Cullinan Therapeutics Inc

Previous wording

CLN-978 is a CD19xCD3 T cell engager ("TCE") that we are developing for autoimmune diseases. Academic and industry groups have generated clinical data and case series demonstrating that CD19 targeted CAR T cell therapy could lead to sustained improvements in disease manifestations, including durable remission from symptoms in some cases, in multiple autoimmune disease indications including systemic lupus erythematosus (“SLE”). Nonetheless, cell therapy has many limitations, including the need for lymphodepleting chemotherapy, which is associated with significant toxicities, a United States Food and Drug Administration ("FDA")-recognized risk of secondary malignancies, and extended manufacturing lead times. More recently, academic investigators have published data demonstrating the potential for a CD19xCD3 TCE to achieve similar outcomes in multiple autoimmune disease indications. Based on these emerging clinical data supporting the efficacy of CD19 directed therapy in multiple autoimmune diseases and our belief that CLN-978 may address many of the limitations of CAR T therapy, we are exploring the development of CLN-978 in a variety of autoimmune diseases and are committed to assessing its broad potential. We plan to submit an investigational new drug ("IND") application to evaluate CLN-978 in patients with SLE as a first indication in the third quarter of 2024. In addition, we plan to initiate a clinical trial to evaluate CLN-978 in patients with rheumatoid arthritis in collaboration with the Friedrich-Alexander University of Erlangen-Nuremberg and Università Cattolica del Sacro Cuore, Rome.

Current wording

Based on the emerging clinical data supporting the efficacy of CD19-directed therapy in multiple autoimmune diseases and our belief that CLN-978 has several potential advantages compared to other CD19-directed therapies in development, we are exploring the development of CLN-978 in a variety of autoimmune diseases and are committed to assessing its broad potential. In September 2024, we received Human Research Ethics Committee approval in Australia to initiate a global Phase 1 clinical trial to evaluate CLN-978 in patients with systemic lupus erythematosus ("SLE"). In October 2024, we received clearance from the FDA for an investigational new drug ("IND") application to evaluate CLN-978 in a Phase 1 clinical trial in patients with moderate to severe SLE. We plan to share initial clinical data for CLN-978 in the fourth quarter of 2025. In the second quarter of 2025, we also plan to initiate a sponsored clinical trial to evaluate CLN-978 in patients with RA designed and executed in collaboration with the Friedrich-Alexander University of Erlangen-Nuremberg and Università Cattolica del Sacro Cuore, Rome.

Previous wording

Clinical observations from three patients treated in a Phase 1 dose escalation trial of patients with relapsed/refractory B-NHL showed that CLN-978 was clinically active at the initial starting dose of 30 micrograms administered subcutaneously once weekly. Two of the three patients experienced objective clinical benefit, including one patient who experienced a complete response. Grade 1 cytokine release syndrome occurred in two patients following the first dose of CLN-978 only, and no patients experienced immune effector cell-associated neurotoxicity syndrome. Other adverse events were mostly low-grade and/or mechanistically based (e.g., transient lymphopenia after the first dose only). Of the two patients with detectable B cells at baseline, both experienced rapid, deep, and sustained B cell depletion after administration of CLN-978. These data support that CLN-978 can not only deplete peripheral blood B cells but also demonstrate clinical activity in a tissue resident disease at a dose with a favorable safety profile.

Current wording

Clinical observations from three patients treated in a Phase 1 dose escalation trial in patients with relapsed/refractory B cell non-Hodgkin lymphoma showed that CLN-978 was clinically active at the initial starting dose of 30 micrograms administered subcutaneously once weekly. Two of the three patients experienced objective clinical benefit, including one patient who experienced a complete response. Grade 1 cytokine release syndrome (fever) occurred in two patients following the first dose of CLN-978 only, and no patients experienced immune effector cell-associated neurotoxicity syndrome. Other adverse events were mostly low-grade and/or mechanistically based (e.g., transient lymphopenia after the first dose only). Of the two patients with detectable B cells at baseline, both experienced rapid and deep B cell depletion after administration of CLN-978. These data support that CLN-978 can not only deplete peripheral blood B cells but also demonstrate clinical activity in a tissue resident disease at a dose with a favorable safety profile.

