Cyclerion Therapeutics Inc

Previous wording

On July 28, 2023, we sold two of our CNS assets (zagociguat and CY3018, or the “Transferred Assets”) to Tisento in exchange for $8.0 million in cash consideration, $2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 for the period between signing and closing of the transaction, and 10% of all of Tisento's Parent's outstanding equity securities. The Cyclerion assets that were retained are olinciguat and praliciguat which are not CNS focused and are either currently out-licensed (praliciguat) or management plans to out-license (olinciguat).

Current wording

On July 28, 2023, we sold two of our CNS assets (zagociguat and CY3018, or the “Transferred Assets”) to Tisento in exchange for $8.0 million in cash consideration, $2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 for the period between signing and closing of the transaction, and 10% of all of Tisento's Parent's outstanding equity securities. The Cyclerion assets that were retained are olinciguat and praliciguat which are not CNS focused and are either currently out-licensed (praliciguat) or management is seeking to out-license (olinciguat).

Previous wording

We have shifted our strategy to identify non-sGC stimulator assets, mainly within the CNS therapeutic area, to build a new portfolio. If the Company identifies suitable new assets the Company will seek to develop the new assets and retain contract research, development and manufacturing organizations for these specific purposes, as well as seek to raise funds for further research and development activities in a fit for purpose way. The Company’s goal is to find the best combination of capital, capabilities, and transactions that will enable the advancement of current and any future assets the Company may acquire for patients in a way that maximizes shareholder value.

Current wording

We have shifted our strategy to identify non-sGC stimulator assets, mainly within the CNS therapeutic area, to build a new portfolio. If the Company identifies suitable new assets, the Company will seek to develop the new assets and retain contract research and development and seek to outsource to manufacturing organizations for these specific purposes, as well as seek to raise funds for further research and development activities. The Company’s goal is to find the best combination of capital, capabilities, and transactions that will enable the advancement of current and any future assets the Company may acquire for patients in a way that maximizes shareholder value.

Previous wording

Praliciguat is an orally administered, once-daily systemic sGC stimulator. On June 3, 2021, we entered into a license agreement with Akebia relating to the exclusive worldwide license to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing praliciguat and other related products and forms thereof enumerated in such agreement. Cyclerion is eligible to receive up to $585 million in total potential future development, regulatory, and commercialization milestone payments.

Current wording

Praliciguat is an orally administered, once-daily systemic sGC stimulator. On June 3, 2021, we entered into a license agreement with Akebia relating to the exclusive worldwide license to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing praliciguat and other related products and forms thereof enumerated in such agreement. Cyclerion is eligible to receive up to $585 million in total potential future development, regulatory, and commercialization milestone payments. Cyclerion is also eligible to receive tiered, sales-based royalties ranging from single-digit to high-teen percentages and subject to reduction upon expiration of patent rights or the launch of a generic product.

Previous wording

Olinciguat is a Phase 2, orally administered, once-daily, vascular sGC stimulator that we are seeking to out-license to an entity with strong cardiovascular and/or cardiopulmonary capabilities.

Current wording

Olinciguat is a Phase 2 orally administered, once-daily, vascular sGC stimulator that Cyclerion intends to out-license to an entity with strong cardiovascular and/or cardiopulmonary capabilities.

Previous wording

The following table summarizes our research and development expenses, employee and facility related costs allocated to research and development expense, and discovery and pre-clinical phase programs, for the three months ended March 31, 2024 and 2023. The product pipeline expenses relate primarily to external costs associated with nonclinical studies and clinical trial costs.

Current wording

The following table summarizes our research and development expenses, employee and facility related costs allocated to research and development expense, and discovery and pre-clinical phase programs, for the three and six months ended June 30, 2024 and 2023. The product pipeline expenses relate primarily to external costs associated with nonclinical studies and clinical trial costs.

Previous wording

Research and development expense. The Company had further reductions of workforce in 2023 in connection with the sale of the Transferred Assets to Tisento and change to the Company’s strategy. The decrease in research and development expense of approximately $0.5 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 was driven by decreases of approximately $0.2 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $0.1 million in IT services, approximately $0.1 million in lab equipment and service and approximately $0.1 million in professional services.

Current wording

Research and development expense. The Company had further reductions of workforce in 2023 in connection with the sale of the Transferred Assets to Tisento and change to the Company’s strategy. The decrease in research and development expense of approximately $0.2 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 was driven by decreases of approximately $0.1 million in lab equipment and service and approximately $0.1 million in lab space rent.

Previous wording

General and administrative expense. The decrease in general and administrative expenses of approximately $1.1 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 was primarily driven by decreases of approximately $0.2 million in employee-related expenses primarily due to the workforce reduction in 2023 and approximately $0.9 million in legal services.

Current wording

General and administrative expense. The decrease in general and administrative expenses of approximately $0.2 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 was primarily driven by decreases of approximately $0.2 million in insurance expenses, approximately $0.1 million in legal services and approximately $0.1 million in IT service, offset by an increase of approximately $0.1 million of professional consulting.

Previous wording

Loss from discontinued operations. The decrease in loss from discontinued operations of approximately $3.8 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 was driven by the sale of Transferred Assets in July 2023. After the sale of Transferred Assets, no discontinued operation was recognized in the income statements.

Current wording

Loss from discontinued operations. The decrease in loss from discontinued operations of approximately $2.4 million and $6.1 million for the three and six months ended June 30, 2024 compared to the three and six months ended June 30, 2023, respectively, was driven by the sale of Transferred Assets in July 2023. After the sale of Transferred Assets, no discontinued operation was recognized in the income statements.

