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 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 Eli Lilly and Company (NYSE: LLY) reported its financial results for the third-quarter of 2025.

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"Lilly delivered another strong quarter, with 54% revenue growth year-over-year driven by continued demand for our incretin portfolio," said David A. Ricks, Lilly chair and CEO. "We advanced orforglipron through four additional Phase 3 trials, enabling global obesity submissions by year-end, and we achieved U.S. FDA approval of Inluriyo (imlunestrant)—marking key progress across our pipeline. We continue to increase manufacturing capacity, announcing new facilities in Virginia and Texas and an expansion of our site in Puerto Rico."

Financial Results

$ in millions, except

per share data

Third-Quarter

2025

2024

% Change

Revenue

$ 17,600.8

$ 11,439.1

54 %

Net income – Reported

5,582.5

970.3

NM

Earnings per share – Reported

6.21

1.07

NM

Net income – Non-GAAP

6,311.9

1,064.5

NM

Earnings per share – Non-GAAP

7.02

1.18

NM

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Third-Quarter Reported Results
In Q3 2025, worldwide revenue was $17.60 billion, an increase of 54% compared with Q3 2024, driven by a 62% increase in volume, partially offset by a 10% decrease due to lower realized prices. Key Products1 revenue grew to $11.98 billion in Q3 2025, led by Mounjaro and Zepbound.

Revenue in the U.S. increased 45% to $11.30 billion, driven by a 60% increase in volume, partially offset by a 15% decrease due to lower realized prices. Price was negatively impacted by a favorable one-time adjustment to estimates for rebates and discounts in Q3 2024. Excluding this base period effect, U.S. price declined by high single digits.

Revenue outside the U.S. increased 74% to $6.30 billion, driven by a 66% increase in volume and to a lesser extent a 6% favorable impact on foreign exchange rates. The volume increase outside the U.S. was driven primarily by Mounjaro. Revenue included a $200.0 million sales-based milestone payment for Jardiance and $180.0 million of revenue associated with the divestiture of the rights to Cialis in select markets outside of the U.S.

The Company defines Key Products as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio, and Zepbound.

Gross margin increased 57% to $14.59 billion in Q3 2025. Gross margin as a percent of revenue was 82.9%, an increase of 1.9 percentage points. The increase in gross margin percent was primarily driven by favorable product mix, partially offset by lower realized prices.

In Q3 2025, research and development expenses increased 27% to $3.47 billion, or 19.7% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 31% to $2.74 billion in Q3 2025, primarily driven by promotional efforts supporting ongoing and future launches.

In Q3 2025, the company recognized acquired in-process research and development (IPR&D) charges of $655.7 million compared with $2.83 billion in Q3 2024. The Q3 2025 charges primarily related to the acquisition of SiteOne Therapeutics, Inc. The Q3 2024 charges were primarily related to the acquisition of Morphic Holding, Inc.

Asset impairment, restructuring and other special charges of $364.9 million in Q3 2025 were primarily related to a litigation charge, as well as acquisition and integration costs associated with the closing of our acquisition of Verve Therapeutics, Inc. In Q3 2024, there was a charge of $81.6 million, that primarily related to impairment of an intangible asset associated with a molecule in development.

The effective tax rate was 22.8% in Q3 2025 compared with 38.9% in Q3 2024. The effective tax rates for Q3 2025 and Q3 2024 were both unfavorably impacted by non-deductible acquired IPR&D charges, with a larger impact occurring in Q3 2024. Additionally, the effective tax rate for Q3 2025 was unfavorably impacted by U.S. tax law changes enacted during the quarter.

In Q3 2025, net income and earnings per share (EPS) were $5.58 billion and $6.21, respectively, compared with net income of $970.3 million and EPS of $1.07 in Q3 2024. EPS in Q3 2025 and Q3 2024 included acquired IPR&D charges of $0.71 and $3.08, respectively.

Third-Quarter Non-GAAP Measures
On a non-GAAP basis, Q3 2025 gross margin increased 56% to $14.71 billion. Gross margin as a percent of revenue was 83.6%, an increase of 1.4 percentage points. The increase in gross margin percent was primarily driven by favorable product mix, partially offset by lower realized prices.