Previous wording

CLN-619, our lead unpartnered oncology program, is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by both cytotoxic innate and adaptive immune cells. CLN-619 is being investigated as both monotherapy and in combination with checkpoint inhibitor (“CPI”) therapy in an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

Current wording

CLN-619, our lead unpartnered oncology program, is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by both cytotoxic innate and adaptive immune cells. CLN-619 is being investigated as both monotherapy and in combination with checkpoint inhibitor (“CPI”) therapy or chemotherapy in an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

Previous wording

In June 2024, we presented the first clinical data from the CPI therapy combination dose escalation module of the clinical trial, as well as updated data from the monotherapy dose escalation module, at the American Society of Clinical Oncology Annual Meeting. The preliminary clinical data from CLN-619 in combination with the CPI pembrolizumab demonstrated objective tumor responses across multiple tumor types. Three partial responses were observed in patients with tumor types typically unresponsive to CPI treatment, including patients with non-small cell lung cancer ("NSCLC") with oncogenic mutations. The preliminary clinical data for CLN-619 as a monotherapy demonstrated objective tumor responses and extended stable disease across multiple tumor types. We observed one complete response, two partial responses and nine stable disease for at least 18 weeks resulting in a clinical benefit rate of 41.4%. The initial clinical data indicates CLN-619 has an acceptable safety profile across all doses assessed in the monotherapy dose escalation and in combination with pembrolizumab. No dose-limiting toxicities were observed. Consistent with other monoclonal antibodies, infusion-related reactions were limited to the first dose and were all Grade 1 or Grade 2 in patients receiving mandated pre-medication.

Current wording

In June 2024, we presented the first clinical data from the CPI therapy combination dose escalation module of the clinical trial, as well as updated data from the monotherapy dose escalation module, at the American Society of Clinical Oncology Annual Meeting. The preliminary clinical data from CLN-619 in combination with the CPI pembrolizumab demonstrated objective tumor responses across multiple tumor types. Three partial responses were observed, including two in patients with non-small cell lung cancer ("NSCLC") with oncogenic mutations, which are tumor types typically unresponsive to CPI treatment. The expanded preliminary clinical observations for CLN-619 as a monotherapy demonstrated objective tumor responses and extended stable disease across multiple tumor types. We observed one complete response, two partial responses and nine stable disease for at least 18 weeks resulting in a clinical benefit rate of 41.4%. In general, this initial clinical data indicates CLN-619 has an acceptable safety profile across all doses assessed as both monotherapy and in combination with pembrolizumab. No dose-limiting toxicities were observed. Similar to other monoclonal antibodies, infusion-related reactions were limited to the first dose and were all Grade 1 or Grade 2 in patients receiving mandated pre-medication.

Previous wording

The Phase 1 clinical trial continues to enroll expansion cohorts in cervical cancer (monotherapy), endometrial cancers (monotherapy and combination), NSCLC (monotherapy and combination), and ovarian cancer (combination). Additional expansion cohorts may be initiated based on clinical activity observed in the current clinical trial. Data from the disease specific expansion cohorts for endometrial and cervical cancers are anticipated in the first half of 2025. Separately, in February 2024, the FDA cleared our IND application to evaluate CLN-619 in a Phase 1 clinical trial in relapsed/refractory multiple myeloma patients.

Current wording

The Phase 1 clinical trial continues to enroll expansion cohorts in cervical cancer (monotherapy), endometrial cancers (monotherapy and combination), NSCLC (monotherapy and combination), and ovarian cancer (chemotherapy combination). Additional expansion cohorts may be initiated based on clinical activity observed in the current clinical trial. Initial data from the disease specific expansion cohorts for endometrial and cervical cancers are anticipated in the second quarter of 2025. In September 2024, we dosed the first patient in the Phase 1 clinical trial to evaluate CLN-619 in patients with relapsed/refractory multiple myeloma.

Previous wording

Zipalertinib (CLN-081/TAS6417), which we are co-developing with an affiliate of Taiho Pharmaceutical Co., Ltd ("Taiho"), is an orally-available small-molecule, irreversible epidermal growth factor receptor ("EGFR") inhibitor that is designed to selectively target cells expressing EGFR exon 20 ("EGFRex20") insertion mutations with relative sparing of cells expressing wild-type EGFR. We will receive 50% of any future pre-tax profits from potential U.S. sales of zipalertinib. The FDA has granted Breakthrough Therapy designation to zipalertinib. In collaboration with our partners at Taiho, we are evaluating zipalertinib in the pivotal Phase 2b portion of the REZILIENT1 clinical trial in patients with EGFRex20 NSCLC who progressed after prior systemic therapy, and in a global Phase 3 clinical trial (“REZILIENT3”) in combination with chemotherapy as a potential first-line treatment for EGFRex20 NSCLC adult patients. We expect to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 clinical trial by year-end 2024.

