Citius Pharmaceuticals Details Near-Term Milestones for Late-Stage Candidates
Citius Pharmaceuticals (Nasdaq: CTXR), a biopharma company, has outlined key milestones for the second half of 2024, hinging on two late-stage candidates: Mino-Lok® and LYMPHIR™. Mino-Lok® has shown positive Phase 3 results for catheter-related bloodstream infections (CRBSIs) and awaits FDA submission and a Type B meeting. LYMPHIR™, an IL-2-based immunotherapy for cutaneous T-cell lymphoma (CTCL), is under FDA review with a decision expected by August 13, 2024. If approved, Citius aims for commercialization in 2024, potentially benefiting from 12 years of exclusivity. The company is also advancing Halo-Lido, a topical treatment for hemorrhoids, and has secured $15 million to strengthen its financial position. Additionally, Citius plans to merge a subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form Citius Oncology, Inc., pending regulatory approval.
- Positive Phase 3 results for Mino-Lok® in CRBSIs.
- LYMPHIR™ BLA under FDA review with a decision expected on August 13, 2024.
- $15 million registered direct offering completed in April 2024.
- Potential 12-year exclusivity for LYMPHIR™ if approved.
- Plans for Citius Oncology formation through a merger with TenX Keane Acquisition, pending regulatory approval.
- Dependence on FDA approval for LYMPHIR™ and Mino-Lok®.
- Potential delays or rejection in regulatory milestones could impact projected commercialization.
Insights
Citius Pharmaceuticals has made significant advancements in its pipeline, with promising results from the Mino-Lok Phase 3 trial and the upcoming FDA decision on LYMPHIR. The financial implications are substantial. If LYMPHIR receives approval, it could provide a substantial
Citius' financial strategy involves leveraging these milestones to extend their cash runway. The
From an investor's perspective, these milestones and financial maneuvers position Citius for potential stock appreciation in the short term, provided the FDA approvals materialize as expected. However, the reliance on FDA decisions introduces risk, as any negative outcome could impact the stock negatively.
The Mino-Lok Phase 3 trial results are a significant achievement. This therapy for catheter-related bloodstream infections (CRBSIs) addresses a critical need, with no other FDA-approved or investigational products currently available. The strong Phase 3 data suggest that Mino-Lok could become standard care, dramatically improving patient outcomes.
LYMPHIR, an IL-2-based immunotherapy for cutaneous T-cell lymphoma (CTCL), is also noteworthy. The potential FDA approval in August 2024 could revolutionize treatment for relapsed or refractory CTCL, offering a novel mechanism of action that might be superior to existing therapies. Moreover, the ongoing Phase 1 studies exploring additional indications enhance its long-term prospects.
While the clinical results are promising, it is essential to consider the potential for regulatory hurdles and the competitive landscape, which could impact market penetration and revenue generation.
The therapeutic landscape for both CRBSIs and CTCL is set to change considerably with the introduction of Mino-Lok and LYMPHIR. Mino-Lok's 'first-and-only' status could secure a significant market share quickly due to the lack of alternatives.
LYMPHIR, if approved, will join the rapidly growing immunotherapy market. The exclusivity period of 12 years provides a strategic advantage, allowing Citius to establish and expand its market presence without immediate competition. This long-term protection is a key driver for revenue stability and growth.
Operationally, the hiring of a National Sales Director indicates proactive steps toward commercialization. This preparation suggests Citius is positioning itself to maximize revenue potential upon product launches.
However, market adoption will depend on payer acceptance and integration into existing treatment protocols. Investors should monitor these factors closely as they will influence the long-term financial performance.
- Multiple catalysts for potentially transformative assets in second half of 2024
- Strong momentum expected from positive topline results of Phase 3 Mino-Lok® trial, commercialization of LYMPHIR™ if approved
- First-and-only advantage for Mino-Lok with no current FDA-approved or investigational products; LYMPHIR expected to be additive to current treatment options with mechanism of action supporting market advantage
- Financial platform and pending oncology spin-off support pipeline development and investment in long-term growth
- Clinical and operational achievements offer powerful levers for value creation
- National Sales Director onboarded to recruit and lead the sales organization in preparation for anticipated launch of LYMPHIR
Leonard Mazur, Chairman and CEO of Citius stated, "Our solid execution since the beginning of the year sets us up for potentially transformative catalysts in the coming months. Mino-Lok's strong Phase 3 topline results support its potential to become part of the standard of care for treating catheter-related bloodstream infections. Mino-Lok would also have a first and only advantage in a market with no approved or investigational products for salvaging infected central venous catheters. For LYMPHIR™, the FDA is currently reviewing our Biologics License Application, with an expected decision on August 13th. We are preparing for near-term commercialization of LYMPHIR if approved. These near-term catalysts should enable the company to optimize its current cash runway, future cash needs, as well as create potential non-dilutive cash opportunities.
