$33.3 million in
cash and cash equivalents as of June 30,
2023; runway through August
2024
CRANFORD, N.J., Aug. 14,
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 third
quarter ended June 30, 2023.
Fiscal Q3 2023 Business Highlights and Subsequent
Developments
- Achieved 92 required events for completion of the
Mino-Lok® Phase 3 trial, subject to confirmation by an
independent review committee;
- Mino-Lok trial to continue recruiting in the near term;
additional patients in active treatment, which may result in
additional events;
- Citius to engage with the FDA to address enhanced product
testing requirements identified in the complete response letter
(CRL) for LYMPHIR™, received July 28,
2023, in preparation for Resubmission; such efforts are not
expected to impact Company's cash runway, which extends to
August 2024;
- Citius preparing for an End of Phase 2 meeting with the FDA
following positive topline results of Phase 2b trial of Halo-Lido for the treatment of
hemorrhoids; and,
- $15 million in capital raised
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 $33.3
million as of June 30,
2023
- R&D expenses were $3.8
million and $11.9 million for
the three and nine months ended June 30,
2023, respectively, compared to $4.9
million and $13.8 million for
the three and nine months ended June 30,
2022, respectively;
- G&A expenses were $3.7
million and $11.1 million for
the three and nine months ended June 30,
2023, respectively, compared to $3.0
million and $9.0 million for
the three and nine months ended June 30,
2022, respectively;
- Stock-based compensation expense was $1.2 million and $3.5
million for the three and nine months ended June 30, 2023, respectively, compared to
$1.0 million and $2.9 million for the three and nine months ended
June 30, 2022, respectively;
and,
- Net loss was $8.5 million and
$22.6 million, or ($0.06) and ($0.15)
per share for the three and nine months ended June 30, 2023, respectively, compared to a net
loss of $8.9 million and $25.6 million, or ($0.06) and ($0.18)
per share for the three and nine months ended June 30, 2022, respectively.
"I am pleased to report significant progress in our pipeline and
positive milestones on multiple fronts. We believe we have achieved
the minimum 92-event threshold required to complete the Phase 3
Mino-Lok trial, pending confirmation by a committee of independent
reviewers. We have also made progress in other areas of our
business, including announcing positive topline results for the
Phase 2b Halo-Lido trial, extending
our financial runway through August
2024 with a $15 million
capital raise, and clarifying our path toward approval for LYMPHIR
(denileukin diftitox)," stated Leonard
Mazur, Chairman and Chief Executive Officer of Citius.
"Although we were disappointed to receive the FDA's complete
response letter for LYMPHIR, we are encouraged that no clinical
data issues related to safety or efficacy were noted. Rather, the
FDA focused primarily on enhanced product testing, which we are
already addressing. We plan to work closely with the FDA in
preparation for a Resubmission package. The timing of our
contemplated spin-off of LYMPHIR will be adjusted in accordance
with the asset's regulatory path. Coupled with our recent
financing, we believe we have sufficient funds to advance our
pipeline, including efforts to remediate the CRL, and continue to
prepare our commercial infrastructure for the ultimate launch of
LYMPHIR, if approved," added Mazur.
THIRD QUARTER 2023 FINANCIAL RESULTS:
Liquidity
As of June 30, 2023, the Company
had $33.3 million in cash and cash
equivalents.
As of June 30, 2023, the Company
had 146,211,130 common shares outstanding.
On May 8, 2023, the Company closed
a registered direct offering of 12,500,001 common shares 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. The warrants have an
exercise price of $1.50 per share,
are exercisable six months from the date of issuance, and expire
five years from the date of issuance. The Company also issued
875,000 warrants to the placement agent as part of the transaction.
Net proceeds of the offering totaled $13.8
million.
The Company estimates that its available cash resources will be
sufficient to fund its operations through August 2024. We anticipate the 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 $3.8 million
and $11.9 million for the three and
nine months ended June 30, 2023,
respectively, compared to $4.9
million and $13.8 million for
the comparable periods ended June 30,
2022. The decrease reflects lower Mino-Lok and LYMPHIR
trial costs offset by higher Halo-Lido Phase 2b study costs as the trial was completed during
the three months ended June 30, 2023.