Previous wording

Interest and other income (expenses), net. Interest and other income (expenses), net decreased by a de minimus amount for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 due to an decreased in money market funds balance.

Current wording

Interest and other income (expenses), net. Interest and other income (expenses) was not changed significantly for the three and six months ended June 30, 2024, compared to the three and six months ended June 30, 2023.

Previous wording

On March 31, 2024, we had approximately $5.7 million of unrestricted cash and cash equivalents. Our cash equivalents include amounts held in U.S. government money market funds. We invest cash in excess of immediate requirements in accordance with our investment policy, which requires all investments held by us to be at least “AAA” rated or equivalent, with a remaining final maturity when purchased of less than twelve months, so as to primarily achieve liquidity and capital preservation.

Current wording

On June 30, 2024, we had approximately $4.6 million of unrestricted cash and cash equivalents. Our cash equivalents include amounts held in U.S. government money market funds. We invest cash in excess of immediate requirements in accordance with our investment policy, which requires all investments held by us to be at least “AAA” rated or equivalent, with a remaining final maturity when purchased of less than twelve months, so as to primarily achieve liquidity and capital preservation.

Previous wording

We have incurred recurring losses since our inception, including a net loss of $1.5 million for the three months ended March 31, 2024. In addition, as of March 31, 2024, we had an accumulated deficit of $266.0 million. We expect that our cash and cash equivalents as of March 31, 2024, will be sufficient to fund operations through the second quarter of 2025, however we will need to obtain additional funding to sustain operations as we expect to continue to generate operating losses for the foreseeable future. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern.

Current wording

We have incurred recurring losses since our inception, including a net loss of $2.9 million for the six months ended June 30, 2024. In addition, as of June 30, 2024, we had an accumulated deficit of $267.3 million. We expect that our cash and cash equivalents as of June 30, 2024, will be sufficient to fund operations into mid-2025, however we will need to obtain additional funding to sustain operations as we expect to continue to generate operating losses for the foreseeable future. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern.

Previous wording

The following is a summary of cash flows for the three months ended March 31, 2024 and 2023:

Current wording

The following is a summary of cash flows for the six months ended June 30, 2024 and 2023:

Previous wording

Net cash used in operating activities was $1.9 million for the three months ended March 31, 2024 was primarily a result of our $1.5 million net loss from operations. The net loss was offset by stock-based compensation expense of $0.2 million and a decrease in prepaid expense of $0.1 million. The net loss was also adjusted by a decrease in accounts payable of $0.5 million and a decrease in accrued expenses and other current liabilities of $0.2 million.

Current wording

Net cash used in operating activities was $3.0 million for the six months ended June 30, 2024 was primarily a result of our $2.9 million net loss from operations. The net loss was offset by non-cash stock-based compensation expense of $0.4 million and a decrease in prepaid expense of $0.3 million. The net loss was also adjusted by a decrease in accounts payable of $0.5 million and a decrease in accrued expenses and other current liabilities of $0.3 million.

Previous wording

Net cash used in operating activities was $6.2 million for the three months ended March 31, 2023 was primarily a result of our $7.0 million net loss from operations. The net loss was offset by stock-based compensation expense of $0.4 million, a decrease in prepaid expense and other current assets of $0.3 million, a decrease in other assets of $0.1 million and an increase in account payable of $1.0 million. The net loss was also adjusted by a decrease in accrued research and development costs of $0.7 million and a decrease in accrued expenses and other current liabilities of $0.4 million.

Current wording

Net cash used in operating activities was $12.8 million for the six months ended June 30, 2023 was primarily a result of our $11.1 million net loss from operations. The net loss was offset by non-cash stock-based compensation expense of $0.8 million, a decrease in accounts receivable of $0.1 million, a decrease in other current assets of $0.1 million, a decrease in operating lease assets of $0.1 million, a decrease in other assets of $0.2 million and an increase in accrued expenses and other current liabilities of $0.1 million. The net loss was also adjusted by an increase in prepaid expense of $0.2 million, a decrease in account payable of $1.1 million and a decrease in accrued research and development costs of $1.7 million.

Previous wording

We expect our expenses to fluctuate as we continue to maintain out-license opportunities and seek to broaden our portfolio through in-licensing of assets. We expect that our cash and cash equivalents as of March 31, 2024, will be sufficient to fund operations through the second quarter of 2025, however we will need to obtain additional funding to sustain operations as we expect to continue to generate operating losses for the foreseeable future. Failure to obtain necessary capital when needed may delay development of any current or potential future product candidates, or other operations.

Current wording

We expect our expenses to fluctuate as we continue to maintain out-license opportunities and seek to broaden our portfolio through in-licensing of assets. We expect that our cash and cash equivalents as of June 30, 2024, will be sufficient to fund operations into mid-2025, however we will need to obtain additional funding to sustain operations as we expect to continue to generate operating losses for the foreseeable future. Failure to obtain necessary capital when needed may delay development of any current or potential future product candidates, or other operations.

Previous wording

As part of the separation benefit of former Chief Financial Officer, we shall pay to our former Chief Financial Officer a payment of $0.1 million on each of the six-month and nine-month anniversaries of November 15, 2023, in the event the former Chief Financial Officer has not secured full-time employment prior to the anniversary date.

Current wording

As part of the separation benefit of the former Chief Financial Officer, we paid $0.1 million in May 2024, as the former Chief Financial Officer had not secured full-time employment prior to the six-month anniversary of November 15, 2023. We shall pay to former Chief Financial Officer another payment of $0.1 million on the nine-month anniversary of November 15, 2023, in the event the former Chief Financial Officer has not secured full-time employment prior to the anniversary date.