Mino-Lok® Pivotal Phase 3 trial
enrollment completed; topline data expected 2Q 2024
LYMPHIR™ BLA resubmission on track for early
2024
CRANFORD, N.J., Jan. 2, 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 full year ended September 30, 2023.
Fiscal Full Year 2023 Business Highlights and Subsequent
Developments
- Completed enrollment in the Mino-Lok® Pivotal Phase
3 trial; topline results anticipated in 2Q 2024;
- Initiated remediation activities in the second half of 2023 to
address comments in the complete response letter (CRL) received
from the U.S. Food and Drug Administration (FDA) related to our
LYMPHIR biologics license application (BLA); BLA resubmission
planned for early 2024;
- Advanced two investigator-initiated trials to investigate
LYMPHIR's potential as an immuno-oncology combination therapy with
checkpoint inhibitor pembrolizumab at the University of Pittsburgh Medical Center, and prior
to CAR-T therapies at the University of
Minnesota, Masonic Cancer Center;
- Announced publication in the journal Frontiers in
Immunology of positive results from a preclinical solid tumor
study (liver cancer and colon cancer) of LYMPHIR in combination
with anti-PD-1 (to assess the contribution that transient depletion
of Tregs has on the anti-tumor activity of checkpoint
inhibition);
- Completed Halo-Lido Phase 2b
trial; end of Phase 2 meeting with FDA expected in early 2024;
- Executed definitive agreement to merge our wholly owned
subsidiary with TenX Keane Acquisition (Nasdaq: TENKU) to form
publicly listed Citius Oncology, Inc.; and,
- Raised gross proceeds of $15
million in a registered direct offering in May 2023.
Financial Highlights
- Cash and cash equivalents of $26.5
million as of September 30,
2023; runway through August
2024;
- R&D expenses were $14.8
million for the full year ended September 30, 2023, compared to $17.7 million for the full year ended
September 30, 2022;
- G&A expenses were $15.3
million for the full year ended September 30, 2023, compared to $11.8 million for the full year ended
September 30, 2022;
- Stock-based compensation expense was $6.6 million for the full year ended September 30, 2023, compared to $3.9 million for the full year ended September 30, 2022; and,
- Net loss was $32.5 million, or
($0.22) per share for the full year
ended September 30, 2023 compared to
a net loss of $33.6 million, or
($0.23) per share for the full year
ended September 30, 2022.
"In 2023, we made substantial progress in our pipeline,
positioning us for an exciting 2024. Concentrating on execution, we
completed enrollment in two trials. With the Mino-Lok pivotal Phase
3 trial enrollment completed, we expect topline results to be
available in the second quarter of 2024. We also completed the
Halo-Lido Phase 2b trial in 2023.
Based on the data from the trial, in which more patients receiving
the high dose formulation reported meaningful improvement compared
to either lidocaine or halobetasol alone, Citius filed patent
applications for the formulation and is actively pursuing
intellectual property protections for the groundbreaking fit for
purpose PRO instrument. In early 2024, we plan to meet with the FDA
to discuss the results of the trial and next steps in the Halo-Lido
program," stated Leonard Mazur,
Chairman and CEO of Citius.
"Despite receiving a complete response letter at the end of
July 2023 for our LYMPHIR BLA, we
were encouraged that the items noted by the FDA were addressable in
a timely manner and unrelated to clinical efficacy or safety. Over
the past several months, our team has engaged with the FDA and
endeavored to remediate the agency's concerns. Consistent with
progress on this front, we plan to resubmit the BLA in early 2024
with a subsequent PDUFA date expected this year. Concurrently, we
announced a definitive agreement to merge our oncology subsidiary
with TenX Kean Acquisition to form a separate publicly traded
company. Now undergoing SEC review, the intent of the spin-out is
to align our oncology-related resources and unlock value for Citius
shareholders," added Mazur.
"As we begin 2024, Citius will continue to focus on execution.
With anticipated topline results for Mino-Lok, the LYMPHIR BLA
resubmission and potential approval, additional clarity in our
development plan for Halo-Lido, and the planned spin-off of our
oncology subsidiary, we believe Citius is well-positioned to
deliver value to shareholders in 2024," concluded Mazur.
Full Year 2022 Financial Results:
Liquidity
As of September 30, 2023, the
Company had $26.5 million in cash and
cash equivalents.
As of September 30, 2023, the
Company had 158,857,798 common shares outstanding.
