in the U.S., U.K., and European Union and expect NEAT site activation and patient screenings to accelerate over the next quarter. We plan to enroll approximately 86 patients with A-T ages six to nine years old randomized (1:1) between EryDex or placebo, and approximately 20 patients with A-T ages 10 years or older. Participants who complete the full treatment period, complete the study assessments, and provide informed consent will be eligible to transition to an open label extension program after trial completion. The primary efficacy endpoint for the NEAT clinical trial will be measured by the change from baseline to last visit completion in RmICARS.

Current wording

We dosed the first patient with A-T in our Phase 3 NEAT clinical trial in the second quarter of 2024. As of November 13, 2024, we have enrolled 32 patients. NEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of EryDex in patients with A-T. To date, we have enrolled seven patients with A-T in the NEAT clinical trial across clinical sites in the U.S., U.K., and European Union and expect NEAT site activation and patient screenings to accelerate over the next quarter. We plan to enroll approximately 86 patients with A-T ages six to nine years old randomized (1:1) between EryDex or placebo, and approximately 20 patients with A-T ages 10 years or older. Participants who complete the full treatment period, complete the study assessments, and provide informed consent will be eligible to transition to an open label extension program after trial completion. The primary efficacy endpoint for the NEAT clinical trial will be measured by the change from baseline to last visit completion in RmICARS.

Previous wording

Research and development expenses were $4.2 million for the three months ended June 30, 2024, compared to $1.4 million for the three months ended June 30, 2023, an increase of $2.8 million.

Current wording

Research and development expenses were $4.9 million for the three months ended September 30, 2024, compared to $1.4 million for the three months ended September 30, 2023, an increase of $3.5 million.

Previous wording

The costs for EryDex development increased by $2.9 million in the three months ended June 30, 2024 compared to the same period from the prior year due to the start-up costs related to the Phase 3 NEAT clinical trial. This increase was primarily due to clinical trial costs of $2.6 million and $0.3 million increase in manufacturing costs.

Current wording

The costs for EryDex development increased by $3.2 million in the three months ended September 30, 2024 compared to the same period from the prior year due to the initiation of the Phase 3 NEAT clinical trial. This increase was primarily due to clinical trial costs of $2.9 million and $0.3 million manufacturing costs.

Previous wording

Our personnel related costs increased by $35.0 thousand during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023, mainly as a result of a $0.3 million increase in personnel related expenses, offset by a $0.3 million decrease in allocated stock-based compensation costs.

Current wording

Our personnel related costs increased by $0.3 million during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023, mainly as a result of an increase in personnel related expenses due to higher employee headcount compared to September 30, 2023.

Previous wording

Facilities and other research and development expenses increased by $54.0 thousand for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023 primarily due to an increase in rent and facilities expenses.

Current wording

Facilities and other research and development expenses increased by $31.0 thousand for the three months ended September 30, 2024, as compared to the three months ended September 30, 2023 primarily due to an increase in rent and facilities expenses.

Previous wording

General and administrative expenses increased by $0.5 million to $4.7 million for the three months ended June 30, 2024, from $4.2 million for the three months ended June 30, 2023. The increase in general and administrative expenses is primarily due to an increase of $1.0 million in personnel related expenses, a $0.2 million increase in commercial and new product planning expenses, and a $0.2 million increase in other professional and administrative expenses year over year. These increases were partially offset by a decrease of $0.7 million in legal fees and $0.2 million decrease in consulting, audit and tax fees.

Current wording

General and administrative expenses decreased by $1.03 million to $3.63 million for the three months ended September 30, 2024, from $4.66 million for the three months ended September 30, 2023. The decrease in general and administrative expenses is primarily due to a decrease of $0.9 million in consulting and professional fees, $0.5 million decrease in legal fees, and $0.1 million decrease in corporate insurance. These decreases were partially offset by an increase of $0.1 million in personnel related expenses, $0.1 million increase in audit and tax fees, $0.1 million increase in commercial and new product planning expenses, and $0.1 million increase in other professional and administrative expenses year over year.