Current wording

Zipalertinib (CLN-081/TAS6417), which we are co-developing with an affiliate of Taiho Pharmaceutical Co., Ltd ("Taiho"), is an orally-available small-molecule, irreversible epidermal growth factor receptor ("EGFR") inhibitor that is designed to selectively target cells expressing EGFR exon 20 ("EGFRex20") insertion mutations with relative sparing of cells expressing wild-type EGFR. We are eligible to receive up to $130.0 million from Taiho tied to EGFRex20 non-small-cell lung cancer regulatory milestones. We will also receive 50% of any future pre-tax profits from potential U.S. sales of zipalertinib. The FDA has granted Breakthrough Therapy designation to zipalertinib. We are evaluating zipalertinib in the pivotal Phase 2b portion of the REZILIENT1 clinical trial in patients with EGFRex20 NSCLC who progressed after prior systemic therapy. Taiho is evaluating zipalertinib in a global Phase 3 clinical trial (“REZILIENT3”) in combination with chemotherapy as a potential first-line treatment for EGFRex20 NSCLC adult patients.

Previous wording

In June 2024, we announced initial clinical data from the pivotal Phase 2b portion of our REZILIENT1 clinical trial of zipalertinib in patients with NSCLC harboring EGFRex20 insertion mutations who received zipalertinib after prior treatment with amivantamab. As of a January 12, 2024 data cut-off, 31 patients had been enrolled. Patients had received a median of three prior systemic anti-cancer regimens, including prior platinum-based chemotherapy, prior anti-PD1/L1 therapy, and prior EGFR tyrosine kinase inhibitor therapy. At the data cut-off, 18 patients were evaluable for response and showed similar anti-tumor activity compared with those post prior chemotherapy in the previously reported Phase 1/2a part of the clinical trial. Zipalertinib demonstrated a manageable safety profile, similar to what has been previously reported. There were no grade 4 or grade 5 treatment-related adverse events. We intend to present additional data from the pivotal Phase 2b portion of our REZILIENT1 clinical trial in an oral abstract at the European Society for Medical Oncology in September 2024.

Current wording

In September 2024, at the European Society for Medical Oncology Congress we announced updated clinical data from the pivotal Phase 2b portion of our REZILIENT1 clinical trial of zipalertinib in patients with NSCLC harboring EGFRex20 insertion mutations who received zipalertinib after prior treatment with amivantamab. As of a March 29, 2024 data cut-off, 45 patients had been enrolled. Patients had received a median of three prior systemic therapies including amivantamab. At the data cut-off, 30 patients were evaluable for response and showed a 40% objective response rate ("ORR"), which was similar to the ORR for patients receiving zipalertinib after prior chemotherapy in the previously reported Phase 1/2a part of the clinical trial. Zipalertinib demonstrated a manageable safety profile, similar to what has been previously reported. There were no grade 4 or grade 5 treatment-related adverse events.

Previous wording

CLN-049 is a FLT3xCD3 T cell engaging bispecific antibody. CLN-049 is being investigated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome ("MDS"). We have also initiated a second Phase 1 clinical trial designed to evaluate the safety of CLN-049 in minimal residual disease (“MRD”)-positive AML. Following a review of data from the Phase 1 clinical trial of CLN-049, we reported that in the ongoing Phase 1 clinical trial of CLN-049 in patients with relapsed/refractory AML and MDS, dose-limiting injection site reactions were observed during dose escalation with subcutaneous administration. Based on these findings, together with observations of preliminary clinical activity, dose escalation is now continuing in the study with intravenous administration.

Current wording

CLN-049 is a FLT3xCD3 T cell engaging bispecific antibody. CLN-049 is being investigated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome ("MDS"). We have also initiated a second Phase 1 clinical trial designed to evaluate the safety of CLN-049 in minimal residual disease (“MRD”)-positive AML. Following a review of data from the Phase 1 clinical trial of CLN-049, we reported that in the ongoing Phase 1 clinical trial of CLN-049 in patients with relapsed/refractory AML and MDS, dose-limiting injection site reactions were observed during dose escalation with subcutaneous administration. Based on these findings, together with observations of preliminary clinical activity, we discontinued subcutaneous administration. Dose escalation continues in the Phase 1 clinical trial of CLN-049 with intravenous administration.

