On November 12, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the third quarter ended September 30, 2025 and other recent business developments.

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"We made significant clinical and regulatory progress in the third quarter," said Brian Sullivan, CEO and co-founder of Celcuity. "At the ESMO (Free ESMO Whitepaper) Congress, we presented potentially practice-changing safety and efficacy results for the gedatolisib regimens from the PIK3CA wild-type cohort of our Phase 3 VIKTORIA-1 trial at a late breaking oral presentation. We remain on track to submit the New Drug Application for gedatolisib later this year based on data from the PIK3CA wild-type cohort. The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected in late Q1 2026 or during Q2 2026."

"There is an urgent need for more efficacious therapies than those currently available for patients with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor. With our strengthened balance sheet, and unprecedented efficacy results in this patient population, we are well positioned to bring gedatolisib to patients should we get FDA approval."

Third Quarter 2025 Business Highlights and Other Recent Developments

● The Company announced positive topline data for both primary endpoints of the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial that evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in patients with HR+, HER2- advanced breast cancer ("ABC") whose disease had progressed on or after prior treatment with a CDK4/6 inhibitor. Detailed safety and efficacy results were subsequently presented at a late breaking oral presentation at the 2025 ESMO (Free ESMO Whitepaper) Congress. The results demonstrate the potential for the gedatolisib regimens to be practice changing for patients with HR+, HER2- ABC.

◌ The gedatolisib-triplet (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ("HR") of 0.24. The median progression free survival ("PFS") was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.
◌ The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.
◌ Clinical benefit of the gedatolisib regimens was consistent across patient subgroups.
◌ The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0% of patients, respectively); rash (4.6%, 5.4%, and 0% of patients, respectively); and hyperglycemia (2.3%, 2.3%, and 0% of patients, respectively).
◌ Study treatment discontinuation due to TRAEs was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doublet.
◌ The PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled with topline data expected sometime in late Q1 2026 or during Q2 2026.

● Updated data from a Phase 1b study evaluating gedatolisib plus darolutamide in men with mCRPC was presented at a poster session at the 2025 ESMO (Free ESMO Whitepaper) Congress.

◌ In this Phase 1b study, 38 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2.
◌ The six-month radiographic PFS ("rPFS") rate and median rPFS for patients from both arms combined was 67% and 9.1 months, respectively. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.
◌ The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE.

● The FDA accepted the Company’s request to submit an NDA for gedatolisib under the Real-Time Oncology Review ("RTOR") program based on data from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial. The Company made its first NDA pre-submission in September 2025 and completion of the NDA submission is targeted for the fourth quarter of 2025.

● In July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant.

● In July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded warrants. The net proceeds from the offerings were $287 million, after deducting underwriting discounts and commissions and the Company’s offering expenses.

● In September 2025, the Company entered into an amendment to its existing senior secured term loan facility with an affiliate of Innovatus Capital Partners, LLC ("Innovatus"), and Oxford Finance LLC and certain of its affiliates (together, "Oxford"). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders.

◌ With the release of the topline data from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 clinical trial, Celcuity achieved the Term D milestone under the term loan facility and was eligible to draw an additional $30 million. In connection with the amendment, the $30.0 million Term D loan was disbursed and the Company received net proceeds of $27.8 million.
◌ The upsized facility strengthens Celcuity’s ability to manage its capital structure efficiently while providing additional funding to support commercial launch preparations for gedatolisib and other strategic initiatives.

● In the third quarter of 2025, investors exercised warrants generating cash proceeds of $12.8 million. The warrants were issued pursuant to a private placement that closed on December 9, 2022 and had an expiration date of 75 days from the release of the topline data from the PIK3CA WT cohort of the VICTORIA-1 Phase 3 clinical trial.

Third Quarter 2025 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2025, compared to the third quarter ended September 30, 2024.

Total operating expenses were $42.8 million for the third quarter of 2025, compared to $30.1 million for the third quarter of 2024.

Research and development ("R&D") expenses were $34.9 million for the third quarter of 2025, compared to $27.6 million for the prior-year period. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch-related activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials.

