Citius Pharmaceuticals (CTXR) posted a 23Q3 loss of $8.5 million or $0.06 per share, $0.01 less than my estimate, mostly because of a $1.1 million decrease in R&D spending associated with all of its clinical programs (except for Halo-Lido, a proposed treatment for hemorrhoids, which was ramping up a Phase 2 clinical trial).  The decline in R&D expense was partially offset by a $0.7 million increase in general and administrative costs associated with pre-launch and market research activities for Lymphir, its oncology immunotherapy for the treatment of cutaneous T-cell lymphoma.  Interest income increased $0.2 million due to higher interest rates; but stock compensation expense rose by about the same amount.

Citius Pharmaceuticals (CTXR) posted a 23Q2 loss of $0.07 per share, $0.02 more than I had anticipated, mostly because of higher R&D spending associated with the ongoing clinical trials of Mino-Lok and Halo-Lido and also due to pre-launch and market research costs associated with I/ONTAK.

Last night, Citius Pharmaceuticals (CTXR) reported that it had completed its 12.5 million share direct offering, issuing 12.5 million shares at $1.20 per share with attached warrants exercisable at $1.50 per share. In total, the offering generated gross proceeds of $15 million, with net proceeds to Citius of just under $14 million after the $1 million placement agent’s fee.

Citius Pharmaceuticals (CTXR) posted a 23Q1 loss of $0.02 per share, better than I had anticipated, mostly because of a $3.6 gain on the sale of net operating loss carryforwards (equivalent to $0.02 per share) from the State of New Jersey and also due to modestly lower-than-expected operating costs.  The lower level of operating costs is apparently expected to continue, as the company now says that it has sufficient cash to fund its operations until February 2024.  (Previously, it had indicated December 2023.)

I recently had the opportunity to view a presentation and ask questions of Leonard Mazur at the Sidoti MicroCap Conference on January 18.  Mr. Mazur helped fill in some of the gaps in my knowledge about company and its plans going forward.  Here is what I learned:

In 2022, Citius Pharmaceuticals completed its Phase 3 trial for I/ONTAK, indicated for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL) and submitted its Biologics Licensing Application to the FDA.  It has a PDUFA target date of July 28, 2023.  It initiated a clinical collaboration with the University of Pittsburgh to evaluate I/ONTAK in combination with KEYTRUDA (pembrolizumab).   CTXR also advanced its Phase 3 trial for Mino-Lok (a treatment to salvage infected catheters), expanding enrollment toward the FDA’s requirement of observing 92 catheter failure events.  However, it said that the expansion will delay the completion of the clinical trial for some months.  It also initiated a Phase 2b trial for its hemorrhoid treatment candidate, Halo-Lido, and expects a data readout during 23H2.

Citius Pharmaceuticals reported a third quarter loss of $8.9 million or $0.06 per share, compared with last year’s loss of $7.3 million or $0.05 per share.  As an early stage drug development company, Citius currently generates no revenues.  The loss was in line with expectations, reflecting the company’s expanding development efforts, including I/ONTAK, which was acquired last year.

Earlier today, Citius Pharmaceuticals issued a press release announcing its intention to spin-off its late stage oncology candidate, I/ONTAK, to a new, standalone publicly-traded company. In making the announcement, the company said that it believed that the market has not adequately valued the potential of its I/ONTAK licensing agreement.

Citius Pharmaceuticals (CXTR) is a specialty pharmaceutical company focused on the development of five potential products: (1) Mino-Lok, an antibiotic lock solution to treat and salvage infected central venous catheters (CVCs) in patients with catheter-related bloodstream infections (CRBSIs); (2) I/ONTAK, a late-stage oncology immunotherapy for the treatment for cutaneous T-cell lymphoma (CTCL), that was acquired from Dr. Reddy’s Laboratories SA in September 2021; (3) Halo-Lido, a topical formation of halobetasol propionate and lidocaine for the treatment of hemorrhoids; (4) Mino-Wrap, a liquefying, gel-based wrap for the reduction of infections associated with breast implants following breast reconstructive surgeries; and (5) a next generation iPSC mesenchymal stem cell (iMSC) mRNA therapy, which is in pre-clinical development, under license from Brooklyn Immunotherapeutics (BTX).