Previous wording

CLN-418 is a B7H4x4-1BB fully human bispecific immune activator designed to achieve conditional activation of 4-1BB by targeting B7H4, a tumor-associated antigen that is highly expressed across multiple cancers with minimal expression on normal tissues. In August 2024, following a review of the data from the Phase 1 clinical trial of CLN-418, we notified Harbour BioMed US Inc. (“Harbour”) of our decision to terminate the license and collaboration agreement for CLN-418 (the “Harbour License Agreement”), effective November 2024. In connection with the termination of the Harbour License Agreement, we will discontinue development of CLN-418 and return development and commercial rights for CLN-418 to Harbour and focus our resources on our other product candidates. Refer to Note 5 of our notes to the consolidated financial statements in this Quarterly Report on Form 10-Q for additional detail regarding the Harbour License Agreement.

Current wording

In August 2024, following a review of the data from the Phase 1 clinical trial of CLN-418, we notified Harbour BioMed US Inc. (“Harbour”) of our decision to terminate the license and collaboration agreement for CLN-418 (the “Harbour License Agreement”), effective November 2024. In connection with the termination of the Harbour License Agreement, we will discontinue development of CLN-418 and return development and commercial rights for CLN-418 to Harbour and focus our resources on our other product candidates. Refer to Note 5 of our notes to the consolidated financial statements in this Quarterly Report on Form 10-Q for additional detail regarding the Harbour License Agreement.

Previous wording

We have a controlling interest in the worldwide intellectual property rights for CLN-619, CLN-049, and CLN-617. We hold the worldwide intellectual property rights for CLN-978 and the U.S. intellectual property rights for CLN-418, and we hold the worldwide intellectual property rights or exclusive options for worldwide intellectual property for our earlier-stage programs. We are co-developing zipalertinib, for which Taiho holds the intellectual property rights, with an affiliate of Taiho. The following table shows our ownership interest as of June 30, 2024 in product candidates in which we have a controlling interest in the worldwide intellectual property rights:

Current wording

We have a controlling interest in the worldwide intellectual property rights for CLN-619, CLN-049, and CLN-617. We hold the worldwide intellectual property rights for CLN-978, and we hold the worldwide intellectual property rights or exclusive options for worldwide intellectual property for our earlier-stage programs. We are co-developing zipalertinib, for which Taiho holds the intellectual property rights, with an affiliate of Taiho. The following table shows our ownership interest as of September 30, 2024 in product candidates in which we have a controlling interest in the worldwide intellectual property rights:

Previous wording

As of June 30, 2024, we had cash, cash equivalents, short-term investments, and interest receivable of $664.9 million. Interest receivable is included in prepaid expenses and other current assets on the consolidated balance sheets and represents accrued and unpaid interest on our marketable securities. We have a history of significant operating losses and have had negative cash flows from operations since our inception. As of June 30, 2024, we had an accumulated deficit of $280.0 million. We expect to continue to generate operating losses for the foreseeable future. Our future viability is dependent on the success of our research and development and our ability to access additional capital to fund our operations. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.

Current wording

As of September 30, 2024, we had cash, cash equivalents, and short-term investments of $578.1 million, and long-term investments and interest receivable of $60.9 million. Interest receivable is included in prepaid expenses and other current assets on the consolidated balance sheets and represents accrued and unpaid interest on our marketable securities. We have a history of significant operating losses and have had negative cash flows from operations since our inception. As of September 30, 2024, we had an accumulated deficit of $320.6 million. We expect to continue to generate operating losses for the foreseeable future. Our future viability is dependent on the success of our research and development and our ability to access additional capital to fund our operations. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

The following table presents our results of operations for the three and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table presents our results of operations for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

The following table summarizes our research and development expenses for the three and six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

The $8.9 million increase in research and development expenses in the three months ended June 30, 2024 compared to the same period in 2023 was primarily due to increases in clinical costs ($2.3 million), chemistry, manufacturing and controls ("CMC") costs ($2.2 million), preclinical costs ($2.2 million), personnel costs relating to additional headcount ($1.5 million), and equity-based compensation costs ($0.6 million).

Current wording

The $1.7 million increase in research and development expenses in the three months ended September 30, 2024 compared to the same period in 2023 was primarily due to increases in personnel costs relating to additional headcount ($1.8 million), other research and development costs ($1.4 million), clinical costs ($1.3 million), preclinical costs ($1.3 million), and equity-based compensation costs ($0.7 million), partially offset by a decrease in chemistry, manufacturing and controls ("CMC") costs ($4.3 million).