General and administrative ("G&A") expenses were $7.9 million for the third quarter of 2025, compared to $2.5 million for the prior-year period. Of the approximately $5.4 million increase in general and administrative expenses, $4.9 million was related to increased employee and consulting expenses. Of this $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation. The remaining $0.5 million of the $5.4 million increase was primarily related to professional fees, expanding infrastructure and other administrative expenses.

Net loss for the third quarter of 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss for the third quarter of 2025 was $37.2 million, or $0.78 loss per share, compared to non-GAAP adjusted net loss of $27.6 million, or $0.65 loss per share, for the third quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2025 was $44.8 million, compared to $20.6 million for the third quarter of 2024.

At September 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $455.0 million. We expect cash, cash equivalents, investments and drawdowns on our debt facility to fund operations through 2027.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2025 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=9d6c00e337. A replay of the webcast will be available on the Celcuity website following the live event.

(Press release, Celcuity, NOV 12, 2025, View Source [SID1234659815])

On November 12, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference in London on Monday, November 17, 2025, at 9:30 a.m. EST (2:30 p.m. GMT).

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Investors interested in arranging a meeting with company management during the conference should contact the Jefferies conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.

(Press release, Supernus, NOV 12, 2025, View Source [SID1234659831])

On November 12, 2025 Genezen, a leading viral vector Contract Development and Manufacturing Organization (CDMO), and Humane Genomics, a biotechnology company developing oncolytic viral therapies, reported a partnership for process transfer and cGMP manufacturing of HGI627, a novel therapy targeting pediatric liver cancer (hepatoblastoma).

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Humane Genomics uses its proprietary synthetic RNA virus platform to rapidly design and engineer RNA viruses with precise anti-cancer capabilities. Through a two-factor selectivity mechanism, these therapies infect and replicate only in targeted cancer cells, leaving healthy tissue unharmed. The company’s platform powers a growing pipeline of next-generation viral therapies across multiple cancer types, including their lead candidate, HGI627.

Under this collaboration, Genezen will perform technology transfer, process development, and cGMP manufacturing of the VSV-based HGI627 therapy.

"Genezen is excited to partner with Humane Genomics on this novel cancer treatment and provide our best-in-class manufacturing expertise to bring this critical therapy to life for pediatric patients," said Steve Favaloro, chairman and chief executive officer of Genezen. "This partnership reinforces our commitment to supporting innovators at every stage of development and highlights the deep technical expertise and commitment to patients of the Genezen team."

Peter Weijmarshausen, co-founder and chief executive officer of Humane Genomics, added, "We are thrilled to partner with Genezen. Their experienced, dynamic team and state-of-the-art facilities make them a perfect match to turn our groundbreaking science into real therapies for patients."

(Press release, Genezen, NOV 12, 2025, View Source [SID1234659854])

On November 12, 2025 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported financial results for the third quarter ended September 30, 2025 and provided an update on its business.

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Recent Corporate Highlights:

CorMedix announces $104.3 million of net revenue and $130.8 million of pro forma net revenue(1) for the third quarter of 2025, largely driven by higher than expected utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $88.8 million of net revenue in the quarter.
In the third quarter of 2025, the Company recognized Net Income of $108.6 million and adjusted EBITDA of $71.9 million(2). Basic and Fully Diluted EPS were $1.42 and $1.26 per share, respectively.
CorMedix again raises its full-year 2025 pro forma net revenue guidance to a range of $390 to $410 million, and fourth quarter net revenue guidance to a range of $115 to $135 million. In addition, the Company is increasing its guidance for fully synergized pro forma adjusted EBITDA for 2025 to a range of $220 – $240 million(3).
The Company’s acquisition of Melinta Therapeutics closed on August 29, 2025. Ongoing integration efforts are proceeding more quickly than projected and CorMedix estimates synergy capture of approximately $30 million, of the total estimated $35 – $45 million, on an annual run-rate basis before the end of 2025.
CorMedix announced today that the Company is re-branding as CorMedix Therapeutics, with all employees operating under the new company name.
In October, the Company announced the completion of enrollment in the ongoing Phase III ReSPECT study of Rezzayo in the prophylaxis of invasive fungal infections in adult patients undergoing blood and marrow transplantation. CorMedix continues to expect top-line data from this study in 2Q of 2026.
In September, the Company completed a strategic minority investment in Talphera, Inc. The strategic investment includes a Board seat and an exclusive right of first negotiation for an acquisition of Talphera following the company’s announcement of Phase 3 clinical data for Niyad, a hospital anticoagulant with a potential indication in patients undergoing Continuous Renal Replacement Therapy.
Cash and short-term investments, excluding restricted cash, at September 30, 2025 amounted to $55.7 million, and the company projects year-end cash of approximately $100 million.
Third Quarter 2025 Financial Results

