TScan Therapeutics Inc

Previous wording

We are advancing a robust pipeline of TCR-T therapy candidates for the treatment of patients with heme malignancies and solid tumors. Our lead product candidates, TSC-100 and TSC-101, are in development for the treatment of patients with heme malignancies to eliminate residual disease and prevent relapse following allogeneic hematopoietic cell transplantation (HCT). TSC-100 and TSC-101 target the antigens HA-1 and HA-2, respectively, which are well-recognized TCR targets that were first identified in patients with exceptional responses to HCT-associated immunotherapy. We have initiated a multi-arm Phase 1 "umbrella" clinical study of TSC-100 and TSC-101, the ALLOHATM Phase 1 heme trial, with over ten clinical sites activated, and we plan to add more sites throughout the remainder of 2024.

Current wording

We are advancing a robust pipeline of TCR-T therapy candidates for the treatment of patients with heme malignancies and solid tumors. Our lead product candidates, TSC-100 and TSC-101, are in development for the treatment of patients with heme malignancies to eliminate residual disease and prevent relapse following allogeneic hematopoietic cell transplantation (HCT). TSC-100 and TSC-101 target the antigens HA-1 and HA-2, respectively, which are well-recognized TCR targets that were first identified in patients with exceptional responses to HCT-associated immunotherapy. We have initiated a multi-arm Phase 1 "umbrella" clinical study of TSC-100 and TSC-101, the ALLOHATM Phase 1 heme trial, with over ten clinical sites activated, and we plan to add additional sites before the end of 2024.

Previous wording

We have incurred significant operating losses since our inception. We reported net losses of $61.8 million and $46.6 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $309.4 million. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We expect that our expenses and capital expenditure requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Current wording

We have incurred significant operating losses since our inception. We reported net losses of $91.7 million and $69.6 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $339.3 million. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We expect that our expenses and capital expenditure requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Previous wording

Revenue for the second quarter of 2024 was $0.5 million, compared to $3.1 million for the second quarter of 2023. The decrease was primarily due to the timing of research activities performed pursuant to our collaboration agreement with Amgen which commenced in May 2023.

Current wording

Revenue for the third quarter of 2024 was $1.0 million, compared to $3.9 million for the third quarter of 2023. The decrease was primarily due to the timing of research activities performed pursuant to our collaboration agreement with Amgen which commenced in May 2023.

Previous wording

Research and development expenses increased $5.7 million and was primarily attributable to a $2.6 million increase in clinical studies expense driven by enrollment in the ALLOHA Phase 1 heme trial and start-up activities and Phase 1 study enrollment in the solid tumor clinical trial. There was also a $1.9 million increase in personnel expenses due to increased headcount in support of expanded research and development activities. Research and development expenses included non-cash stock compensation expense of $1.2 million and $0.6 million for the second quarter of 2024 and 2023, respectively.

Current wording

Research and development expenses increased $3.5 million and was primarily attributable to a $1.9 million increase in clinical studies expense driven by enrollment in the ALLOHA Phase 1 heme clinical trial as well as start-up activities and enrollment in the Phase 1 solid tumor clinical trial. Personnel expenses increased $1.8 million due to additional headcount in support of expanded research and development activities, partially offset by a $0.5 million decrease in laboratory supplies, research materials and studies. Research and development expenses included non-cash stock compensation expense of $1.2 million and $0.9 million for the third quarter of 2024 and 2023, respectively.

Previous wording

General and administrative expenses increased by $1.2 million and was primarily attributable to a $0.7 million increase in personnel expenses due to increased headcount. General and administrative expenses included non-cash stock compensation expense of $1.1 million and $0.6 million for the second quarter of 2024 and 2023, respectively.

Current wording

General and administrative expenses increased by $1.5 million and was primarily attributable to a $0.9 million increase in personnel expenses due to additional headcount. General and administrative expenses included non-cash stock compensation expense of $1.3 million and $0.4 million for the third quarter of 2024 and 2023, respectively.

Previous wording

Other income has increased $1.9 million primarily due to an increase in interest income attributable to higher cash balances available for investment.

Current wording

Other income has increased $1.0 million primarily due to an increase in interest income attributable to higher cash balances available for investment.

Previous wording

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

Current wording

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

Previous wording

Revenue for the six months ended June 30, 2024 and 2023 was $1.1 million and $10.0 million, respectively. The decrease was primarily due to the timing of research activities performed pursuant to our collaboration agreements. Revenue for the 2024 period was related solely to our collaboration agreement with Amgen which commenced in May 2023. Revenue for the 2023 period was primarily driven by $5.8 million related to our collaboration agreement with Novartis, which concluded in March 2023, and $3.1 million related to our collaboration agreement with Amgen.

Current wording

Revenue for the nine months ended September 30, 2024 and 2023 was $2.2 million and $13.8 million, respectively. The decrease was primarily due to the timing of research activities performed pursuant to our collaboration agreements. Revenue for the 2024 period was related solely to our collaboration agreement with Amgen which commenced in May 2023. Revenue for the 2023 period was primarily driven by $7.0 million related to our collaboration agreement with Amgen, and $5.8 million related to our collaboration agreement with Novartis, which concluded in March 2023.

Previous wording

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

Current wording

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

Previous wording

Research and development expenses increased $8.7 million and was primarily attributable to a $4.9 million increase in clinical studies expense driven by enrollment in the ALLOHA Phase 1 heme trial and start-up activities and Phase 1 study enrollment in the solid tumor clinical trial. There was also a $3.9 million increase in personnel expenses due to increased headcount in support of expanded research and development activities. Research and development expenses included non-cash stock compensation expense of $2.3 million and $1.0 million for the six months ended June 30, 2024 and 2023, respectively.

