Citius Pharmaceuticals, Inc 8-K, filed Jul 7, 2021
Citius Pharmaceuticals, Inc. (CTXR)
About this 8-K
Citius Pharmaceuticals, Inc filed this 8-K on July 7, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) July 7, 2021
Citius Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Nevada
(State or other jurisdiction of incorporation)
| 333-206903 | 27-3425913 | |
| (Commission File Number) | (IRS Employer Identification No.) |
| 11 Commerce Drive, 1st Floor, Cranford, NJ | 07016 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code (908) 967-6677
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| ☐ | Securities registered pursuant to Section 12(b) of the Act: |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Common stock, $0.001 par value |
CTXR |
The Nasdaq Capital Market | ||
| Warrants to purchase common stock | CTXRW | The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On July 7, 2021, we posted an updated Corporate Presentation on our website. The Corporate Presentation is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On July 7, 2021, we issued a press release providing an update on our business for the six-month period ended June 30, 2021 and also reported on recent corporate developments and upcoming milestones. The press release is attached hereto as Exhibit 99.2 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits |
| Exhibit No. | Description | |
| 99.1 | Corporate Presentation of July 2021. | |
| 99.2 | Press release of July 7, 2021. |
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CITIUS PHARMACEUTICALS, INC. | |
| Date: July 7, 2020 | /s/ Myron Holubiak |
| Myron Holubiak | |
| President and Chief Executive Officer |
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Exhibit 99.1
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) CORPORATE OVERVIEW JULY 2021
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 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 . 2 FORWARD - LOOKING STATEMENTS
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Citius is a late - stage biopharmaceutical company focused on the development and commercialization of first - in - class critical care products, with a pipeline of anti - infectives in adjunct cancer care, stem cell therapy and unique prescription products Citius | Altius | Fortius Olympic Motto Faster | Higher | Stronger 3 OVERVIEW
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 4 INVESTMENT HIGHLIGHTS • Extensive pharma operational and financial track record • Experienced “Blue Ribbon” Board of Directors • Scientific Advisory Board of leading KOL’s in infectious disease, pulmonology (ARDS), and breast surgery • Multi - billion $ in successfully completed transactions pre - Citius • Cash runway into 2023 ($103.7M cash as of 3/31/21) • $26.5M invested by management / founders • Diversified Pipeline with Four Active Programs • Mino - Lok ® (Phase 3): potential to be first and only FDA - approved product to salvage infected CVCs causing CRBSI/CLABSI • NC i - MSC Œ : novel mRNA stem cell therapy for acute respiratory distress syndrome (ARDS) • Mino - Wrap: potential to be first and only FDA - approved product to prevent infections associated with post mastectomy breast implants • Halo - Lido Rx: potential to be first and only FDA - approved Rx therapy for hemorrhoids • Multi - billion $ global market opportunities • CRBSI/CLABSI market est. >$1.8B worldwide • ARDS market large with no approved therapies • Tissue expander infection prevention est. $400M worldwide • Rx hemorrhoid market est. >$2B US G ROWING P IPELINE WITH L ATE S TAGE L EAD A SSET L ARGE A DDRESSABLE M ARKETS S EASONED M ANAGEMENT & ADVISORS S TRONG F INANCIAL P LATFORM
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE F ASTER TO M ARKET Invest in assets with differentiated upside potential Advance assets with a unique commercial advantage Create long - term sustainable value for shareholders 5 THREE PILLARS OF OUR STRATEGY N EW C HEMICAL E NTITY B ENEFITS F INANCIAL S TEWARDSHIP
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE PROGRAM INVESTIGATIONAL INDICATION ESTIMATED MARKET (WW) PRECLINICAL PHASE I PHASE II PHASE III ANTICIPATED MILESTONES MINO - LOK ® T REAT CVC I NFECTIONS > $1.8B HALO - LIDO (CITI - 002) R X T HERAPY FOR H EMORRHOIDS > $2B MINO - WRAP (CITI - 101) P REVENT I NFECTIONS A SSOCIATED WITH B REAST I MPLANTS > $400M NC i - MSC Œ (CITI - 401) T REAT ARDS Multi - billion • NDA 2022 6 FOUR ACTIVE PIPELINE PROGRAMS • IND 2021 • Ph 2b 2021 • IND 2022 • IND 2022 *As of 7/2021, best estimate subject to impact of COVID - 19 pandemic on operations Unlocking Potential. Faster.