Previous wording

The $12.6 million decrease in research and development expenses in the six months ended June 30, 2024 compared to the same period in 2023 was primarily due to the one-time upfront in-licensing fee for CLN-418 in 2023 ($25.0 million), partially offset by increases in clinical costs ($7.5 million), preclinical costs ($2.3 million), personnel costs relating to additional headcount ($2.3 million), and equity-based compensation costs ($0.7 million).

Current wording

The $10.9 million decrease in research and development expenses in the nine months ended September 30, 2024 compared to the same period in 2023 was primarily due to the one-time upfront in-licensing fee for CLN-418 in 2023 ($25.0 million) and lower CMC costs ($3.9 million), partially offset by increases in clinical costs ($8.7 million), personnel costs relating to additional headcount ($4.1 million), preclinical costs ($3.5 million), and equity-based compensation costs ($1.4 million).

Previous wording

The $3.6 million increase in general and administrative expenses in the three months ended June 30, 2024 compared to the same period in 2023 was primarily due to increases in both equity-based compensation costs ($2.0 million) and personnel costs ($1.5 million) relating to additional headcount.

Current wording

The $2.4 million increase in general and administrative expenses in the three months ended September 30, 2024 compared to the same period in 2023 was primarily due to increases in other professional fees ($1.3 million) and equity-based compensation costs ($1.0 million).

Previous wording

The $5.2 million increase in general and administrative expenses in the six months ended June 30, 2024 compared to the same period in 2023 was primarily due to increases in both personnel costs ($2.9 million) and equity-based compensation costs ($2.9 million) relating to additional headcount.

Current wording

The $7.6 million increase in general and administrative expenses in the nine months ended September 30, 2024 compared to the same period in 2023 was primarily due to increases in both equity-based compensation costs ($3.9 million) and personnel costs ($3.1 million) relating to additional headcount, and increases in other professional fees ($2.0 million), partially offset by decreases in occupancy costs ($0.9 million) and legal fees ($0.5 million).

Previous wording

The $2.6 million and $3.6 million increases in other income for the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023 were primarily related to higher investment income.

Current wording

The $2.2 million and $5.9 million increases in other income for the three and nine months ended September 30, 2024, respectively, compared to the same periods in 2023 were primarily related to higher investment income.

Previous wording

We have a history of significant operating losses and have had negative cash flows from operations since our inception and expect to continue to generate operating losses for the foreseeable future. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from the sale of equity securities and from licensing or selling the rights to our product candidates. As of June 30, 2024, we had cash, cash equivalents, short-term investments, and interest receivable of $664.9 million.

Current wording

We have a history of significant operating losses and have had negative cash flows from operations since our inception and expect to continue to generate operating losses for the foreseeable future. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from the sale of equity securities and from licensing or selling the rights to our product candidates. As of September 30, 2024, we had cash, cash equivalents, and short-term investments of $578.1 million, and long-term investments and interest receivable of $60.9 million.

Previous wording

In May 2023, we entered into an agreement with Cowen and Company, LLC (“Cowen”) to establish an at-the-market equity offering program (the "ATM"), pursuant to which we may offer and sell up to $125.0 million of our common stock from time to time through Cowen, acting as our sales agent. We made no sales under the ATM in the six months ended June 30, 2024. Through June 30, 2024, we have sold approximately 3.3 million shares under the ATM and received net proceeds of $38.4 million, after deducting commissions. As of June 30, 2024, we had $85.6 million in shares of our common stock remaining under the ATM.

Current wording

In May 2023, we entered into an agreement with Cowen and Company, LLC (“Cowen”) to establish an at-the-market equity offering program (the "ATM"), pursuant to which we may offer and sell up to $125.0 million of our common stock from time to time through Cowen, acting as our sales agent. We made no sales under the ATM in the nine months ended September 30, 2024. Through September 30, 2024, we have sold approximately 3.3 million shares under the ATM and received net proceeds of $38.4 million, after deducting commissions. As of September 30, 2024, we had $85.6 million in shares of our common stock remaining under the ATM.

Previous wording

Comparison of Cash Flows for the Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of Cash Flows for the Nine Months Ended September 30, 2024 and 2023

Previous wording

The following table summarizes our sources and uses of cash for the six months ended June 30, 2024 and 2023 (in thousands):

Current wording

The following table summarizes our sources and uses of cash for the nine months ended September 30, 2024 and 2023 (in thousands):

Previous wording

For the six months ended June 30, 2024, our operating activities used $74.5 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $74.1 million and a $9.3 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $6.7 million, and a net income tax refund of $2.3 million. The non-cash operating expenses primarily consisted of equity-based compensation expense.