The Company estimates that its available cash resources will be
sufficient to fund its operations through August 2024.
Research and Development (R&D) Expenses
R&D expenses were $14.8
million for the full year ended September 30, 2023, compared to $17.7 million for the full year ended
September 30, 2022. The decrease of
$2.9 million is primarily associated
with the completion of the LYMPHIR Phase 3 trial and the completion
and submission of the related Biologics License Application to the
FDA which was filed in September
2022.
We expect that research and development expenses will continue
to stabilize in fiscal 2024 as we continue to focus on the
commercialization of LYMPHIR and complete the Phase 3 trial for
Mino-Lok and the Phase 2b trial for
Halo-Lido.
General and Administrative (G&A) Expenses
G&A expenses were $15.3
million for the full year ended September 30, 2023, compared to $11.8 million for the full year ended
September 30, 2022. The increase was
primarily due to costs associated with pre-launch and market
research activities 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 full year ended September 30,
2023, stock-based compensation expense was $6.6 million as compared to $3.9 million for the prior year. The increase of
$2.7 million is largely due to the
grant of options under the Citius Oncology stock plan. Option
expense under the Citius Oncology stock plan was $1.97 million during the year ended September 30, 2023. In fiscal year 2023, we
granted options under the Citius Pharma and Citius Oncology stock
plans to our new employees and additional options to other
employees, our directors, and consultants.
At September 30, 2023,
unrecognized total compensation cost related to unvested options
for Citius Pharma common stock of $4.8
million is expected to be recognized over a weighted average
period of 1.5 years, unrecognized total compensation cost related
to unvested options for Citius Oncology common stock of
$18.9 million is expected to be
recognized over a weighted average period of 2.6 years, and
unrecognized total compensation cost related to unvested options
for NoveCite common stock of $0.5
million is expected to be recognized over a weighted average
period of 0.7 years
Net loss
Net loss was $32.5 million, or
($0.22) per share for the year ended
September 30, 2023, compared to a net
loss of $33.6 million, or
($0.23) per share for the year ended
September 30, 2022. The decrease in
net loss reflects an increase in operating expenses of $3.4 million offset by an increase of
$4.5 million in other income.
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 is preparing to resubmit 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 cost and timing of the
resubmission of the BLA for LYMPHIR; the FDA may not approve
LYMPHIR; risks relating to the results of research and development
activities, including those from 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.
|
CONSOLIDATED BALANCE SHEETS
|
SEPTEMBER 30, 2023 AND 2022
|
|
|
|
2023
|
|
|
2022
|
ASSETS
|
|
|
|
|
|
Current Assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
26,480,928
|
|
|
$
|
41,711,690
|
Prepaid
expenses
|
|
|
7,889,506
|
|
|
|
2,852,580
|
Total Current
Assets
|
|
34,370,434
|
|
|
|
44,564,270
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
1,432
|
|
|
|
4,100
|
|
|
|
|
|
|
|
|
Operating lease right-of-use asset,
net
|
|
454,426
|
|
|
|
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
|
|
$
|
103,611,150
|
|
|
$
|
113,999,302
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
Current Liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,927,334
|
|
|
$
|
1,165,378
|
Accrued
expenses
|
|
476,300
|
|
|
|
1,405,394
|
Accrued
compensation
|
|
2,156,983
|
|
|
|
1,762,251
|
Operating lease
liability
|
|
218,380
|
|
|
|
196,989
|
Total Current
Liabilities
|
|
5,778,997
|
|
|
|
4,530,012
|
|
|
|
|
|
|
|
|
Deferred tax
liability
|
|
6,137,800
|
|
|
|
5,561,800
|
Operating lease
liability – non current
|
|
262,865
|
|
|
|
481,245
|
Total
Liabilities
|
|
12,179,662
|
|
|
|
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; 158,857,798 and
146,211,130
|
|
|
158,858
|
|
|
|
146,211
|
shares issued and
outstanding at September 30, 2023 and 2022, respectively
|
Additional paid-in
capital
|
|
252,903,629
|
|
|
|
232,368,121
|
Accumulated
deficit
|
|
(162,231,379)
|
|
|
|
(129,688,467)
|
Total Citius
Pharmaceuticals, Inc. Stockholders' Equity
|
90,831,108
|
|
|
|
102,825,865
|
Non-controlling interest
|
|
600,380
|
|
|
|
600,380
|
Total
Equity
|
|
|
91,431,488
|
|
|
|
103,426,245
|
|
|
|
|
|
|
|
|
Total Liabilities and Equity
|
$
|
103,611,150
|
|
|
$
|
113,999,302
|
|
|
|
|
|
|
|
|
CITIUS PHARMACEUTICALS, INC.