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE LEAD PRODUCT CANDIDATE: MINO - LOK ® 7 First and Only antibiotic lock therapy under investigation to sterilize and salvage infected Central Venous Catheters (CVCs) CRBSI/CLABSI infections annually in the U.S.** ~500,000 Central Venus Catheters (CVCs) used annually in the U.S.* 7 Million CRBSI/CLABSI associated mortality & morbidity** 12 - 25% * Shah H., Bosch W., Hellinger W. C., Thompson K. M. (2013). Intravascular catheter - related bloodstream infection. Neurohospitalist 3, 144 – 151. doi : 10.1177/1941874413476043. ** Antoňáková Němčíková A, Bednárovská E. Catheter - related bloodstream infections: do we know all of it? Klin Onkol . 2017;30(6):405 – 411. doi : 10.14735/amko2017405. 4 Million Long - term CVCs (>1 month) in the U.S.
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 8 MINO - LOK ® PENETRATES BIOFILM Biofilm formation protects pathogen colonies from traditional antibiotic lock therapies
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 9 CURRENT STANDARD OF CARE IS A POOR OPTION • Limited availability of other vascular sites • Does not address need to maintain infusion therapy • Potential for complications: infectious, thrombotic and mechanical • 57% - 67% patients experience adverse physical and psychological symptoms from catheter R&R* • High cost • ~$10K cost of R&R procedure • $4 6K - $65K cost of CRBSI/CLABSI episode * Chaftari , AM et al, . Unnecessary Removal of CVCs in Cancer Patients with CRBSI : Impact on Symptom Burden . Poster presentation at ID Week 2017 , Infectious Diseases Society of America (IDSA)Oct 04 - 08 , 2017 Removing & replacing infected CVCs has multiple limitations
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE POTENTIAL GOLD STANDARD IN CLABSI TREATMENT x Limited duration IV therapy x Limits disruption of infusion therapy x Ease of Administration • Locking a catheter is a well known SOP • Procedure can be performed by any healthcare provider x Not flushed into the venous system x Lower cost alternative • Significantly < R&R 5 - 7 DAYS Mino - Lok ® addresses the complications, discomfort and cost of CVC removal and replacement
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE MINO - LOK ® PHASE 2B TRIAL RESULTS 11 *1 polymicrobial patient had Gr+ and Gr – organism cultured; ** 6 patients had >1 complication; ***all 3 CVCs were removed within 1 month. Effective in salvaging CVCs in all patients treated with Mino - Lok ® Patients treated with Mino - Lok ® all had complete microbiologic eradication with no relapse No SAEs in patients treated with Mino - Lok ® Complication rate for Mino - Lok ® patients was 0% vs. 18% for control arm patients N % N % Patients 30 100% 60 100% Cancer Type - Hematologic 20 67% 48 80% - Solid tumor 10 33% 12 20% ICU Admission 4 13% 4 7% Mech. Ventilator 3 10% - 0% Bacteremia - Gram+ 17 57%* 32 53% - Gram - 14 47%* 28 47% Neutropenia (<500 ) 19 63% 36 60% Microbiologic Eradication 30 100% 60 100% - Relapse - 0% 3 5%*** Complications - 0% 8 13% SAEs related to R&R - 0% 6 10% Overall Complication Rate - 0% 11** 18% Parameter Mino-Lok Arm Control Arm 100% 100% 0% 0% Mino - Lok ® demonstrated a strong safety and efficacy signal
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Active Arm (n=72) Mino - Lok® Solution Control Arm (n=72) Antibiotic Lock Patients with CRBSI (n~144) R Multi - center, randomized, open label, blinded assessor, active control superiority study Anticipated median time of 21 days vs. 38 days to achieve significance Interim Analyses: • Futility performed at 35 - 40 events; superior efficacy and futility at 50% and 65% of anticipated events • DMC recommended proceeding with trial without modification following all 3 reviews Primary Endpoint: Comparison of “Time to Catheter Failure” TOC = 6 weeks (42 days) 12 MINO - LOK ® PHASE 3 PIVOTAL TRIAL UNDERWAY
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 2019 2020 2021 2022 Pivotal Phase 3 ALT Study PRE - CLINICAL & CLINICAL DEVELOPMENT REGULATORY PRODUCT & CMC FDA filings** NDA submission *As of 7/2021, best estimate subject to impact of COVID - 19 pandemic on operations ** in vitro disc study…catheter integrity protocol Commercial preparation Interim Analysis Completing Phase 3 pivotal superiority trial 13 MINO - LOK ® DEVELOPMENT PLAN* Interim Safety / Efficacy Analysis Interim Futility Analysis FDA Review Meeting
