Mino-Lok data analysis on track with topline
results anticipated this quarter
LYMPHIR biologics license application accepted
with PDUFA target action date set for August
13, 2024
CRANFORD, N.J., May 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 second quarter 2024 ended
March 31, 2024.
Second Quarter 2024 Business Highlights and Subsequent
Developments
- LYMPHIR™ (denileukin diftitox) biologics license application
(BLA) accepted by the U.S. Food and Drug Administration (FDA) with
August 13, 2024, assigned as
Prescription Drug User Fee Act (PDUFA) target action date;
- Data analysis underway for completed Mino-Lok®
Pivotal Phase 3 trial with topline results anticipated in calendar
2Q 2024;
- Continued engagement with FDA following end of Phase
2b meeting to determine next phase in
the development of Halo-Lido for the treatment of hemorrhoids;
- Merger of our wholly owned subsidiary with TenX Keane
Acquisition (Nasdaq: TENK) to form
publicly listed Citius Oncology, Inc. is progressing and pending
review by Securities and Exchange Commission (SEC) and TENK shareholder approval;
- Robert Smith elected to the
Citius Board of Directors at the Annual Meeting of Stockholders;
and,
- Completed $15 million registered
direct offering in April 2024
extending the Company's cash runway.
Financial Highlights
- Cash and cash equivalents of $12.6
million as of March 31,
2024;
- $15 million in gross proceeds
from a registered direct offering on April
30, 2024, extends the Company's cash runway through
December 2024;
- R&D expenses were $3.6
million and $6.2 million for
the three and six months ended March 31,
2024, respectively, compared to $4.7
million and $8.2 million for
the three and six months ended March 31,
2023, respectively;
- G&A expenses were $4.3
million and $7.9 million for
the three and six months ended March 31,
2024, respectively, compared to $4.8
million and $7.4 million for
the three and six months ended March 31,
2023, respectively;
- Stock-based compensation expense was $3.1 million and $6.1
million for the three and six months ended March 31, 2024, respectively, compared to
$1.2 million and $2.4 million for the three and six months ended
March 31, 2023, respectively;
and,
- Net loss was $8.5 million and
$17.8 million, or ($0.05) and ($0.11)
per share for the three and six months ended March 31, 2024, respectively, compared to a net
loss of $10.5 million and
$14.1 million, or ($0.07) and ($0.10)
per share for the three and six months ended March 31, 2023, respectively.
"I am pleased to share that we made solid progress this quarter
as we focused on execution and managing our finances. The data
analysis of our late-stage asset, Mino-Lok, the only treatment of
its kind in development to salvage infected catheters, remains on
track. We look forward to reporting the topline results later this
quarter. Once we review the results, we plan to engage with the FDA
to determine the optimal next steps in the program and look forward
to advancing this much-needed alternative to the current standard
of care, which often involves painful and costly catheter removal
and replacement," stated Leonard
Mazur, Chairman and CEO of Citius.
"Importantly, the BLA submission for LYMPHIR, our novel IL-2
receptor targeted oncology therapy, was accepted by the FDA, and
assigned a late summer 2024 PDUFA target action date. In
anticipation of potential approval, we continue to align the
organization for a successful launch," added Mazur.
"Despite a tough capital market environment for pre-revenue
companies, we successfully completed a $15
million registered direct offering, expanding our cash
runway and providing capital to support the execution of our
strategic plan. We believe that the merger of our oncology
subsidiary with TenX to form a publicly listed company will make
our company more attractive to investors and increase the value of
our assets. This transaction is progressing, and we expect it to be
completed in the coming months as we finalize SEC review and await
approval by TENK shareholders. As we
continue to meet our goals, we believe additional opportunities to
strengthen our capital structure will become available," concluded
Mazur.
SECOND QUARTER 2024 FINANCIAL RESULTS:
Liquidity
As of March 31, 2024, the Company
had $12.6 million in cash and cash
equivalents.
As of March 31, 2024, the Company
had 159,094,781 common shares outstanding.
Based on our cash and cash equivalents as of March 31, 2024, and after giving effect to a
capital raising that closed on April 30,
2024, we expect to have sufficient funds to continue our
operations through December 2024. We
expect to raise additional capital in the future to support our
operations beyond December 2024.
Research and Development (R&D) Expenses
R&D expenses were $3.6 million
for the quarter ended March 31, 2024,
compared to $4.7 million for the
quarter ended March 31, 2023. For the
six months ended March 31, 2024,
R&D expenses were $6.2 million as
compared to $8.2 million during the
six months ended March 31, 2023, a
decrease of $1.9 million. The
decrease primarily reflects incremental costs related to the
completion of the Mino-Lok Phase 3 trial and remediation activities
for the LYMPHIR BLA resubmission, offset by lower costs in the
current period due to the completion of the Halo-Lido Phase
2b trial.