Previous wording

For the three months ended June 30, 2024, we recorded a fair value adjustment for contingent consideration which resulted in a $2.2 million charge primarily due to the passage of time related to the contingent consideration earnouts resulting from the EryDel Acquisition and achieving the first milestone after dosing the first patient in our Phase 3 NEAT clinical trial.

Current wording

For the three months ended September 30, 2024, we recorded a fair value adjustment for contingent consideration which resulted in a $2.7 million charge primarily due to the passage of time related to the contingent consideration earnouts resulting from the EryDel Acquisition and achieving and paying the first milestone after dosing the first patient in our Phase 3 NEAT clinical trial.

Previous wording

Interest income increased by $18.0 thousand for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023. The change was due to increased yields on our investment portfolio which were offset by decreased average balances.

Current wording

Interest income decreased by $276.0 thousand for the three months ended September 30, 2024, as compared to the three months ended September 30, 2023. The change was due to a decreased yields on our investment portfolio which and decreased average balances.

Previous wording

Other income (expense), net increased by $0.2 million for the three months ended June 30, 2024 primarily due to $0.2 million unrealized gains resulting from changes in foreign exchange rates.

Current wording

Other income (expense), net increased by $0.4 million for the three months ended September 30, 2024 primarily due to $0.3 million unrealized gains resulting from changes in foreign exchange rates.

Previous wording

We recorded $36.0 thousand of tax expense for the three months ended June 30, 2024, primarily related to foreign withholding tax, interest on uncertain tax position liability and net of tax benefit from decrease in EryDel's deferred tax liabilities.

Current wording

We recorded tax expense of $13.0 thousand for the three months ended September 30, 2024, primarily related to foreign withholding tax, interest on uncertain tax position liability and net of tax benefit from decrease in EryDel's deferred tax liabilities.

Previous wording

Comparison of the six months ended June 30, 2024 to the six months ended June 30, 2023

Current wording

Comparison of the nine months ended September 30, 2024 to the nine months ended September 30, 2023

Previous wording

The following sets forth our results of operations for the six months ended June 30, 2024 and 2023 (in thousands, except for percentages):

Current wording

The following sets forth our results of operations for the nine months ended September 30, 2024 and 2023 (in thousands, except for percentages):

Previous wording

Research and development expenses were $7.8 million for the six months ended June 30, 2024, compared to $4.6 million for the six months ended June 30, 2023, an increase of $3.3 million.

Current wording

Research and development expenses were $12.8 million for the nine months ended September 30, 2024, compared to $6.0 million for the nine months ended September 30, 2023, an increase of $6.8 million.

Previous wording

The costs for EryDex development increased by $5.7 million compared to the same period from the prior year due to the start-up costs related to the Phase 3 NEAT clinical trial. This increase was primarily due to clinical trial costs of $5.2 million and $0.5 million increase in manufacturing costs.

Current wording

The costs for EryDex development increased by $8.9 million compared to the same period from the prior year due to the start-up and ramping up costs related to our Phase 3 NEAT clinical trial. This increase was primarily due to clinical trial costs of $8.1 million and $0.8 million in manufacturing costs.

Previous wording

Our personnel related costs decreased by $0.4 million during the six months ended June 30, 2024 as compared to the six months ended June 30, 2023, mainly as a result of a $0.5 million decrease in allocated stock-based compensation costs, offset by a $0.1 million increase in personnel related expenses.

Current wording

Our personnel related costs decreased by $0.1 million during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, mainly as a result of a $0.6 million decrease in allocated stock-based compensation costs, offset by a $0.5 million increase in personnel related expenses.

Previous wording

Facilities and other research and development expenses increased by $11.0 thousand for the six months ended June 30, 2024, as compared to the six months ended June 30, 2023 primarily due to an increase in rent and facilities expenses.

Current wording

Facilities and other research and development expenses increased by $43.0 thousand for the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023 primarily due to an increase in rent and facilities expenses.