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE IP PROTECTION THROUGH 2036 Mino - Lok TM is supported by a robust intellectual property portfolio • Composition of Matter and Method of Use patents that provide protection until June 2024 • Formulation patent has been issued and will add protection through 2036 Creators Description of Patent Patent Numbers Issued Expiry Issam Raad , M.D. et al Composition of Matter • US: 7,601,731 • EP: 04754538.9 • CA: 2,528,522 2009 2024 Issam Raad , M.D. Joel Rosenblatt, Ph.D. et al Formulation/Enhanced Stability • US: 10,086,114 • Pub.No .: US 2017/051373 A1 • Global IP: UTFC.P1283WO 2018 2036 Issam Raad , M.D. et al Method of Use • US: 9,078,441 • EP: 1644024 • CA:. 2528522 2015 2024
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE REGULATORY PROTECTIONS Qualified Infectious Disease Product (US) • Priority Review reduces NDA review time from 12 to 6 months • Additional 5 years of market exclusivity upon approval, combined with Hatch - Waxman Fast Track Designation (US) • Expedites review of drugs which treat a serious or life - threatening condition and fills an unmet medical need. • Rolling review allows for completed sections of the New Drug Application (NDA) to be submitted when ready Supplementary Protection Certificate (EU) • Extends patent protection up to 5 years
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE COMPETITIVE LANDSCAPE Company Product Status Limitation NDA accepted by the FDA in August 2020 CRL received from FDA in March 2021 Available in Europe (CE Mark) Prevention only Anti - infective only being used in prophylaxis • No company has US regulatory approval • There are no lock solutions in development for treating CRBSI patients and salvaging indwelling, infected CVCs • CorMedix is focused on development of lock solutions for the prevention of CRBSI in hemodialysis patients There are no products being developed for treatment of infected central venous lines Defencath Ʀ
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Regulatory Environment Reimbursement Commercial With modest penetration at conservative pricing >$500M peak year US sales achievable with a worldwide opportunity of $1.8B DISARM Act pending • create a DRG carveout for QIDP products • Allow for full reimbursement for CMS programs; not part of the payment bundle Pricing Cost - Saving Mino - Lok will be < R&R Targeting Accounts with high CLABSI medical claims Apply for NTAP (all QDIP), increased to 75% of list price Apply for transitional pass - through reimbursement Ex - US United States PURSUE DIRECTLY PARTNER 17 MARKET OPPORTUNITY >4 million CLABSI’s per year* * DelveInsight “Catheter - Related Blood Stream Infections (CRBSI) - Market Insights, Epidemiology & Market Forecast – 2028”
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 18 MINO - LOK ® SUMMARY Potential market - leading antibiotic lock therapy to salvage the CVC in patients with CRBSI/CLABSI Patented solution • Breaks down biofilm barriers • Provides anti - clotting properties to maintain CVC patency • Worldwide license from The University of Texas MD Anderson Cancer Center (MDACC) • Patent protection through 2036 Market Opportunity • First and only therapy under investigation to salvage infected CVCs • Est. >$1.8B WW sales opportunity • Cost advantage over current SOC • No direct competition • ~16 years of exclusivity at time of launch Clinical & regulatory milestones • Phase 2b trial: 100% effective in salvaging CVCs with no SAEs • Phase 3 multicenter trial is currently enrolling patients • QIDP & Fast Track designation Key Advantages • Effective at penetrating biofilm • Avoids R&R complications • Shorter treatment time • Lower cost to providers and patients • Benefits support rapid and sustained market penetration
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 19 EXPANDING PORTFOLIO: ENGINEERED STEM CELL THERAPY Privately - held pre - clinical stage biotechnology company with patented non - immunogenic mRNA technology for gene editing Majority - owned subsidiary of Citius Developing next generation mesenchymal stem cells (NC i - MSCs Π) Derived from an iPSC master cell bank Primary focus is ARDS Worldwide license for respiratory conditions associated with acute inflammation Strong patent protection +
