On February 10, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, reported business and financial results for the first fiscal quarter of 2022 ended December 31, 2021 (Press release, Citius Pharmaceuticals, FEB 10, 2022, View Source [SID1234608000]).
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Fiscal Q1 2022 Business Highlights and Subsequent Developments
Pivotal Phase 3 trial of I/ONTAK (E7777) completed in December 2021 with topline results anticipated in the first half of 2022 and a biologics license application (BLA) submission planned in the second half of 2022;
Mino-Lok Phase 3 trial completion anticipated in 2022; and,
Regulatory, manufacturing, clinical and commercial capabilities expanded to support late-stage pipeline with the addition of seasoned executives with extensive pharmaceutical industry experience:
Catherine Kessler MS – EVP, Regulatory Affairs
Kelly Creighton, PhD – EVP, Chemistry, Manufacturing and Controls
Kevin Carey – VP, Program Management
Preeti Singh, MD – Medical Director
Financial Highlights
Cash and cash equivalents of $65.4 million as of December 31, 2021;
R&D expenses were $5.5 million for the first quarter ended December 31, 2021, compared to $6.2 million for the first quarter ended December 31, 2020;
G&A expenses were $2.9 million for the first quarter ended December 31, 2021, compared to $1.7 million for the first quarter ended December 31, 2020;
Stock-based compensation expense was $0.9 million for the first quarter ended December 31, 2021, compared to $0.3 million for the first quarter ended December 31, 2020; and,
Net loss was $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the first quarter ended December 31, 2020.
"We anticipate 2022 will be a year of important catalysts for Citius. The timeline for the I/ONTAK program remains on track, with topline results anticipated in the first half of 2022, followed by a planned BLA filing in the second half of the year. Moreover, the FDA confirmed that no pediatric study will be required for I/ONTAK, further de-risking this asset," stated Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.
"Covid-19 continues to pose a challenge to the Mino-Lok Phase 3 trial. We remain committed to completing the trial this year and believe we are well-positioned to continue our efforts as Covid-19 infections and hospitalizations subside, restrictions are lifted and the overall environment for clinical trials improves. These efforts include active engagement with our existing sites, and evaluation of additional trial sites. We continue to believe that there is a significant unmet medical need to salvage catheters so that critically ill patients need not undergo the painful and costly removal and replacement of a central venous line. Our primary focus remains to execute a plan that ensures we have a robust dataset that maximizes the potential success of Mino-Lok," added Mr. Holubiak.
"To further support the launch of our two late-stage product candidates, I/ONTAK and Mino-Lok, if approved, and to advance our other pipeline programs, we have added several key regulatory, clinical, commercial and manufacturing industry veterans to our team. Their expertise will help propel our activities to bring these important products to market, and our strong balance sheet continues to support these efforts. We look forward to sharing our value-creating milestones with our stakeholders in the coming months," concluded Mr. Holubiak.
Key Recent Hires
Catherine Kessler, MS – EVP, Regulatory Affairs
Ms. Kessler is a well-respected biotech executive with more than 25 years of experience in the pharmaceutical industry, including 20 years of experience in regulatory affairs and 16 years of expertise in managing regulatory affairs and operations activities supporting early and late-stage product development in multiple therapeutic areas. She has prepared regulatory submissions for the US FDA, EMEA and other regulatory authorities for investigational drugs. Catherine’s deep expertise in developing regulatory paths to market for unique investigational products, engaging health authorities through complex stages of clinical development, tactical aspects of regulatory applications, and efficient resourcing of application-related activities will allow her to successfully chart the regulatory paths for each of the pipeline programs at Citius.
Kelly Creighton, PhD – EVP, Chemistry, Manufacturing and Controls
Mr. Creighton is a senior regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products. He joined Citius from Clinipace Worldwide, a leading global contract research organization. As head of global CMC regulatory activities for investigational products, he has led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU.
Kevin Carey – VP, Program Management
Mr. Carey is a seasoned pharmaceutical executive with more than 20 years of experience in complex global pharmaceutical project management, and more than 10 years of experience in combination drug/device development. Kevin has managed all phases of the pharmaceutical drug development lifecycle including discovery and development, preclinical research, clinical research, and FDA drug review and approval, including seven NDA submissions and approvals throughout his career. Mr. Carey joined Citius from Dr. Reddy’s Laboratories where he was a Senior Director and head of the Program and Alliance Management Office, and was integral to the I/ONTAK (E7777) program.
Preeti Singh, MD – Medical Director
Dr. Singh is an accomplished clinical strategy and development leader with more than a decade of experience in drug development from proof-of-concept studies to Phase 3 trials and life cycle management in the areas of oncology, dermatology, neurology, and pediatric and adult gastroenterology. She brings diverse and well-rounded experience in medical affairs, drug commercialization and strategy, with extensive knowledge of new drug approval and regulatory compliance, to the newly formed role at Citius. Dr. Singh joined Citius from Dr. Reddy’s Laboratories where she was the Subject Matter Expert on I/ONTAK (E7777).
FIRST QUARTER ENDED DECEMBER 31, 2021 Financial Results:
Liquidity
As of December 31, 2021, the Company had $65.4 million in cash and cash equivalents and no debt.
As of December 31, 2021, the Company had 146,012,169 common shares issued and outstanding.
The Company estimates that its available cash resources will be sufficient to fund its operations through March 2023.
Research and Development (R&D) Expenses
R&D expenses were $5.5 million for the fiscal quarter ended December 31, 2021, compared to $6.2 million for the fiscal quarter ended December 31, 2020. The decrease of $0.7 million is primarily due to a $4.8 million decrease in research and development expenses related to our proposed novel cellular therapy for ARDS offset by increases in R&D expenses related to I/ONTAK, Mino-Lok, Halo-Lido and Mino-Wrap. During the three months ended December 31, 2020, we expensed a $5,000,000 license fee paid to Novellus.
We expect that research and development expenses will increase in fiscal 2022 as we continue to focus on our Phase 3 trials for Mino-Lok and I/ONTAK, progress the Halo-Lido product candidate, and continue our research and development efforts related to ARDS and Mino-Wrap.
General and Administrative (G&A) Expenses
G&A expenses were $2.9 million for the fiscal quarter ended December 31, 2021, compared to $1.7 million for the fiscal quarter ended December 31, 2020. The increase of $1.2 million is primarily due to costs associated with additional compensation costs for new employees and performance bonuses. General and administrative expenses consist primarily of compensation costs, professional fees related to our capital raising activities, corporate development services, and investor relations.
Stock-based Compensation Expense
For the fiscal quarter ended December 31, 2021, stock-based compensation expense was $0.9 million as compared to $0.3 million for the prior year period. The increase primarily reflects expenses related to new grants made by Citius to employees, directors and consultants.
Net loss
Net loss was $9.2 million, or ($0.06) per share for the fiscal quarter ended December 31, 2021, compared to a net loss of $8.1 million, or ($0.15) per share for the fiscal quarter ended December 31, 2020. The increase in net loss is primarily due an increase in general and administrative expenses.