The non-GAAP effective tax rate was 17.7% in Q3 2025 compared with 37.6% in Q3 2024. The effective tax rates for Q3 2025 and Q3 2024 were both unfavorably impacted by non-deductible acquired IPR&D charges, with a larger impact occurring in Q3 2024.

On a non-GAAP basis, Q3 2025 net income and EPS were $6.31 billion and $7.02, respectively, compared with net income of $1.06 billion and EPS of $1.18 in Q3 2024. Non-GAAP EPS in Q3 2025 and Q3 2024 included acquired IPR&D charges of $0.71 and $3.08, respectively.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Third-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 6.21

$ 1.07

NM

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other
special charges

.36

.07

Net losses (gains) on investments in equity
securities

(.04)

(.09)

U.S. Tax Law Change

.39

—

Earnings per share (non-GAAP)

$ 7.02

$ 1.18

NM

Acquired IPR&D

.71

3.08

(77) %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Third-Quarter

Year-to-Date

Selected Products

2025

2024

%
Change

2025

2024

%
Change

Mounjaro

$ 6,515.1

$ 3,112.7

109 %

$ 15,555.8

$ 8,010.0

94 %

Zepbound

3,588.1

1,257.8

185 %

9,281.3

3,018.4

NM

Verzenio

1,470.2

1,369.3

7 %

4,118.3

3,751.5

10 %

Total Revenue

17,600.8

11,439.1

54 %

45,887.0

31,509.9

46 %

NM – not meaningful

Mounjaro
For Q3 2025, worldwide Mounjaro revenue increased 109% to $6.52 billion. U.S. revenue was $3.55 billion, an increase of 49%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $2.97 billion compared with $728.0 million in Q3 2024, primarily driven by volume growth.

Zepbound
For Q3 2025, U.S. Zepbound revenue increased 184% to $3.57 billion, compared with $1.26 billion in Q3 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q3 2025, worldwide Verzenio revenue increased 7% to $1.47 billion. U.S. revenue was $880.3 million, compared with $878.8 million in Q3 2024, reflecting an increase in volume which was offset by lower realized prices. Revenue outside the U.S. was $589.8 million, an increase of 20%, primarily driven by volume growth and, to a lesser extent, favorable impact on foreign exchange rates.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Lilly’s Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis (announcement)

Lilly’s Kisunla (donanemab) receives marketing authorization by European Commission for the treatment of early symptomatic Alzheimer’s disease (announcement)

U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer (announcement)

Lilly’s olomorasib receives U.S. FDA’s Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers (announcement)

Clinical

Lilly’s Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis (announcement)

Lilly’s EBGLYSS (lebrikizumab-lbkz) delivered durable disease control when administered once every eight weeks in patients with moderate-to-severe atopic dermatitis (announcement)

Lilly’s baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial (announcement)

Lilly’s Verzenio (abemaciclib) prolonged survival in HR+, HER2-, high-risk early breast cancer with two years of treatment (announcement)

Lilly’s oral GLP-1, orforglipron, demonstrated superior glycemic control in two successful Phase 3 trials, reconfirming its potential as a foundational treatment in type 2 diabetes (announcement)

Lilly’s Omvoh (mirikizumab-mrkz) is the first and only IL-23p19 antagonist to show four years of sustained, corticosteroid-free comprehensive patient outcomes in ulcerative colitis (announcement)

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, reduced A1C by an average of 2.2% in a Phase 3 trial of children and adolescents with type 2 diabetes (announcement)

Lilly’s oral GLP-1, orforglipron, superior to oral semaglutide in head-to-head trial (announcement)

Lilly’s oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results published in The New England Journal of Medicine (announcement)

Lilly’s Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, significantly improved progression-free survival in patients with treatment-naïve CLL/SLL (announcement)

Lilly’s Verzenio (abemaciclib) increases overall survival in HR+, HER2-, high-risk early breast cancer with two years of therapy (announcement)

Lilly’s oral GLP-1, orforglipron, is successful in third Phase 3 trial, triggering global regulatory submissions this year for the treatment of obesity (announcement)

Other

Lilly announces more than $1.2 billion investment in Puerto Rico facility to boost oral medicine manufacturing capacity in the United States (announcement)

LillyDirect and Walmart Pharmacy launch first retail pick-up option with direct-to-consumer pricing for Zepbound (announcement)

Lilly partners with NVIDIA to build the industry’s most powerful AI supercomputer, supercharging medicine discovery and delivery for patients (announcement)