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE SINGLE DONOR / CLONAL • Genetically identical i - MSCs Œ derived from mutation - free iPSCs • One homogeneous, validated source for all future cells • NO repeat harvesting from multiple donors; NO repeat donor testing SCALABLE MFG • Rapid production from master i - MSC Œ cell bank • Substantial expansion potential (trillions of cells for higher and repeat doses) RESTORED TELOMERES • Result in longer therapeutic lifespan compared to donor - derived cells Next generation allogeneic engineered stem cell platform under development for the treatment of ARDS 20 DIFFERENTIATED STEM CELL PLATFORM MORE POTENT • Higher levels of therapeutic proteins compared to donor - derived cells
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE i - MSC Œ A CCESSION C ELL B ANK 4 W EEKS FROM I PSC TO I - MSC Œ C ELL C ULTURE One homogeneous, validated source for all future cells Patented synthetic, non - immunogenic mRNA high efficiency cell reprogramming S INGLE DONOR IRB QUALIFIED “A NGEL C ELL ” R EPROGRAMMING TO I PSC “F OOTPRINT F REE ” (11 - 14 DAYS ) 6 D AILY TRANSFECTIONS 5 M RNA CONSTRUCTS >60 C OLONIES D ERMAL F IBROBLAST S YNTHETIC M RNA N O V IRAL V ECTORS P ERPETUAL I PSC M ASTER C ELL B ANK C LONAL Virtually limitless number of cells from “Angel Cell” Rapid 4 - week production process from iPSC cell bank cGMP compliant scalable manufacturing for preclinical and clinical studies i - MSCs Œ packaged in cryopreserved minibags MCB CHARACTERIZATION MCB EXPANDED FOR CLINICAL SUPPLY AND FINAL PACKAGING I - MSC Œ ACCESSION CELL BANK TO C GMP MASTER CELL BANK Performance enhanced with longer therapeutic lifespan i - MSCs A LLOGENEIC C GMP I - MSC S Œ FOR PATIENT THERAPY 21 i - MSCs Œ : FROM ONE CELL TO TRILLIONS
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE P/F ratio Pulmonary Lymph Flow Pulmonary Lymph Protein Loss Norepinephrine Requirement Improved Oxygenation Reduced Lung Vascular Injury Less Systemic Shock Animals receiving i - MSC s Πdemonstrated stronger therapeutic effects v. control INTERIM RESULTS OF i - MSC ΠSTUDY IN SHEEP MODEL OF ARDS 22
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 2020 2021 2022 2023 POC sheep studies Preclinical Toxicology studies Phase 1/2 Phase 3 In vitro studies Pre - IND FDA consultations End of Ph2 Mtg IND Submission Pre - NDA FDA Mtg NDA Submission Product development & testing i - MSC ΠMCB Chemical & Manufacturing Control (CMC) development Preparing cGMP NC i - MSC ΠMaster Cell Bank to support future trials, with IND submission planned for 2022 23 NC i - MSC ΠDEVELOPMENT PLAN* *As of 7/2021, best estimate subject to impact of COVID - 19 pandemic on operations PRE - CLINICAL & CLINICAL DEVELOPMENT REGULATORY PRODUCT & CMC
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 24 DIVERSIFIED PIPELINE WITH NEAR TERM CATALYSTS Q2 2021 • Mino - Lok ® DMC recommends proceeding with trial as planned Q3 2021 • Dosing to commence in NC i - MSC Œ pilot study Q4 2021 • Halo - Lido (CITI - 002) IND filing • Halo - Lido (CITI - 002) Phase 2b trial start 2022 • Mino - Lok ® NDA filing • Mino - Wrap (CITI - 101) IND filing • NC i - MSC Œ (CITI - 401) IND filing H ALO - L IDO M INO - L OK Treat CVC Infections NC i - MSC Œ Treat ARDS M INO - W RAP Prevent Infections Associated with Breast Implants post - mastectomy Rx Therapy for Hemorrhoids *As of 7/2021, best estimate subject to impact of COVID - 19 pandemic on operations
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 25 MANAGEMENT TEAM WITH PROVEN TRACK RECORD LEONARD MAZUR EXECUTIVE CHAIRMAN, DIRECTOR MYRON HOLUBIAK PRESIDENT & CEO, DIRECTOR JAMIE BARTUSHAK EVP, CFO GARY TALARICO EVP, OPERATIONS DR. MYRON CZUCZMAN EVP, CHIEF MEDICAL OFFICER DR. ALAN LADER VP, CLINICAL OPERATIONS ILANIT ALLEN INVESTOR RELATIONS
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE CELL THERAPY ADVISORS Michael A. Matthay, MD University of California at San Francisco (UCSF) Lorraine B. Ware, MD Vanderbilt University Mitchell M. Levy, MD Brown University, Rhode Island Hospital Perenlei Enkhbaatar MD, PhD, FAHA University of Texas John Laffey MD, MA, FCAI, FJFICMI National University of Ireland (NUI Galway) INFECTIOUS DISEASE / CANCER ADVISORS Isaam Raad , MD University of Texas MD Anderson Cancer Center Mark Rupp, MD University of Nebraska Medical Center Leonard A. Mermel , DO US Dept. of Health & Human Services Jesse Selber , MD University of Texas MD Anderson Cancer Center George Viola, MD The University of Texas MD Anderson Cancer Center, Baylor College of Medicine 26 SCIENTIFIC ADVISORY BOARD OF LEADING KOLS
