Resubmitted LYMPHIR™ Biologics License
Application; awaiting PDUFA date
Completed enrollment in the Mino-Lok® Pivotal
Phase 3 trial
CRANFORD, N.J., Feb. 14,
2024 /PRNewswire/ -- 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
- Resubmitted LYMPHIR™ (denileukin diftitox) biologics
license application (BLA) to the U.S. Food and Drug Administration
(FDA); awaiting Prescription Drug User Fee Act (PDUFA) target
date;
- Completed enrollment in the Mino-Lok® Pivotal
Phase 3 trial; topline results anticipated in calendar 2Q
2024;
- Scheduled end of Phase 2b trial
meeting with FDA in calendar 2Q 2024 to discuss next steps in
development of Halo-Lido for the treatment of
hemorrhoids;
- Executed definitive agreement to merge our wholly owned
subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form publicly listed Citius Oncology,
Inc.; transaction is expected to be completed in the first half of
2024; and,
- Nominated Robert Smith to be
elected to the Citius Board of Directors at the upcoming
Annual Meeting of Stockholders.
Financial Highlights
- Cash and cash equivalents of $20.3
million as of December 31,
2023; runway through August
2024;
- 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;
- 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;
- Stock-based compensation expense was $3.1 million for the first quarter ended
December 31, 2023, compared to
$1.2 million for the first quarter
ended December 31, 2022; and,
- Net loss was $9.2 million, or
($0.06) per share for the first
quarter ended December 31, 2023,
compared to a net loss of $3.6
million, or ($0.02) per share
for the first quarter ended December 31,
2022.
"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 and CEO of Citius.
"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.
FIRST QUARTER 2024 Financial Results:
Liquidity
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
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:
Investor Contact:
Ilanit
Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
-- Financial Tables Follow –
CITIUS
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
|
|
|
|
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 AND 2022
(Unaudited)
|
|
|
|
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 AND 2022
(Unaudited)
|
|
|
|
2023
|
|
|
2022
|
|
Cash Flows From
Operating Activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(9,231,185)
|
|
|
$
|
(3,593,645)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
3,058,185
|
|
|
|
1,201,081
|
|
Issuance of common
stock for services
|
|
|
76,146
|
|
|
|
—
|
|
Amortization of
operating lease right-of-use asset
|
|
|
50,430
|
|
|
|
46,457
|
|
Depreciation
|
|
|
578
|
|
|
|
730
|
|
Deferred income tax
expense
|
|
|
144,000
|
|
|
|
144,000
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
25,010
|
|
|
|
(2,577,545)
|
|
Accounts
payable
|
|
|
(280,083)
|
|
|
|
372,200
|
|
Accrued
expenses
|
|
|
(199,403)
|
|
|
|
(714,992)
|
|
Accrued
compensation
|
|
|
273,688
|
|
|
|
344,763
|
|
Operating lease
liability
|
|
|
(52,676)
|
|
|
|
(47,488)
|
|
Net Cash Used In
Operating Activities
|
|
|
(6,135,310)
|
|
|
|
(4,824,439)
|
|
|
|
|
|
|
|
|
|
|
Net Change in Cash
and Cash Equivalents
|
|
|
(6,135,310)
|
|
|
|
(4,824,439)
|
|
Cash and Cash
Equivalents - Beginning of Period
|
|
|
26,480,928
|
|
|
|
41,711,690
|
|
Cash and Cash
Equivalents - End of Period
|
|
$
|
20,345,618
|
|
|
$
|
36,887,251
|
|
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SOURCE Citius Pharmaceuticals, Inc.