We expect that research and development expenses will stabilize
at current levels 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 $4.3 million
for the quarter ended March 31, 2024,
compared to $4.8 million for the
quarter ended March 31, 2023.
The decrease was primarily due to lower costs for pre-launch
and market research activities associated with LYMPHIR during the
period.
For the six months ended March 31,
2024, G&A expenses were $7.9
million as compared to $7.4
million during the six months ended March 31, 2023. The primary reason for the
increase was higher costs for 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 quarter ended March 31,
2024, stock-based compensation expense was $3.1 million as compared to $1.2 million for the quarter ended March 31, 2023. For the six months ended
March 31, 2024, stock-based
compensation expense was $6.1 million
as compared to $2.4 million for the
six months ended March 31, 2023. The
increase is primarily due to the Citius Oncology stock plan.
Net loss
Net loss was $8.5 million, or
($0.05) per share for the quarter
ended March 31, 2024, compared to a
net loss of $10.5 million, or
($0.07) per share for the quarter
ended March 31, 2023. The
$2 million decrease in the net loss
was due to decreases of $1.1 million
in research and development expenses and $0.5 million in general and administrative
expenses, and the increase in other income of $2.3 million, being partially offset by the
increase in stock-based compensation expense of $1.9 million.
Net loss was $17.8 million, or
($0.11) per share for the six months
ended March 31, 2024, compared to a
net loss of $14.1 million, or
($0.10) per share for the six months
ended March 31, 2023. The increase in
the net loss was primarily due to the increase in stock-based
compensation expense.
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.
The Biologics License Application for LYMPHIR™, a novel IL-2R
immunotherapy for an initial indication in cutaneous T-cell
lymphoma, is currently under review by the FDA with August 13, 2024 assigned as the PDUFA target
action date. Citius previously 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: risks relating to the results of
research and development activities, including those from existing
and new pipeline assets; our need for substantial additional funds;
uncertainties relating to preclinical and clinical testing; the FDA
may not approve LYMPHIR; 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; 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; our ability to realize some or all of the benefits
expected to result from the anticipated spinoff of Citius Oncology
or the delay of such benefits; our ongoing businesses which may be
adversely affected and subject to certain risks and consequences as
a result of the anticipated spinoff transaction; 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 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
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.
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)
|
|
|
|
|
|
March
31,
|
|
|
September 30,
|
|
|
|
2024
|
|
|
2023
|
|
ASSETS
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
12,559,607
|
|
|
$
|
26,480,928
|
|
Prepaid
expenses
|
|
|
9,014,124
|
|
|
|
7,889,506
|
|
Total Current Assets
|
|
|
21,573,731
|
|
|
|
34,370,434
|
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
|
275
|
|
|
|
1,432
|
|
Operating lease
right-of-use asset, net
|
|
|
352,505
|
|
|
|
454,426
|
|
Deposits
|
|
|
38,062
|
|
|
|
38,062
|
|
In-process research and
development
|
|
|
59,400,000
|
|
|
|
59,400,000
|
|
Goodwill
|
|
|
9,346,796
|
|
|
|
9,346,796
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
90,711,369
|
|
|
$
|
103,611,150
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,669,507
|
|
|
$
|
2,927,334
|
|
Accrued
expenses
|
|
|
151,204
|
|
|
|
476,300
|
|
Accrued
compensation
|
|
|
1,123,076
|
|
|
|
2,156,983
|
|
Operating lease
liability
|
|
|
229,733
|
|
|
|
218,380
|
|
Total Current Liabilities
|
|
|
4,173,520
|
|
|
|
5,778,997
|
|
|
|
|
|
|
|
|
|
|
Deferred tax
liability
|
|
|
6,425,800
|
|
|
|
6,137,800
|
|
Operating lease
liability – noncurrent
