CTXR

September 20, 2024

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CTXR has $17.9 million in cash reserves as of June 2024

Citius is transforming from a development-stage biopharma into a commercial-stage organization, following the approval of its breakthrough cancer treatment

READ THE INVESTOR PRESENTATION HERE

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‍Hello Everyone,

We have a new profile for you to research immediately before we head into the weekend.

This is a company that we have profiled several times in the past on this newsletter but it has been over a year since we last took a look at this one.

Pull up CTXR immediately.

In August 2024, Citius gained FDA approval for an innovative targeted immunotherapy to treat Cutaneous T-cell Lymphoma (CTCL), a rare and challenging form of cancer. This treatment not only targets a critical unmet need, but it has also been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, solidifying its place as a recommended treatment option. The NCCN Guidelines are widely regarded as the gold standard for clinical decision-making in oncology, and this inclusion paves the way for broader adoption and reimbursement by payors, including Medicare and Medicaid (CMS). ^(8)(9)(10)

Citius isn’t stopping there. The company’s late-stage pipeline includes groundbreaking therapies aimed at tackling critical issues in oncology, infectious diseases, and gastrointestinal disorders. This diversified pipeline provides Citius with multiple chances to drive near-term growth and long-term success. Recently, the company achieved critical milestones, including the successful completion of a Phase 3 trial for one of its key therapies. This progress highlights the company’s focus on delivering life-saving treatments that address high-need areas of patient care. ^(8)(9)(10)

Why Should You Pay Attention?

Here’s why Citius Pharmaceuticals (Nasdaq: CTXR) represents a compelling company for market enthusiast:

FDA-approved treatment for a rare and aggressive form of cancer, backed by significant clinical data and now included in NCCN Guidelines. This boosts its profile and adoption among healthcare professionals. ^(8)(9)(10)

Diversified pipeline that spans oncology, infectious diseases, and gastrointestinal care. With multiple late-stage candidates, Citius has numerous catalysts on the horizon, increasing its growth potential. ^(8)(9)(10)

65% forecasted earnings growth per year. Analysts are watching closely, and this consistent growth projection makes Citius one of the more attractive options in the biopharma space. ⁽⁶⁾

Strong technical momentum. The company’s technical analysis points to positive growth trends, signaling strong market interest and potential for further gains as its products reach the market. ^(8)(9)(10)

Financial Health and Leadership Strength

Citius Pharmaceuticals is financially strong, with $17.9 million in cash reserves as of June 2024. This financial cushion provides the company with the flexibility to continue funding in its late-stage pipeline while also supporting its new product launch. Additionally, Citius completed a $15 million capital raise earlier in the year, further extending its operational runway through December 2024. This ensures that Citius has the resources necessary to advance its development programs and prepare for the commercialization of its FDA-approved therapy. ⁽¹¹⁾

Moreover, Citius is led by a seasoned management team with deep experience in biopharma development and commercialization. The leadership’s focus on value creation and operational efficiency has already delivered tangible results, as evidenced by the company’s multiple milestones in 2024. This strong track record gives us confidence in Citius’ ability to execute its growth strategy successfully. ^{(8)(9)(10)(11)}

A Transformative Company

Citius Pharmaceuticals (Nasdaq: CTXR) is poised to make a major impact in the critical care market. Its innovative therapies, supported by regulatory approvals and favorable clinical data, position the company at the forefront of multi-billion-dollar markets in oncology, infectious diseases, and gastrointestinal treatments. The company’s commitment to advancing life-saving therapies is underscored by its drive to fill unmet medical needs in high-impact areas. ^(8)(9)(10)

This is an exciting time for Citius. The company is transforming from a development-stage biopharma into a commercial-stage organization, following the approval of its breakthrough cancer treatment. This shift represents a significant turning point, not only for the company but for the market as well. Don’t miss the chance to get in on a company with a diversified portfolio, strong financial backing, and a leadership team that’s laser-focused on long-term growth. ^(8)(9)(10)

Pull it up and research it immediately as we head into next week.

Watch for updates!