For the third quarter of 2025, CorMedix recorded $104.3 million in net revenue from sales of DefenCath and partial quarter sales of the Melinta portfolio, and recorded $108.6 million in net income, or $1.26 per diluted share, compared with a net loss of $2.8 million, or $0.05 per diluted share, in the third quarter of 2024. Net income for the third quarter of 2025 was driven primarily by net product sales in the period as well as a one-time tax benefit of $59.7 million. The tax benefit was derived from the realization of deferred tax assets primarily associated with the anticipated future use of 100% of CorMedix, Inc. Net Operating Loss (NOL) carryforwards due to projected sustained profitability of the Company.

Total operating expenses in the third quarter of 2025 were $41.7 million, compared with $14.1 million in the third quarter of 2024, an increase of approximately 197%. The increase of $28.5 million over the prior period was driven primarily by $12.7 million of non-recurring costs, including transaction, integration and severance costs associated with the Melinta acquisition, as well as by the contribution of operating expenses from Melinta’s business for the month of September. Other drivers of increases year-over-year include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN.

The Company reported cash, cash equivalents and short-term investments of $55.7 million at September 30, 2025, excluding restricted cash.

(1) Q3 2025 unaudited pro forma net revenue was prepared by combining the estimated financial results for CorMedix and Melinta for the full fiscal quarter ended September 30, 2025, as if the transaction had closed as of the first day of the fiscal quarter. Pro Forma 2025 Net Revenue guidance was prepared by combining the estimated financial results and guidance for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025.

(2) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as stock-based compensation and certain non-recurring items. See "Non-GAAP Financial Measures" on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure.

(3) Pro forma Adjusted EBITDA was prepared by combining the estimated financial results for CorMedix and Melinta for the full year ended December 31, 2025 and adding estimated synergies to be captured in 2025, as if the transaction had closed on January 1, 2025. Such reconciliation is not included in this release because certain items excluded from GAAP cannot be calculated or predicted at this time. Accordingly, a reconciliation is not available without unreasonable effort. Pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the Company.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 12, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Wednesday, November 12th @ 8:30am ET

Domestic: 1-844-676-2922
International: 1-412-634-6840
Webcast: Webcast Link

(Press release, CorMedix, NOV 12, 2025, View Source [SID1234659816])

On November 12, 2025 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"Following a productive meeting with the FDA, we now have a clearly defined pivotal trial design for TSC-101, and we also have an improved commercial-ready manufacturing process in place. We are focused on advancing this promising program for patients with AML and MDS and look forward to sharing updated results from the ALLOHA Phase 1 trial at ASH (Free ASH Whitepaper) next month," said Gavin MacBeath, Ph.D., Chief Executive Officer. "After infusing the first two patients with multiplex TCR-T in our PLEXI-T trial, we have now paused further enrollment to focus on preclinical development of in vivo engineering to treat patients with solid tumors. We believe this approach represents a promising and more cost-efficient way to deliver off-the-shelf, multiplexed TCR-T cells."

Recent Corporate Highlights

•
The Company recently announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding its pivotal trial design for TSC-101. The FDA has agreed to a study design that mirrors the current ALLOHA Phase 1 trial (NCT05473910) using a biologically-assigned internal control arm. TScan believes the design of the pivotal trial, which is expected to begin in the second quarter of 2026, will enable efficient enrollment and streamlined assessment of study endpoints.

