TScan Therapeutics Inc

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing a robust pipeline of T cell receptor (TCR)-engineered T cell, or TCR-T, therapies for the treatment of patients with cancer. Our approach is based on the central premise that we can learn from patients who are winning their fight against cancer to treat those who are not. Over the past several years, we have built our ImmunoBank, a repository of therapeutic TCRs that recognize diverse targets and are associated with multiple human leukocyte antigen, or HLA, types. These TCRs are then used to manufacture enhanced TCR-T therapies to treat a broad population of patients with both heme and solid tumor malignancies. Every TCR in our ImmunoBank has come from our proprietary platform technologies, and we are continuing to expand our ImmunoBank. Using TargetScan, we analyze the T cells of cancer patients with exceptional responses to immunotherapy to discover how the immune system naturally recognizes and eliminates tumor cells in these patients. This allows us to precisely identify the targets of TCRs that are driving these exceptional responses. We then use these anti-cancer TCRs to treat patients by genetically engineering T cells to recognize and eliminate their cancer. In addition to discovering TCRs against novel targets, we are using our ReceptorScan technology to identify high affinity naturally occurring TCRs for known targets. Once we identify therapeutic candidates using these technologies, we aim to reduce the safety risk of clinical development by comprehensively screening these TCRs against the human proteome using SafetyScan to identify potential off-target interactions. We then eliminate any TCR-T therapy candidates that cross-react with proteins expressed at high levels in normal tissues.

Current wording

We are a clinical-stage biotechnology company focused on developing a robust pipeline of T cell receptor (TCR)-engineered T cell, or TCR-T, therapies for the treatment of patients with cancer. Our approach is based on the central premise that we can learn from patients who are winning their fight against cancer to treat those who are not. Over the past several years, we have built our ImmunoBank, a repository of therapeutic TCRs that recognize diverse targets and are associated with multiple human leukocyte antigen, or HLA, types. These TCRs are then used to manufacture enhanced TCR-T therapies to treat a broad population of patients with both hematologic, or heme, and solid tumor malignancies. Every TCR in our ImmunoBank has come from our proprietary platform technologies, and we are continuing to expand our ImmunoBank. Using TargetScan, we analyze the T cells of cancer patients with exceptional responses to immunotherapy to discover how the immune system naturally recognizes and eliminates tumor cells in these patients. This allows us to precisely identify the targets of TCRs that are driving these exceptional responses. We then use these anti-cancer TCRs to treat patients by genetically engineering T cells to recognize and eliminate their cancer. In addition to discovering TCRs against novel targets, we are using our ReceptorScan technology to identify high affinity naturally occurring TCRs for known targets. Once we identify therapeutic candidates using these technologies, we aim to reduce the safety risk of clinical development by comprehensively screening these TCRs against the human proteome using SafetyScan to identify potential off-target interactions. We then eliminate any TCR-T therapy candidates that cross-react with proteins expressed at high levels in normal tissues.

Previous wording

We are advancing a robust pipeline of TCR-T therapy candidates for the treatment of patients with hematologic malignancies and solid tumors. Our lead product candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic 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 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 more sites throughout the remainder of 2024.

Previous wording

In addition, we are developing multiple TCR-T therapy candidates for the treatment of solid tumors. One of the challenges of treating solid tumors is that they are heterogeneous - not every tumor cell expresses a given target and some tumor cells lose half their HLA genes. To address this challenge, we are developing what we refer to as multiplex TCR-T therapy - treating a patient with more than one TCR-T therapy candidate at a time. We are designing these multiplex therapies to be a simultaneous administration of up to three highly active TCR-T therapy candidates, selected from our ImmunoBank, that are customized for each patient based on which targets are expressed in their tumors and which HLA genes are still intact. We continue to prioritize expanding the ImmunoBank with TCRs for multiple targets and multiple HLA types for each target. We have now advanced six TCR-T therapy candidates into Phase 1 development for solid tumors: TSC-203-A0201 (PRAME, HLA-A02:01); TSC-200-A0201 (HPV16, HLA-A02:01); TSC-201-B0702 (MAGE-C2, HLA-B07:02); TSC-204-A0201 (MAGE-A1, HLA-A02:01); TSC-204-C0702 (MAGE-A1, HLA-C07:02); and TSC-204-A0101 (MAGE-A1, HLA-A01:01). In addition to clearing these six solid-tumor investigational new drug (IND) applications, the FDA has cleared our IND application for T-Plex, enabling us to treat patients with multiplex TCR-T therapy. We plan to further expand the ImmunoBank by filing IND applications for additional TCR-T therapy candidates.

