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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 18, 2024 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and 12 months ended December 31, 2024, and provided operating and partner program updates (Press release, OmniAb, MAR 18, 2025, View Source [SID1234651234]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2024 was a remarkable year featuring double-digit percentage growth in the number of both active partners and programs. Clinical-stage programs advanced well, and we launched new technologies and enhancements that strengthened our platform and expanded our reach," said Matt Foehr, Chief Executive Officer of OmniAb. "We exceeded our internal goals for key metrics and continued to build momentum while optimizing the scalability of our business. We believe our commitment to innovation is a significant competitive advantage and creates exciting opportunities for future growth. We remain steadfast in our strategic direction and are excited about the prospects that lie ahead."

Fourth Quarter 2024 Financial Results

Revenue for the fourth quarter of 2024 was $10.8 million, compared with $4.8 million for the same period in 2023, with the increase primarily due to higher license and milestone revenue partially offset by lower service and royalty revenue.

Research and development expense was $13.3 million for the fourth quarter of 2024, compared with $14.8 million for the same period in 2023, with the decrease primarily due to lower stock-based compensation expense and outside expenses associated with third-party services. General and administrative expense was $7.4 million for the fourth quarter of 2024, compared with $7.9 million for the same period in 2023, with the decrease primarily due to lower stock-based compensation expense and lower external marketing and legal expenses.

Net loss for the fourth quarter of 2024 was $13.1 million, or $0.12 per share, compared with a net loss of $14.1 million, or $0.14 per share, for the same period in 2023.

Full Year 2024 Financial Results

Revenue for 2024 was $26.4 million, compared with $34.2 million for 2023, with the decrease primarily due to the recognition of a $10.0 million TECVAYLI milestone in 2023. Royalty revenue decreased primarily due to lower net product sales by partners.

Research and development expense for 2024 was $55.1 million, compared with $56.5 million for 2023, with the decrease primarily due to lower personnel costs and external expenses. General and administrative expense for 2024 was $30.7 million, compared with $33.3 million for 2023, with the decrease primarily due to non-recurring consulting and other outside service expenses incurred in 2023 related to our spin-out as a public company and lower legal and stock-based compensation expense.

Net loss for 2024 was $62.0 million, or $0.61 per share, compared with a net loss of $50.6 million, or $0.51 per share, for 2023.

As of December 31, 2024, OmniAb had cash, cash equivalents and short-term investments of $59.4 million.

2025 Financial Guidance

OmniAb today introduced 2025 financial guidance. OmniAb expects 2025 revenue to be in the range of $20 million to $25 million and operating expense to be in the range of $90 million to $95 million. In addition, OmniAb expects 2025 cash use to be lower than its cash use in 2024. Cash use in 2024 was $38.9 million, excluding the 2024 ATM issuance. The 2025 full year effective tax rate is expected to be approximately 0%.

Fourth Quarter 2024 and Recent Business Highlights

As of December 31, 2024, OmniAb had 91 active partners and 363 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized. The Company signed 10 new license agreements in 2024, including two in the fourth quarter with Incyte Corporation and Photinia Biosciences. In addition, five new OmniAb-derived antibodies entered the clinic in 2024.

In December 2024, OmniAb launched OmniHub , a unified interface designed to provide partners with secure access to datasets to visualize their discovery campaign data with a variety of custom tools. This bioinformatics portal is designed to enable scalable and secure data transfer, advanced visualization and computational tool access.

Fourth quarter 2024 and recent partner highlights include the following:

IMVT-1402

Immunovant announced that its lead asset, IMVT-1402, is rapidly progressing with six Investigational New Drug (IND) applications now cleared and pivotal Phase 2b studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis now enrolling.
Immunovant is on track to initiate potentially registrational programs for three additional indications for IMVT-1402 by March 31, 2025. In addition, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of 10 indications by March 31, 2026.
Batoclimab

Immunovant reported that the top-line results of the batoclimab trial in myasthenia gravis and the initial results from period 1 of the batoclimab trial in chronic inflammatory demyelinating polyneuropathy are expected by March 31, 2025.
Immunovant also plans to announce additional data from the batoclimab proof-of-concept study in GD, including six-month, treatment-free remission data in the summer 2025.
Additionally, Immunovant reported that top-line results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves’ ophthalmopathy, are expected in the second half of 2025.
HanAll Biopharma announced that batoclimab has received Orphan Drug Designation from Japan’s Ministry of Health, Labor, and Welfare for active TED.
Acasunlimab

Genmab announced that a Phase 3 trial with acasunlimab as a second-line therapy in non-small cell lung cancer (NSCLC) is now enrolling patients and that they expect to provide an additional Phase 2 data update in NSCLC in 2025.
Zimberelimab

Arcus Biosciences expects to present overall survival (OS) data from the Phase 2 EDGE-Gastric study, which is evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal adenocarcinomas, in the fall of 2025.
Arcus Biosciences also expects to initiate three new expansion cohorts within the Phase 1/1b ARC-20 study in the first quarter of 2025, including one cohort for casdatifan plus zimberelimab in all-comer first-line clear cell renal cell carcinoma.
Sugemalimab

CStone announced the publication of the Phase 3 GEMSTONE-303 study results for sugemalimab in patients with unresectable locally advanced or metastatic G/GEJ adenocarcinoma in theJournal of the American Medical Association. Results showed that in patients with PD-L1 combined positive score ≥5, sugemalimab significantly improved both OS and progression-free survival (PFS) compared with the control group. Median OS was 15.6 months versus 12.6 months, and median PFS was 7.6 months versus 6.1 months.
CStone announced that they have entered into a strategic partnership with Pharmalink Store for commercialization of sugemalimab in the Middle East, North Africa and South Africa. Additionally, CStone has partnered with SteinCares to market sugemalimab in Latin America.
Mipletamig

Aptevo Therapeutics announced that 100% of patients in Cohort 1 of the mipletamig RAINIER Phase 1b/2 dose-optimization trial for frontline acute myeloid leukemia achieved remission within 30 days of treatment. Trial enrollment is ongoing. Aptevo also anticipates providing multiple data readouts in 2025 and presenting results at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in the fourth quarter of 2025.
RNDO-564

Rondo Therapeutics presented data from preclinical studies of RNDO-564, a novel CD28 x Nectin-4 costimulatory bispecific antibody for advanced bladder cancer, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. RNDO-564 demonstrated robust anti-tumor activityin vivoandin vitro, including in an antibody-drug-conjugate-resistant bladder cancer model. Based on promising preclinical findings, Rondo is advancing RNDO-564 through IND-enabling studies and expects to initiate a Phase 1/b trial in relapsed/refractory, locally advanced/metastatic bladder cancer by year-end 2025.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549-8228 using the conference ID 84579. Slides, as well as the live and replay webcast of the call, are available at 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!