On March 18, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported that the Company will participate in multiple sessions at the Immuno-Oncology 360° (IO360°) Conference 2025, held March 24-26, 2025, in Boston, MA (Press release, In8bio, MAR 18, 2025, View Source [SID1234651219]).

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William Ho, Chief Executive Officer and co-founder of IN8bio, will be Co-Chairing Day 2 of the conference starting at 8:15 AM EDT on March 25, 2025. He will deliver the welcoming remarks and discuss, "Tackling the Tough Questions in IO for Autoimmunity Disease." After, he will Chair the session, "State of the IO Market, Investments and Deals Plenary."

During the afternoon session, at 4:35 PM EDT, Mr. Ho will present on the topic of "Picking our Horse in the Race for Autoimmunity: The Gamma-Delta T cell Engager," and provide a corporate overview of IN8bio’s recently announced INB-619, T cell engager program for oncology and autoimmune diseases.

As co-chair and panelist, Mr. Ho expects to discuss the rationale and promise of a gamma-delta T cell engager in addressing autoimmunity, a rapidly emerging frontier for immunotherapies.

Presentation and Panel Details

Co-Chairs’ Welcome & Tackling the Tough Questions in IO for Autoimmunity Disease

Date/Time: March 25, 2025, at 8:15 AM EDT
Picking Our Horse in the Race for Autoimmunity: The Gamma-Delta T Cell Engager

Date/Time: March 25, 2025, at 4:35 PM EDT
For those interested in coordinating a time to meet with the IN8bio during IO360°, please email [email protected].

For more information about the event, visit https://io360summit.com.

On March 18, 2025 Exicure, Inc. (Nasdaq: XCUR) reported that it has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets (Press release, Exicure, MAR 18, 2025, View Source [SID1234651218]). In September 2022, the Company announced a significant reduction in force, suspension of preclinical activities and halting of all research and development, and that the Company was exploring strategic alternatives to maximize stockholder value. We continue to engage in a broader exploration of strategic alternatives. This effort involves exploring growth through transactions with potential partners that see opportunity in joining an existing, publicly-traded organization.

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2024 Financial Results

Cash Position: Cash and cash equivalents were $12.5 million as of December 31, 2024, as compared to $0.8 million as of December 31, 2023. Our current liquidity may not be sufficient to fund operations for the next 12 months. Additional financing will be needed to fund our ongoing operations and exploration of strategic alternatives and pursue any alternatives that we identify.

Research and Development (R&D) Expense: Research and development expenses were $0 for the year ended December 31, 2024, as compared to $1.4 million for the year ended December 31, 2023. The decrease in R&D expense for the year ended December 31, 2024 of $1.4 million reflects the stoppage of clinical, preclinical, and discovery program activities and a reduction in employee headcount in December 2021 and September 2022. The Company began exploring strategic alternatives in April 2023. As a result, the Company determined it was no longer appropriate to record any research and development expenses after the first quarter of 2023.

General and Administrative (G&A) Expense: General and administrative expenses were $5.4 million for the year ended December 31, 2024, as compared to $11.7 million for the year ended December 31, 2023. The decrease in G&A expense of $6.3 million for the year ended December 31, 2024 was due to higher costs in 2023 from separation pay of former executives and related stock based compensation expense, payroll and related benefits, legal and consulting fees, facility and lease costs, depreciation from assets sold, and the research and development wind down costs that no longer met the criteria to be classified as research and development due to the shift in our historical operations suspending all research and development activities as previous discussed.

Litigation legal expense: The increase of $0.6 million for the year ended December 31, 2024 was due to accruals recorded for the amount of the unsatisfied self insured retainer and legal defense costs related to the securities litigation lawsuit.

Other Income: The Company sold samples of its clinical products during the second quarter to a private clinical stage biopharmaceutical company and sold certain assets pursuant to the Asset Purchase Agreement. The Purchaser acquired the Company’s historical biotechnology intellectual property and other assets and include spherical nucleic acid-related technology, research and development programs, and clinical assets.

Net Loss: The Company had a net loss of $(9.7) million for the year ended December 31, 2024, as compared to a net loss of $16.9 million for the year ended December 31, 2023. The decrease in net loss of $7.2 million was due to lower operating (G&A) expenses as well as some revenues and other income earned in 2024, partially offset by the right-of-use asset impairment loss resulted from the impairment analysis of the Company’s right-of-use asset related to its office lease.

Going Concern: Management believes that the Company’s existing cash and cash equivalents may not be sufficient to fund operations. As a result, there is substantial doubt about our ability to continue as a going concern. Additional financing will be needed to fund our ongoing operations and exploration of strategic alternatives and pursue any alternatives that we identify. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.

