On May 15, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the first quarter ended March 31, 2026, and provided business updates.

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"We are excited that new survival data from 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP in our Phase 2a clinical trial will be reported in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting on June 1st," said Ben Zeskind, Chief Executive Officer of Immuneering. "We believe the upcoming presentation at ASCO (Free ASCO Whitepaper) is an excellent opportunity to build on the recent momentum in second-line pancreatic cancer and demonstrate atebimetinib’s potential to provide a differentiated first-line option for patients. Our Phase 3 study of atebimetinib + mGnP in first-line pancreatic cancer patients, MAPKeeper 301, is now recruiting patients, and we remain on track to dose the first patient by mid-2026. Our Phase 2 lung cancer trial is on track to dose the first patient in the second half of the year. I believe we are entering a new era in cancer care where treatments have the potential to drive longer survival with fewer harsh side effects, and that atebimetinib will play an important role in that future."

Recent Corporate Highlights

Upcoming oral presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: On June 1, 2026, Dr. Peter Vu, MD, MHA, UC San Diego Health, will present new survival data from an expanded cohort totaling 55 first-line pancreatic cancer patients treated with atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in Immuneering’s Phase 2a clinical trial. The oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting utilizes a data cutoff in April 2026.

Pivotal Phase 3 MAPKeeper 301 trial now recruiting: The global randomized Phase 3 trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) versus modified gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic cancer (NCT07562152) is now recruiting patients across multiple clinical sites. The company remains on track to dose the first patient by mid-2026.

New genetic data from atebimetinib-treated patients demonstrating the mechanism’s potential to improve durability and survival: At the 2026 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on April 20, 2026, Immuneering presented new genetic data in a poster presentation demonstrating a key mechanism that may improve durability and survival, supporting the use of atebimetinib as a first-line treatment in pancreatic cancer and beyond. The circulating tumor DNA (ctDNA) data from 123 atebimetinib-treated patients showed that acquired MAPK pathway alterations were rarely seen. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients, while potentially preserving sensitivity to subsequent treatments.

27 months progression free survival to date in a third-line pancreatic cancer patient treated with atebimetinib monotherapy: The company provided an update on a third-line pancreatic cancer patient, with over 18 centimeters of tumors at baseline, who began receiving atebimetinib monotherapy 27 months ago. The patient continues on treatment, with an 85% reduction in tumor burden as of the most recent scan, with complete resolution of four lesions: a bone lesion, two liver lesions, and a non-target pancreatic lesion. The patient has gained 23 pounds over the course of treatment and reported improved quality of life with no grade 3 adverse events. A detailed description of the case is planned for submission to a medical journal.
Anticipated Near-Term Milestones

Immuneering remains on track to achieve several near-term anticipated milestones related to atebimetinib, including:

Q2 2026: Report updated survival data from an expanded cohort totaling 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP at the 2026 ASCO (Free ASCO Whitepaper) annual meeting.
Mid-2026: Dose the first patient in pivotal Phase 3 MAPKeeper 301 clinical trial of atebimetinib + mGnP in first-line pancreatic cancer.
2H 2026: Dose the first patient in trial of atebimetinib + Libtayo in RAS-mutant first-line non-small cell lung cancer.
First Quarter 2026 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $198.6 million, compared with $217.0 million as of December 31, 2025.

Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $10.6 million, compared with $11.5 million for the first quarter of 2025. The decrease in R&D expenses was primarily attributable to decreases in clinical spend related to the envometinib (IMM-6-415) program, partially offset by increased clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs.

General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $4.7 million, compared with $4.0 million for the first quarter of 2025. The increase in G&A expenses was primarily attributable to employee related costs and increased professional fees in connection with the general and administrative functions supporting the Company’s business.

Net Loss: Net loss attributable to common stockholders was $13.5 million, or $0.21 per share, for the first quarter ended March 31, 2026, compared to $15.0 million, or $0.42 per share, for the first quarter ended March 31, 2025. 

2026 Financial Guidance

Based on cash, cash equivalents and marketable securities as of March 31, 2026, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

(Press release, Immuneering, MAY 15, 2026, View Source [SID1234665770])

On May 15, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported new results from extended follow-up of its randomized, double-blind, placebo-controlled pivotal phase 3 trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in intermediate- to high-risk localized prostate cancer. These findings demonstrate consistent clinical benefit across multiple exploratory endpoints, reinforcing the positive topline data announced in December 2024 after an additional 20 months of follow-up, with a cutoff date of March 15, 2026.

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The data were presented by Mark G. Garzotto, M.D., Professor of Urology and Radiation Medicine at Oregon Health & Science University, during the "Practice-changing, Paradigm-shifting Clinical Trials in Urology" oral plenary session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.

