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])

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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.

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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).

•
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])

On November 12, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,472,205 on November 18, 2025, covering key aspects of the Company’s breast cancer vaccine technology. The patent protects novel methods of inducing an immune response to α-lactalbumin protein—a protein typically found only in normal breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies. The co-inventors of the patent are the late Dr. Vincent Tuohy, and Dr. Justin Johnson of Cleveland Clinic.

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"Our breast cancer vaccine program is a cornerstone of our strategy to develop next-generation preventive immunotherapies," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "This new patent meaningfully extends the duration of our intellectual property protection and reinforces our commitment to addressing a disease that affects hundreds of thousands of women each year. With a strong and growing global patent portfolio, we are well-positioned to advance a vaccine that could fundamentally change how we prevent breast cancer in healthy women."

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences. This patent issuance builds upon the Company’s broad and expanding intellectual property portfolio, strengthening foundational patent protection for the breast cancer vaccine program into the mid-2040s.

Despite significant progress in breast cancer treatment, the disease remains the most commonly diagnosed cancer among women worldwide. In the United States alone, over 297,000 new cases of invasive breast cancer are projected in 2025, with approximately 43,000 women expected to die from the disease. No FDA-approved vaccine currently exists to prevent breast cancer, representing a major and unmet need in the field of preventive oncology.

Anixa’s investigational vaccine aims to stimulate the immune system to recognize and eliminate pre-malignant and malignant cells expressing α-lactalbumin—while sparing normal tissue. By targeting this "retired" protein, which is generally absent from healthy tissue except during lactation, the vaccine has the potential to minimize off-target effects and provide long-lasting immune protection.

(Press release, Anixa Biosciences, NOV 12, 2025, View Source [SID1234659855])