On March 19, 2025 Jacobio Pharma (1167.HK) reported its 2024 annual results, with revenue of RMB160 million, R&D expense of RMB330 million (Press release, Jacobio Pharmaceuticals, MAR 19, 2025, View Source [SID1234651271]). Major operating and financing activities generated RMB320 million cash inflows. By the end of 2024, cash and bank balances and bank credit balances amounted to RMB1.45 billion. Jacobio also announced recent business progress and expected milestones.

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"2024 is a transforatmive year for Jacobio. We have submitted a New Drug Application (NDA) for the KRAS G12C inhibitor glecirasib and have licensed out the China rights of glecirasib and the SHP2 inhibitor sitneprotafib to our partner. This marks Jacobio’s successful transformation from the early R&D stage to an innovation-driven value realization stage," said Dr.Yinxiang Wang, the Chairman and CEO of Jacobio Pharma. "Looking ahead to 2025, glecirasib is expected to receive the official approval for marking, which will continuously generate cash flow to invest in Jacobio’ subsequent pipeline."

Development of core clinical stage products

Glecirasib (JAB-21822, KRAS G12C inhibitor) and sitneprotafib (JAB-3312, SHP2 inhibitor)

The commercialization and further clinical development in China of glecirasib and sitneprotafib were licensed to Allist on August 30, 2024.
Non-small cell lung cancer (NSCLC)
The NDA application of glecirasib monotherapy in second-line and above NSCLC was submitted to the CDE (China Drug Evaluation Center) in May 2024 and the priority review designation was granted in the same month. Glecirasib is expected to be approved in the first half of 2025.
The Phase III pivotal trial of glecirasib combined with sitneprotafib in front-line NSCLC enrolled the first patient in China on August 7, 2024.
Multi-tumor basket
The multi-tumor basket registration phase II trial of glecirasib for the treatment of pancreatic cancer, biliary tract cancer, gastric cancer, small bowel cancer, appendiceal cancer and other indications has been initiated in China. Glecirasib has received orphan drug designation (ODD) from FDA and EMA for pancreatic cancer.
Colorectal cancer
The Phase III trial of glecirasib mono or in combination with cetuximab in third line was approved by the CDE in May 2024
JAB-23E73 (pan-KRAS inhibitor)

The IND (Investigational New Drug) applications were approved in China and the United States in September 2024
The first patient was enrolled in November 2024
The dose escalation phase is expected to be completed in the second half of 2025
JAB-30355 (p53 Y220C activator)

The IND application of FIH (first-in-human) global trial of JAB-30355 was approved by the FDA in March 2024 and by the CDE in June 2024.
The first patient was enrolled in July 2024
The dose escalation is expected to be completed in the second half of 2025
JAB-8263 (BET inhibitor)

The dose escalation for JAB-8263 in solid tumors and hematologic malignancy were completed in the U.S. and China, respectively. The RP2D (phase II recommended doses) was obtained.
Dose expansion in patients with myelofibrosis is ongoing.
Solid tumor portion with specific biomarkers is being explored. .
JAB-2485 (Aurora A inhibitor)

A Phase I/IIa global trial of JAB-2485 is ongoing in the U.S. and China.
Dose escalation phase is expected to be completed in the first half of 2025
The expansion of monotherapy and combination with chemotherapy are being planned.
Development of pre-clinical pipelines

JAB-BX467 (HER2-STING iADC)

Clinical candidate of HER2-STING iADC has been nominated in the second half of 2024.
The IND application is being planned to be submitted in 2026.
JAB-BX600 (KRAS G12D ADC)

The clinical candidate is expected to be nominated in the second half of 2025.
As of December 31, 2024, Jacobio has filed more than 360 patent applications worldwide, including 126 authorized patents.

Conference call information

Jacobio Pharma will hold a conference call at 9:30 AM (Beijing time) on March 20, 2024. Participants, please register in advance through this link: View Source

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 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, HCW Biologics Inc. (the "Company") and WY Biotech Co., Ltd. ("WY Biotech") reported to have agreed to amend their License, Research and Co-Development Agreement ("Agreement") dated November 17, 2024, due to a delay in WY Biotech coming to a definitive agreement with their designated contract development and manufacturing organization ("CDMO") (Filing, 8-K, HCW Biologics, MAR 18, 2025, View Source [SID1234651256]). Specifically, in order to accommodate that delay, the parties agreed to restructure the payment schedule for the $7.0 million upfront license fees, including delaying the initial $4.0 million portion thereof that was originally due on or about March 17, 2025, to reduce the performance milestones that the Company must complete in order to earn the full $7.0 million nonrefundable upfront payments in June 2025, and to provide that either party may terminate the Agreement if WY Biotech is not able to definitively engage its CDMO by June 2025. There were no other material changes to the Agreement, which involves the grant to WY Biotech of an exclusive, world-wide license to use and apply HCW11-006 for in vivo applications. In particular, the Company will retain the Opt-In Right thereunder, which gives the Company the option to assume all control and responsibility for the development, manufacture and commercialization of HCW11-006 for in vivo applications in the North America, South America, and Central America. The foregoing summary of certain terms of the Agreement and the referenced amendment does not purport to be complete.

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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.