$29.1 million in
cash and cash equivalents as of March 31,
2023; $15 million registered
direct offering in May 2023 extends
runway through May 2024
Halo-Lido Phase 2b trial completed with topline results
anticipated by end of calendar Q2 2023
CRANFORD, N.J., May 12, 2023
/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 ended March 31, 2023.
Fiscal Q2 2023 Business Highlights and Subsequent
Developments
- Achieved 85 of 92 required events in the
Mino-Lok® Phase 3 trial as of April 24, 2023, with 16 patients in active
treatment or pending study completion data review;
- Completed Phase 2b trial of
Halo-Lido for the treatment of hemorrhoids with data analysis under
way; topline results anticipated by the end of calendar Q2
2023;
- Continued efforts to spin off oncology asset, I/ONTAK, into a
standalone public company; the biologics license application (BLA)
for I/ONTAK is under review by the FDA, with a targeted decision
date (PDUFA) set for July 28, 2023;
and,
- Raised $15 million in capital
through a registered direct offering of common stock and warrants
at a purchase price of $1.20 per
share on May 8, 2023.
Financial Highlights
- Cash and cash equivalents of $29.1
million as of March 31, 2023;
$15 million in gross proceeds from
equity financing as of May 8,
2023;
- R&D expenses were $4.7
million and $8.2 million for
the three and six months ended March 31,
2023, respectively, compared to $3.5
million and $8.9 million for
the three and six months ended March 31,
2022, respectively;
- G&A expenses were $4.8
million and $7.4 million for
the three and six months ended March 31,
2023, respectively, compared to $3.1
million and $6.0 million for
the three and six months ended March 31,
2022, respectively;
- Stock-based compensation expense was $1.2 million and $2.4
million for the three and six months ended March 31, 2023, respectively, compared to
$1.0 million and $1.9 million for the three and six months ended
March 31, 2022, respectively;
and,
- Net loss was $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, compared to a net
loss of $7.6 million and $16.8 million, or ($0.05) and ($0.11)
per share for the three and six months ended March 31, 2022, respectively.
"The Citius team continues to focus on execution as we move
through 2023. With the Halo-Lido Phase 2b trial now complete, we are on track to have
topline results available by the end of this quarter, ahead of
plan. Additionally, as we recently reported, we have achieved 85 of
92 required events in the Mino-Lok Phase 3 trial, with additional
patients in treatment, and sites in the U.S. and India continuing to enroll patients. We remain
encouraged that the momentum in enrollment will enable us to
complete the trial this year, achieving another key value-creating
milestone for Citius. And, importantly, we continue to advance our
I/ONTAK (E7777) program on multiple fronts. As the targeted
July 28, 2023 BLA decision date
(PDUFA) approaches, we remain actively engaged in the regulatory
review process and continue to lay the commercial and manufacturing
foundation for a successful product launch, if approved. Moreover,
we believe that at this time, a spinoff of I/ONTAK into a separate
publicly traded company would be in the best interest of Citius
shareholders and allow us to maximize the value of this asset. To
that end, we have worked diligently with financial advisors to
advance those efforts and look forward to sharing additional
details, as appropriate, in the coming months," stated Leonard Mazur, Chairman and CEO of Citius.
"Given the challenging financial environment for small
biopharmaceutical companies, we took the opportunity earlier this
month to raise $15 million from two
institutional funds. With this additional capital, we believe that,
as of March 31, 2023, our cash runway
extends through May 2024. Our
priority remains to advance our leading programs and deliver on the
multiple value-driving catalysts we outlined for 2023," concluded
Mazur.
SECOND quarter 2023 Financial Results:
Liquidity
As of March 31, 2023, the Company
had $29.1 million in cash and cash
equivalents.
As of March 31, 2023, the Company
had 146,357,797 common shares outstanding.
On May 4, 2023, the Company
entered into definitive agreements with certain healthcare-focused
and institutional investors for the purchase of an aggregate of
12,500,001 shares of its common stock and accompanying warrants to
purchase up to an aggregate of 12,500,001 shares of its common
stock, at a purchase price of $1.20
per share and accompanying warrant in a registered direct
offering. The warrants have an exercise price of $1.50 per share, will be exercisable six months
from the date of issuance, and will expire five years from the date
of issuance.
The closing of the offering occurred on May 8, 2023, in which the aggregate gross
proceeds were $15.0 million before
deducting the placement agent fees and other offering expenses
payable by the Company.
