Citius Prescription drugs, Inc. Reviews Fiscal Full 12 months 2021 Monetary Outcomes and Offers Enterprise Replace

CRANFORD, N.J., Dec. 15, 2021 /PRNewswire/ — Citius Prescription drugs, Inc. (“Citius” or the “Firm”) (Nasdaq: CTXR), a late-stage biopharmaceutical firm devoted to the event and commercialization of first-in-class crucial care merchandise with a concentrate on oncology, anti-infective merchandise in adjunct most cancers care, distinctive prescription merchandise, and stem cell therapies, at present reported enterprise and monetary outcomes for the fiscal full yr ended September 30, 2021.

Fiscal Full 12 months 2021 Enterprise Highlights and Subsequent Developments

  • Accomplished topic remedy in December 2021 in Pivotal Part 3 trial of I/ONTAK (E7777) with topline outcomes anticipated within the first half of 2022 and a biologics license software (BLA) submission within the second half of 2022;
  • Acquired Dr. Reddy’s Laboratories’ license for late-Part 3 oncology immunotherapy I/ONTAK for the remedy of cutaneous T-cell lymphoma (CTCL) and different most cancers indications;
  • Obtained third constructive suggestion from unbiased Information Monitoring Committee to proceed the Mino-Lok® Part 3 scientific superiority trial as deliberate with out modifications; no security considerations recognized;
  • Accomplished dose-ranging proof-of-concept sheep research of iPSC-derived novel induced-mesenchymal stem cells (i-MSCs) for the remedy of acute respiratory misery syndrome (ARDS); evaluation and documentation underway for peer-reviewed publication submission;
  • Expanded scientific, manufacturing and business capabilities with the addition of seasoned pharmaceutical executives;
  • Citius added to the Russell 3000® and 2000® indexes; and,
  • Raised internet proceeds of $120.6 million in financing actions through the yr.

Monetary Highlights

  • Money and money equivalents of $70.1 million as of September 30, 2021;
  • R&D bills had been $12.2 million for the total yr ended September 30, 2021, in comparison with $8.8 million for the total yr ended September 30, 2020;
  • G&A bills had been $9.8 million for the total yr ended September 30, 2021, in comparison with $8.1 million for the total yr ended September 30, 2020;
  • Inventory-based compensation expense was $1.5 million for the total yr ended September 30, 2021, in comparison with $0.8 million for the total yr ended September 30, 2020; and,
  • Web loss was $23.1 million, or ($0.23) per share for the total yr ended September 30, in comparison with a internet lack of $17.5 million, or ($0.45) per share for the total yr ended September 30, 2020.

“2021 was a transformative yr for Citius as we positioned the corporate financially and strategically to drive progress. We raised greater than $120 million in proceeds to assist our actions, offering us with the flexibleness to advance our scientific packages and spend money on alternatives for extra progress. With the current addition of most cancers immunotherapy I/ONTAK to our portfolio, we now have a sturdy pipeline that features two late Part 3 packages and three doubtlessly first-in-class merchandise,” said Myron Holubiak, President and Chief Govt Officer of Citius Prescription drugs.

“As we transfer into 2022, we anticipate a number of constructive milestones. These embody: accelerated enrollment and completion of the Mino-Lok® trial through the yr, topline leads to the primary half of 2022 for the not too long ago accomplished I/ONTAK Pivotal Part 3 trial adopted by a BLA submission within the second half of the yr, initiation of the Halo-Lido research in early 2022 and completion of the research by the top of the yr, and continued progress on Mino-Wrap and our iPSC-derived mesenchymal stem cells for the remedy of acute respiratory misery syndrome (ARDS). With the addition of key personnel to our scientific, manufacturing and business groups, we’re aligning our assets to make sure continued progress throughout every of our growth packages, and the profitable launch of doubtless two business merchandise in 2023. We imagine our sturdy stability sheet will permit us to execute our growth packages as deliberate in 2022 and we don’t anticipate a necessity to lift extra capital within the coming yr,” concluded Mr. Holubiak.