Current wording

In addition, we are developing multiple TCR-T therapy candidates for the treatment of solid tumors. One of the challenges of treating solid tumors is that they are heterogeneous - not every tumor cell expresses a given target and some tumor cells lose half their HLA genes. To address this challenge, we are developing what we refer to as multiplex TCR-T therapy - treating a patient with more than one TCR-T therapy candidate at a time. We are designing these multiplex therapies to be a simultaneous administration of up to three highly active TCR-T therapy candidates, selected from our ImmunoBank, that are customized for each patient based on which targets are expressed in their tumors and which HLA genes are still intact. We continue to prioritize expanding the ImmunoBank with TCRs for multiple targets and multiple HLA types for each target. We have now advanced six TCR-T therapy candidates into Phase 1 development for solid tumors: TSC-203-A0201 (PRAME, HLA-A02:01); TSC-200-A0201 (HPV16, HLA-A02:01); TSC-201-B0702 (MAGE-C2, HLA-B07:02); TSC-204-A0201 (MAGE-A1, HLA-A02:01); TSC-204-C0702 (MAGE-A1, HLA-C07:02); and TSC-204-A0101 (MAGE-A1, HLA-A01:01). In addition to clearing these six solid-tumor investigational new drug (IND) applications, the U.S. Food and Drug Administration (FDA) has cleared our IND application for T-Plex, enabling us to treat patients with multiplex TCR-T therapy. We plan to further expand the ImmunoBank by filing IND applications for additional TCR-T therapy candidates.

Previous wording

Since our inception in 2018, we have devoted our efforts to raising capital, obtaining financing, filing, prosecuting and maintaining intellectual property rights, organizing and staffing our Company and incurring research and development costs related to the identification of novel targets for TCRs and development of TCR-T therapy candidates to target and eliminate cancer cells. We do not have any therapies approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from sales of capital stock, revenue received under our collaboration agreements, as well as a debt facility with K2HV.

Current wording

Since our inception in 2018, we have devoted our efforts to raising capital, obtaining financing, filing, prosecuting and maintaining intellectual property rights, organizing and staffing our Company and incurring research and development costs related to the identification of novel targets for TCRs and development of TCR-T therapy candidates to target and eliminate cancer cells. We do not have any therapies approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from sales of capital stock, revenue received under our collaboration agreements, and a debt facility with K2 Health Venures LLC (K2HV).

Previous wording

We have incurred significant operating losses since our inception. We reported net losses of $30.1 million and $22.6 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $277.7 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 $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:

Previous wording

We will not generate revenue from sales of our therapies unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our commercialization capability to support the sales, marketing and distribution of those therapies. Further, we expect to incur additional costs associated with operating as a public company.

Current wording

We will not generate revenue from sales of our therapies unless and until we successfully complete clinical development and obtain regulatory approval for one or more of our product candidates. If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our commercialization capability to support the sales, marketing and distribution of those therapies. Further, we expect to continue to incur costs associated with operating as a public company.

Previous wording

We believe that our existing cash, cash equivalents and marketable securities, along with the proceeds received from our underwritten public offering completed in April 2024, will enable us to fund our current operating plan into the fourth quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. For additional information regarding our liquidity, see “Liquidity and Capital Resources” and “Risk factors—Risks related to our financial position and need for additional capital.”

Current wording

We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our current operating plan into the fourth quarter of 2026. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. For additional information regarding our liquidity, see “Liquidity and Capital Resources” and “Risk Factors—Risks related to our financial position and need for additional capital.”

Previous wording

Research and development expenses increased $3.1 million and was primarily attributable to a $2.3 million increase in clinical studies expense due to Phase 1 study enrollment for TSC-100 and TSC-101 and Phase 1 study start-up activities for the solid tumor clinical trial, as well as a $2.1 million increase in personnel expenses due to increased headcount in support of expanded research and development activities, offset by lower laboratory, research and facility costs of $1.9 million. Research and development expenses included non-cash stock compensation expense of $1.1 million and $0.4 million for the first quarter of 2024 and 2023, respectively.

Current 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.

Previous wording

Other income has increased $1.1 million primarily due to an increase in interest income attributable to higher cash balances available for investment.

Current wording

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

Previous wording

Revenue for the first quarter of 2024 was $0.6 million, compared to $6.8 million for the first quarter of 2023. The decrease was primarily due the timing of research activities performed pursuant to our collaboration agreements. Revenue for the first quarter of 2024 was related solely to our collaboration agreement with Amgen which commenced in May 2023. Revenue for the first quarter of 2023 was primarily related to our collaboration agreement with Novartis, which concluded in March 2023.