Previous wording

General and administrative expenses increased by $1.6 million to $9.7 million for the six months ended June 30, 2024, from $8.1 million for the six months ended June 30, 2023. The increase in general and administrative expenses is primarily due to an increase of $1.6 million in personnel related expenses, $0.2 million increase in commercial and new product planning expenses, $0.1 million increase in consulting, audit, and tax fees, and $0.8 million increase in other professional and administrative expenses year over year. These increases were partially offset by a decrease of $1 million in legal fees and $0.1 million in corporate insurance expenses.

Current wording

General and administrative expenses increased by $0.5 million to $13.3 million for the nine months ended September 30, 2024, from $12.8 million for the nine months ended September 30, 2023. The increase in general and administrative expenses is primarily due to an increase of $1.9 million in personnel related expenses, $0.2 million increase in commercial and new product planning expenses, $0.2 million increase in audit and tax fees, and $0.6 million increase in other professional and administrative expenses year over year. These increases were partially offset by a decrease of 1.5 million in legal fees, $0.7 million in consulting and professional fees expenses, and $0.2 million in corporate insurance expenses.

Previous wording

For the six months ended June 30, 2024, we recorded a fair value adjustment for contingent consideration which resulted in a $4.8 million charge primarily due to the passage of time related to the contingent consideration earnouts resulting from the EryDel Acquisition and achieving the first milestone after dosing the first patient in our Phase 3 NEAT clinical trial.

Current wording

For the nine months ended September 30, 2024, we recorded a fair value adjustment for contingent consideration which resulted in a $2.1 million charge primarily due to the passage of time related to the contingent consideration earnouts resulting from the EryDel Acquisition and achieving and paying the first milestone after dosing the first patient in our Phase 3 NEAT clinical trial.

Previous wording

For the six months ended June 30, 2024, we recorded a fair value adjustment for long-term debt which resulted in a $0.8 million charge primarily due to the passage of time and the interest accrued for the loan with the EIB.

Current wording

For the nine months ended September 30, 2024, we recorded a fair value adjustment for long-term debt which resulted in a $1.3 million charge primarily due to the passage of time and the interest accrued for the loan with the EIB.

Previous wording

During the six months ended June 30, 2024, we conducted an impairment analysis of our goodwill that resulted from the acquisition of EryDel in October 2023. That assessment included a qualitative assessment of deteriorating macro-economic conditions, including inflationary pressures and high interest rates, and the continuing decline in our market capitalization from the date of the acquisition. This qualitative assessment indicated that our goodwill was potentially impaired. To determine the extent, if any, by which our goodwill was impaired, we conducted additional quantitative analyses which resulted in our fair value being significantly below our current carrying value. As a result of the analyses, we recorded a non-cash goodwill impairment charge of $17.1 million for the six months ended June 30, 2024.

Current wording

During the nine months ended September 30, 2024, we conducted an impairment analysis of our goodwill that resulted from the acquisition of EryDel in October 2023. That assessment included a qualitative assessment of deteriorating macro-economic conditions, including inflationary pressures and high interest rates, and the continuing decline in our market capitalization from the date of the acquisition. This qualitative assessment indicated that our goodwill was potentially impaired. To determine the extent, if any, by which our goodwill was impaired, we conducted additional quantitative analyses which resulted in our fair value being significantly below our current carrying value. As a result of the analyses, we recorded a non-cash goodwill impairment charge of $17.1 million for the nine months ended September 30, 2024.

Previous wording

During the six months ended June 30, 2023, we conducted an impairment analysis of our intangible asset IPR&D that resulted from the purchase of Novosteo, Inc. in May 2022. To determine the extent, if any, by which our IPR&D Intangible Asset was impaired, we conducted a quantitative analysis which resulted in our fair value being significantly below our current carrying value due to the assumptions changing as a result of the decision to hold this asset for sale in January 2023. As a result of the analyses, we recorded a non-cash intangible asset IPR&D impairment charge of $5.9 million for the six months ended June 30, 2023.