Full 12 months 2021 Monetary Outcomes:

Liquidity

As of September 30, 2021, the Firm had $70.1 million in money and money equivalents. Throughout the fiscal yr ended September 30, 2021, the Firm obtained internet proceeds of $120.6 million from financing actions.

In January 2021, the Firm closed a non-public placement for widespread inventory and warrants totaling gross proceeds of roughly $20 million and internet proceeds of $18.5 million. In February 2021, the Firm closed a registered direct providing of its widespread inventory and warrants for gross proceeds of $76.5 million and internet proceeds of $71 million. Throughout the yr ended September 30, 2021, the Firm obtained $31.2 million in proceeds from the train of widespread inventory choices and warrants.

On June 21, 2021, stockholders accredited an modification to the Firm’s Articles of Incorporation to extend the approved variety of shares from 210,000,000 to 410,000,000 and the approved variety of widespread shares from 200,000,000 to 400,000,000. As of September 30, 2021, the Firm had 145,979,429 widespread shares issued and excellent.

In 2021, the Firm raised a complete of $127.6 million via financing actions. We estimate that we’ll have enough funds for our operations via March 2023.

Analysis and Improvement (R&D) Bills 

R&D bills had been $12.2 million for the total yr ended September 30, 2021, in comparison with $8.8 million for the total yr ended September 30, 2020. The rise of $3.4 million is primarily as a consequence of a rise in analysis and growth bills for our proposed novel mobile remedy for ARDS of $6.1 million, of which $5 million was a license payment paid to Novellus, and a rise in R&D bills associated to the I/ONTAK license and Mino-Wrap, offset by decreases in analysis and growth bills associated to our Mino-Lok® and Halo-Lido product candidates.

We anticipate that analysis and growth bills will enhance in fiscal 2022 as we proceed to concentrate on our Part 3 trial for Mino-Lok®, progress the Halo-Lido product candidate, and proceed our analysis and growth efforts associated to ARDS, Mino-Wrap and I/ONTAK (E7777).

Normal and Administrative (G&A) Bills

G&A bills had been $9.8 million for the total yr ended September 30, 2021, in comparison with $8.1 million for the total yr ended September 30, 2020. The first motive for the rise is prices related to extra compensation prices for brand new staff and efficiency bonuses. Normal and administrative bills consist primarily of compensation prices, skilled charges associated to our capital elevating actions, company growth companies, and investor relations.

Inventory-based Compensation Expense

For the total yr ended September 30, 2021, stock-based compensation expense was $1.5 million as in comparison with $0.8 million for the prior yr. The rise displays bills associated to new grants made by Citius and the NoveCite inventory possibility plan.

Web loss

Web loss was $23.1 million, or ($0.23) per share for the yr ended September 30, in comparison with a internet lack of $17.5 million, or ($0.45) per share for the yr ended September 30, 2020. The rise in internet loss is primarily as a result of $3.4 million enhance in our analysis and growth bills and a $1.6 million enhance generally and administrative bills.

About Citius Prescription drugs, Inc.

Citius is a late-stage biopharmaceutical firm devoted to the event and commercialization of first-in-class crucial care merchandise, with a concentrate on oncology, anti-infectives in adjunct most cancers care, distinctive prescription merchandise, and stem cell therapies. The Firm has two late-stage product candidates, Mino-Lok®, an antibiotic lock resolution for the remedy of sufferers with catheter-related bloodstream infections (CRBSIs), which is at present enrolling sufferers in a Part 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an preliminary indication in cutaneous T-cell lymphoma (CTCL), which has accomplished topic remedy in its Pivotal Part 3 trial.  Mino-Lok® was granted Quick Observe designation by the U.S. Meals and Drug Administration (FDA). I/ONTAK has obtained orphan drug designation by the FDA for the remedy of CTCL and peripheral T-cell lymphoma (PTCL). By its subsidiary, NoveCite, Inc., Citius is growing a novel proprietary mesenchymal stem cell remedy derived from induced pluripotent stem cells (iPSCs) for acute respiratory circumstances, with a near-term concentrate on acute respiratory misery syndrome (ARDS).  For extra data, please go to www.citiuspharma.com.