Lilly announces roster of Team USA athletes for the Olympic and Paralympic Games Milano Cortina 2026, pledges to translate U.S. Olympic and Paralympic milestones into meaningful community impact (announcement)

Lilly to Acquire Adverum Biotechnologies (announcement)

Lilly opens newest Gateway Labs site in San Diego to boost local biotechnology ecosystem (announcement)

Lilly plans to build a new $6.5 billion facility to manufacture active pharmaceutical ingredients in Texas (announcement)

Lilly announces plans to build $5 billion manufacturing facility in Virginia (announcement)

Lilly launches TuneLab platform to give biotechnology companies access to AI-enabled drug discovery models built through over $1 billion in research investment (announcement)

Anne White to Retire as Executive Vice President and President, Lilly Neuroscience (announcement)

For information on important public announcements, visit the news section of Lilly’s website.

2025 Financial Guidance
The company has increased full-year revenue guidance to be in the range of $63.0 billion to $63.5 billion, primarily driven by strong underlying business performance across the portfolio and foreign exchange rates.

The performance margin2 is now expected to be in the range of 43.5% and 44.5% on a reported basis and 45.0% and 46.0% on a non-GAAP basis. Both ratios reflect the increase in revenue guidance.

Other income (expense) on a reported basis is now expected to be expense in the range of $700 million to $600 million due to a decrease in net losses on investments in equity securities and is still expected to be expense in the range of $700 million to $600 million on a non-GAAP basis.

The 2025 estimated effective tax rate on a reported basis and a non-GAAP basis remain unchanged at approximately 19% and 17%, respectively.

Based on these changes, EPS guidance has been increased to be in the range of $21.80 to $22.50 on a reported basis and $23.00 to $23.70 on a non-GAAP basis. The company’s updated 2025 financial guidance reflects adjustments shown in the reconciliation table below.

2025

Guidance

Earnings per share (reported)

$21.80 to $22.50

U.S. tax legislation

.39

Amortization of intangible assets

.43

Asset impairment, restructuring, and other special charges

.39

Net losses on investments in equity securities

—

Earnings per share (non-GAAP)

$23.00 to $23.70

Numbers may not add due to rounding

The Company defines performance margin as gross margin less R&D, Marketing, Selling, and Administrative and Asset Impairment, Restructuring and Other Charges divided by Revenue.

The following table summarizes the company’s updated 2025 financial guidance:

Prior

Revenue

$60.0 to $62.0 billion

$63.0 to $63.5 billion

Performance Margin(4)

(reported)

42.0% to 43.5%

43.5% to 44.5%

(non-GAAP)

43.0% to 44.5%

45.0% to 46.0%

Other Income/(Expense) (reported)

($750) to ($650) million

($700) to ($600) million

Other Income/(Expense) (non-GAAP)

($700) to ($600) million

Unchanged

Tax Rate (reported)

Approx. 19%

Unchanged

Tax Rate (non-GAAP)

Approx. 17%

Unchanged

Earnings per Share (reported)

$20.85 to $22.10

$21.80 to $22.50

Earnings per Share (non-GAAP)

$21.75 to $23.00

$23.00 to $23.70

(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.

(2) Guidance includes acquired IPR&D charges through Q3 2025 of $2.38 billion or $2.57 on a per share basis. Guidance does not include acquired IPR&D either incurred, or expected to be incurred, after Q3 2025.

(3) This guidance is based on the existing tariff and trade environment as of October 30, 2025, and does not reflect any policy shifts, including pharmaceutical sector tariffs, that could impact business.

(4) The Company defines performance margin as gross margin less R&D, Marketing, Selling, and Administrative, and Asset Impairment, Restructuring and Other Charges divided by Revenue.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q3 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

(Press release, Eli Lilly, OCT 30, 2025, View Source [SID1234657147])

On October 30, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the third quarter ended September 30, 2025, and provides an overview of recent and upcoming business highlights.

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"Our team continues to execute solidly across the three most important business verticals: diagnostics, therapeutics, and capital structure," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "In the fourth quarter, we plan to build on growing momentum in these three areas as we expand our commercial team and footprint for CNSide, seek to clarify our clinical development and pivotal plan for REYOBIQ with the FDA, and bolster our financial position in the capital markets."