Key Highlights from AUA 2026 Presentation:

Among the 745 patients enrolled in the randomized, double-blind, placebo-controlled trial, the aglatimagene arm exhibited a 39% improvement in prostate cancer-specific disease-free survival (PCa-specific DFS) compared to placebo (hazard ratio [HR] 0.61; 95% confidence interval [CI]: 0.44, 0.85; p=0.0031) after a median follow-up of 58 months (data as of March 15, 2026). Two prostate cancer-specific deaths occurred (1 in each arm) after median follow-up of less than 10 years.

We observed consistently favorable trends in the ITT population across all secondary and exploratory endpoints, including time to biochemical failure (TTBF; HR 0.72, CI 0.40,1.31), time to metastasis (TTM; HR 0.58, CI 0.21, 1.59), rate of metastasis [(1.6% (8/496) vs. 2.8% (7/249)], and time to salvage anti-cancer therapy (time to new treatment (TTNT) HR 0.72, CI 0.39, 1.31), when comparing the aglatimagene arm with placebo on top of standard-of-care radiotherapy.

Within the intermediate-risk subgroup (635 patients, 85% of the ITT population), the aglatimagene arm demonstrated 41% improvement in PCa-specific DFS (HR 0.59, 95% CI 0.41, 0.84, p=0.0034) relative to placebo. In addition, descriptive analyses showed 52% improvement in TTBF (HR 0.48, CI 0.22, 1.03), 90% improvement in TTM (HR 0.1, CI 0.01, 0.85), lower rate of metastatic disease [0.24% (1/422) vs. 2.35% (5/213)], and 49% improvement in TTNT (HR 0.51, CI 0.24, 1.1), when comparing the aglatimagene arm with the placebo arm.

In December 2024, we reported that aglatimagene significantly improved the rate of pathological complete response in 2-year biopsies compared with placebo, suggesting the cancer had been eradicated at a microscopic level.1 Previously published work has shown that histologic changes precede clinical evidence of recurrence and that prostate biopsies, positive for cancer cells ≥ 2 years after radiotherapy, are predictive of subsequent clinically meaningful outcomes, including biochemical failure and development of metastases.2 While the number of events for biochemical failure and development of metastases presented at AUA is, as expected, still too small to achieve statistical significance for most outcomes, the observed trends are consistent and in line with this published literature, supporting the potentially long-term clinical benefit of aglatimagene. We will continue to monitor the patients over time.

"After prolonged follow-up, these data further demonstrated that aglatimagene delivered a statistically significant and clinically meaningful improvement in prostate cancer–specific disease-free survival, with a 39% reduction in the risk of recurrence," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel Therapeutics. "Importantly, we are seeing consistent, favorable trends across multiple clinically relevant secondary and exploratory endpoints, including time to biochemical failure, time to metastasis, and need for subsequent anti-cancer therapy. These findings, combined with earlier evidence of increased pathological complete response at two years, reinforce our confidence that aglatimagene has the potential to deliver durable control of both local and systemic disease and to meaningfully reduce the risk of recurrence for patients undergoing radiotherapy with curative intent for localized prostate cancer. We will continue to follow patients as these data mature, with the expectation that the long-term clinical benefit may become even more apparent over time."

"I am grateful for the opportunity to have presented these data at the AUA Annual Meeting on behalf of all of our study investigators," said Mark G. Garzotto, M.D. "What is particularly compelling is the clear translation of biologic activity into meaningful clinical benefit: patients are experiencing longer periods free from recurrence and the need for additional therapy. These results move us closer to what matters most to patients—living free from cancer—and underscore the potential of aglatimagene to potentially redefine the standard-of-care in localized prostate cancer."

Current standard-of-care radiation therapy for intermediate- to-high-risk localized prostate cancer has remained largely unchanged, with a significant unmet medical need, as approximately 30% of patients experience disease recurrence within 10 years. If approved, aglatimagene immunotherapy could represent the first new therapy for men with localized prostate cancer in over 20 years. Candel continues to plan to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the fourth quarter of 2026. Details from the presentation are available on the Candel website at View Source

Conference Call and Webcast Replay:

Candel hosted a webcast and conference call on Friday, May 15, 2026, which discussed the Company’s extended follow-up data from the phase 3 clinical trial of aglatimagene in patients with intermediate- to high-risk localized prostate cancer.

The replay of the webcast can be accessed here and on the Candel website at View Source under Events & Presentations, in the Investors section of the website.

About aglatimagene besadenovec (CAN-2409)

Aglatimagene, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use.