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE FINANCIAL SUMMARY * 27 CURRENT CAP ITALIZATION SHA R ES % OF FULLY DILUTED BASIC SHARES OUTSTANDING 145,979,429 76.5 % WARRANTS 40,234,172 21.1 % OPTIONS 4,655,166 2.4 % FULLY DILUTED SHARES OUTSTANDING 190,868,767 100% ( 1 ) Beneficial stock ownership as calculated under rules of the Securities Exchange Commission as filed with the Citius Def 14 A Proxy Statement in April 2021. PRINCIPAL INSIDER SHAREHOLDERS (1) LEONARD MAZUR ( 12.6 %) MYRON HOLUBIAK ( 2.7 %) Bandwidth to Execute • $127.6M Financing activities 1H 2021 • $7.7M R&D expense 1H 2021 • Runway into 2023 • $26.5M invested by insiders *As of 06/30/21 unless otherwise noted.
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE 28 CITIUS: WHY INVEST? WHY NOW? Diversified pipeline of potential first - in - class products addressing recognized unmet medical needs Attractive diversified multi - billion dollar opportunities in adjunctive cancer care, infectious disease and gastrointestinal disease Multiple staged near - term catalysts anticipated Seasoned executives with successful execution - focused track record Strong research partnerships to advance pipeline • MD Anderson Cancer Center in developing novel anti - infectives in cancer • Novellus developing promising i - MSC Œ therapy Well capitalized to advance pipeline and invest in long - term growth • $103.7M in cash as of 3/31/21; runway into 2023 • $26.5M invested by insiders
NASDAQ: CTXR CLICK TO EDIT MASTER TITLE STYLE Citius Pharmaceuticals, Inc. 11 Commerce Drive First Floor Cranford, NJ 07016 www.citiuspharma.com Investor Relations Contact Ilanit Allen iallen@citiuspharma.com
Exhibit 99.2
Citius Pharmaceuticals, Inc. Provides First Half 2021 Business Update, Highlights Upcoming Milestones
| - | Phase 3 Mino-Lok® trial proceeding as planned following recommendation by independent Data Monitoring Committee (DMC), highlighting important safety and efficacy signals - |
| - | Mino-Lok® New Drug Application (NDA) submission planned for 2022 following anticipated completion of Phase 3 trial by the end of 2021 or early 2022 – |
| - | Citius financial flexibility expanded with $127.6 million in financing activities during the first half of 2021, including $16.9 million in cash proceeds from warrants exercised during the quarter ended June 30, 2021 – |
CRANFORD, N.J., July 7, 2021 -- Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today provided a business update for the six-month period ended June 30, 2021 and reported on recent corporate developments.
Recent Highlights and Upcoming Milestones
| ● | On July 1, 2021, Citius reported that the independent DMC recommended continuation of the Phase 3 Mino-Lok® pivotal superiority trial as planned with no modifications or safety concerns, |
| ● | Citius expects to complete the Mino-Lok® trial by the end of 2021 or early 2022, subject to continued easing of COVID-19 restrictions in the U.S., |
| ● | Citius plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2022 following completion of its Phase 3 Mino-Lok® trial, and |
| ● | Subsequent to March 31, 2021, Citius issued 11.2 million shares of Citius common stock upon the exercise of warrants, for aggregate proceeds of $16.9 million during the quarter and a total of $127.6 million in financing activities during the first half of 2021. |
“On July 1, 2021, we reported that the independent Data Monitoring Committee (DMC), following its third interim review, recommended continuing the Phase 3 trial for Mino-Lok® without modification. This recommendation affirms that there is an important efficacy signal that merits moving forward with the trial, there are no safety concerns to warrant halting the trial, and that the full data set upon trial completion may support statistically significant superiority. Whether Mino-Lok® demonstrates statistical superiority will only be known to us once the trial is finished and the data is unblinded. We view the recommendation of the DMC as a strong positive signal, and remain fully committed to completing the trial in a timely manner,” stated Myron Holubiak, President and Chief Executive Officer of Citius.
