By David Bautz, PhD
READ THE FULL IMNN RESEARCH REPORT
Enterprise Replace
Replace on IMNN-101
Imunon, Inc. (NASDAQ:IMNN) is growing IMNN-101, which is a COVID-19 seasonal vaccine booster based mostly on the corporate’s PlaCCine know-how. It’s a DNA vaccine that addresses plenty of limitations of present vaccines, together with the sturdiness of antigen expression, stability, and adaptability to adapt to mutating viruses.
• In February 2024, Imunon introduced the publication of a peer-reviewed article titled “Robust immunogenicity & safety in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a useful polymer” (Sood et al., 2024). Within the examine, the spike antigens from COVID-19 variants D614G (pVAC15), Delta (pVAC16), or each (pVAC17) have been cloned into DNA vectors. The plasmids have been formulated with a useful polymer that resulted in protein expression for as much as 85 days. Comparative research between PlaCCine vectors and Moderna’s mRNA vaccine (mRNA-1273) demonstrated that vaccination with PlaCCine induced antibody responses that have been corresponding to these induced by mRNA-1273. Immunization with pVAC17 resulted within the induction of cross neutralizing antibodies and safety in mice towards each a D614G and Delta problem.
• In February 2024, Imunon introduced optimistic outcomes from a reside virus problem examine performed by the Wistar Institute with IMNN-101 towards the SARS-CoV-2 variant XBB.1.5. That variant was declared the variant of concern for the 2023-2024 vaccine by the U.S. FDA Vaccines and Associated Organic Merchandise Advisory Committee. The examine performed by the Wistar Institute confirmed that IMNN-101 elicited strong IgG and neutralizing antibody responses in a dose-dependent method after a single injection and that difficult the mice with reside virus 21 days after the second vaccination confirmed full response.
• In March 2024, Imunon introduced it filed an Investigational New Drug (IND) software with the U.S. FDA for IMNN-101 for a Section 1/2 scientific examine with a seasonal COVID-19 booster vaccine. The examine is at the moment deliberate to enroll roughly 24 topics evaluating three escalating doses of IMNN-101, which has been designed to guard towards the SARS-CoV-2 Omicron XBB1.5 variant. We anticipate the trial initiating within the second quarter of 2024.
Replace on IMNN-001
In September, 2023, Imunon introduced interim progression-free survival (PFS) and general survival (OS) knowledge for IMNN-001 within the Section 1/2 OVATION 2 trial. IMNN-001 is the corporate’s IL-12 gene-mediated immunotherapy that’s based mostly on the TheraPlas know-how. The OVATION 2 examine is evaluating the dosing, security, efficacy, and organic exercise of intraperitoneal IMNN-001 together with neoadjuvant chemotherapy (NACT) in sufferers with newly recognized superior epithelial ovarian, fallopian tube, or main peritoneal most cancers. Full enrollment of 110 sufferers for the trial was reached in September 2022.
Being a Section 1/2 trial, it isn’t powered for significance. It was designed with an 80% confidence interval to point out an roughly 33% enchancment in PFS when evaluating the remedy arm (NACT+IMNN-001) with the management arm (NACT solely). The ultimate readout of the examine is anticipated in mid-2024, with optimistic outcomes informing subsequent improvement steps.
Interim knowledge from the intent-to-treat inhabitants present efficacy developments in PFS, with a delay in illness development within the remedy arm of roughly 33% in contrast with the management arm. Preliminary OS knowledge confirmed an identical pattern, with an roughly 9-month enchancment within the remedy arm in comparison with the management arm. A non-prespecified subgroup evaluation confirmed that sufferers handled with a PARP inhibitor (PARPi) as upkeep remedy had longer PFS and OS in the event that they have been additionally handled with IMNN-001 in contrast with sufferers handled with NACT solely. The PARPi subgroup was not pre-defined earlier than initiation of the OVATION 2 trial as PARPi’s have been first authorized after the OVATION 2 trial had initiated.
The median PFS within the PARPi+NACT group and the PARPi+NACT+IMNN-001 group was 15.7 months and 23.7 months, respectively. The median OS within the PARPi+NACT group was 45.6 months and had not but been reached within the PARPi+NACT+IMNN-001 group. These knowledge are preliminary, however sufferers handled with PARPi’s together with IMNN-001 seem to have the best profit and can doubtless be a magnet for the corporate shifting ahead.
Further optimistic developments have been seen in secondary end result measures, together with an roughly 25% larger R0 tumor resection rating and a doubling of the CRS 3 chemotherapy response rating to roughly 30% within the remedy arm in comparison with 14% within the management arm. Security knowledge from the trial continues to point out that IMNN-001 is nicely tolerated on this setting.
In October 2023, Imunon reported that the primary affected person was enrolled within the Section 1/2 scientific trial of IMNN-001 together with bevacizumab in superior ovarian most cancers on the College of Texas MD Anderson Most cancers Middle. The trial is anticipated to enroll 50 sufferers with Stage III/IV superior ovarian most cancers. Sufferers present process frontline neoadjuvant remedy might be randomized 1:1 to obtain commonplace chemotherapy plus bevacizumab or chemotherapy plus bevacizumab and IMNN-001. The first endpoint is detection of minimal residual illness (MRD) by re-assessment laparoscopy (SLL) and the secondary endpoint is PFS. Preliminary SLL knowledge are anticipated inside one 12 months following the completion of enrollment whereas closing PFS knowledge are anticipated roughly three years following completion of enrollment. The corporate just lately introduced that 4 sufferers have been enrolled within the examine up to now and that MD Anderson Most cancers Middle has joined in enrolling sufferers.
Monetary Replace
On March 28, 2024, Imunon introduced monetary outcomes for 2023. The corporate reported $0 in income in 2023 in comparison with $500,000 in know-how improvement and licensing income in 2022. The $500,000 stemmed from a non-refundable know-how switch charge of $5 million paid by Hisun in January 2013 to assist the event of ThermoDox® in China that was recorded as deferred income and was amortized over the ten-year time period of the settlement. As of December 31, 2022, the contract has been totally amortized and acknowledged as income.
In 2023, the corporate reported a internet lack of $19.5 million, or $2.16 per share, in contrast with a internet lack of $35.9 million, or $5.03 per share, in 2022. R&D bills in 2023 have been $11.3 million, in comparison with $11.7 million in 2022. The lower was primarily as a consequence of decreased prices related to the OVATION 2 and OPTIMA research. G&A bills in 2023 have been $9.7 million, in comparison with $13.7 million in 2022. The lower was primarily as a consequence of decrease non-cash inventory compensation, decrease employee-related prices, decrease authorized prices, and decrease insurance coverage and public firm bills.
Imunon exited 2023 with roughly $15.7 million in money, money equivalents, investments, and accrued curiosity receivable. Together with the long run deliberate sale of the corporate’s remaining $1.3 million in New Jersey Internet Working Losses (NOLs), we estimate that the corporate has adequate capital to fund operations into the fourth quarter of 2024. Imunon at the moment has roughly 9.4 million frequent shares excellent and, when factoring in inventory choices and warrants, a totally diluted share rely of roughly 10.7 million.
Conclusion
We look ahead to the initiation of the Section 1/2 scientific trial of IMNN-101 within the second quarter of 2024. IMNN-101 has proven promising preclinical outcomes and we might be very to see if these outcomes translate into the clinic. We additionally look ahead to outcomes from the IMNN-001 trial, which we anticipate in mid-2024. With no adjustments to our mannequin our valuation stays at $15 per share.
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