In addition, the Company announced that it has implemented a commercial-ready manufacturing process that shortens manufacturing time by five days, both lowering the associated cost of goods and reducing the extent of ex vivo T cell expansion. An initial technology transfer of this process to an external contract development and manufacturing organization has been completed. The commercial-ready process will be used in the ongoing Phase 1 as well as future pivotal study.

•
In early November, the Company made the strategic decision to prioritize the clinical development of its heme program and pause further enrollment in its solid tumor Phase 1 trial, while focusing its preclinical efforts on in vivo engineering for solid tumors and target discovery in autoimmunity. As a result of these actions, the Company’s existing cash, cash equivalents, and marketable securities are now expected to fund its current operating plan into the second half of 2027.

•
In October, the Company presented at the American College of Rheumatology Convergence 2025 where the Company highlighted the potential application of its proprietary TargetScan technology to identify novel targets in T cell-driven autoimmune disorders, including ankylosing spondylitis, scleroderma, and ulcerative colitis. The presentation materials can be found on the Publications tab of the Company’s website at www.tscan.com.

Upcoming Anticipated Milestones

Heme Malignancies Program: TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT) (the ALLOHA trial, NCT05473910).

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Plans to present updated clinical data from the ALLOHA Phase 1 heme trial, including two-year relapse data on initial patients treated with TSC-101, at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

Title: TSC-101 eliminates recipient hematopoietic cells and demonstrates potential for improved relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT: Updated results from the Phase 1 (ALLOHA) trial.
Publication Number: 2391
Presentation Date and Time: December 6, 2025, 5:30-7:30 PM ET

•
Plans to submit investigational new drug (IND) applications for two additional TCR-T product candidates to expand HLA coverage of the heme program in the fourth quarter of 2025.
•
Plans to launch pivotal trial for TSC-101 for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the second quarter of 2026.

Solid Tumor Program: TScan’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity and resistance that may arise from either target or HLA loss (the PLEXI-T trial, NCT05973487).

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PLEXI-T enrollment paused, shifting efforts to preclinical development of an in vivo engineering platform for solid tumors.
•
Plans to share safety and efficacy data on patients infused to date in the PLEXI-T solid tumor trial in the first quarter of 2026.

Third Quarter 2025 Financial Results

Revenue: Revenue for the third quarter of 2025 was $2.5 million, compared to $1.0 million for the third quarter of 2024. The increase was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen.

R&D Expenses: Research and development (R&D) expenses for the third quarter of 2025 were $31.7 million, compared to $26.3 million for the third quarter of 2024. The increase of $5.4 million was primarily driven by increased manufacturing and clinical activities, as well as personnel costs to support these activities. R&D expenses included non-cash stock compensation expense of $1.7 million and $1.2 million for the third quarter of 2025 and 2024, respectively.

G&A Expenses: General and administrative (G&A) expenses for the third quarter of 2025 were $7.9 million, compared to $7.4 million for the third quarter of 2024. The increase of $0.5 million was primarily driven by personnel costs to support business activities. G&A expenses included non-cash stock compensation expense of $1.3 million and $1.3 million for the third quarter of 2025 and 2024, respectively.

Net Loss: Net loss was $35.7 million for the third quarter of 2025, compared to $29.9 million for the third quarter of 2024, and included net interest income of $1.3 million and $2.7 million, respectively.

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2025, were $184.5 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the second half of 2027.

Share Count: As of September 30, 2025, the Company had 56,747,993 shares of common stock outstanding, consisting of 52,471,405 shares of voting common stock and 4,276,588 shares of non-voting common stock. In addition, the Company had 73,087,945 of prefunded warrants outstanding to purchase shares of voting common stock at an exercise price of $0.0001 per share. Pro forma outstanding shares as of September 30, 2025, inclusive of both common stock and prefunded warrants, were 129,835,938.

(Press release, TScan Therapeutics, NOV 12, 2025, View Source [SID1234659832])