Additionally, a decrease of $1
million for the three months ended June 30, 2023, reflects NoveCite manufacturing
startup costs incurred in the three months ended June 30, 2022, which are no longer realized.
We expect that research and development expenses will stabilize
in fiscal 2023 as we focus on the commercialization of LYMPHIR 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 $3.7 million
and $11.1 million for the three and
nine months ended June 30, 2023,
respectively, compared to $3.0
million and $9.0 million for
the comparable periods ended June 30,
2022. The increase was primarily due to 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 fiscal quarter ended June 30,
2023, stock-based compensation expense was $1.2 million as compared to $1.0 million for the prior year period. For the
nine months ended June 30, 2023,
stock-based compensation expense was $3.5
million as compared to $2.9
million for the nine months ended June 30, 2022. The increase reflects expenses
related to new grants made to employees (including new hires),
directors and consultants.
Net loss
Net loss was $8.5 million, or
($0.06) per share for the three
months ended June 30, 2023, compared
to a net loss of $8.9 million, or
($0.06) per share for the three
months ended June 30, 2022.
The decrease in the net loss was primarily due to a decrease in
research and development offset by an increase in general and
administrative expenses.
Net loss was $22.6 million, or
($0.15) per share for the nine months
ended June 30, 2023, compared to a
net loss of $25.6 million, or
($0.18) for the nine months ended
June 30, 2022.
The decrease in net loss 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 LYMPHIR, a novel IL-2R immunotherapy for an
initial indication in CTCL. 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; 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, 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)
|
|
|
|
June 30,
|
|
|
September 30,
|
|
|
|
2023
|
|
|
2022
|
|
ASSETS
|
|
|
|
|
|
|
Current Assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
33,281,830
|
|
|
$
|
41,711,690
|
|
Prepaid
expenses
|
|
|
7,832,320
|
|
|
|
2,852,580
|
|
Total Current
Assets
|
|
|
41,114,150
|
|
|
|
44,564,270
|
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
|
2,010
|
|
|
|
4,100
|
|
|
|
|
|
|
|
|
|
|
Operating lease
right-of-use asset, net
|
|
|
503,817
|
|
|
|
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
|
|
$
|
110,404,835
|
|
|
$
|
113,999,302
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Current Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
3,079,667
|
|
|
$
|
1,165,378
|
|
Accrued
expenses
|
|
|
892,874
|
|
|
|
1,405,394
|
|
Accrued
compensation
|
|
|
1,605,445
|
|
|
|
1,762,251
|
|
Operating lease
liability
|
|
|
212,871
|
|
|
|
196,989
|
|
Total Current
Liabilities
|
|
|
5,790,857
|
|
|
|
4,530,012
|
|
|
|
|
|
|
|
|
|
|
Deferred tax
liability
|
|
|
5,993,800
|
|
|
|
5,561,800
|
|
Operating lease
liability – noncurrent
|
|
|
320,011
|
|
|
|
481,245
|
|
Total
Liabilities
|
|
|
12,104,668
|
|
|
|
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 shares issued and outstanding
at June 30, 2023 and September
30, 2022, respectively
|
|
|
158,858
|
|
|
|
146,211
|
|
Additional paid-in
capital
|
|
|
249,828,398
|
|
|
|
232,368,121
|
|
Accumulated
deficit
|
|
|
(152,287,469)
|
|
|
|
(129,688,467)
|
|
Total Citius Pharmaceuticals, Inc. Stockholders'
Equity
|
|
|
97,699,787
|
|
|
|
102,825,865
|
|
Non-controlling
interest
|
|
|
600,380
|
|
|
|
600,380
|
|
Total
Equity
|
|
|
98,300,167
|
|
|
|
103,426,245