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NEWS

MANAGEMENT TEAM

Leonard MazurCo-Founder, CEO and Chairman of the Board of Directors

Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive withnotable success in founding and building multiple healthcare companies and creating valueand returns for investors throughout his five-decade career. Mr. Mazur was the co-founderand Chairman of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March2016. He was previously the co-founder and Vice Chairman of Akrimax Pharmaceuticals, LLC,which specialized in cardiovascular and general pharmaceutical products. From 2005 to2012, Mr. Mazur co-founded and served as the Chief Operating Officer of TriaxPharmaceuticals LLC, a specialty pharmaceutical company producing prescriptiondermatological drugs. As founder and Chief Executive Officer of Genesis Pharmaceuticals,Inc., a dermatological products company that marketed its products throughdermatologists’ offices and co-promoted products for major pharmaceutical companies, hesuccessfully negotiated the company’s sale in 2003 to Pierre Fabre, a leading globalpharmaceutical company. Mr. Mazur has extensive sales, marketing, and businessdevelopment experience from previous tenures at Medicis Pharmaceutical Corporation, ICNPharmaceuticals, Inc., Knoll Pharma (a division of BASF), and Cooper Laboratories, Inc. Mr.Mazur was born in Ansbach, Germany, and emigrated with his family to the U.S. at an earlyage. Mr. Mazur served in the U.S. Marine Corps Reserve while studying at Temple Universityfor his undergraduate degree. He earned his MBA from Temple University’s Fox School ofBusiness in 1975. Mr. Mazur is a recipient of the Ellis Island Medal of Honor presentedannually to those who immigrated to the United States during the Ellis Island era and haveshown an outstanding commitment to serving the United States either professionally,culturally, or civically.

Myron HolubiakCo-Founder, Executive Vice Chairman

Mr. Holubiak has extensive experience in managing and leading both large and emergingpharmaceutical and life sciences companies. Mr. Holubiak was co-founder, director and CEOof Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. Mr.Holubiak was the President of Roche Laboratories, Inc., a premier multinational research-based pharmaceutical company, from 1998 to 2001. As President of Roche, Mr. Holubiakhelped transform Roche Labs into a leading antibiotic and biotechnology company. Beforebeing named President, he held sales and marketing positions at Roche during his 19-yeartenure. Earlier, Mr. Holubiak founded Emron, Inc., a health economics and managed careconsulting company, and helped to create the Academy of Managed Care Pharmacy(AMCP). He was also a director of Bioscrip, Inc., a national home infusion company, servingas its Chairman of the Board from 2012 through 2016. Since 2010, Mr. Holubiak has servedas a member of the Board of Directors of Assembly Biosciences, Inc. and its predecessor,Ventrus Biosciences, Inc., and is a trustee of the Academy of Managed Care PharmacyFoundation. Mr. Holubiak received a BS in molecular biology and biophysics from theUniversity of Pittsburgh. He received advanced business training from Harvard BusinessSchool and the University of London, as well as advanced training in health economics fromthe University of York’s Centre for Health Economics.

Jaime BartushakChief Financial Officer & Chief Business Officer

Mr. Bartushak is an experienced finance and operations professional for early-stagepharmaceutical companies, and has over 20 years of corporate finance, businessdevelopment, M&A, restructuring, capital formation, and strategic planning expertise. Mr.Bartushak is a founder of Leonard-Meron Biosciences, and, as CFO, was instrumental inobtaining initial investment capital for its start-up in 2014. Earlier, Mr. Bartushak helped leadthe sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc., andbefore that, he led the financial efforts for the successful sale of Triax Pharmaceuticals toPreCision Dermatology. Mr. Bartushak holds a Master of Science and BS from the NewJersey Institute of Technology.