"Our primary purpose and mission for these late-stage assets is to provide best-in-class, highly effective treatment options for patients and caregivers," Mazur added. "Ultimately, we believe our achievements and milestones offer powerful levers for value creation."
Late-Stage Assets: Mino-Lok® and LYMPHIR™
Citius significantly advanced its two late-stage product candidates in the first six months of 2024, and expects several key milestones in the near term.
- Mino-Lok: Citius recently announced positive topline data from the Phase 3 study of Mino-Lok® in catheter-related bloodstream infections (CRBSIs). Primary and secondary endpoints were met with statistical significance.
- Next steps for the Mino-Lok program are to prepare a submission to the
U.S. Food and Drug Administration (FDA) and schedule a Type B meeting. - LYMPHIR™: In March 2024, the FDA accepted the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
- A decision on the LYMPHIR BLA is expected on August 13, 2024, the FDA's assigned Prescription Drug User Fee Act (PDUFA) action date. If approved, Citius is preparing for LYMPHIR commercialization in 2024.
- Considered a new biologic by the FDA, LYMPHIR would potentially be eligible for 12 years of exclusivity, if approved.
- In addition to the initial indication, two investigator-initiated Phase 1 studies of LYMPHIR are underway to explore how the differentiated mechanism-of-action may offer potential indications beyond CTCL. The studies are in progress at the University of
Pittsburgh and the University ofMinnesota .
Specialty Pharma Asset: Halo-Lido
- An end of Phase 2b trial meeting with the FDA was held to discuss the positive data for Halo-Lido, a prescription strength topical for symptomatic hemorrhoid treatment. The data showed a meaningful reduction in symptom severity when compared to individual components alone.
- Continuing engagement with the FDA will guide the Company's next phase of development for Halo-Lido.
Operational Milestones
Operational achievements by Citius in the first six months of 2024 delivered additional capital and stronger levers for value creation.
- Citius took steps to strengthen its capital structure in preparation for LYMPHIR™ commercialization, if approved. A
$15 million - Citius plans to merge a wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form publicly listed company, Citius Oncology, Inc. The transaction is pending review by the
U.S. Securities and Exchange Commission (SEC) and TENK shareholder approval as well as contractual and customary closing conditions.
About Mino-Lok
Mino-Lok (MLT), a novel antibiotic lock solution that combines minocycline, ethanol and edetate disodium, is designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of PTCL and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in
About Halo-Lido
Halo-Lido (CITI-002) is a proprietary topical formulation intended to provide symptomatic relief to individuals suffering from hemorrhoids. Hemorrhoids are a gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. Although hemorrhoids are not life-threatening, individual patients often suffer painful symptoms that can limit social activities and have a negative impact on the quality of life. More than half of the
About Citius Pharmaceuticals, Inc.
Citius Pharma is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates. In May 2024, Citius announced positive topline results of Mino-Lok®, its antibiotic lock solution to salvage catheters in patients with bloodstream infections. The Biologics License Application for LYMPHIR™, a novel IL-2R immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma, is currently under review by the FDA with August 13, 2024 assigned as the PDUFA target action date. Citius previously announced plans to form Citius Oncology, a standalone publicly traded company with LYMPHIR as its primary asset. LYMPHIR received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In addition, Citius completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to an approval of LYMPHIR and Mino-Lok by the FDA; our ability to commercialize our products, including LYMPHIR and Mino-Lok, if approved by the FDA; our need for substantial additional funds; our ability to procure cGMP commercial-scale supply; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our dependence on third-party suppliers; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by Covid-19 and could be impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at www.sec.gov, including in our Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, and updated by our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Relations for Citius Pharmaceuticals:
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.
FAQ
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