Zacks Small Cap Analysis – IMNN: Constructive Outcomes for OVATION 2 Trial Helps Advancing IMNN-001 Into Part 3 Examine… – Cyber Tech

By David Bautz, PhD

NASDAQ:IMNN

READ THE FULL IMNN RESEARCH REPORT

Enterprise Replace

Constructive Outcomes from OVATION 2 Trial Help Advancing IMNN-001 to Part 3 Examine

On July 30, 2024, Imunon, Inc. (NASDAQ:IMNN) introduced constructive topline outcomes from the Part 2 OVATION 2 trial of IMNN-001 in sufferers with newly recognized superior epithelial ovarian, fallopian tube, or major peritoneal most cancers. IMNN-001 is a DNA-based immunotherapeutic drug that consists of an interleukin (IL)-12 plasmid that enables for focused expression of IL-12 to keep away from toxicities and poor pharmacokinetics of systemically administered IL-12.

Interim knowledge launched in September 2023 confirmed a 9-month enchancment in survival and a hazard ratio (HR) of 0.86, nevertheless as the general survival (OS) knowledge have matured, the advance in survival elevated to 11.1 months with a hazard ratio of 0.74, as proven within the following desk.

A abstract of the topline outcomes is offered under. Along with the 11.1-month improve in OS within the intent-to-treat (ITT) inhabitants, there was additionally a 15.7-month improve in OS by IMNN-001 in sufferers who had a minimum of 20% of protocol-specified remedies in each arms. As a reminder, the OVATION 2 examine was not powered for statistical significance.

We anticipate the total knowledge set to be offered at an upcoming scientific convention and the total outcomes will likely be submitted for publication in a peer-reviewed medical journal. The corporate is inside days of requesting an ‘Finish-of-Part 2’ assembly with the FDA to make clear the parameters of the upcoming Part 3 trial, which we estimate will start within the first quarter of 2025. Whereas the tempo of the trial will likely be dictated by a lot of completely different parameters, together with funding and affected person enrollment, presently the corporate estimates a topline knowledge readout on the finish of 2028. We anticipate additional particulars in regards to the design of the Part 3 examine following the assembly with the FDA and because it will get nearer to initiating.

MRD Examine Continues

Imunon additionally offered an replace on the examine evaluating IMNN-001 on minimal residual illness (MRD) as decided by laparoscopy when administered together with Avastin and neoadjuvant chemotherapy (NACT). The examine is being principally funded by the Break By means of Most cancers basis and initiated on the College of Texas MD Most cancers Heart underneath the management of Dr. Amir Jazaeri. Thus far, seven sufferers have been enrolled and acquired therapy with a goal enrollment of fifty sufferers. To this point, the corporate is happy with the speed of enrollment and now that two extra scientific websites will likely be used within the trial, Memorial Sloan Kettering is open for enrollment and Johns Hopkins will likely be opening for enrollment quickly, the enrollment fee could improve additional. Dr. Jazaeri can even be initiating a pilot examine to testing circulating tumor DNA (ctDNA) in sufferers which have accomplished the therapy protocol.

Part 1 Trial of IMNN-101 Underway

In Could 2024, Imunon introduced that the primary web site was activated and prepared for affected person recruitment for the Part 1 scientific trial of IMNN-101, the corporate’s seasonal COVID-19 vaccine. The examine is deliberate to enroll 24 topics evaluating three escalating doses of IMNN-101. For this examine, IMNN-101 was designed to guard towards SARS-CoV-2 Omicron XBB1.5 variant, which was in accordance with the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee’s June 2023 announcement. The first aims of the examine are to judge security and tolerability of the vaccine in wholesome adults. Secondary aims embrace neutralizing antibody response, mobile responses, and their related sturdiness. We anticipate topline outcomes earlier than the tip of 2024. At that time, the corporate will likely be actively searching for a associate to proceed improvement of IMNN-101.

Monetary Replace

On August 14, 2024, Imunon introduced monetary outcomes for the second quarter of 2024. As anticipated, the corporate didn’t report any income through the second quarter of 2024. R&D bills within the second quarter of 2024 had been $2.8 million in comparison with $3.1 million within the second quarter of 2023. The lower was primarily as a result of decrease prices related to the PLACCINE know-how improvement together with decrease CMC prices. G&A bills within the second quarter of 2024 had been $2.2 million in comparison with $2.3 million for the second quarter of 2023. The lower was primarily as a result of decrease non-cash stock-based compensation and employee-related prices.

As of June 30, 2024, Imunon had roughly $5.3 million in money, money equivalents, investments, and curiosity receivable. Subsequent to the tip of the quarter, the corporate raised internet proceeds of roughly $9.0 million from a registered direct providing of 5.0 million shares at a value of $2.00 per share. We estimate that the corporate has adequate capital to fund operations into the third quarter of 2025. Imunon presently has roughly 14.4 million widespread shares excellent and, when factoring in inventory choices and warrants, a completely diluted share depend of roughly 20.9 million.

Conclusion

The topline outcomes of the OVATION 2 trial had been very encouraging and constantly present that IMNN-001 is having a constructive impact on the lives of superior ovarian most cancers sufferers as exhibited by the rise in general survival, notably in sufferers that acquired extra doses of drug and those who had been on PARP inhibitor remedy. We stay up for the result of the ‘Finish-of-Part 2’ assembly with the FDA and extra particulars of the upcoming Part 3 examine of IMNN-001.

SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to obtain our articles and experiences emailed on to you every morning. Please go to our web site for extra info on Zacks SCR. 

DISCLOSURE: Zacks SCR has acquired compensation from the issuer straight, from an funding supervisor, or from an investor relations consulting agency, engaged by the issuer, for offering analysis protection for a interval of at least one 12 months. Analysis articles, as seen right here, are a part of the service Zacks SCR gives and Zacks SCR receives quarterly funds totaling a most price of as much as $40,000 yearly for these providers offered to or relating to the issuer. Full Disclaimer HERE.