On October 30, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported to have strengthened its financial position through different capital markets activities. As a result, Evaxion now has cash on hand to fund its operations and R&D programs into the second half of 2027, extended from first half of 2027.

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In total, Evaxion has raised $7.2 million in recent weeks, with $4.5 million coming from sale of shares in an at-the-market (ATM) offering and $2.7 million coming from exercise of investor warrants.

The proceeds strengthens both Evaxion’s cash position and equity and follows the influx of $7.5 million paid by MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) when licensing vaccine candidate EVX-B3 in September 2025.

"We are pleased to have bolstered our cash position thereby extending our runway into the second half of 2027, allowing us to fully focus on executing on our strategy and plans," says Thomas Schmidt, CFO of Evaxion.

The recent exercises of investor warrants have reduced the number of outstanding warrants to purchase Evaxion ADSs by 1.0 million. The total number of outstanding warrants is now 2.8 million, including employee warrants, with a weighted average exercise price of $10.94.

Evaxion expects to accumulate an operational cash spend of $14 million in 2025. By the end of the second quarter 2025, Evaxion had cash at hand of $14.7 million. We have since had a gross inflow of cash of $14.7 million as mentioned above.

Evaxion had debt of $9.2 million by the end of the second quarter 2025. The debt was reduced by $4.1 million through a debt-to-equity conversion agreement with the European Investment Bank in July 2025, also bolstering Evaxion’s equity.

(Press release, Evaxion Biotech, OCT 30, 2025, View Source [SID1234657148])

On October 30, 2025 REGiMMUNE Limited ("REGiMMUNE" or "the Company"), a clinical stage biopharma company developing novel immune therapeutics targeting regulatory T cells (Treg), reported preclinical data of its antibody program at the meeting of Antibody Engineering & Therapeutics Asia 2025 in Kyoto, Japan from Oct. 20 – 22.

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REGiMMUNE, while pursuing RGI-2001 in advanced clinical development for (Graft vs Host Disease (GvHD), armed with our long-time expertise in human immunology and Treg cells, has been actively developing its therapeutic antibody program. This pipeline currently includes RGI-6004 and AB01, both targeting tumor infiltrating Treg cells, reflecting the two strategies of therapeutic modulation of Treg cells, namely, depleting vs silencing, and AB08-H1 targeting a surface marker shared by blood-borne and solid malignancies.

The presentation in Kyoto included RGI-6004 and AB08-H1. RGI-6004 was developed to highly selectively target tumor infiltrating Treg cells while maintaining all other immune effector cells intact to alleviate the immune suppression in the tumor microenvironment, and consequently enhance anti-cancer immunity. AB08-H1 is an antibody developed to kill malignant cells of Hodgkin & Non-Hodgkin diseases and solid cancer cells via a unique target.

RGI-6004, an Afucosylated Antibody to Target GARP/LAP-TGFβ1 for Selective Depletion of Activated Tregs. RGI-6004, a fully human IgG1 against GARP/Latent-TGFb1 complex, designed to deplete tumor infiltrating activated Treg cells. The antibody specifically binds to activated human Treg cells with high affinity, but none to non-activated Treg cells, and CD4+ and CD8+ T effector cells. The antibody recognizes tumor infiltrating Treg cells in clinical solid tumor tissues. Its afucosylated version highly selectively depletes activated Treg cells with a significantly enhanced efficacy of ~10 pM, but none of CD4+ and CD8+ effector T cells, while granzyme B induction & proliferation of CD4+ and CD8+ effector T cells are not affected. RGI-6004 has minimal impact on platelets (counts and degranulation), minimal binding to major immune cells, nor observable impact on hematological profile of normal human blood. In cynomolgus monkey, its t1/2 is shown to be ~10 days, while its clinical hematology, coagulation, blood chemistry, immunophenotyping in peripheral blood, serum cytokine analysis, and pathology, does not demonstrate safety alarms. In sum, the behavior of RGI-6004 highlights the potential as a next-generation Treg-depleting agent in cancer immunotherapy.

AB08-H1, A humanized antibody that directly kills cancer target cells without ADCC and CDC. AB08-H1 is a humanized IgG that specifically targets pan MHC II (synonym for HLA II, human leukocyte antigen). Upon binding to the cell surface MHC class II molecule, the antibody induces homotypic aggregation, lysosomal membrane permeabilization, and ultimately cell lysis of the target malignant cells directly without the involvement of ADCC and CDC. REGiMMUNE overcame the original bottleneck of protein production of the humanized IgG, developed a high yield method to manufacture it in mammalian cells. As MHC Class II molecules are found highly expressed on lymphoid malignant cells, and have been increasingly recognized to express highly in major solid cancer cells, AB08-H1 is expected to treat various types of lymphoid malignancies (Hodgkin and Non-Hodgkin lymphomas), and solid cancers.