The Company also issued 875,000 warrants to the placement agent
as part of the transaction.
The Company estimates that its available cash resources will be
sufficient to fund its operations through May 2024. We anticipate the need to raise
additional capital in the future to support our operations beyond
May 2024.
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, 2023,
respectively, compared to $1.6
million and $7.7 million for
the comparable periods ended March 31,
2022. The increase primarily reflects incremental
Mino-Lok trial costs related to the expansion of the trial to
include sites outside of the U.S. and higher Halo-Lido Phase
2b study costs as the trial
approached completion in April 2023,
offset by lower I/ONTAK expenses due to the completion and filing
of the BLA with the FDA in September
2022.
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 $4.8 million
and $7.4 million for the three and
six months ended March 31, 2023,
respectively, compared to $3.1
million and $6.0 million for
the comparable periods ended March 31,
2022. The increase was primarily due to pre-launch and
market research activities associated with I/ONTAK. 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,
2023, stock-based compensation expense was $1.2 million as compared to $1.0 million for the prior year period. For the
six months ended March 31, 2023,
stock-based compensation expense was $2.4
million as compared to $1.9
million for the six months ended March 31, 2022. 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
Net loss was $10.5 million, or
($0.07) per share for the three
months ended March 31, 2023, compared
to a net loss of $7.6 million, or
($0.05) per share for the three
months ended March 31, 2022.
The increase in the net loss was primarily due to an increase in
research and development and general and administrative
expenses.
Net loss was $14.1 million, or
($0.10) per share for the six months
ended March 31, 2023, compared to a
net loss of $16.8 million, or
($0.11) for the six months ended
March 31, 2022.
The decrease in net loss for the six months ended March 31, 2023 primarily reflects an increase in
other income from the $3.6 million
gain recognized in connection with the sale of certain New Jersey income tax net operating losses to
a third party under the New Jersey Technology Business Tax
Certificate Transfer Program offset by increased operating expenses
during the period.
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. At the end of March 2023, Citius completed enrollment in its
Phase 2b trial of CITI-002, a topical
formulation for the relief of hemorrhoids. For more information,
please visit www.citiuspharma.com.
Safe Harbor
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, including Mino-Lok; 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; our need for substantial
additional funds; 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, 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 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,
|
|
|
|
2023
|
|
|
2022
|
|
ASSETS
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
29,065,522
|
|
|
$
|
41,711,690
|
|
Prepaid
expenses
|
|
|
5,835,602
|
|
|
|
2,852,580
|
|
Total Current Assets
|
|
|
34,901,124
|
|
|
|
44,564,270
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
|
2,639
|
|
|
|
4,100
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
right-of-use asset, net
|
|
|
552,205
|
|
|
|
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
|
|
$
|
104,240,826
|
|
|
$
|
113,999,302
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,725,593
|
|
|
$
|
1,165,378
|
|
Accrued
expenses
|
|
|
2,250,836
|
|
|
|
1,405,394
|
|
Accrued
compensation
|
|
|
1,025,777
|
|
|
|
1,762,251
|
|
Operating lease
liability
|
|
|
207,471
|
|
|
|
196,989
|
|
Total Current Liabilities
|
|
|
6,209,677
|
|
|
|
4,530,012
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax
liability
|
|
|
5,849,800
|
|
|
|
5,561,800
|
|
Operating lease
liability – noncurrent
|
|
|
374,831
|
|
|
|
481,245
|
|
Total Liabilities
