CTOR

Penny Stocks to Watch: MySize, QuantaSing Group Ltd., and Citius Oncology are highlighted as top penny stocks to monitor on April 1, 2025, based on their high Dollar Volume and recent stock price increases.

Company Highlights: MySize saw a 20.1% stock surge after reporting an 18% revenue increase; QuantaSing's stock rose 17.5% following its entry into the pop toys market; while Citius Oncology experienced a nearly 40% jump despite recent volatility.

Xos, Inc. Performance: Xos, Inc. shares rose 9% in pre-market trading after reporting a revenue increase to $56 million for 2024, up from $44.5 million in 2023, alongside improved gross margins and unit deliveries.

Market Movements: Several stocks experienced significant pre-market trading changes, with Treasure Global Inc. gaining 75.3% and Damon Inc. falling 48.3%, reflecting a mix of gains and losses across various companies.

Business Developments: Citius Pharmaceuticals reported significant progress in the first quarter of fiscal 2025, including advancements for the commercial launch of LYMPHIR and securing a new J-code for reimbursement. They also announced promising preliminary results from clinical trials involving LYMPHIR and engaged with the FDA regarding their pipeline assets.

Financial Overview: The company experienced a net loss of $10.3 million for the quarter, with cash and cash equivalents totaling $1.1 million as of December 31, 2024. Despite a decrease in R&D expenses, G&A expenses rose due to pre-launch activities for LYMPHIR, highlighting ongoing financial challenges and the need for additional capital.

Business Developments: Citius Oncology reported progress in preparing for the launch of its targeted oncology therapy, LYMPHIR™, including securing a new J-code for reimbursement and engaging Jefferies as a financial advisor to explore strategic alternatives for maximizing shareholder value.

Financial Performance: For the fiscal first quarter ending December 31, 2024, Citius Oncology experienced an increase in net loss to $6.7 million compared to $4.7 million in the same period the previous year, attributed to rising operating expenses related to R&D and G&A activities.

Approval and J-Code Assignment: LYMPHIR (denileukin diftitox-cxdl) has been approved by the FDA for treating adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma, and it will have a permanent J-code (J9161) effective April 1, 2025, to facilitate billing and reimbursement.

Safety Information: The treatment comes with significant safety warnings, including risks of capillary leak syndrome, visual impairment, infusion-related reactions, and hepatotoxicity, necessitating careful monitoring during administration.

Launch of LYMPHIR™: Citius Pharmaceuticals announced preparations for the commercial launch of LYMPHIR™, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), expected in the first half of 2025 following its FDA approval in August 2024.

Key Initiatives and Safety Information: The company is focusing on manufacturing, healthcare provider education, market access, and patient support initiatives while highlighting important safety information regarding potential side effects such as capillary leak syndrome and visual impairment associated with LYMPHIR.

Citius Oncology's Strategic Review: Citius Oncology has engaged Jefferies LLC as its exclusive financial advisor to explore strategic alternatives aimed at maximizing shareholder value, which may include partnerships, mergers, or acquisitions.

LYMPHIR™ Approval and Market Potential: The company recently received FDA approval for LYMPHIR™, a targeted immunotherapy for cutaneous T-cell lymphoma, with an estimated initial market exceeding $400 million, highlighting its commitment to improving patient outcomes in oncology.

Business Highlights: Citius Pharmaceuticals achieved FDA approval for LYMPHIR™, an immunotherapy for cutaneous T-cell lymphoma, and is preparing for its commercial launch in 2025. The company also reported positive results from the Phase 3 trial of Mino-Lok® and completed a merger to form Citius Oncology, Inc.

Financial Overview: For the fiscal year ending September 30, 2024, Citius Pharma reported a net loss of $39.4 million, with cash and equivalents totaling $3.3 million. R&D expenses decreased to $11.9 million, while G&A expenses rose to $18.2 million due to pre-launch activities for LYMPHIR™.

Business Highlights: Citius Oncology received FDA approval for LYMPHIR™, an immunotherapy for cutaneous T-cell lymphoma, and began trading on Nasdaq under the ticker CTOR after merging with TenX Keane. The company is preparing for a commercial launch in 2025, including manufacturing inventory and marketing efforts.

Financial Results: For the fiscal year ending September 30, 2024, Citius Oncology reported a net loss of $21.1 million, an increase from the previous year's loss of $12.7 million, attributed to rising research and administrative expenses as well as stock-based compensation.

Credo Technology Group Performance: Shares of Credo Technology Group surged 40.2% in pre-market trading after reporting better-than-expected second-quarter results and issuing optimistic guidance.

Market Movements: Several stocks experienced significant pre-market fluctuations, with Cheetah Net Supply Chain Service gaining 157%, while Ocean Power Technologies saw a decline of 40% following disappointing financial results.

Maxim Group Coverage: On November 27, 2024, Maxim Group initiated coverage of Citius Oncology (NasdaqCM:CTOR) with a Buy recommendation.

Shareholder Ownership: Various shareholders hold small percentages of Citius Oncology, with Yakira Capital Management owning 0.02% and others like Virtu Financial and Advisor Group Holdings holding even less.

Clinical Trial Results: A Phase I clinical trial evaluating the combination of pembrolizumab and LYMPHIR™ in patients with recurrent solid tumors, particularly gynecological cancers, has shown a 27% objective response rate and a 33% clinical benefit rate, with a median progression-free survival of 57 weeks.

Safety Profile: The chemotherapy-free regimen was well-tolerated, with no serious immune-related adverse events reported, indicating potential for further research into its efficacy across various solid tumor types.

Clinical Trial Results: A Phase I clinical trial evaluating the combination of pembrolizumab and LYMPHIR™ in patients with recurrent solid tumors, particularly gynecological cancers, shows a 27% objective response rate and a 33% clinical benefit rate, with a median progression-free survival of 57 weeks. The regimen is well-tolerated with no serious immune-related adverse events reported.

Future Research Directions: The study aims to further investigate the effects of this immunomodulatory treatment on the tumor immune microenvironment and plans to expand research into a Phase II study to evaluate its efficacy across a broader range of solid tumor types.

Upcoming Presentation: Leonard Mazur, CEO of Citius Pharmaceuticals, will present at the H.C. Wainwright & Co. 26th Annual Global Investment Conference on September 10, 2024, discussing recent business developments including FDA approval of LYMPHIR™ and the merger forming Citius Oncology.

Recent Achievements: Citius Pharmaceuticals has achieved significant milestones such as FDA approval for LYMPHIR™, successful completion of Phase 3 trials for Mino-Lok®, and ongoing engagement with the FDA for future steps in their product pipeline.

Approval and Inclusion in Guidelines: Citius Pharmaceuticals announced that LYMPHIR™, an immunotherapy for Cutaneous T-cell Lymphoma (CTCL), has been added to the NCCN Clinical Practice Guidelines with a Category 2A recommendation, indicating its appropriateness for patients after prior systemic therapy.

Mechanism and Safety Information: LYMPHIR targets IL-2 receptors on malignant T-cells, demonstrating efficacy in clinical trials; however, it carries risks such as capillary leak syndrome and visual impairment, necessitating careful monitoring during treatment.