Current wording

For the nine months ended September 30, 2024, our operating activities used $108.7 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $113.5 million and a $7.5 million net change in our non-tax operating assets and liabilities, partially offset by interest income, excluding accretion on marketable securities, of $10.2 million, and a net income tax refund of $2.3 million. The non-cash operating expenses primarily consisted of equity-based compensation expense.

Previous wording

For the six months ended June 30, 2023, operating activities used $82.0 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $85.0 million and income taxes paid of $4.7 million, partially offset by interest income, excluding accretion on marketable securities, of $6.3 million and a $1.2 million benefit from the net change in our non-tax operating assets and liabilities. The non-cash operating expenses primarily consisted of equity-based compensation expense.

Current wording

For the nine months ended September 30, 2023, our operating activities used $116.1 million of cash, which primarily consisted of our operating expenses, excluding non-cash items, of $122.0 million and income taxes paid of $4.7 million, partially offset by interest income, excluding accretion on marketable securities, of $9.2 million and a $1.1 million benefit from the net change in our non-tax operating assets and liabilities. The non-cash operating expenses primarily consisted of equity-based compensation expense.

Previous wording

For the six months ended June 30, 2023, net cash provided by investing activities was $27.3 million, which primarily consisted of proceeds of $198.1 million from the maturities of marketable securities, partially offset by $170.6 million used for the purchase of marketable securities.

Current wording

For the nine months ended September 30, 2024, net cash used in investing activities was $152.3 million, which consisted of $553.1 million of purchases of marketable securities, partially offset by $400.8 million of proceeds from the maturities of marketable securities.

Previous wording

For the six months ended June 30, 2024, net cash used in investing activities was $172.2 million, which primarily consisted of $456.3 million of purchases of marketable securities, partially offset by $284.1 million of proceeds from the maturities of marketable securities.

Current wording

For the nine months ended September 30, 2023, net cash used in investing activities was $15.7 million, which primarily consisted of $307.4 million of purchases of marketable securities, partially offset by $291.9 million of proceeds from the maturities of marketable securities.

Previous wording

For the six months ended June 30, 2024, net cash provided by financing activities was $263.3 million, which primarily consisted of $262.7 million of net proceeds from the issuance of common stock under our 2024 Private Placement and $4.4 million in net proceeds from the issuance of common stock under equity-based compensation plans, partially offset by $3.8 million paid to acquire shares of our CLN-619 development subsidiary that were held by noncontrolling interests.

Current wording

For the nine months ended September 30, 2024, net cash provided by financing activities was $264.6 million, which consisted of $262.7 million of net proceeds from the issuance of common stock under our 2024 Private Placement and $6.4 million in net proceeds from the issuance of common stock under equity-based compensation plans, partially offset by $4.4 million paid to acquire shares and options to purchase shares of our CLN-619 development subsidiary that were held by noncontrolling interests.

Previous wording

For the six months ended June 30, 2023, net cash provided by financing activities was $40.4 million, which primarily consisted of $38.4 million of net proceeds from the issuance of common stock under our ATM, and $1.8 million from the issuance of a convertible note by our CLN-619 development subsidiary to a noncontrolling interest.

Current wording

For the nine months ended September 30, 2023, net cash provided by financing activities was $40.5 million, which primarily consisted of $38.4 million of net proceeds from the issuance of common stock under our ATM, and $1.8 million from the issuance of a convertible note by our CLN-619 development subsidiary to a noncontrolling interest.

Previous wording

We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we advance the clinical trials and manufacturing of our product candidates along with preclinical activities for our current and potential future product candidates. In addition, we have and will continue to incur additional costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses.

Current wording

We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we:

Previous wording

hire and retain additional personnel, such as non-clinical, clinical, pharmacovigilance, quality assurance, regulatory affairs, manufacturing, distribution, legal, compliance, medical affairs, finance, general and administrative, commercial, and scientific personnel; and

Current wording

hire and retain additional personnel, such as nonclinical, clinical, pharmacovigilance, quality assurance, regulatory affairs, manufacturing, distribution, legal, compliance, medical affairs, finance, general and administrative, commercial, and scientific personnel; and

Previous wording

As of June 30, 2024, total future minimum lease payments were $3.0 million with $1.4 million payable within twelve months. See Note 10 to our consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail on our lease obligations and the timing of expected future payments.

Current wording

As of September 30, 2024, total future minimum lease payments were $2.7 million with $1.5 million payable within twelve months. See Note 10 to our consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail on our lease obligations and the timing of expected future payments.