Protected Harbor

This press launch might comprise “forward-looking statements” throughout the that means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Change Act of 1934. Such statements are made based mostly on our expectations and beliefs regarding future occasions impacting Citius. You possibly can determine these statements by the truth that they use phrases reminiscent of “will,” “anticipate,” “estimate,” “anticipate,” “plan,” “ought to,” and “might” and different phrases and phrases of comparable that means or use of future dates. Ahead-looking statements are based mostly on administration’s present expectations and are topic to dangers and uncertainties that might negatively have an effect on our enterprise, working outcomes, monetary situation and inventory value.  Components that might trigger precise outcomes to vary materially from these at present anticipated are: dangers regarding the outcomes of analysis and growth actions, together with these from current and new pipeline belongings; uncertainties regarding preclinical and scientific testing; the early stage of merchandise beneath growth; our means to efficiently undertake and full scientific trials and the outcomes from these trials for our product candidates; our want for substantial extra funds; our dependence on third-party suppliers; the estimated markets for our product candidates and the acceptance thereof by any market; the flexibility of our product candidates to impression the standard of lifetime of our goal affected person populations; our means to commercialize our merchandise if accredited by the FDA; market and different circumstances; our means to draw, combine, and retain key personnel; dangers associated to our progress technique; patent and mental property issues; our means to draw, combine, and retain key personnel; our means to acquire, carry out beneath and keep financing and strategic agreements and relationships; our means to determine, purchase, shut and combine product candidates and corporations efficiently and on a well timed foundation; our means to acquire cGMP commercial-scale provide; authorities regulation; competitors; in addition to different dangers described in our SEC filings. These dangers have been and could also be additional impacted by Covid-19. Accordingly, these forward-looking statements don’t represent ensures of future efficiency, and you’re cautioned to not place undue reliance on these forward-looking statements. Dangers relating to our enterprise are described intimately in our Securities and Change Fee (“SEC”) filings which can be found on the SEC’s web site at www.sec.gov, together with in our Annual Report on Kind 10-Ok for the yr ended September 30, 2021, filed with the SEC on December 15, 2021 and up to date by our subsequent filings with the Securities and Change Fee. These forward-looking statements communicate solely as of the date hereof, and we expressly disclaim any obligation or enterprise to launch publicly any updates or revisions to any forward-looking statements contained herein to mirror any change in our expectations or any adjustments in occasions, circumstances or circumstances on which any such assertion relies, besides as required by legislation.

Investor Relations for Citius Prescription drugs:

Ilanit Allen
Vice President, Company Communications and Investor Relations
T: 908-967-6677 x113
E: [email protected]

— Monetary Tables Observe –

 

CITIUS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS SEPTEMBER 30, 2021 AND 2020
2021 2020
ASSETS
Present Belongings:
Money and money equivalents $ 70,072,946 $ 13,859,748
Pay as you go bills 2,741,404 122,237
Whole Present Belongings 72,814,350 13,981,985
Property and tools, internet 7,023 1,577
Working lease right-of-use asset, internet 822,828 986,204
Different Belongings:
Deposits 38,062 57,093
In-process analysis and growth 59,400,000 19,400,000
Goodwill 9,346,796 9,346,796
Whole Different Belongings 68,784,858 28,803,889
Whole Belongings $ 142,429,059 $ 43,773,655
LIABILITIES AND STOCKHOLDERS’ EQUITY
Present Liabilities:
Accounts payable $ 1,277,095 $ 1,856,235
Accrued bills 621,960 164,040
Accrued compensation 1,906,000 1,654,919
Accrued curiosity 89,970
Notes payable – associated events 172,970
Working lease legal responsibility 177,237 158,999
Whole Present Liabilities 3,982,292 4,097,133
Word payable – paycheck safety program 164,583
Deferred tax legal responsibility 4,985,800 4,985,800
Working lease legal responsibility – non present 678,234 855,471
Whole Liabilities 9,646,326 10,102,987
Commitments and Contingencies
Stockholders’ Fairness:
Most well-liked inventory – $0.001 par worth; 10,000,000 shares approved; no shares issued and 
Frequent inventory – $0.001 par worth; 400,000,000 shares approved; 145,979,429 and  145,979 55,577
Further paid-in capital 228,084,195 104,208,958
Collected deficit (96,047,821) (70,593,867)
Whole Citius Prescription drugs, Inc. Stockholders’ Fairness 132,182,353 33,670,668
Non-controlling curiosity 600,380
Whole Fairness 132,782,733 33,670,668
Whole Liabilities and Fairness $ 142,429,059142,587,832 $ 43,773,655
See accompanying report of unbiased registered public accounting agency and notes to the consolidated monetary statements.

