Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Fiscal
First Quarter 2023 Financial Results and Provides Business Update
$36.9 million in cash and cash equivalents
as of December 31, 2022; runway through February 2024
Uptick in patient recruitment for Mino-Lok
Halo-Lido Phase 2b trial nearing completion
CRANFORD, N.J., February 10, 2023 -- 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 ended December 31, 2022.
Fiscal Q1 2023 Business Highlights and Subsequent Developments
Financial Highlights
"As we entered 2023, Citius continued to build momentum across
the pipeline. Our Mino-Lok Phase 3 trial is actively enrolling patients in the U.S. and India. We believe the recent uptick in recruitment
at clinical sites will aid in completing the trial this year. Regarding our I/ONTAK (E7777) BLA, we anticipate the FDA's decision
in late July. Accordingly, we remain focused on ensuring that our regulatory, commercial and manufacturing activities are positioned to
support a successful launch, if approved. Moreover, our team has worked diligently to align resources to support the Phase 2b Halo-Lido
trial as it nears completion," stated Leonard Mazur, Chairman and CEO of Citius.
"In addition to the progress we are making on the clinical front,
we continue to strengthen our corporate infrastructure. On February 7, 2023, shareholders approved the nomination of Dennis McGrath to
our Board of Directors. We are very fortunate to have a seasoned leader of Dennis's caliber join our Board. His deep public company,
financial and strategic expertise will help guide our path forward. Dennis assumes the Board position formerly held by Dr. William Kane.
Since March 2014, Dr. Kane has shared his expertise and insights as a valued member of our Board. We are grateful for his contributions
and support through the years. With multiple value-creating catalysts anticipated this year, I look forward to updating shareholders as
we work to achieve these milestones," concluded Mazur.
First quarter 2023 Financial
As of December 31, 2022, the Company had $36.9 million in cash and
As of December 31, 2022, the Company had 146,211,130 common shares
The Company estimates that its available cash resources will be sufficient
to fund its operations through February 2024.
Research and Development (R&D) Expenses
R&D expenses were $3.4 million for the first quarter ended December
31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021. The decrease primarily reflects the completion of the
I/ONTAK (E7777) Phase 3 trial and lower Halo-Lido Phase 2b study costs, offset by incremental Mino-Lok Phase 3 trial costs related to
the expansion of the trial to include clinical sites outside the U.S.
We expect that research and development expenses will stabilize in
fiscal 2023 as we focus on the commercialization of I/ONTAK and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.
General and Administrative (G&A) Expenses
G&A expenses were $2.6 million for the first quarter ended December
31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021. The decrease was primarily due to reduced costs for
performance bonuses and investor relations expenses. 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, 2022, stock-based compensation
expense was $1.2 million as compared to $0.9 million for the prior year. The increase reflects expenses related to new grants made under
the Citius and NoveCite equity incentive plans and new grants made to employees (including new hires), directors and consultants.
Net loss was $3.6 million, or ($0.02) per share for the year ended
December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the year ended December 31, 2021. The $5.6 million
decrease in the net loss was primarily due to an increase in other income and a decrease in research and development expenses.
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 oncology, anti-infectives in adjunct cancer care, unique
prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok ,
an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections, which is currently enrolling patients
in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in CTCL, for which
a BLA is under review by the FDA. Mino-Lok was granted Fast Track designation by the FDA. I/ONTAK has received orphan drug designation
by the FDA for the treatment of CTCL and PTCL. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation
for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com.
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; risks relating to
the results of research and development activities, including those from existing and new pipeline assets; uncertainties relating to preclinical
and clinical testing; the early stage of products under development; our need for substantial additional funds; our dependence on third-party
suppliers; 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 commercialize our products if approved by the FDA; our
ability to procure cGMP commercial-scale supply; 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 attract, integrate, and retain key personnel;
our ability to obtain, perform under and maintain financing and strategic agreements and relationships; 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. 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, 2022, filed with the SEC on December 22, 2022 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.