On March 18, 2025 Enzo Biochem, Inc. (NYSE: ENZ) ("Enzo" or the "Company") reported financial results for the fiscal second quarter ended January 31, 2025, with sequential quarter improvement in revenue, gross margin and operating profit / loss (Press release, Enzo Biochem, MAR 18, 2025, View Source [SID1234651217]).

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Financial Highlights

● The Company’s second-quarter gross margin percentage of 52% increased sequentially from 37% during Q1 2025 and increased from 49% during the second quarter of the prior year. These improvements were driven by change in revenues, cost efficiency actions completed, and mix of products sold.

● The Enzo Life Sciences Products segment, which excludes discontinued operations and Corporate overhead, achieved a $0.5 million operating profit during Q2 FY25, a $2M sequential improvement compared to a $1.5 operating loss during Q1 FY25, and a $0.2 million improvement compared to the second quarter of the prior year. These improvements were driven by change in revenues, cost efficiency actions completed, and mix of products sold.

● The operating loss results for the first half of FY25 for the Company’s continuing operations improved by $2.4 million. Through cost containment, the company reduced cost of revenues by 14%. In addition, spend in SG&A and R&D decreased by 22% and 27%, respectively. Product launches continue, despite the reduction in R&D.

● The Company’s second-quarter revenue of $7.3 million increased sequentially by $1.1 million from $6.2 million. This is an improvement of 18%. Year-over-year quarterly period revenue declined by 14% primarily from the timing of large order fulfillment and the market slowdown in the US.

● Enzo ended the second quarter with aggregate cash and cash equivalents of $40.3 million. The Board of Directors and management continue to be focused on conserving cash.

● Product Life Cycle maintenance continues with an increasing number of SKU launches. Enzo increased product launches to bolster the base business within the first half of the fiscal year, doubling the count of new products compared to the prior full year.

Recent Events

● As previously disclosed, the Company and plaintiffs have reached a class-wide settlement agreement pertaining to the April 2023 cyber incident and filed an unopposed motion for preliminary approval with the Court. The Court granted the motion and set a final fairness hearing on June 10, 2025. The settlement value of $7.5 million had been accrued for in our prior year financial statements and an initial payment was made subsequent to January 31, 2025 in an amount of $0.8 million.

● We continue to explore all strategic alternatives to maximize value for the Company’s stockholders, including without limitation, improving the market position and profitability of our services in the marketplace, and enhancing our valuation. We may pursue our goals through organic growth and strategic initiatives. Additionally, we will continue to review information regarding potential acquisitions or joint ventures, and provide information to third parties regarding potential dispositions of assets or business lines, including a potential sale of the Company, from time to time.

● The Company submitted a plan on February 21, 2025 to cure the market capitalization, stockholder’s equity and average closing stock price deficiencies and to return to compliance with the NYSE’s continued listing standards. The plan considers all available alternatives to cure the deficiencies identified by the NYSE, which plan is being reviewed by the NYSE. The Common Stock continues to be listed and trade on the NYSE, subject to the Company’s ongoing compliance with the NYSE’s other continued listing standards and the acceptance by the NYSE of this plan.

On March 18, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson (Press release, Can-Fite BioPharma, MAR 18, 2025, View Source [SID1234651216]).

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Compassionate use is the term used when a physician is requesting for a single patient to gain access to an investigational drug for a serious disease. Such investigational drug has not yet been approved by the FDA.

Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: "We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase 2a clinical trial, as we remain committed to advancing the availability of our drug."

Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the FDA and the European Medicines Agency (EMA). The drug is currently being tested in Israel in a Phase IIa pancreatic cancer clinical study.

Namodenoson, has been also granted Orphan Drug Designation by the FDA for pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

On March 17, 2025 Anocca AB, a leading T-cell immunotherapy company, reported the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state (Press release, Anocca, MAR 17, 2025, View Source [SID1234655345]). VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V. ANOC-001 is a novel discovery from Anocca’s platform and will be manufactured in the company’s in-house cGMP facility.

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The CTA approval is the first regulatory authorisation in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice, paving the way for the execution of Anocca’s scalable clinical product manufacturing strategy.

Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025.

Reagan Jarvis, co-founder and Chief Executive Officer, commented, "This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. Our highly skilled team is focused on discovering, optimising and manufacturing innovative next generation treatments that harness T-cell immunity and ANOC-001 represents the first of many products that will advance to the clinic in the coming years."

Zahid Bashir, Chief Medical Officer at Anocca, elaborated, "We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer."

About the VIDAR-1 clinical programme

VIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. The company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enrol if they have an HLA, and KRAS mutation, matching an available product.

More information about the clinical trial can be found at the EU’s clinical trials website.

About KRAS and PDAC

Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2).

References

1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon1166

2. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24. doi: 10.1038/s41575-023-00840-w