 

CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED SEPTEMBER 30, 2021 AND 2020
2021 2020
Revenues $ $
Working Bills:
Analysis and growth 12,240,503 8,812,810
Normal and administrative 9,836,412 8,094,614
Inventory-based compensation – common and administrative 1,454,979 803,261
Whole Working Bills 23,531,894 17,710,685
Working Loss (23,531,894) (17,710,685)
Different Revenue (Expense):
Curiosity earnings 261,825 68,066
Achieve on forgiveness of word payable – Paycheck Safety Program and accrued  166,557
Different earnings 59,917 110,207
Curiosity expense (10,839) (15,673)
Whole Different Revenue, Web 477,460 162,600
Web Loss (23,054,434) (17,548,085)
Deemed dividend on warrant extension 1,450,876
Web Loss Relevant to Frequent Stockholders $ (24,505,310) $ (17,548,085)
Web Loss Per Share Relevant to Frequent Stockholders – Primary and Diluted $ (0.23) $ (0.45)
Weighted Common Frequent Shares Excellent
Primary and diluted 108,599,080 39,165,248
See accompanying report of unbiased registered public accounting agency and notes to the consolidated monetary statements.

 

CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED SEPTEMBER 30, 2021 AND 2020
2021 2020
Money Flows From Working Actions:
Web loss $ (23,054,434) $ (17,548,085)
Changes to reconcile internet loss to internet money utilized in working 
Inventory-based compensation 1,454,979 803,261
Issuance of widespread inventory for companies 68,000 528,770
Amortization of working lease right-of-use asset 163,376 151,520
Depreciation 1,492 844
Achieve from forgiveness of notes payable – paycheck safety  (166,557)
Modifications in working belongings and liabilities:
Pay as you go bills (2,619,167) (74,126)
Deposits 19,031
Accounts payable (579,140) (857,307)
Accrued bills 457,920 (82,185)
Accrued compensation 251,081 254,231
Accrued curiosity (87,996) 15,673
Working lease legal responsibility (158,999) (123,254)
Web Money Used In Working Actions (24,250,414) (16,930,658)
Money Flows From Investing Actions:
Buy of property and tools (6,938) (1,831)
Buy of in-process analysis and growth (40,000,000)
Web Money Used In Investing Actions (40,006,938) (1,831)
Money Flows From Financing Actions:
Proceeds from notes payable – paycheck safety program 164,583
Principal paid on notes payable – associated events (172,970)
Proceeds from sale of NoveCite, Inc. widespread inventory 500
Proceeds from widespread inventory warrant workout routines 31,130,134 7,156,549
Proceeds from widespread inventory possibility workout routines 82,634
Web proceeds from underwritten choices 8,700,201
Web proceeds from non-public placement 18,450,410
Web proceeds from registered direct choices 70,979,842 6,877,100
Web Money Offered By Financing Actions 120,470,550 22,898,433
Web Change in Money and Money Equivalents 56,213,198 5,965,944
Money and Money Equivalents – Starting of 12 months 13,859,748 7,893,804
Money and Money Equivalents – Finish of 12 months $ 70,072,946 $ 13,859,748
Supplemental Disclosures of Money Circulation Data and 
     Non-cash Actions:
Working lease right-of-use asset and legal responsibility recorded upon  $ $ 1,137,724
See accompanying report of unbiased registered public accounting agency and notes to the consolidated monetary statements.

 

 

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SOURCE Citius Prescription drugs, Inc.

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