Current wording

During the nine months ended September 30, 2023, we conducted an impairment analysis of our intangible asset IPR&D that resulted from the purchase of Novosteo, Inc. in May 2022. To determine the extent, if any, by which our IPR&D Intangible Asset was impaired, we conducted a quantitative analysis which resulted in our fair value being significantly below our current carrying value due to the assumptions changing as a result of the decision to hold this asset for sale in January 2023. As a result of the analyses, we recorded a non-cash intangible asset IPR&D impairment charge of $5.9 million for the nine months ended September 30, 2023.

Previous wording

Interest income increased by $0.2 million for the six months ended June 30, 2024, as compared to the six months ended June 30, 2023. The change was due to increased yields on our investment portfolio which were partially offset by decreased average balances.

Current wording

Interest income decreased by $0.1 million for the nine months ended September 30, 2024, as compared to the nine months ended September 30, 2023. The change was due to decreased yields on our investment portfolio and decreased average balances.

Previous wording

Other income (expense), net increased by $45.0 thousand for the six months ended June 30, 2024 primarily due to unrealized gains resulting from changes in foreign exchange rates.

Current wording

Other income (expense), net increased by $0.3 million for the nine months ended September 30, 2024 primarily due to unrealized gains resulting from changes in foreign exchange rates.

Previous wording

We recorded $67.0 thousand of tax expense for the six months ended June 30, 2024 and tax benefit of $248,000 for the six months ended June 30, 2023. The change is primarily related to foreign withholding tax, interest on uncertain tax position liability and net of tax benefit from decrease in EryDel's deferred tax liabilities.

Current wording

We recorded tax expense of $0.1 million for the nine months ended September 30, 2024 and tax benefit of $0.2 million for the nine months ended September 30, 2023. The change is primarily related to foreign withholding tax, interest on uncertain tax position liability and net of tax benefit from decrease in EryDel's deferred tax liabilities.

Previous wording

To date, we have not generated any revenue and we have never been profitable. We have incurred net losses since the commencement of our operations. As of June 30, 2024, we had an accumulated deficit of $358.5 million. We incurred a net loss of $38.9 million in the six months ended June 30, 2024. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a drug candidate, and we cannot assure you that we will ever generate significant revenue or profits.

Current wording

To date, we have not generated any revenue and we have never been profitable. We have incurred net losses since the commencement of our operations. As of September 30, 2024, we had an accumulated deficit of $364.0 million. We incurred a net loss of $44.4 million in the nine months ended September 30, 2024. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a drug candidate, and we cannot assure you that we will ever generate significant revenue or profits.

Previous wording

In connection with the acquisition of EryDel on October 20, 2023, we assumed an unsecured line of credit between EryDel and the European Investment Bank (the "EIB Loan"). The EIB Loan was amended and restated as of the acquisition date. The EIB Loan provides for maximum borrowings of 30.0 million euro through four tranches; tranche A, 3.0 million euro; tranche B, 7.0 million euro; tranche C, 10.0 million euro; and tranche D, 10.0 million euro. Each tranche is subject to conditions precedent related to our business and capitalization. As of June 30, 2024, only tranches A and B have been drawn. All amounts due under tranche A and B are payable on their maturity date of August 2026. Tranche C and D are payable in equal installments of principal together with all amounts outstanding under the tranches on the repayment dates specified in the relevant Disbursement Offer. The first Repayment Date of tranche C shall fall not earlier than twelve months from the Disbursement Date of such tranche. The last Repayment Date of tranche C and tranche D shall fall not later than 5 years from the Disbursement Date of tranche C and tranche D, respectively. The EIB Loan bears interest at fixed rates for each tranche and is payable on the maturity date for each Tranche. The fixed rates range from 7.0% to 9.0% per annum. As of June 30, 2024, principal of 10.0 million euros ($10.8 million) was outstanding on the EIB Loan and it is recorded as Long-term debt on the condensed consolidated balance sheet at fair value with imputed interest of 9.0% included.