Current 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.

Previous wording

Pursuant to the Loan Agreement with K2HV (the Loan Agreement), K2HV may provide us with convertible term loans in an aggregate principal amount of up to $60 million, of which $30 million gross proceeds was provided on the closing date. We have the option to draw the remaining tranches subject to certain conditions, including certain clinical milestones. See “Notes to Condensed Consolidated Financial Statements” and “Risk factors—Risks related to our financial position and need for additional capital” for additional details regarding the Loan Agreement.

Current wording

Pursuant to the Loan Agreement with K2HV (the Loan Agreement), K2HV may provide us with convertible term loans in an aggregate principal amount of up to $60 million, of which $30 million gross proceeds was provided on the closing date. We have the option to draw a third tranche subject to a joint agreement between us and K2HV. See “Notes to Condensed Consolidated Financial Statements” and “Risk Factors—Risks related to our financial position and need for additional capital” for additional details regarding the Loan Agreement.

Previous wording

On April 24, 2024, we completed an underwritten public offering resulting in the issuance and sale of (a) 4,958,068 shares of Voting Common Stock, including the partial exercise of the underwriters’ option to purchase 2,485,487 additional shares of Voting Common Stock, at the closing market price on April 16th of $7.13 per share, and (b) Pre-Funded Warrants to purchase up to 18,577,419 shares of the Voting Common Stock, at a price of $7.1299 per warrant with an exercise price of $0.0001 per share. We received aggregate net proceeds of approximately $161.4 million after deducting underwriting discounts, commissions and other estimated offering expenses.

Current wording

On April 24, 2024, we completed an underwritten public offering resulting in the issuance and sale of (a) 4,958,068 shares of Voting Common Stock, including the partial exercise of the underwriters’ option to purchase 2,485,487 additional shares of Voting Common Stock, at the closing market price on April 16, 2024, of $7.13 per share, and (b) Pre-Funded Warrants to purchase up to 18,577,419 shares of the Voting Common Stock, at a price of $7.1299 per warrant with an exercise price of $0.0001 per share. We received aggregate net proceeds of approximately $161.4 million after deducting underwriting discounts, commissions and other estimated offering expenses.

Previous wording

As of March 31, 2024, we had cash, cash equivalents and marketable securities of $162.8 million, excluding restricted cash of $5.0 million.

Current 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.

Previous wording

We believe that our existing cash, cash equivalents and marketable securities, along with the proceeds received from our underwritten public offering completed in April 2024, will enable us to fund our current operating plan into the fourth quarter of 2026. 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 marketable securities will enable us to fund our current operating plan into the fourth quarter of 2026. 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

During the three months ended March 31, 2024, net cash used in operating activities of $29.3 million was primarily driven by our net loss of $30.1 million, partially offset by non-cash charges of $3.0 million related to depreciation expense, accretion of marketable securities, stock-based compensation, and non-cash interest expense related to note payable. During the three months ended March 31, 2024, working capital changes resulted in a use of $2.1 million. The change in working capital was primarily driven by changes in accrued expenses related to research and development activities.

Current 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.

Previous wording

During the three months ended March 31, 2023, net cash used in operating activities of $23.6 million was primarily driven by our net loss of $22.6 million, partially offset by non-cash charges of $2.9 million related to depreciation expense, stock-based compensation, and non-cash interest expense related to note payable. During the three months ended March 31, 2023, working capital changes resulted in a use of $3.9 million. The change in working capital was primarily driven by changes in deferred revenue related to the completion of the Novartis Agreement.

Current 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.

Previous wording

During the three months ended March 31, 2024, net cash provided by investing activities was $36.2 million, primarily related to the purchases and maturities of marketable securities, and the purchases of property and equipment.

Current 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.

Previous wording

During the three months ended March 31, 2023, net cash used in investing activities was $0.8 million, related to the purchases of property and equipment.

Current 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.

Previous wording

During the three months ended March 31, 2024, net cash provided by financing activities was $0.3 million, consisting of proceeds from the exercise of stock options.

Current 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.

Previous wording

The JOBS Act permits an “emerging growth company” to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. The Company qualifies as “emerging growth company” under the JOBS Act and has elected to “opt in” to the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.

Current wording

The Jumpstart Our Business Startups Act of 2012 (JOBS Act) permits an “emerging growth company” to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. The Company qualifies as an “emerging growth company” under the JOBS Act and has elected to “opt in” to the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.