|
|
|
145,098
|
|
|
|
262,865
|
|
Total Liabilities
|
|
|
10,744,418
|
|
|
|
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; 159,094,781 and
158,857,798
shares issued
and outstanding at March 31, 2024 and September 30, 2023,
respectively
|
|
|
159,095
|
|
|
|
158,858
|
|
Additional paid-in
capital
|
|
|
259,214,194
|
|
|
|
252,903,629
|
|
Accumulated
deficit
|
|
|
(180,006,718)
|
|
|
|
(162,231,379)
|
|
Total Citius
Pharmaceuticals, Inc. Stockholders' Equity
|
|
|
79,366,571
|
|
|
|
90,831,108
|
|
Non-controlling
interest
|
|
|
600,380
|
|
|
|
600,380
|
|
Total Equity
|
|
|
79,966,951
|
|
|
|
91,431,488
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Equity
|
|
$
|
90,711,369
|
|
|
$
|
103,611,150
|
|
CITIUS
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND
SIX MONTHS ENDED MARCH 31, 2024 AND 2023
(Unaudited)
|
|
|
|
|
|
Three Months
Ended
|
|
|
Six Months
Ended
|
|
|
|
March
31,
|
|
|
March
31,
|
|
|
March
31,
|
|
|
March
31,
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
3,605,898
|
|
|
|
4,726,855
|
|
|
|
6,227,808
|
|
|
|
8,172,370
|
|
General and
administrative
|
|
|
4,285,911
|
|
|
|
4,792,850
|
|
|
|
7,946,639
|
|
|
|
7,396,137
|
|
Stock-based
compensation – general and administrative
|
|
|
3,078,392
|
|
|
|
1,165,595
|
|
|
|
6,136,577
|
|
|
|
2,366,676
|
|
Total Operating
Expenses
|
|
|
10,970,201
|
|
|
|
10,685,300
|
|
|
|
20,311,024
|
|
|
|
17,935,183
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Loss
|
|
|
(10,970,201)
|
|
|
|
(10,685,300)
|
|
|
|
(20,311,024)
|
|
|
|
(17,935,183)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
182,205
|
|
|
|
303,275
|
|
|
|
435,843
|
|
|
|
517,824
|
|
Gain on sale of New
Jersey net operating losses
|
|
|
2,387,842
|
|
|
|
—
|
|
|
|
2,387,842
|
|
|
|
3,585,689
|
|
Total
Other Income
|
|
|
2,570,047
|
|
|
|
303,275
|
|
|
|
2,823,685
|
|
|
|
4,103,513
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before Income
Taxes
|
|
|
(8,400,154)
|
|
|
|
(10,382,025)
|
|
|
|
(17,487,339)
|
|
|
|
(13,831,670)
|
|
Income tax
expense
|
|
|
144,000
|
|
|
|
144,000
|
|
|
|
288,000
|
|
|
|
288,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(8,544,154)
|
|
|
$
|
(10,526,025)
|
|
|
$
|
(17,775,339)
|
|
|
$
|
(14,119,670)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share -
Basic and Diluted
|
|
$
|
(0.05)
|
|
|
$
|
(0.07)
|
|
|
$
|
(0.11)
|
|
|
$
|
(0.10)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
Common Shares Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
159,072,239
|
|
|
|
146,251,945
|
|
|
|
159,013,769
|
|
|
|
146,231,313
|
|
CITIUS
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS
ENDED MARCH 31, 2024 AND 2023
(Unaudited)
|
|
|
|
|
|
2024
|
|
|
2023
|
|
Cash Flows From
Operating Activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(17,775,339)
|
|
|
$
|
(14,119,670)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
6,136,577
|
|
|
|
2,366,676
|
|
Issuance of common
stock for services
|
|
|
174,225
|
|
|
|
102,000
|
|
Amortization of
operating lease right-of-use asset
|
|
|
101,921
|
|
|
|
93,869
|
|
Depreciation
|
|
|
1,157
|
|
|
|
1,461
|
|
Deferred income tax
expense
|
|
|
288,000
|
|
|
|
288,000
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(1,124,618)
|
|
|
|
(2,983,022)
|
|
Accounts
payable
|
|
|
(257,827)
|
|
|
|
1,560,215
|
|
Accrued
expenses
|
|
|
(325,096)
|
|
|
|
845,442
|
|
Accrued
compensation
|
|
|
(1,033,907)
|
|
|
|
(736,474)
|
|
Operating lease
liability
|
|
|
(106,414)
|
|
|
|
(95,932)
|
|
Net Cash Used In
Operating Activities
|
|
|
(13,921,321)
|
|
|
|
(12,677,435)
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From
Financing Activities:
|
|
|
|
|
|
|
|
|
Proceed from common
stock option exercise
|
|
|
—
|
|
|
|
31,267
|
|
Net Cash Provided By
Financing Activities
|
|
|
—
|
|
|
|
31,267
|
|
|
|
|
|
|
|
|
|
|
Net Change in Cash
and Cash Equivalents
|
|
|
(13,921,321)
|
|
|
|
(12,646,168)
|
|
Cash and Cash
Equivalents - Beginning of Period
|
|
|
26,480,928
|
|
|
|
41,711,690
|
|
Cash and Cash
Equivalents - End of Period
|
|
$
|
12,559,607
|
|
|
$
|
29,065,522
|
|
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SOURCE Citius Pharmaceuticals, Inc.