Cyclerion Therapeutics Inc

Previous 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.

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. On July 22, 2024, we entered into an Option to License Agreement (the “Option Agreement”) with a third party (the “Optionee”), pursuant to which the Optionee has an option (the “Option”) to enter into an exclusive license to olinciguat for human therapeutics, subject to certain carveouts. Under the terms of the Option Agreement, the Optionee paid the Company an Option fee of $150,000 in August 2024. The Optionee may exercise the Option on or before February 22, 2025, which may be extended for an additional two-month period for an additional fee of $25,000. If the Optionee exercises the Option during the Option Period, the Parties shall promptly commence negotiations of the definitive license agreement. The terms of the license agreement will be negotiated in good faith within a period not to exceed 90 days after the date of exercise of the Option. If the parties cannot reach agreement, all rights revert to the Company. In addition, the Optionee has agreed to reimburse the Company for certain patent expenses incurred during the Option period.

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 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.

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 nine months ended September 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 $0.2 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.

Current wording

Research and development expense. We 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 September 30, 2024 compared to the three months ended September 30, 2023 was driven by decreases of approximately $0.3 million in employee-related expenses primarily due to the workforce reduction in 2023 and a decrease of approximated of $0.2 million in other miscellaneous expenses including professional consulting expense, research study costs and outside service fees.

Previous wording

The decrease in research and development expense of approximately $0.8 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was driven by decreases of approximately $0.2 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $0.2 million in IT services, approximately $0.2 million in lab equipment and service and approximately $0.1 million in lab space rent.

Current wording

The decrease in research and development expense of approximately $1.3 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was driven by decreases of approximately $0.5 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $0.2 million in information technology services, approximately $0.1 million in research study costs, approximately $0.1 million in outside service fee, approximately $0.2 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 $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.

Current wording

General and administrative expense. The decrease in general and administrative expenses of approximately $0.9 million for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 was primarily 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 board member fees, approximately $0.1 million in outside service fee, approximately $0.4 million in legal services and approximately $0.1 million in audit service.

Previous wording

The decrease in general and administrative expenses of approximately $1.4 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was primarily driven by decreases of approximately $0.1 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $1.0 million in legal services, approximately $0.1 million in audit and tax services, $0.3 million in insurance expenses and approximately $0.2 million in computer hardware, offset by an increase of approximately of $0.4 million in professional consulting.

Current wording

The decrease in general and administrative expenses of approximately $2.3 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily driven by decreases of approximately $0.3 million in employee-related expenses primarily due to the workforce reduction in 2023, approximately $1.4 million in legal services, approximately $0.2 million in audit and tax services, approximately $0.2 million in outside services, $0.3 million in insurance expenses and approximately $0.3 million in information technology services, offset by an increase of approximately of $0.4 million in professional consulting.

Previous 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.

Current wording

Gain from discontinued operations. The decrease in gain from discontinued operations of approximately $13.5 million and $7.3 million for the three and nine months ended September 30, 2024 compared to the three and nine months ended September 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

Our ability to continue to fund our operations and meet capital needs will depend on our ability to generate cash from operations and access to capital markets and other sources of capital, as further described below. We anticipate that our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures and other general corporate purposes.

Current wording

Our ability to continue to fund our operations and meet capital needs in the next twelve months will depend on our ability to generate cash from operations and access to capital markets and other sources of capital, as further described below. We anticipate that our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures and other general corporate purposes.

Previous 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.

Current wording

On September 30, 2024, we had approximately $2.9 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 $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.

Current wording

We have incurred recurring losses since our inception, including a net loss of $3.6 million for the nine months ended September 30, 2024. In addition, as of September 30, 2024, we had an accumulated deficit of $268.0 million. We expect that our cash and cash equivalents as of September 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 six months ended June 30, 2024 and 2023:

Current wording

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

Previous 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.

Current wording

Net cash used in operating activities was $4.7 million for the nine months ended September 30, 2024 was primarily a result of our $3.6 million net loss from operations. The net loss was offset by non-cash stock-based compensation expense of $0.5 million. The net loss was also adjusted by gain from settlement of accounts payable of $0.4 million, an increase in prepaid expense of $0.2 million, a decrease in accounts payable of $0.5 million and a decrease in accrued expenses and other current liabilities of $0.5 million.

Previous 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.

Current wording

Net cash used in operating activities was $19.7 million for the nine months ended September 30, 2023 was primarily a result of our $3.6 million net loss from operations. The net loss was offset by impairment loss of $3.3 million, non-cash stock-based compensation expense of $1.0 million, a decrease in account receivable of $0.1 million, a decrease in prepaid expenses of $0.1 million, a decrease in other current assets of $0.1 million, a decrease in operating lease assets of $0.1 million and a decrease in other assets of $0.2 million. The net loss was also adjusted by gain on disposal of discontinued operations of $15.8 million, a decrease in account payable of $2.2 million, a decrease in accrued research and development costs of $1.9 million and a decrease in accrued expenses and other current liabilities of $1.2 million.

Previous wording

There was no financing activity in the six months ended June 30, 2024. Net cash provided by financing activities for the six months ended June 30, 2023 of $5.0 million was due to cash received from the May 2023 stock purchase agreement of $5 million.

Current wording

There was no financing activity in the nine months ended September 30, 2024. Net cash provided by financing activities for the nine months ended September 30, 2023 of $5.0 million was due to cash received from the May 2023 stock purchase agreement of $5 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 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.

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 September 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. Additional funding may not be available on acceptable terms, if at all to continue as a going concern and advance our current and any potential future product candidates. Failure to obtain capital when needed may force us to delay, limit or terminate our product development efforts or other operations. Raising additional capital may dilute our existing shareholders, restrict our operations or cause us to relinquish valuable rights.

Previous 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.

Current wording

As part of the separation benefit of the former Chief Financial Officer, we paid $0.1 million in May 2024 and August 2024, as the former Chief Financial Officer had not secured full-time employment prior to the six-month anniversary and nine-month anniversary of November 15, 2023. We have no further separation benefits obligation as of September 30, 2024.