REGiMMUNE is encouraged by the recent news of Nobel Prize in Physiology granted to Dr. Shimon Sakaguchi and others, for their works on Treg cells. We are pleased to see that the fundamental roles of Treg cells in autoimmune disease, GvHD, cancer, and infectious disease are recognized in highest profile. REGiMMUNE is committed to developing therapeutics with, as Dr. Shimon Sakaguchi well put it, Treg-up strategies vs Treg-down strategies.

(Press release, REGimmune, OCT 30, 2025, View Source [SID1234657165])

On October 30, 2025 Novocure (NASDAQ: NVCR) reported financial results for the third quarter that ended September 30, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"Q3 was a solid quarter with steady commercial execution in glioblastoma, geographic expansion, and material progress for our clinical and product development pipelines," said Ashley Cordova, CEO, Novocure. "With four indications expected in market by year-end 2026, we are well on our way to becoming a platform therapy company — and we remain sharply focused on reaching profitability and expanding patient impact."

Financial updates for the third quarter ended September 30, 2025:

Total net revenues for the quarter were $167.2 million, an increase of 8% compared to the same period in 2024. This increase was primarily driven by active patient growth, as well as $3.3 million in exchange rate benefits.
The U.S., Germany, France and Japan contributed $96.6 million, $20.3 million, $19.6 million and $9.4 million, respectively, with other active markets contributing $15.7 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.6 million.
Recognized revenue from Optune Lua in the quarter was $3.1 million, including $1.6 million from non-small cell lung cancer (NSCLC) and $1.5 million from malignant pleural mesothelioma (MPM).
Gross margin for the quarter was 73% compared to 77% in the prior year. The reduction was primarily driven by the continued roll out of our Head Flexible Electrode (HFE) transducer array for use with Optune Gio, costs associated with treating NSCLC patients prior to establishing broad reimbursement, and increased tariffs. Additionally, this quarter Novocure recognized a $2.9 million expense related to an inventory obsolescence provision for Optune Lua arrays.
Research, development and clinical study expenses for the quarter were $54.0 million, an increase of 4% from the same period in 2024. This was primarily driven by increased product development costs and increased regulatory expenses related to the premarket approval (PMA) applications for the use of TTFields therapy in the treatment of locally advanced pancreatic cancer and brain metastases from NSCLC.
Sales and marketing expenses for the quarter were $58.5 million, a decrease of 2% compared to the same period in 2024. This was primarily driven by lower share-based compensation expenses.
General and administrative expenses for the quarter were $45.9 million, an increase of 15% compared to the same period in 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional services expenses to support the greater company build-out, particularly in enterprise technology as we invest in our digital infrastructure to enable scale.
Net loss for the quarter was $37.3 million with loss per share of $0.33.
Adjusted EBITDA* for the quarter was $(3.0) million.
Cash, cash equivalents and short-term investments were $1,033.5 million as of September 30, 2025.
Operational updates for the third quarter ended September 30, 2025:

As of September 30, 2025, there were 4,416 total active patients on TTFields therapy globally.
Optune Gio
1,675 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 954; 227; 191 and 130 prescriptions, respectively, with the remaining 173 prescriptions contributed by other active markets.
As of September 30, 2025, there were 4,277 Optune Gio active patients on therapy, an increase of 5% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,176; 595; 499 and 474 Optune Gio active patients, respectively, with the remaining 533 active patients contributed by other active markets.
Optune Lua
130 total prescriptions for Optune Lua were received in the quarter. 109 Optune Lua prescriptions were received for the treatment of NSCLC and 21 prescriptions were received for the treatment of MPM.
As of September 30, 2025, there were 139 active Optune Lua patients on therapy, including 100 patients treated for metastatic NSCLC and 39 patients treated for MPM.
Quarterly updates and achievements:

In August 2025, Novocure’s PMA application to the U.S. Food and Drug Administration (FDA) for the use of TTFields therapy for the treatment of locally advanced pancreatic cancer was accepted for filing. This submission is supported by data from the Phase 3 PANOVA-3 trial, which evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for adults with unresectable, locally advanced pancreatic cancer.
In August 2025, Novocure announced the coverage of Optune Gio through the Spanish National Health System for the treatment of adult patients with newly diagnosed glioblastoma
In September 2025, Novocure received approval for Optune Lua use concurrently with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced/recurrent NSCLC who progressed on or after platinum-based chemotherapy from the Japanese Ministry of Health, Labour and Welfare.
Anticipated clinical and regulatory milestones:

Novocure intends to submit a PMA application to the FDA for the treatment of brain metastases from NSCLC based on results of the Phase 3 METIS clinical trial in Q4 2025.
The topline data readout from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in Q1 2026.
The topline data readout from the Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma is expected in Q2 2026.
Conference call details
Novocure will host a conference call and webcast to discuss third quarter 2025 financial results at 8:00 a.m. EDT today, Thursday, October 30, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

(Press release, NovoCure, OCT 30, 2025, View Source [SID1234657183])

On October 30, 2025 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported updates for its Selective ARID1B, Selective CBP, and Selective EP300 degrader programs, which will be presented during a Foghorn-hosted virtual investor event.

