NEW YORK, March 17, 2023 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc. (Nasdaq: INDP), today announced financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided a corporate update.
“With the initiation of our INDP-D101 trial at the end of December 2022 and the subsequent dosing of our first patient in the first cohort, we are well underway in our Phase 1 trial of Decoy20 for the treatment of solid tumors,” said Jeffrey Meckler, chief executive officer of Indaptus. “Following the initial dosing we were encouraged to learn that the subject experienced manageable and expected adverse events related to the immune response we anticipated. We are looking forward to analyzing the data generated from that first patient and finishing the first arm of the trial per the protocol. As we continue to bring new centers online and enroll patients, we will continue to prudently manage our cash position, and update stakeholders on our progress as it develops.”
Key highlights from Q4 2022 to date:
- The Company reported the first dosing of a study subject in the INDP-D101 trial in March 2023. After Decoy20 dosing, the subject experienced expected and manageable adverse events believed to be related to the immune system activating components known to be in the product. A second subject in the first three-subject cohort is expected to be enrolled following final assessment of the safety and tolerability associated with dosing of the first subject, per the study protocol.
- In February 2023, Indaptus activated Morristown Medical Center as the second trial site in the INDP-D101 trial. The third site, Emory Winship Cancer Institute in Atlanta, GA, was activated in March 2023.
- Robert Martell, M.D., Ph.D. was elected to the Indaptus Therapeutics Board of Directors in February 2023.
- In December 2022, the Company initiated its first-in-human, Phase 1, open-label dose escalation and expansion clinical trial of Decoy20 in patients with advanced solid tumors where currently approved therapies have failed. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. The Phase 1 study has begun with a single dose escalation followed by an expansion with continuous administration of Decoy20. The initial trial site was the USC Norris Cancer Center in Los Angeles, CA. More information can be found at www.clinicaltrials.gov.
Financial Highlights for Fourth Quarter and Fiscal Year Ended December 31, 2022
Research and development expenses for the three-month period ended December 31, 2022, were approximately $1.9 million, an increase of approximately $0.9 million, or approximately 90%, compared with approximately $1.0 million in the three-month period ended December 31, 2021. Research and development expenses for the twelve-month period ended December 31, 2022, were approximately $6.3 million, an increase of approximately $3.8 million, or approximately 150%, compared with approximately $2.5 million in the twelve-month period ended December 31, 2021. The increase in each of the three and twelve-month periods was primarily due to increased payroll and related expenses, share-based compensation, Phase 1 clinical trial activities including the IND preparation and submission, and costs associated with the manufacturing processes of our lead clinical candidate.
General and administrative expenses for the three-month period ended December 31, 2022, were approximately $2.2 million, a decrease of approximately $0.1 million, or approximately 4%, compared with approximately $2.3 million in the three-month period ended December 31, 2021. General and administrative expenses for the twelve-month period ended December 31, 2022, were approximately $8.6 million, an increase of approximately $3.4 million, or approximately 65%, compared to approximately $5.2 million for the twelve-month period ended December 31, 2021. The increase in the twelve-month period was primarily due to increased payroll and related expenses, stock-based compensation expense resulting from increased headcount of our executive team, directors’ and officers’ insurance expenses, professional fees and other expenses associated with being a public company following the merger.
Loss per share for the twelve-month period ended December 31, 2022, was approximately $1.73 compared with approximately $1.89 for the twelve-month period ended December 31, 2021.
As of December 31, 2022, the Company had cash and cash equivalents and marketable securities of approximately $26.4 million. As of December 31, 2021, the Company had cash and cash equivalents of approximately $39.1 million. The Company expects that its current cash, cash equivalents and marketable securities will support its ongoing operating activities into the second quarter of 2024. This cash runaway guidance is based on the Company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Indaptus continues to assess all financing options that would support its corporate strategy.
Net cash used in operating activities was approximately $13.1 million for the twelve-month period ended December 31, 2022, compared with net cash used in operating activities of approximately $11.3 million for the twelve-month period ended December 31, 2021. The approximately $1.8 million increase in net cash used was primarily attributable to expenses related to research and development activities in connection with the Phase 1 clinical trial and general and administrative expenses associated with being a public company following the merger.
There was no net cash provided by financing activities for the twelve-month period ended December 31, 2022. Net cash provided by financing activities was approximately $48.3 million for the year ended December 31, 2021 which was primarily due to the merger and the private placement that closed in August 2021 as well as a series of SAFEs (Simple Agreements for Future Equity) that was issued to accredited investors at the effective time of the merger.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR) agonist Decoy platform. The products are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy products represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy products in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated safe i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy products have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
