Indaptus Therapeutics Q1 Update: Company Advances Decoy20 Immunotherapy To Fight Cancer, Maxim Group Analyst Reiterates Buy Rating

Next-generation immunotherapy cancer drug company Indaptus Therapeutics Inc. INDP narrowed its loss and hit key milestones during Q1 as it advanced its quest to exploit bacteria's natural ability to activate both innate and adaptive cellular immune pathways to fight cancer. 

For the quarter ending Mar. 31, 2025, Indaptus narrowed its loss per share to $0.32, an improvement from the $0.45 loss per share in the year-earlier first quarter, even as a $3.2 million raise gave the company some more runway capital. Equally importantly, the company made progress advancing its pipeline of proprietary, attenuated and killed non-pathogenic gram-negative bacterial candidates designed to be widely accessible, with broad antitumor and antiviral activity. 

Decoy Trials Taking Shape 

Known at the company as Decoy Therapeutics candidates, Indaptus says its Decoy20 program is unique in it sability to work with a variety of existing therapies, including checkpoint therapy and targeted antibodies, to produce strong anti-tumor responses against established tumors. 

What's more, the company says its Decoy Therapeutics are out of the body within a few hours, reducing the potential for long-term toxicity. In humans, Indaptus says Decoy Therapeutics transiently activate more than 50 cytokines/chemokines that may work together to attack tumors.

During the first quarter, the company kicked off the expansion arm of its phase 1b/2 clinical trial of Decoy20. This arm is evaluating Decoy20 in combination with BeOne's (formerly known as Beigene) PD-1 checkpoint inhibitor, Tislelizumab, with a focus on safety, dose optimization and early signals of anti-tumor activity. PD-1 inhibitors are considered key agents in modern immunotherapy and have produced impressive response rates in some patients, reports Indaptus. 

In preclinical studies, Indaptus said Decoy20, when used in combination with a PD-1 inhibitor and an oral non-steroidal anti-inflammatory agent, demonstrated tumor eradication rates of 80-100%. Indaptus hopes to find a treatment combination that similarly improves outcomes in humans.

Expanding Its Know-How 

In Q1, the company also received patent approvals in China, Japan and Israel for the use of its Decoy bacteria compositions to fight hepatitis B virus (HBV) and human immunodeficiency virus (HIV). The patents also extend to combination therapies with a variety of both approved and investigational treatments, expanding the company's intellectual property. 

If that wasn't enough to keep Indaptus busy during the first quarter, the company also enrolled 32 patients in the weekly dosing among the two Decoy20 dose levels and decided to conclude enrollment for this arm and shift focus to the combination treatment of Decoy20 with Tislelizumab. Indaptus reports that early data from the weekly dosing suggests that Decoy20 is generally well-tolerated, with a favorable safety profile and encouraging signs of clinical benefit, including instances of stable disease. The company kicked off a cost reduction plan given its focus on the combination study. 

The shift to focus on the combination with Tislelizumab has garnered some attention on Wall Street, given it aligns with a main focus of immuno-oncology. PD-1 inhibitors put a stop to T-cells, while Decoy20’s mechanism activates the immune system. In essence, Decoy20 could prime the immune system while tislelizumab stops tumor-induced immunosuppression. A day after the company reported Q1 earnings, Maxim Group analyst Jason McCarthy recently reiterated his buy rating on the stock with a $2.00 price target. McCarthy is encouraged by Indaptus' advancements in its clinical trials.

Indaptus' research and development expenses for the first quarter were $2.8 million, compared with $1.6 million in the year-ago third quarter. The change was primarily due to an increase of $1.5 million in expenses for the company's phase 1 clinical trial and was offset by a decrease of $0.3 million in payroll and related expenses. 

General and administrative expenses fell to $1.8 million from $2.4 million in Q1 last year,  primarily due to a decrease in payroll and related expenses and in legal fees. Indapatus ended the quarter with $3.9 million in cash and noted it will need to obtain additional capital to fund its ongoing activities beyond the second quarter. The $3.2 million raise mentioned earlier was through stock and warrant sales and also gave the company some breathing room.

"We made meaningful progress in the first quarter across multiple fronts of our clinical and research programs," Jeffrey Meckler, Indaptus Therapeutics' CEO said when announcing first quarter results.

With Decoy Therapeutic trials underway and the company expanding its IP, Indaptus is betting its approach to using the body's immune system to prevent the growth of tumors will prove effective. Having made progress on advancing its Decoy20 platform in Q1, the company is gearing up to hit more milestones in 2025, and may be one to watch.

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