Citius Pharmaceuticals, Inc.
(NASDAQ: CTXR)
Corporate Update
SEPTEMBER 2023
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FORWARD-LOOKING STATEMENTS
This presentation has been prepared by Citius Pharmaceuticals, Inc. (the "Company") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the Company or any director, employee, agent, or adviser of the Company. This presentation does not purport to be all-inclusive or to contain all of the information you may desire. The information contained in this presentation and the comments and remarks of the representatives of the Company made during any presentation to which this presentation relates are integrally related and, as such, are intended to be delivered and understood together. Information provided in this presentation speaks only as of the date hereof. The Company assumes no obligation to update any statement after the date of this presentation as a result of new information, subsequent events or any other circumstances.
This presentation also includes express and implied forward-looking statements regarding the current expectations, estimates, opinions and beliefs of the Company that are not historical facts. Such forward-looking statements may be identified by words such as "believes", "expects", "endeavors", "anticipates", "intends", "plans", "estimates", "projects", "should", "objective" and variations of such words and similar words. The accuracy of such statements is dependent upon future events, and involves known and unknown risks, uncertainties and other factors beyond the Company's control that may cause actual results to differ materially from what is presented herein. Investors are strongly encouraged to carefully review the Company's SEC filings for a listing of the risks that could cause actual results to differ from these forward looking statements. These forward-looking statements speak only as of the date of this presentation and should not be construed as statements of facts.
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INVESTMENT HIGHLIGHTS
1 Diversified Pipeline: Building a Biotech Platform
- LYMPHIR™: purified reformulation of IL-2 diphtheria toxin fusion protein for CTCL1 (P3 completed)
- Mino-Lok®: potential to be first and onlyFDA-approved product to salvage infected CVCs causing CLABSI (P3)
- Halo-Lido:potential to be first and onlyFDA-approved Rx therapy for hemorrhoids (P2b completed)
- NC i-MSC™: novel stem cell therapy for acute respiratory distress syndrome (ARDS) (Pre-clinical)
- Mino-Wrap:potential to be first and onlyFDA-approved product to prevent infections associated with post mastectomy breast implants (Pre-clinical)
2 Attractive Multi-billion $ Global Market Opportunities
- CTCL market est. $300-$400+M with larger potential in PTCL and immuno-oncology (I/O)
- CRBSI/CLABSI market est. >$1.8B worldwide
- Rx hemorrhoid market est. >$2B US
- ARDS market large with no approved therapies
- Tissue expander infection prevention est. $400M worldwide
3
3
Healthy Financial Platform
- $33.3 M cash as of 6/30/23 with runway through August 2024
- $15 million registered direct offering May 2023
- Complete Response Letter (CRL) remediation efforts not expected to impact cash runway
- $26.5 million invested by insiders
Anticipated Value Driving Catalysts
- Completion of Mino-Lok Phase 3 trial; topline results expected first half of 2024
- Resubmission of LYMPHIR planned for early 2024
1. LYMPHIRTM has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed brand name for I/ONTAK (E7777).
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MANAGEMENT TEAM WITH PROVEN TRACK RECORD
LEONARD MAZUR | MYRON HOLUBIAK | JAIME BARTUSHAK | DR. MYRON CZUCZMAN | GARY TALARICO |
CHAIRMAN, CEO & CO-FOUNDER | VICE CHAIRMAN & CO-FOUNDER | EVP, CFO & CBO | EVP, CHIEF MEDICAL OFFICER | EVP, OPERATIONS |
KELLY CREIGHTON | CATHERINE KESSLER | NIK BURLEW | JAY WADEKAR | DR. ALAN LADER |
EVP, CMC | EVP, REGULATORY AFFAIRS | EVP, QUALITY ASSURANCE | SVP, BUSINESS STRATEGY | SVP, CLINICAL OPERATIONS |
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MILESTONES & RECENT DEVELOPMENTS
2021 | 2022 | 2023 | 2024 | ||||||
• | |||||||||
LYMPHIR | Q4: Phase 3 Clinical Trial | Q3: Filed BLA | July 28: CRL | Early 2024: | |||||
Completed | • | Citius addressing enhanced | resubmission | ||||||
product testing required by | planned | ||||||||
FDA | |||||||||
• No clinical data issues | |||||||||
related to safety or efficacy | |||||||||
• | Citius planning for | ||||||||
resubmission | |||||||||
MINO-LOK | Expanded trial to sites in | • | 92 required events achieved | First half 2024: | |||||
India | for trial completion, subject | topline results | |||||||
to confirmation by | anticipated | ||||||||
independent reviewers | |||||||||
• Patients in active treatment | |||||||||
may result in additional |
events
• Trial to continue enrolling in near term
HALO-LIDO
- Phase 2b trial enrollment completed April 2023
- Positive Phase 2b results reported
-
Preparations underway for end of Phase 2 meeting with
FDA
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Citius Pharmaceuticals Inc. published this content on 11 September 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 September 2023 12:16:07 UTC.