Q3 2025 AND RECENT HIGHLIGHTS

Corporate

•
Received additional $1.9 million advance payment from Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally, as part of the Company’s previously awarded non-dilutive $17.6 million grant for leptomeningeal cancer targeted radiotherapeutic development
•
Regained compliance with applicable Nasdaq listing criteria, including both Market Value of Listing Securities standard and alternative stockholder’s equity threshold

REYOBIQ Clinical Trials

•
Presented positive ReSPECT-LM Phase 1 single dose escalation trial results at SNO/ASCO CNS Metastases Conference. The data demonstrated treatment of leptomeningeal metastases (LM) with REYOBIQ is feasible, has favorable safety profile, and shows promising efficacy signal

CNSide CSF Assay Platform

•
Expanded commercial readiness and purpose driven footprint for CNSide to support commercial scale up and patient-led innovative research. Appointed new leadership in commercial strategy and technical operations, in addition to new hires, to meet commercial and operational targets
•
Announced first of planned national coverage agreements, with UnitedHealthcare effective September 15, 2025 covering over 51 million people throughout the U.S., to provide the CNSide Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test (LDT)
•
Received successful accreditation and certification from Centers for Medicare and Medicaid Services (CMS) under the Clinical Lab Improvement Amendments (CLIA) for the Houston Texas laboratory, which has met all requirements for proficiency testing, personnel qualifications, and quality control. The certification also paves the way for state licensing, commercial payor coverage, access to Medicare/Medicaid, and payment coding expansion
•
Presented positive CNSide CSF assay platform results at the 2025 SNO/ASCO CNS Metastases Conference. Data from a retrospective, multi-center analysis of 613 CNSide assays showed that CNSide can quantify LM over time and monitor changes in the expression of multiple targetable mutations. CNSide may also catalyze LM treatment initiation, allowing physicians to adapt treatment with real time shifts in tumor biology
•
Provided a CNSide Diagnostics launch update, with our CSF assay platform and testing services commercially available in Texas in August 2025. Initial commercial focus will be on National Cancer Institute Designated Cancer Centers, which treat the highest number of patients at risk for leptomeningeal metastases and previously used CNSide

Q3 2025 FINANCIAL RESULTS

•
The Company’s cash and investments balance was $16.6 million on September 30, 2025, up from $6.9 million on June 30, 2025 and $3.6 million on December 31, 2024
•
Recognized $1.4 million in grant revenue in the third quarter of 2025 compared to $1.5 million in the same quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM
•
Total operating loss for the third quarter of 2025 was $4.5 million compared to a loss of $3.8 million in the same quarter of 2024 with the increase primarily attributed to compensation expense and professional fees
•
Net loss for the third quarter of 2025 was $4.4 million, or loss of $0.04 per share, compared to a net loss of $2.9 million, or loss of $0.37 per share, for the same quarter in the prior year; the change in the net loss for the quarter was primarily due to $1 million of change in fair value of derivative instruments in Q3 2024

(Press release, Plus Therapeutics, OCT 30, 2025, View Source [SID1234657146])

On October 30, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported the presentation of new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

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CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).

"The RedTail platform represents a major advance in virotherapy and genetic medicines," said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "RedTail allows for systemically administered genetic medicines that avoid immune clearance, are tropic for tumor cells, induce tumor lysis and immunologically prime the TME, and can deliver a genetic payload."

"In our syngeneic models, CLD-401 can reach metastatic sites when administered systemically where it can destroy tumor cells through a novel mechanism that also induces an immune priming effect," added Eric Poma, PhD, Chief Executive Officer. "CLD-401 builds on these mechanisms by also delivering high levels of IL-15 superagonist to the TME to activate a potent T-cell and NK cell response to the tumor."

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026. The company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

CLD-401 Presentation

Meeting: SITC (Free SITC Whitepaper) 40th Anniversary Annual Meeting, November 7–9, 2025, National Harbor, MD
Title: In Situ Tumor Delivery of IL-15 Superagonist via RedTail Gene Therapy Achieves Durable Tumor Clearance
Abstract Number: 1175
Presentation Time: Friday, November 7, 2025, 12:15–1:45 PM and 5:35–7:00 PM

(Press release, Calidi Biotherapeutics, OCT 30, 2025, View Source [SID1234657145])