(Press release, Candel Therapeutics, MAY 15, 2026, View Source [SID1234665790])

On May 15, 2026 Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company"), a clinical-stage biotechnology company, reported financial results for the first quarter ended March 31, 2026, and provided a strategic corporate update.

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Junyi Dai, Indaptus Therapeutics’ Chief Executive Officer and Chairman of the Board, commented, "Following recent changes in executive management, the Company has conducted a review of its development programs, operating resources and ongoing corporate initiatives. While this transition period involves certain operational and organizational adjustments, the Company remains focused on supporting and advancing its therapeutic and research activities."

"Currently we are evaluating our Decoy platform, including its preclinical data and underlying scientific rationale, as we assess its potential relevance to the Company’s ongoing therapeutic, immunological and translational research activities. As part of this process, we believe it is prudent to reassess the Company’s development priorities, operating initiatives and resource allocation considerations," Mr. Dai commented.

Key Highlights

● Executive management transition. Recent changes in executive management have resulted in a transition period during which certain operational and organizational adjustments are underway. The Company continues to evaluate operational priorities, ongoing corporate initiatives and resource allocation matters.
● Corporate and development evaluation activities. The Company continues to evaluate corporate initiatives, research activities and potential development opportunities intended to support the Company’s long-term operational and therapeutic objectives. Any such activities will be assessed based on scientific validation, clinical and regulatory considerations, resource availability and overall development planning.
● Preferred stock conversion completed. During the first quarter of 2026, all outstanding shares of the Company’s Series AA Preferred Stock and Series AAA Preferred Stock were converted into shares of common stock.

Financial Highlights for the First Quarter Ended March 31, 2026

Research and development expenses for the three months ended March 31, 2026 were approximately $0.5 million, a decrease of approximately $2.3 million from approximately $2.8 million in the three months ended March 31, 2025. The change was primarily due to a decrease of approximately $1.9 million in clinical costs related to the Company’s Phase 1 study, as well as a decrease of approximately $0.4 million in payroll and related expenses due to reductions in headcount and base salaries.

General and administrative expenses for the three months ended March 31, 2026 were approximately $1.7 million, a decrease of approximately $0.1 million, or 5%, from approximately $1.8 million for the three months ended March 31, 2025. The decrease was primarily attributable to a decrease in certain expenses related to operating as a public company and the transition of management.

Net loss for the three months ended March 31, 2026 was approximately $2.5 million, compared with a net loss of approximately $4.5 million for the three months ended March 31, 2025. Loss per share for the three months ended March 31, 2026 was approximately $0.23, compared with approximately $9.11 for the three months ended March 31, 2025. The change in our other income (expense)was approximately $0.4 million and consists primarily of the warrant repricing as well as income earned on the Company’s cash and cash equivalent accounts. All share and per-share amounts have been retroactively adjusted to reflect the Company’s one-for-twenty-eight reverse stock split effected on June 27, 2025.

As of March 31, 2026, the Company had cash and cash equivalents of approximately $1.5 million, compared with approximately $8.5 million as of December 31, 2025. The Company will need to raise additional capital to support its business objectives, and there can be no assurance that such financing will be available on acceptable terms, or at all. The Company continues to assess financing alternatives and strategic options that would support its corporate strategy.

Net cash used in operating activities was approximately $7.0 million for the three months ended March 31, 2026, compared with net cash used in operating activities of approximately $5.0 million for the three months ended March 31, 2025. The increase in net cash used in operating activities was primarily attributable to a decrease in accounts payable and other current liabilities, partially offset by a decrease in net loss.

There was no net cash provided by financing activities during the three months ended March 31, 2026, compared with net cash provided by financing activities of approximately $3.2 million for the three months ended March 31, 2025, which was primarily provided by the issuance and sale of common stock and warrants in the January 2025 financing and the issuance and sale of common stock under the Company’s standby equity purchase agreement.

(Press release, Indaptus Therapeutics, MAY 15, 2026, View Source [SID1234665806])

On May 15, 2026 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a biotechnology company focused on identifying and advancing innovative therapeutics, reported its first quarter 2026 financial results and provided a corporate update.

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Recent Highlights

Instil is evaluating potential acquisitions and in-licensing that may provide access to promising novel therapeutic candidates
Cash position of approximately $74.7 million as of March 31, 2026 expected to fund current operating plan beyond 2027
"We continue to make progress refining Instil’s strategy and positioning the company for its next phase of growth," said Bronson Crouch, Chief Executive Officer, Instil Bio. "We are actively evaluating a range of acquisition and in-licensing opportunities, with a focus on assets that align with our capabilities and offer the potential to create long-term value. With a strong balance sheet, we are well positioned to act with discipline and flexibility as we work to build a focused, high-quality pipeline and advance new treatment options for patients."