Current wording

In connection with the acquisition of EryDel on October 20, 2023, we assumed an unsecured line of credit between EryDel and the European Investment Bank (the "EIB Loan"). The EIB Loan was amended and restated as of the acquisition date. The EIB Loan provides for maximum borrowings of 30.0 million euro through four tranches; tranche A, 3.0 million euro; tranche B, 7.0 million euro; tranche C, 10.0 million euro; and tranche D, 10.0 million euro. Each tranche is subject to conditions precedent related to our business and capitalization. As of September 30, 2024, only tranches A and B have been drawn. All amounts due under tranche A and B are payable on their maturity date of August 2026. Tranche C and D are payable in equal installments of principal together with all amounts outstanding under the tranches on the repayment dates specified in the relevant Disbursement Offer. The first Repayment Date of tranche C shall fall not earlier than twelve months from the Disbursement Date of such tranche. The last Repayment Date of tranche C and tranche D shall fall not later than 5 years from the Disbursement Date of tranche C and tranche D, respectively. The EIB Loan bears interest at fixed rates for each tranche and is payable on the maturity date for each Tranche. The fixed rates range from 7.0% to 9.0% per annum. As of September 30, 2024, principal of 10.0 million euros ($11.2 million) was outstanding on the EIB Loan and it is recorded as Long-term debt on the condensed consolidated balance sheet at fair value with imputed interest of 9.0% included.

Previous wording

As of June 30, 2024 and December 31, 2023, we had cash, cash equivalents and short-term investments of $59.4 million and $75.1 million, respectively. Based on our current business plans, we believe that our existing capital resources will be sufficient to fund our projected operating requirements for at least the next twelve months from the date of the issuance of the accompanying condensed consolidated financial statements. Our cash, cash equivalents, and marketable debt securities are held in a variety of deposit accounts, interest-bearing accounts, U.S government securities, debt securities in government-sponsored entities, and money market funds. Cash in excess of immediate requirements is invested with a view toward liquidity and capital preservation, and we seek to minimize the potential effects of concentration and credit risk. Our cash equivalents and short-term investments are held in money market funds, certificate of deposits, and government agency obligations.

Current wording

As of September 30, 2024 and December 31, 2023, we had cash, cash equivalents and short-term investments of $47.8 million and $75.1 million, respectively. Based on our current business plans, we believe that our existing capital resources will be sufficient to fund our projected operating requirements for at least the next twelve months from the date of the issuance of the accompanying condensed consolidated financial statements. Our cash, cash equivalents, and marketable debt securities are held in a variety of deposit accounts, interest-bearing accounts, U.S government securities, debt securities in government-sponsored entities, and money market funds. Cash in excess of immediate requirements is invested with a view toward liquidity and capital preservation, and we seek to minimize the potential effects of concentration and credit risk. Our cash equivalents and short-term investments are held in money market funds, certificate of deposits, and government agency obligations.

Previous wording

We believe that our existing cash, cash equivalents and investments will be sufficient to fund our planned operations into at least 2026, but does not include any costs or cash expenditures associated with initiating additional programs. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Current wording

We believe that our existing cash, cash equivalents and investments will be sufficient to fund our planned operations into the first quarter of 2026, but does not include any costs or cash expenditures associated with initiating additional programs. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Previous wording

Cash used in operating activities was $17.1 million for the six months ended June 30, 2024. Cash used in operating activities was primarily due to our net loss of $38.9 million for the period, adjusted for $24.0 million of non-cash items, including $17.1 million goodwill impairment charge, $4.8 million change in the fair value of contingent consideration liabilities, $2.5 million in stock-based compensation, and a net increase in our operating assets of $2.3 million, offset by a net increase in our accounts payable, accrued expenses and other current liabilities of $0.1 million.

Current wording

Cash used in operating activities was $24.4 million for the nine months ended September 30, 2024. Cash used in operating activities was primarily due to our net loss of $44.4 million for the period, adjusted for $22.4 million of non-cash items, including $17.1 million goodwill impairment charge, $2.1 million change in the fair value of contingent consideration liabilities, $3.6 million in stock-based compensation, and a net increase in our operating assets of $2.5 million, offset by a net increase in our accounts payable, and accrued expenses and other current liabilities of $0.1 million.

