Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Fiscal
First Quarter 2024 Financial Results and Provides Business Update
Resubmitted LYMPHIR Biologics License Application;
Completed enrollment in the Mino-Lok Pivotal
CRANFORD, N.J., February 14, 2024 -- 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 today reported business and
financial results for the fiscal first quarter 2024 ended December 31, 2023.
First Quarter 2024 Business Highlights and
Subsequent Developments
Financial Highlights
"We had a strong first quarter of fiscal
2024 during which we achieved multiple mission critical goals. We are hopeful that topline results from our completed Mino-Lok pivotal
Phase 3 trial, which we expect to be available in the second quarter of 2024, support the benefit of using Mino-Lok to clear infected
catheters. The data will clarify the path forward for Mino-Lok and our opportunities to monetize the asset. Likewise, our upcoming end
of Phase 2 meeting with the FDA should provide valuable input on the development plan for Halo-Lido," stated Leonard Mazur, Chairman
"Importantly, we believe we have addressed
the items noted by the FDA in our BLA submission for LYMPHIR and have resubmitted the application. We look forward to receiving a PDUFA
date shortly and potential approval later this year. In parallel, we executed an agreement to merge our oncology subsidiary with TenX
to form a publicly listed company. With unanimous board of directors' approval, we believe the transaction will ultimately provide
greater financial flexibility and drive sustained value for all stakeholders. The transaction is expected to be completed in the first
half of 2024," added Mazur.
"For the balance of 2024, our focus will
remain on financial stewardship and execution to maximize the value of our pipeline," concluded Mazur.
QUARTER 2024 Financial Results:
As of December 31, 2023, the Company had $20.3
million in cash and cash equivalents.
As of December 31, 2023, the Company had 158,966,576
common shares outstanding.
The Company estimates that its available cash
resources will be sufficient to fund its operations through August 2024. We expect to need to raise additional capital in the future to
support our operations beyond August 2024.
Research and Development (R&D) Expenses
R&D expenses were $2.6 million for the first
quarter ended December 31, 2023, compared to $3.4 million for the first quarter ended December 31, 2022. The decrease primarily reflects
the completion of Mino-Lok Phase 3 trial recruitment and completion of the Halo-Lido Phase 2b trial, offset by incremental costs related
to remediation activities for the LYMPHIR BLA resubmission.
We expect that research and development expenses
will stabilize in fiscal 2024 as we focus on the commercialization of LYMPHIR, complete our Phase 3 trial for Mino-Lok, and analyze the
data from our Phase 2b trial and begin planning our Phase 3 trial for Halo-Lido.
General and Administrative (G&A) Expenses
G&A expenses were $3.7 million for the first
quarter ended December 31, 2023, compared to $2.6 million for the first quarter ended December 31, 2022. The increase was primarily due
to pre-launch and market research activity costs associated with LYMPHIR. General and administrative expenses consist primarily of compensation
costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the first quarter ended December 31, 2023,
stock-based compensation expense was $3.1 million as compared to $1.2 million for the prior year. The increase reflects a $1.9 million
expense for the recently adopted Citius Oncology stock plan.
Net loss was $9.2 million, or ($0.06) per share
for the quarter ended December 31, 2023, compared to a net loss of $3.6 million, or ($0.02) per share for the quarter ended December 31,
2022. The $5.6 million decrease in the net loss was primarily due to a decrease in research and development expenses and other income
offset by an increase in general and administrative expenses and stock-based compensation.
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. At the end of 2023, Citius completed enrollment in a Phase 3 Pivotal superiority trial of
Mino-Lok , an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. Citius resubmitted
the Biologics License Application for LYMPHIR, a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma, in
early 2024, and 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 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: the FDA may not approve LYMPHIR; risks relating to the results of research and development activities, including those from the resubmission
of the BLA for LYMPHIR, the Mino-Lok Phase 3 trial and other existing and new pipeline assets; our need for substantial additional funds;
our ability to commercialize our products if approved by the FDA; our dependence on third-party suppliers; 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; our ability to obtain, perform under and maintain
financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products
under development; market and other conditions; our ability to attract, integrate, and retain key personnel; 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:
-- Financial Tables Follow -
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| December 31, | September 30, | |||||||
| 2023 | 2023 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 20,345,618 | $ | 26,480,928 | ||||
| Prepaid expenses | 7,864,496 | 7,889,506 | ||||||
| Total Current Assets | 28,210,114 | 34,370,434 | ||||||
| Property and equipment, net | 854 | 1,432 | ||||||
| Operating lease right-of-use asset, net | 403,996 | 454,426 | ||||||
| Other Assets: | ||||||||
| Deposits | 38,062 | 38,062 | ||||||
| In-process research and development | 59,400,000 | 59,400,000 | ||||||
| Goodwill | 9,346,796 | 9,346,796 | ||||||
| Total Other Assets | 68,784,858 | 68,784,858 | ||||||
| Total Assets | $ | 97,399,822 | $ | 103,611,150 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,647,251 | $ | 2,927,334 | ||||
| Accrued expenses | 276,897 | 476,300 | ||||||
| Accrued compensation | 2,430,671 | 2,156,983 | ||||||
| Operating lease liability | 224,000 | 218,380 | ||||||
| Total Current Liabilities | 5,578,819 | 5,778,997 | ||||||
| Deferred tax liability | 6,281,800 | 6,137,800 | ||||||
| Operating lease liability - noncurrent | 204,569 | 262,865 | ||||||
| Total Liabilities | 12,065,188 | 12,179,662 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock - $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding | - | - | ||||||
| Common stock - $0.001 par value; 400,000,000 shares authorized; 158,966,576 and 158,857,798 shares issued and outstanding at December 31, 2023 and September 30, 2023, respectively | 158,967 | 158,858 | ||||||
| Additional paid-in capital | 256,037,851 | 252,903,629 | ||||||
| Accumulated deficit | (171,462,564 | ) | (162,231,379 | ) | ||||
| Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 84,734,254 | 90,831,108 | ||||||
| Non-controlling interest | 600,380 | 600,380 | ||||||
| Total Equity | 85,334,634 | 91,431,488 | ||||||
| Total Liabilities and Equity | $ | 97,399,822 | $ | 103,611,150 |
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2023
| Three Months Ended | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Revenues | $ | - | $ | - | ||||
| Operating Expenses | ||||||||
| Research and development | 2,621,910 | 3,445,515 | ||||||
| General and administrative | 3,660,728 | 2,603,287 | ||||||
| Stock-based compensation - general and administrative | 3,058,185 | 1,201,081 | ||||||
| Total Operating Expenses | 9,340,823 | 7,249,883 | ||||||
| Operating Loss | (9,340,823 | ) | (7,249,883 | ) | ||||
| Other Income | ||||||||
| Interest income | 253,638 | 214,549 | ||||||
| Gain on sale of New Jersey net operating losses | - | 3,585,689 | ||||||
| Total Other Income | 253,638 | 3,800,238 | ||||||
| Loss before Income Taxes | (9,087,185 | ) | (3,449,645 | ) | ||||
| Income tax expense | 144,000 | 144,000 | ||||||
| Net Loss | $ | (9,231,185 | ) | $ | (3,593,645 | ) | ||
| Net Loss Per Share - Basic and Diluted | $ | (0.06 | ) | $ | (0.02 | ) | ||
| Weighted Average Common Shares Outstanding | ||||||||
| Basic and diluted | 158,955,935 | 146,211,130 |
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2023