Current wording

Research and development expenses increased $12.2 million and was primarily attributable to a $6.8 million increase in clinical studies expense driven by enrollment in the ALLOHA Phase 1 heme clinical trial as well as start-up activities and enrollment in the Phase 1 solid tumor clinical trial. There was also a $5.7 million increase in personnel expenses due to additional headcount in support of expanded research and development activities, a $1.1 million decrease in laboratory supplies, research materials and studies due to timing of license fees, and a $0.7 million decrease in facility-related expenses. Research and development expenses included non-cash stock compensation expense of $3.5 million and $1.9 million for the nine months ended September 30, 2024 and 2023, respectively.

Previous wording

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

Current wording

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

Previous wording

General and administrative expenses increased by $0.6 million and included non-cash stock compensation expense of $2.0 million and $1.3 million for the six months ended June 30, 2024 and 2023, respectively.

Current wording

General and administrative expenses increased by $2.1 million and was primarily attributable to a $1.0 million increase in personnel expenses due to additional headcount. General and administrative expenses included non-cash stock compensation expense of $3.3 million and $1.8 million for the nine months ended September 30, 2024 and 2023, respectively.

Previous wording

Other income has increased $2.9 million primarily due to an increase in interest income attributable to higher cash balances available for investment.

Current wording

Other income has increased $3.9 million primarily due to an increase in interest income attributable to higher cash balances available for investment.

Previous wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $297.7 million, excluding restricted cash of $5.0 million.

Current wording

As of September 30, 2024, we had cash, cash equivalents and marketable securities of $271.1 million, excluding restricted cash of $5.0 million.

Previous wording

During the six months ended June 30, 2024, net cash used in operating activities of $55.5 million was primarily driven by our net loss of $61.8 million, partially offset by non-cash charges of $6.2 million related to depreciation expense, accretion of marketable securities, stock-based compensation, and non-cash interest expense related to note payable. During the six months ended June 30, 2024, working capital changes resulted in a source of $0.1 million.

Current wording

During the nine months ended September 30, 2024, net cash used in operating activities of $83.4 million was primarily driven by our net loss of $91.7 million, partially offset by non-cash charges of $8.5 million related to depreciation expense, accretion of marketable securities, stock-based compensation, and non-cash interest expense related to note payable. During the nine months ended September 30, 2024, working capital changes resulted in a use of $0.2 million.

Previous wording

During the six months ended June 30, 2023, net cash used in operating activities of $45.6 million was primarily driven by our net loss of $46.6 million, partially offset by non-cash charges of $5.6 million related to depreciation expense, stock-based compensation, and non-cash interest expense related to note payable. During the six months ended June 30, 2023, working capital changes resulted in a use of $4.6 million. The change in working capital was primarily driven by changes in accounts receivable and deferred revenue related to the completion of the Novartis Agreement and commencement of the Amgen Agreement.

Current wording

During the nine months ended September 30, 2023, net cash used in operating activities of $37.6 million was primarily driven by our net loss of $69.6 million, partially offset by non-cash charges of $8.2 million related to depreciation expense, accretion of marketable securities, stock-based compensation, and non-cash interest expense related to note payable. During the nine months ended September 30, 2023, working capital changes resulted in a source of $23.8 million. The change in working capital was primarily driven by changes in accounts receivable and deferred revenue related to the completion of the Novartis Agreement and commencement of the Amgen Agreement.

Previous wording

During the six months ended June 30, 2024, net cash provided by investing activities was $2.4 million, primarily related to the purchases and maturities of marketable securities, and the purchases of property and equipment.

Current wording

During the nine months ended September 30, 2024, net cash used in investing activities was $79.9 million, primarily related to the purchases and maturities of marketable securities, and the purchases of property and equipment.

Previous wording

During the six months ended June 30, 2023, net cash used in investing activities was $1.3 million, related to the purchases of property and equipment.

Current wording

During the nine months ended September 30, 2023, net cash used in investing activities was $62.7 million, primarily related to the purchases of marketable securities, and the purchases of property and equipment.

Previous wording

During the six months ended June 30, 2024, net cash provided by financing activities was $161.8 million, consisting of net proceeds of $161.4 million from our follow-on public offering in April 2024 and $0.4 million of proceeds from the exercise of stock options.

Current wording

During the nine months ended September 30, 2024, net cash provided by financing activities was $163.1 million, consisting of net proceeds of $161.4 million from our follow-on public offering in April 2024 and $1.7 million of proceeds from the exercise of stock options.

Previous wording

During the six months ended June 30, 2023, net cash provided by financing activities was $135.7 million, consisting of net proceeds of $135.0 million from our follow-on public offering in June 2023 and $0.7 million of proceeds from the exercise of stock options.

Current wording

During the nine months ended September 30, 2023, net cash provided by financing activities was $135.4 million, consisting of net proceeds of $134.7 million from our follow-on public offering in June 2023 and $0.7 million of proceeds from the exercise of stock options.

Previous wording

We are also a “smaller reporting company”, meaning that the market value of our stock held by non-affiliates plus the aggregate amount of gross proceeds to us as a result of the initial public offering is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Current wording

We are also a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held by non-affiliates exceeds $250 million as of the prior June 30, or (ii) our annual revenues exceed $100 million during such completed fiscal year and the market value of our common stock held by non-affiliates exceeds $700 million as of the prior June 30. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.