Previous wording

Cash used in operating activities was $7.4 million for the six months ended June 30, 2023. Cash used in operating activities was primarily due to our net loss of $17.1 million for the period, adjusted for $7.9 million of non-cash items, including $2.8 million in stock-based compensation and $5.9 million in impairment loss due to the write down of the IPR&D asset, as well as a net decrease in our current assets of $2.8 million, offset by a net decrease in accounts payable, accrued expenses and other current liabilities of $1.0 million.

Current wording

Cash used in operating activities was $12.2 million for the nine months ended September 30, 2023. Cash used in operating activities was primarily due to our net loss of $22.5 million for the period, adjusted for $8.6 million of non-cash items, including $4.1 million in stock-based compensation and $5.9 million in impairment loss due to the write down of the IPR&D asset, as well as a net increase in our current assets of $2.4 million, offset by a net decrease in accounts payable, accrued expenses and other current liabilities of $0.7 million.

Previous wording

Cash provided by investing activities was $3.9 million for the six months ended June 30, 2024, primarily related to the maturities of short-term investments of $89.7 million, and the purchase of investments of $85.7 million.

Current wording

Cash provided by investing activities was $11.0 million for the nine months ended September 30, 2024, primarily related to the maturities of short-term investments of $100.7 million, and the purchase of investments of $89.6 million.

Previous wording

Cash used in investing activities was $14.8 million in the six months ended June 30, 2023, primarily related to the purchase of investments of $50.1 million and maturities of investments of $35.4 million.

Current wording

Cash used by investing activities was $11.1 million in the nine months ended September 30, 2023, primarily related to the purchase of investments of $95.1 million, and maturities of investments of $84.5 million.

Previous wording

Cash provided by financing activities was $0.2 million for the six months ended June 30, 2024, which consisted of net proceeds from the exercise of stock options in the period.

Current wording

Cash used in financing activities was $4.8 million for the nine months ended September 30, 2024, which consisted of a cash milestone payment of $5 million, partially offset by proceeds of $0.2 million from the exercise of stock options in the period.

Previous wording

Cash provided by financing activities was $0.1 million in the six months ended June 30, 2023, which consisted of net proceeds from the exercise of stock options in the period.

Current wording

Cash provided by financing activities was $0.1 million in the nine months ended September 30, 2023, which consisted of net proceeds from the exercise of stock options in the period.

Previous wording

We enter into contracts in the normal course of business with third party contract organizations for clinical trials, non-clinical studies and testing, manufacturing, and other services and products for operating purposes. The amount and timing of the payments under these contracts varies based upon the timing of the services. We have recorded accrued expense of approximately $1.0 million in our condensed consolidated balance sheet for expenditures incurred by these vendors as of June 30, 2024. We have approximately $29.6 million in cancellable future operating expense commitments based on existing contracts as of June 30, 2024. These obligations will be satisfied in the normal course of business, but generally no longer than 12 months. As of June 30, 2024, the fair value of the EIB loan is $13.8 million and it is recorded as long-term debt on the condensed consolidated balance sheet at fair value. As of June 30, 2024, the fair value of long-term contingent consideration on our books for the earnout related to the EryDel Acquisition is $57.5 million and the short-term portion is $5.0 million, refer to Note 3 to the condensed consolidated financial statements for further details.

Current wording

We enter into contracts in the normal course of business with third party contract organizations for clinical trials, non-clinical studies and testing, manufacturing, and other services and products for operating purposes. The amount and timing of the payments under these contracts varies based upon the timing of the services. We have recorded accrued expense of approximately $1.5 million in our condensed consolidated balance sheet for expenditures incurred by these vendors as of September 30, 2024. We have approximately $27.5 million in cancellable future operating expense commitments based on existing contracts as of September 30, 2024. These obligations will be satisfied in the normal course of business, but generally no longer than 12 months. As of September 30, 2024, the fair value of the EIB loan is $14.9 million and it is recorded as long-term debt on the condensed consolidated balance sheet at fair value. As of September 30, 2024, the fair value of long-term contingent consideration on our books for the earnout related to the EryDel Acquisition is $54.8 million, refer to Note 3 to the condensed consolidated financial statements for further details.