|
|
|
12,434,308
|
|
|
|
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; 146,357,797
and 146,211,130 shares issued and outstanding at March
31, 2023 and September
30, 2022, respectively
|
|
|
146,358
|
|
|
|
146,211
|
|
Additional paid-in
capital
|
|
|
234,867,917
|
|
|
|
232,368,121
|
|
Accumulated
deficit
|
|
|
(143,808,137)
|
|
|
|
(129,688,467)
|
|
Total Citius
Pharmaceuticals, Inc. Stockholders' Equity
|
|
|
91,206,138
|
|
|
|
102,825,865
|
|
Non-controlling
interest
|
|
|
600,380
|
|
|
|
600,380
|
|
Total Equity
|
|
|
91,806,518
|
|
|
|
103,426,245
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Equity
|
|
$
|
104,240,826
|
|
|
$
|
113,999,302
|
|
CITIUS
PHARMACEUTICALS, INC
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND
SIX MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited)
|
|
|
|
Three Months
Ended
|
|
|
Six Months
Ended
|
|
|
|
March
31,
|
|
|
March
31,
|
|
|
March
31,
|
|
|
March
31,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
4,726,855
|
|
|
|
3,452,210
|
|
|
|
8,172,370
|
|
|
|
8,910,059
|
|
General and
administrative
|
|
|
4,792,850
|
|
|
|
3,117,417
|
|
|
|
7,396,137
|
|
|
|
6,014,166
|
|
Stock-based
compensation – general and administrative
|
|
|
1,165,595
|
|
|
|
1,020,998
|
|
|
|
2,366,676
|
|
|
|
1,925,602
|
|
Total Operating
Expenses
|
|
|
10,685,300
|
|
|
|
7,590,625
|
|
|
|
17,935,183
|
|
|
|
16,849,827
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Loss
|
|
|
(10,685,300)
|
|
|
|
(7,590,625)
|
|
|
|
(17,935,183)
|
|
|
|
(16,849,827)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
303,275
|
|
|
|
29,571
|
|
|
|
517,824
|
|
|
|
63,553
|
|
Gain on sale of New
Jersey net operating losses
|
|
|
—
|
|
|
|
—
|
|
|
|
3,585,689
|
|
|
|
—
|
|
Total
Other Income
|
|
|
303,275
|
|
|
|
29,571
|
|
|
|
4,103,513
|
|
|
|
63,553
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before Income
Taxes
|
|
|
(10,382,025)
|
|
|
|
(7,561,054)
|
|
|
|
(13,831,670)
|
|
|
|
(16,786,274)
|
|
Income tax
expense
|
|
|
144,000
|
|
|
|
—
|
|
|
|
288,000
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(10,526,025)
|
|
|
$
|
(7,561,054)
|
|
|
$
|
(14,119,670)
|
|
|
$
|
(16,786,274)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share -
Basic and Diluted
|
|
$
|
(0.07)
|
|
|
$
|
(0.05)
|
|
|
$
|
(0.10)
|
|
|
$
|
(0.11)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
Common Shares Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
146,251,945
|
|
|
|
146,041,852
|
|
|
|
146,231,313
|
|
|
|
146,026,847
|
|
CITIUS
PHARMACEUTICALS, INC
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS
ENDED MARCH 31, 2023 AND 2022
(Unaudited)
|
|
|
|
2023
|
|
|
2022
|
|
Cash Flows From Operating
Activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(14,119,670)
|
|
|
$
|
(16,786,274)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
2,366,676
|
|
|
|
1,925,602
|
|
Issuance of common
stock for services
|
|
|
102,000
|
|
|
|
273,884
|
|
Amortization of
operating lease right-of-use asset
|
|
|
93,869
|
|
|
|
86,619
|
|
Depreciation
|
|
|
1,461
|
|
|
|
1,461
|
|
Deferred income tax
expense
|
|
|
288,000
|
|
|
|
—
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(2,983,022)
|
|
|
|
238,295
|
|
Accounts
payable
|
|
|
1,560,215
|
|
|
|
428,033
|
|
Accrued
expenses
|
|
|
845,442
|
|
|
|
714,669
|
|
Accrued
compensation
|
|
|
(736,474)
|
|
|
|
(1,112,750)
|
|
Operating lease
liability
|
|
|
(95,932)
|
|
|
|
(86,253)
|
|
Net Cash Used In Operating
Activities
|
|
|
(12,677,435)
|
|
|
|
(14,316,714)
|
|
|
|
Cash Flows From Financing
Activities:
|
|
|
|
|
|
|
|
|
Proceeds from common stock option exercise
|
|
|
31,267
|
|
|
|
—
|
|
Net Cash Provided By Financing
Activities
|
|
|
31,267
|
|
|
|
—
|
|
|
|
Net Change in Cash and Cash
Equivalents
|
|
|
(12,646,168)
|
|
|
|
(14,316,714)
|
|
Cash and Cash Equivalents - Beginning of
Period
|
|
|
41,711,690
|
|
|
|
70,072,946
|
|
Cash and Cash Equivalents - End of
Period
|
|
$
|
29,065,522
|
|
|
$
|
55,756,232
|
|
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SOURCE Citius Pharmaceuticals, Inc.