|
CONSOLIDATED STATEMENTS OF
OPERATIONS
|
FOR THE YEARS ENDED SEPTEMBER 30, 2023 AND
2022
|
|
|
|
2023
|
|
|
2022
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
Operating Expenses:
|
|
|
|
|
|
|
Research and development
|
|
14,819,729
|
|
|
|
17,655,482
|
General and administrative
|
|
15,295,584
|
|
|
|
11,754,609
|
Stock-based compensation – general and administrative
|
|
6,616,705
|
|
|
|
3,905,954
|
Total Operating Expenses
|
|
36,732,018
|
|
|
|
33,316,045
|
|
|
|
|
|
|
|
|
Operating Loss
|
|
|
(36,732,018)
|
|
|
|
(33,316,045)
|
|
|
|
|
|
|
|
|
Other Income:
|
|
|
|
|
|
|
|
Interest income
|
|
|
1,179,417
|
|
|
|
251,399
|
Gain on sale of New Jersey net operating losses
|
|
3,585,689
|
|
|
|
—
|
Total Other Income
|
|
4,765,106
|
|
|
|
251,399
|
|
|
|
|
|
|
|
|
Loss before Income Taxes
|
|
(31,966,912)
|
|
|
|
(33,064,646)
|
Income tax expense
|
|
576,000
|
|
|
|
576,000
|
|
|
|
|
|
|
|
|
Net Loss
|
|
|
(32,542,912)
|
|
|
|
(33,640,646)
|
Deemed dividend on warrant extension
|
|
1,151,208
|
|
|
|
—
|
|
|
|
|
|
|
|
|
Net Loss Applicable to Common
Stockholders
|
$
|
(33,694,120)
|
|
|
|
(33,640,646)
|
|
|
|
|
|
|
|
|
Net Loss Per Share Applicable to Common Stockholders
- Basic and Diluted
|
$
|
(0.22)
|
|
|
|
(0.23)
|
|
|
|
|
|
|
|
|
Weighted Average Common Shares
Outstanding
|
|
|
|
|
|
Basic and diluted
|
|
151,294,729
|
|
|
|
146,082,399
|
CITIUS
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED
SEPTEMBER 30, 2023 AND 2022
|
|
|
|
|
|
2023
|
|
|
2022
|
|
Cash Flows From
Operating Activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(32,542,912)
|
|
|
$
|
(33,640,646)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
6,616,705
|
|
|
|
3,905,954
|
|
Issuance of
common stock for services
|
|
|
102,000
|
|
|
|
378,204
|
|
Amortization of
operating lease right-of-use asset
|
|
|
191,648
|
|
|
|
176,754
|
|
Depreciation
|
|
|
2,668
|
|
|
|
2,923
|
|
Deferred income
tax expense
|
|
|
576,000
|
|
|
|
576,000
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(5,036,926)
|
|
|
|
(111,176)
|
|
Accounts
payable
|
|
|
1,761,956
|
|
|
|
(111,717)
|
|
Accrued
expenses
|
|
|
(929,094)
|
|
|
|
783,434
|
|
Accrued
compensation
|
|
|
394,732
|
|
|
|
(143,749)
|
|
Operating lease
liability
|
|
|
(196,989)
|
|
|
|
(177,237)
|
|
Net Cash Used In Operating Activities
|
|
|
(29,060,212)
|
|
|
|
(28,361,256)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From
Financing Activities:
|
|
|
|
|
|
|
|
|
Proceeds from
common stock option exercises
|
|
|
31,267
|
|
|
|
—
|
|
Net proceeds
from registered direct offerings
|
|
|
13,798,183
|
|
|
|
—
|
|
Net Cash Provided By
Financing Activities
|
|
|
13,829,450
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Net Change in Cash and Cash
Equivalents
|
(15,230,762)
|
|
|
|
(28,361,256)
|
|
Cash and Cash Equivalents – Beginning of
Year
|
|
41,711,690
|
|
|
|
70,072,946
|
|
Cash and Cash Equivalents – End of
Year
|
$
|
26,480,928
|
|
|
$
|
41,711,690
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Citius Pharmaceuticals, Inc.