Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2022 Financial Results and Provides Business Update Mino-Lok Phase 3 trial expanded to include sites outside the U.S.; trial enrollment expected to be completed

Citius Pharmaceuticals, Inc. Reports Fiscal

Second Quarter 2022 Financial Results and Provides Business Update

Mino-Lok Phase 3 trial

expanded to include sites outside the U.S.; trial enrollment expected to be completed by end of 2022

Topline results of Phase 3 trial in

cancer immunotherapy I/ONTAK consistent with prior formulation; BLA submission on track for 2H 2022

$55.8 million in cash and cash equivalents

as of March 31, 2022 and no debt

CRANFORD, N.J., May 12, 2022 -- Citius

Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical

company developing and commercializing first-in-class critical care products, today reported business and financial results

for the second fiscal quarter of 2022 ended March 31, 2022.

Fiscal Q2 2022 Business Highlights and Subsequent

Financial Highlights

"We continue to make significant progress

with our three clinical development programs. To date in 2022, we actively engaged with our U.S. Mino-Lok trial sites to drive increased

enrollment as COVID-19 infections waned, engaged an additional CRO to expand Mino-Lok patient recruitment to sites outside the U.S., announced

topline results for the Phase 3 trial of I/ONTAK that were consistent with the prior FDA-approved formulation (ONTAK), and initiated a

Phase 2b study of Halo-Lido for patients suffering from hemorrhoids. Moreover, we expect additional important catalysts from these programs

in the second half of the calendar year as we remain on track with a BLA submission for I/ONTAK in the second half of 2022, and expect

to complete enrollment in the Mino-Lok and Halo-Lido trials by the end of the year," stated Leonard Mazur, Chairman and CEO of Citius.

"Covid-19 remains an enduring challenge

worldwide. Although our Mino-Lok trial has been impacted, we are actively engaging with existing sites to drive enrollment during periods

of waning infection, and expanding recruitment sites outside the U.S. to mitigate the risk of future Covid-19 waves. Our aim is to achieve

the events required to complete the Mino-Lok trial this year," added Mr. Mazur.

"The Citius balance sheet remains healthy

with $55.8 million in cash available to execute our near-term plans. As stewards of Citius shareholders' capital, we focus on creating

long-term value in the business and will continue to evaluate all strategic and financial options available to us. These may include non-equity

financing, out-licensing agreements, asset sales or other strategic arrangements that would support the commercialization of our two late-Phase

3 assets," concluded Mr. Mazur.

QUARTER ENDED MARCH 31, 2022 Financial Results:

As of March 31, 2022, the Company had $55.8 million

in cash and cash equivalents and no debt.

As of March 31, 2022, the Company had 146,129,630

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 $3.5 million and $8.9 million

for the three and six months ended March 31, 2022, respectively, compared to $1.6 million and $7.7 million for the comparable periods

ended March 31, 2021. The increase during the quarter is primarily due to additional R&D expenses related to I/ONTAK which Citius

in-licensed in September 2021, and start-up costs associated with the Halo-Lido Phase 2b trial, offset by decreases in Mino-Lok

During the six months ended March 31, 2022, ARDS-related

R&D expenses decreased by $4.7 million compared to $5.3 million during the prior year period. R&D expense for the six months ended

March 31, 2021 reflected a $5.0 million 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 $3.1 million and $6.0 million

for the three and six months ended March 31, 2022, respectively, compared to $2.3 million and $4.0 million for the comparable periods

ended March 31, 2021. The increase is primarily due to additional compensation costs for new employees, increased investor relations costs

and additional insurance expense. 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 fiscal quarter ended March 31, 2022, stock-based

compensation expense was $1.0 million as compared to $0.3 million for the prior year period. For the six months ended March 31, 2022,

stock-based compensation expense was $1.9 million as compared to $0.6 million for the six months ended March 31, 2021. The increase primarily

reflects expenses related to new grants made by Citius to employees (including new hires), directors and consultants.

Net loss was $7.6 million, or ($0.05) per share

for the three months ended March 31, 2022, compared to a net loss of $4.1 million, or ($0.04) per share for the three months ended March

Net loss was $16.0 million, or ($0.11) per share

for the six months ended March 31, 2022, compared to a net loss of $12.2 million, or ($0.16) for the six months ended March 31, 2021.

The increase in net loss is primarily due to an

increase in research and development and general and administrative 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 has two late-stage product candidates, Mino-Lok ,

an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), 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 cutaneous

T-cell lymphoma (CTCL), which has completed subject treatment in its Pivotal Phase 3 trial. Mino-Lok was granted Fast Track designation

by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and

peripheral T-cell lymphoma (PTCL). 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). 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 "believe," "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;

our ability to commercialize our products if approved by the FDA; 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; 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; our need for substantial additional funds; the early stage of products under development; our ability

to attract, integrate, and retain key personnel; our dependence on third-party suppliers; 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 ability to identify, acquire, close and integrate product candidates and companies successfully and

on a timely basis; 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, 2021, filed with

the SEC on December 15, 2021 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.