CONSOLIDATED BALANCE SHEETS
| December 31, | September 30, | |||||||
| 2022 | 2022 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 36,887,251 | $ | 41,711,690 | ||||
| Prepaid expenses | 5,430,125 | 2,852,580 | ||||||
| Total Current Assets | 42,317,376 | 44,564,270 | ||||||
| Property and equipment, net | 3,370 | 4,100 | ||||||
| Operating lease right-of-use asset, net | 599,617 | 646,074 | ||||||
| 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 | $ | 111,705,221 | $ | 113,999,302 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 1,537,578 | $ | 1,165,378 | ||||
| Accrued expenses | 690,402 | 1,405,394 | ||||||
| Accrued compensation | 2,107,014 | 1,762,251 | ||||||
| Operating lease liability | 202,178 | 196,989 | ||||||
| Total Current Liabilities | 4,537,172 | 4,530,012 | ||||||
| Deferred tax liability | 5,705,800 | 5,561,800 | ||||||
| Operating lease liability - noncurrent | 428,568 | 481,245 | ||||||
| Total Liabilities | 10,671,540 | 10,573,057 | ||||||
| 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; 146,211,130 shares issued and outstanding at December 31, 2022 and September 30, 2022 | 146,211 | 146,211 | ||||||
| Additional paid-in capital | 233,569,202 | 232,368,121 | ||||||
| Accumulated deficit | (133,282,112 | ) | (129,688,467 | ) | ||||
| Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 100,433,301 | 102,825,865 | ||||||
| Non-controlling interest | 600,380 | 600,380 | ||||||
| Total Equity | 101,033,681 | 103,426,245 | ||||||
| Total Liabilities and Equity | $ | 111,705,221 | $ | 113,999,302 |
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2022
| Three Months Ended | ||||||||
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Revenues | $ | - | $ | - | ||||
| Operating Expenses | ||||||||
| Research and development | 3,445,515 | 5,457,849 | ||||||
| General and administrative | 2,603,287 | 2,896,749 | ||||||
| Stock-based compensation - general and administrative | 1,201,081 | 904,604 | ||||||
| Total Operating Expenses | 7,249,883 | 9,259,202 | ||||||
| Operating Loss | (7,249,883 | ) | (9,259,202 | ) | ||||
| Other Income | ||||||||
| Interest income | 214,549 | 33,982 | ||||||
| Gain on sale of New Jersey net operating losses | 3,585,689 | - | ||||||
| Total Other Income | 3,800,238 | 33,982 | ||||||
| Loss before Income Taxes | (3,449,645 | ) | (9,225,220 | ) | ||||
| Income tax expense | 144,000 | - | ||||||
| Net Loss | $ | (3,593,645 | ) | $ | (9,225,220 | ) | ||
| Net Loss Per Share - Basic and Diluted | $ | (0.02 | ) | $ | (0.06 | ) | ||
| Weighted Average Common Shares Outstanding | ||||||||
| Basic and diluted | 146,211,130 | 146,012,169 |
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2022
| 2022 | 2021 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | (3,593,645 | ) | $ | (9,225,220 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation expense | 1,201,081 | 904,604 | ||||||
| Issuance of common stock for services | - | 95,884 | ||||||
| Amortization of operating lease right-of-use asset | 46,457 | 42,879 | ||||||
| Depreciation | 730 | 730 | ||||||
| Deferred income tax expense | 144,000 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses | (2,577,545 | ) | 217,852 | |||||
| Accounts payable | 372,200 | 512,108 | ||||||
| Accrued expenses | (714,992 | ) | 2,514,649 | |||||
| Accrued compensation | 344,763 | 327,690 | ||||||
| Operating lease liability | (47,488 | ) | (42,698 | ) | ||||
| Net Cash Used In Operating Activities | (4,824,439 | ) | (4,651,522 | ) | ||||
| Net Cash Used In Investing Activities | - | - | ||||||
| Net Cash Provided By Financing Activities | - | - | ||||||
| Net Change in Cash and Cash Equivalents | (4,824,439 | ) | (4,651,522 | ) | ||||
| Cash and Cash Equivalents - Beginning of Period | 41,711,690 | 70,072,946 | ||||||
| Cash and Cash Equivalents - End of Period | $ | 36,887,251 | $ | 65,421,424 |