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and
Equity
|
|
$
|
110,404,835
|
|
|
$
|
113,999,302
|
|
CITIUS
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS FOR THE THREE AND NINE MONTHS ENDED JUNE
30, 2023 AND 2022 (Unaudited)
|
|
|
|
Three Months
Ended
|
|
|
Nine Months
Ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
3,764,675
|
|
|
|
4,888,192
|
|
|
|
11,937,045
|
|
|
|
13,798,251
|
|
General and
administrative
|
|
|
3,733,326
|
|
|
|
3,024,783
|
|
|
|
11,129,463
|
|
|
|
9,038,949
|
|
Stock-based
compensation – general and administrative
|
|
|
1,174,111
|
|
|
|
1,003,677
|
|
|
|
3,540,787
|
|
|
|
2,929,279
|
|
Total Operating
Expenses
|
|
|
8,672,112
|
|
|
|
8,916,652
|
|
|
|
26,607,295
|
|
|
|
25,766,479
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Loss
|
|
|
(8,672,112)
|
|
|
|
(8,916,652)
|
|
|
|
(26,607,295)
|
|
|
|
(25,766,479)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
336,780
|
|
|
|
53,020
|
|
|
|
854,604
|
|
|
|
116,573
|
|
Gain on sale of New
Jersey net operating losses
|
|
|
—
|
|
|
|
—
|
|
|
|
3,585,689
|
|
|
|
—
|
|
Total
Other Income
|
|
|
336,780
|
|
|
|
53,020
|
|
|
|
4,440,293
|
|
|
|
116,573
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before Income
Taxes
|
|
|
(8,335,332)
|
|
|
|
(8,863,632)
|
|
|
|
(22,167,002)
|
|
|
|
(25,649,906)
|
|
Income tax
expense
|
|
|
144,000
|
|
|
|
—
|
|
|
|
432,000
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(8,479,332)
|
|
|
$
|
(8,863,632)
|
|
|
$
|
(22,599,002)
|
|
|
$
|
(25,649,906)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share -
Basic and Diluted
|
|
$
|
(0.06)
|
|
|
$
|
(0.06)
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.18)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
Common Shares Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
153,775,380
|
|
|
|
146,129,630
|
|
|
|
148,746,002
|
|
|
|
146,061,108
|
|
CITIUS
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS FOR THE NINE MONTHS ENDED JUNE 30, 2023 AND
2022 (Unaudited)
|
|
|
|
2023
|
|
|
2022
|
|
Cash Flows From
Operating Activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(22,599,002)
|
|
|
$
|
(25,649,906)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
3,540,787
|
|
|
|
2,929,279
|
|
Issuance of common
stock for services
|
|
|
102,000
|
|
|
|
273,884
|
|
Amortization of
operating lease right-of-use asset
|
|
|
142,257
|
|
|
|
131,235
|
|
Depreciation
|
|
|
2,090
|
|
|
|
2,192
|
|
Deferred income tax
expense
|
|
|
432,000
|
|
|
|
—
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(4,979,740)
|
|
|
|
(48,915)
|
|
Accounts
payable
|
|
|
1,914,289
|
|
|
|
413,425
|
|
Accrued
expenses
|
|
|
(512,520)
|
|
|
|
679,239
|
|
Accrued
compensation
|
|
|
(156,806)
|
|
|
|
(628,499)
|
|
Operating lease
liability
|
|
|
(145,352)
|
|
|
|
(130,686)
|
|
Net Cash Used In
Operating Activities
|
|
|
(22,259,997)
|
|
|
|
(22,028,752)
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From
Financing Activities:
|
|
|
|
|
|
|
|
|
Net proceeds from registered
direct offering
|
|
|
13,798,870
|
|
|
|
—
|
|
Proceeds from common stock
option exercise
|
|
|
31,267
|
|
|
|
—
|
|
Net Cash Provided By
Financing Activities
|
|
|
13,830,137
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Net Change in Cash
and Cash Equivalents
|
|
|
(8,429,860)
|
|
|
|
(22,028,752)
|
|
Cash and Cash
Equivalents - Beginning of Period
|
|
|
41,711,690
|
|
|
|
70,072,946
|
|
Cash and Cash
Equivalents - End of Period
|
|
$
|
33,281,830
|
|
|
$
|
48,044,194
|
|
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SOURCE Citius Pharmaceuticals, Inc.