Myron S. Czuczman, MDChief Medical Officer and EVP

Dr. Czuczman is an experienced physician-scientist, academic oncologist, and pharmaexecutive with decades of experience in strategic design, implementation, and oversight forthe global development of novel therapeutics for hematologic malignancies. Dr. Czuczmanjoined Citius from Celgene where he was Vice President, Global Clinical Research andDevelopment, Therapeutic Area Head of Lymphoma/CLL. In this role, Dr. Czuczmanmanaged a global team of physicians and scientists responsible for cross-functionaldevelopment of compounds from proof-of-principle to worldwide registration. Prior to hiscareer in pharma, Dr. Czuczman practiced medicine for over two decades at Roswell ParkCancer Institute, an NCI-designated comprehensive cancer center in Buffalo, NY, where heserved as chief of the Lymphoma/Myeloma Service and head of the Lymphoma TranslationalResearch Laboratory. In addition to his extensive publications record, membership andleadership roles on national and international research organizations, and consulting andadvisory to dozens of pharma companies, Dr. Czuczman also attained the positions oftenured Professor of Medicine at the State University of New York at Buffalo School ofMedicine and Biomedical Sciences and Professor of Oncology at Roswell ParkComprehensive Cancer Center. Dr. Czuczman received his medical degree from thePennsylvania State University College of Medicine after graduating magna cum laude inbiochemistry from the University of Pittsburgh. He completed his Internal Medicineresidency training at Weill Cornell North Shore University/MSKCC Program, followed byMedical Oncology/Hematology fellowship training at Memorial Sloan-Kettering CancerCenter in New York City.

Gary F. TalaricoEVP, Operations

Mr. Talarico has served as EVP, Operations since March 2016. Mr. Talarico has successfullybuilt and led all commercial activities for a number of start-up companies. Most recently, hewas a founder, partner and Executive Vice President of Leonard-Meron Biosciences, Inc.; hewas instrumental in acquiring its lead product. Previously, Mr. Talarico served as Senior VicePresident of Triax Pharmaceuticals, from its founding to the sale of its assets. Mr. Talaricowas a founder and Executive Vice President of Sales and Marketing for ReliantPharmaceuticals, LLC; Reliant was later sold to GlaxoSmithKline plc. Before Reliant, he wasExecutive Vice President of Business Development for Ventiv Health. His earlier experienceincluded tenures as Vice President of Sales for Medicis Pharmaceutical Corporation at itsstart-up, and Director of Sales at ICN Pharmaceuticals, Inc. Mr. Talarico is a graduate ofLewis University.

Jay WadekarSVP, Business Strategy

Mr. Wadekar has been associated with Citius since its inception. Prior to Citius, he lead theclinical program at Ischemix, Inc., a company developing novel therapies for cardiovascularconditions. Mr. Wadekar has more than thirty years of experience in areas of finance,corporate strategy, sales and senior leadership in the healthcare field. Mr. Wadekar has heldnumerous executive level positions throughout his career in biotechnology andpharmaceutical industries including Chairman and CEO of Able Laboratories, Inc. Mostrecently he served as a strategic advisor to Camber Pharmaceuticals, Inc. where he wasinstrumental in building the executive team and establishing Camber’s Sales Operationssystems.

Kelly Creighton, PhDEVP, Chemistry, Manufacturing and Controls

Kelly joined Citius from Clinipace Worldwide, a leading global contract researchorganization, where he served as Vice President of Regulatory and Strategic Development.As a senior-level regulatory affairs and quality assurance expert with nearly two decades ofexperience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene andcellular therapies, and combination products, he has provided comprehensive regulatorystrategy assessments, development plans and regulatory dossiers for programs across awide range of therapeutic areas. As head of a global CMC regulatory activities forinvestigational products, he has led teams throughout North America, Europe and the AsiaPacific region overseeing submissions and negotiations with regulatory authorities, as wellas biosafety and environmental agencies in each of these regions. Kelly has directed theimplementation of multiple CMC development plans including: contract manufacturingorganization selection, product manufacturing, analytical development, productcharacterization, specification establishment, container closure systems and stabilityrequirements. Additionally, his substantial product development experience extends tobiologics/biosimilars, small molecule, gene and cellular therapies, cancer immunotherapies,live oncolytic biotherapeutics, and microbiome therapies. Twenty products for which heprepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in theUS and EU. Additionally, he has performed internal and external quality assurance audits fordrug products, drug substance, and tissue and cell therapy products. Kelly earned his BSfrom New Mexico State University and his MSc and PhD from the University of Nebraska.