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"We have made significant progress across our degrader portfolio, further highlighting our ability to address challenging and prevalent targets," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "Earlier this week, we presented new preclinical data at the TPD and Induced Proximity Summit demonstrating significant progress for our first-in-class Selective ARID1B degrader, with potential as a new therapy for endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer. Our Selective CBP degrader, with potential in EP300-mutant cancers and ER+ breast cancer, is advancing towards IND in 2026 and on track for non-GLP toxicology studies this quarter. Additionally, our Selective EP300 degrader shows encouraging anti-tumor efficacy with favorable tolerability in hematological malignancies in preclinical studies. This is particularly exciting in multiple myeloma where we believe we are significantly differentiated versus dual CBP/ EP300 programs. These advancements along with our continued innovation and disciplined execution are positioning Foghorn at the forefront in the field of targeted protein degradation."

Steven Bellon, Chief Scientific Officer of Foghorn, added, "ARID1B has long been difficult to selectively drug due to its high homology to ARID1A, lack of enzymatic activity, and its largely unstructured nature. Our demonstration of selective degradation of ARID1B represents a major scientific breakthrough that underscores the strength of our protein degrader capabilities to overcome challenges that have historically limited the field."
The live webcast for the investor presentation will be available under the Events & Presentations section of Foghorn’s website, and a replay of the event and presentation will be available immediately following the event.
Selective ARID1B Degrader Program

ARID1A is the most mutated subunit in the BAF complex and amongst the most mutated proteins in cancer. These mutations lead to a dependency on ARID1B in up to 5% of all solid tumors including endometrial, gastric, gastroesophageal junction, bladder and non-small cell lung cancer (NSCLC). Attempts to selectively drug ARID1B have been challenging because of the high degree of similarity between ARID1A and ARID1B and the fact that ARID1B has no enzymatic activity to target.

Foghorn is developing a Selective ARID1B degrader that is advancing towards in vivo proof of concept in 2026. Key program updates include:
•Developed VHL and cereblon based bifunctional degraders with potential for oral delivery
•Selective degradation of ARID1B achieved
•Modulation of downstream target genes following ARID1B degradation
Data presented at the TPD and Induced Proximity Summit is available under the Science section of the Company’s website.
Selective CBP Degrader Program
CBP is an acetyltransferase that selectively targets a synthetic relationship established in EP300-mutated cancers, which includes endometrial, cervical, ovarian, bladder and colorectal cancer. Attempts to selectively drug CBP have been challenging due to the high level of similarity with EP300, and dose-limiting toxicities associated with dual inhibition of both CBP and EP300. CBP lineage dependencies are established in several cancers, including ER+ breast cancer.
Foghorn is advancing a Selective CBP degrader, on track to be Investigational New Drug (IND)-ready in 2026. Key updates include:
•Highly potent and selective lead candidate CBPd-171 advancing to dose range finding toxicology studies in Q4 2025
•Anti-tumor activity in EP300-mutant solid tumors and in CBP-dependent cancers, including promising potential in ER+ breast cancer
•No significant impact on platelet counts and megakaryocytes spared with CBPd-171 dosing
•Long Acting Injectable (LAI) formulation optimized for subcutaneous injection weekly or every
other week for convenient administration
Selective EP300 Degrader Program
EP300 is an acetyltransferase that is implicated in hematological malignancies such as multiple myeloma (MM) and diffuse large b-cell lymphoma (DLBCL), and prostate cancer. Attempts to selectively drug EP300 have been challenging due to the high level of similarity with CBP, and dose-limiting toxicities associated with dual inhibition of both CBP and EP300.
Foghorn is advancing a Selective EP300 degrader program, with an initial focus in MM and DLBCL, on track for IND-enabling studies in 2026. Key updates include:
•Broad anti-tumor activity in over 70% of all heme sub-lineages tested
•VHL based selective degrader shows efficacy in MM without hematological toxicities, including thrombocytopenia
•EP300 degraders show efficacy in IMiD-resistant MM cell lines
•Tolerability profile with widespread potential for combinations

(Press release, Foghorn Therapeutics, OCT 30, 2025, View Source [SID1234657149])

On October 30, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported that Michael A. Metzger, Chief Executive Officer, as well as members of the Syndax management team, will participate in the following upcoming investor conferences:

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UBS Global Healthcare Conference 2025 with a fireside chat on Monday, November 10, 2025, at 11:00 a.m. ET.
Guggenheim Second Annual Healthcare Innovation Conference with a fireside chat on Tuesday, November 11, 2025, at 3:00 p.m. ET.
Stifel 2025 Healthcare Conference with a fireside chat on Thursday, November 13, 2025, at 10:00 a.m. ET.
Jefferies 2025 London Healthcare Conference with a fireside chat on Thursday, November 20, 2025, at 10:00 a.m. GMT/ 5:00 a.m. ET.
A live webcast of the fireside chats will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

(Press release, Syndax, OCT 30, 2025, View Source [SID1234657166])