“Mino-Lok® trial patients represent an extremely ill population, which is challenging to enroll under the best of circumstances. Like many clinical trials conducted during the pandemic, the timeline for our study has been impacted by COVID-19. It has taken longer than anticipated to enroll patients due to restrictions established at our trial sites during the height of the pandemic. These restrictions, in place for close to half of the duration of our trial, reflect a series of challenges including: site closures, limited site and patient access, reallocation of resources away from clinical trials to COVID-patient treatment, modifications to catheter infection treatment protocols, and lengthy approval time to qualify new study sites, resulting in fewer monthly patient screenings compared to pre-pandemic levels. The ability of sites to ramp back up for the Mino-Lok® trial depends largely on how these varied and complex factors are addressed. Several institutions have resumed our trial, and provided that COVID restrictions continue to ease and are not reinstated, we believe it would be possible for our trial sites to complete enrollment in the Mino-Lok® study as early as the end of the year. That would put us on target to submit an NDA in 2022,” added Mr. Holubiak.
“We intend to aggressively pursue all options to expedite completion of the Mino-Lok® trial. During the first half of 2021, we raised more than $127 million, of which approximately $17 million was from warrants exercised since March 31, 2021. We intend to leverage these resources to accelerate our outreach efforts to advance the trial. Moreover, we believe we are well capitalized to advance Mino-Lok® beyond trial completion, and will engage closely with the FDA in the coming months to do so. Concurrently, we are actively advancing three additional first-and-only or novel pipeline products as outlined in our updated corporate presentation published on our website this morning. With a late-stage product candidate moving toward completion of its Phase 3 trial, depth in our pipeline, and the financial resources to execute our near-term strategy, we believe Citius is better positioned than ever before to deliver long-term value to shareholders,” concluded Mr. Holubiak.
About Mino-Lok®
Citius is developing Mino-Lok®, an antibiotic lock solution to treat patients with catheter-related blood stream infections that was licensed from The University of Texas MD Anderson Cancer Center. Citius believes Mino-Lok® provides a superior alternative to removing and replacing a central venous catheter (CVC), leading 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.
The Mino-Lok® Phase 3 pivotal superiority trial is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
Approximately 144 subjects diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study are to be randomized in a 1:1 ratio to receive either Mino-Lok® therapy or standard of care antibiotic lock therapy.
Subjects in the Mino-Lok® arm receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.
Three planned interim analyses were performed as defined by the study protocol. The primary role of the independent DMC, defined in the DMC charter, is to safeguard the interests of study participants, assess the safety of the treatment, and monitor the overall conduct of the study. In order to ensure the protection of patients enrolled in the trial and to assure the timely and efficient completion of the study, each DMC recommendation is bound by strict parameters outlined in the DMC charter. A recommendation to continue the trial as planned indicates that the data reviewed by the DMC, at this juncture, is within the statistical boundaries determined by Citius in order to complete the trial with the protocol-defined sample size and power to achieve the primary endpoint.
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About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapy. The Company’s lead product candidate, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), is currently enrolling patients in a Phase 3 pivotal superiority trial. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on acute respiratory distress syndrome (ARDS) associated with COVID-19. For more information, please visit www.citiuspharma.com.
Safe Harbor
This press release may contain “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: our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates, including Mino-Lok®; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; 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; our need for substantial additional funds; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; 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. 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, 2020, filed with the SEC on December 16, 2020 and updated by our subsequent filings with the SEC. 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:
Andrew Scott
Vice President, Special Projects
T: 908-967-6677 x105
E: ascott@citiuspharma.com
Ilanit Allen
Vice President, Corporate Communications and Investor Relations
T: 908-967-6677 x113
E: iallen@citiuspharma.com
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