Alan Lader, PhDSVP, Head of Clinical Operations and Quality Assurance

Dr. Lader has over 25 years of experience in medical research. Prior to joining Citius, Dr.Lader was the Director of Clinical Operations for Ischemix, Inc. Dr. Lader was an Instructor inMedicine at Harvard Medical School and Brigham and Women’s Hospital, where he taughtIntegrated Human Physiology, and was Principal Investigator for NIH-funded studies inmechanisms of lung cancer metastasis. Dr. Lader has authored over 20 publications in peer-reviewed journals, and has presented more than 20 abstracts at scientific meetings. Hereceived his PhD from the University of South Carolina School of Medicine. He received anMS degree from Rensselaer Polytechnic Institute in Biomedical Engineering and a BS degreein Bioengineering from Syracuse University.

Ilanit AllenVP, Investor Relations

Ms. Allen has more than 20 years of experience in corporate communications, investorrelations, strategy and investment banking. Since 2014, Ms. Allen has provided investorrelations counsel to more than two dozen private and public life science companies.Previously, she advised executives across a broad spectrum of industries and growth stages,including technology startups and Fortune 500 financial institutions. Ilanit began her careeras an investment banking analyst at SG Cowen with a focus on mergers and acquisitions.Ms. Allen holds an MBA from Harvard Business School, a Bachelor of Science degree inFinance from The Wharton School, and a Bachelor of Arts degree in International Relationsfrom the University of Pennsylvania.

John WestmanVP, Project Management

John Westman has led commercial efforts—including strategy, sales management,marketing, business development, customer service and strategic partnerships—resulting inimproved business results for market-leading and start-up healthcare companies. Priorpositions include co-founder and Executive Vice President of Novellus, Inc., GeneralManager and Vice President of Marketing and Sales for PrecisionMD, NxStage, Fresenius,PharMetrics and Decision Resources Pharmaceutical. John led U.S. and global marketing andsales training at Baxter Healthcare’s Renal division and started his career at Bain Consulting/Baxter consulting firm. John is a Fulbright Scholar who received a B.A. in French and Englishfrom Colgate, an M.A. in international relations from the University of Wisconsin, and anMBA in marketing and finance from the Kellogg Graduate School of Management atNorthwestern. John is on the faculty at Harvard and Boston College.

Paul SowyrdaVP, Business Development & Market Intelligence

Paul Sowyrda is a seasoned Biopharmaceutical leader and inventor with over 25 years ofexperience helping to build and lead development stage and commercial companies. He isco-founder of Novellus, Inc. which was sold to Brooklyn ImmunoTherapeutics, Inc. in July2021, and served as its Executive Vice President. Mr. Sowyrda held previous positions as VicePresident of Drug Development at CIBA, and Vice President of Development and Marketingat Dusa Pharmaceuticals, which was acquired by Sun Pharma. Mr. Sowyrda is an inventorand holds more than 15 patents, He has served on the Board of Directors for the Society ofConcurrent Product Development and is a member of the American Academy ofDermatology and International Society of Dermatologic Surgery. He earned his B.S. and M.S.from the University of Notre Dame, his MBA from Babson College, and completed the MITSloan School of Management Senior Executives Program.

SINCERELY,

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Sources:

1. https://finance.yahoo.com/quote/CTXR/

2. https://finance.yahoo.com/quote/CTXR/history/

3. https://finance.yahoo.com/quote/CTXR/key-statistics/

4. bit.ly/4epZeXj

5. bit.ly/3XN4q1o

6. bit.ly/3XRl7sH

7. https://citiuspharma.com/home/default.aspx

8. bit.ly/3BdHpvO

9. bit.ly/4gtKUhJ

10. https://finance.yahoo.com/news/citius-pharmaceuticals-inc-citius-oncology-123000058.html

11. https://finance.yahoo.com/news/citius-pharmaceuticals-inc-reports-fiscal-212800540.html