There can be no assurance that any transaction will result from these efforts, nor as to the timing of any such outcome. Instil does not intend to provide further updates unless and until a specific transaction is approved or disclosure is otherwise deemed appropriate.

First Quarter 2026 Financial and Operating Results:

As of March 31, 2026, Instil had approximately $74.7 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $5.0 million in cash and cash equivalents, $0.1 million in restricted cash and $69.5 million in marketable securities, compared to $76.3 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $6.6 million in cash and cash equivalents, $0.2 million in restricted cash, and $69.5 million in marketable securities, as of December 31, 2025. Instil expects that its cash, cash equivalents, restricted cash and marketable securities as of March 31, 2026 will enable it to fund its current operating plan beyond 2027.

Research and development expenses were $0.7 million for the three months ended March 31, 2026, compared to $5.4 million for the three months ended March 31, 2025.

General and administrative expenses were $5.3 million for the three months ended March 31, 2026, compared to $9.1 million for the three months ended March 31, 2025.

Restructuring and impairment charges were $1.0 million for the three months ended March 31, 2026, compared to $16.1 million for the three months ended March 31, 2025.

Net loss per share, basic and diluted was $0.62 for the three months ended March 31, 2026, compared to $4.32 for the three months ended March 31, 2025. Non-GAAP net loss per share, basic and diluted was $0.32 for the three months ended March 31, 2026, compared to $1.32 for the three months ended March 31, 2025.

(Press release, Instil Bio, MAY 15, 2026, View Source [SID1234665771])

On May 15, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported an update on corporate progress and reported third quarter financial results as of March 31, 2026 (Year end June 30).

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Corporate and R&D Highlights

Executes Service Agreement with FyoniBio GmbH to Establish & Validate Pharmacokinetics Assay for Phase 1b First-In-Human Study

Management has executed a service agreement with FyoniBio GmbH (formerly Glycotope, est. 2010), a German Contract Development Organization (CDO) based in Berlin for establishing and validating a liquid chromatography-mass spectrometry (LC-MS) based pharmacokinetics (PK) assay. The objective is to quantify the Company’s lead asset, PRP, consisting of two proenzymes trypsinogen and chymotrypsinogen, as well as their activated enzyme forms trypsin and chymotrypsin from human serum during the Phase 1b, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors.

Executes Multi-Yr, Anti-Aging & Cancer Research Collaboration with the Universities of Jaén and Granada, Spain

A multi-year Joint Research Collaboration Agreement has been established with the Universities of Jaén (UJA) and Granada (UGR), Spain. The collaboration involves the evaluation of a senescence-modulating (i.e., anti-aging) compound to mitigate senescence and to complete experiments to further support the claims of recently filed fibrosis and cancer related patent applications, requested by Propanc Biopharma Inc. to the research group "Biological Technologies of The University of Jaén" and UGR’s Research Group, "Advanced Therapies: Differentiation, Regeneration and Cancer."

Corporate and Financial Updates

Propanc entered into a private placement agreement for up to $100 million to accelerate clinical development. The Company received an initial $1,000,000 investment upon issuance of 100 shares of Series C Convertible Preferred Stock. As of March 31st, a further $1,000,000 investment was received upon exercise of 100 shares of Series C Convertible Preferred Stock.

Q3 Financial Summary (Quarter Ended March 31, 2026)

Total assets: $14.33 million

Total liabilities reduced by $2.10 million

Convertible notes reduced to $55,000 (from $538,000)

Net cash from financing activities: $4.47 million

Quarter-end cash: $443,702

$0.5 million tranche from the Series C facility subsequently received
The Company expects the financing facility to continually support planned R&D activities, including advancement of PRP and Rec-PRP.

Management Commentary

"We are entering a pivotal phase of development for the Company’s lead asset, PRP, which is progressing to a world first, Phase 1b, First-In-Human study, in 30 – 40 advanced cancer patients suffering from solid tumors. Execution of an agreement with Fyoni Bio will facilitate method development and validation of the pharmacokinetics method in preparation for the pivotal clinical study. In addition, management is engaging with CDMOs (Contract Development and Manufacturing Organizations) for the GMP manufacture of PRP for supply of the finished drug product, CROs (Clinical Research Organizations) to discuss management of future clinical trial operations, as well as preparing regulatory documentation for the Clinical Trial Application targeting submission later this year," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Additionally, our multi-year research agreement with the Universities of Jaén and Granada will continue to support, strengthen and grow our intellectual property around the use of proenzymes not just in cancer, but also focusing on cell rejuvenation to overcome age-related, chronic diseases, such as fibrosis. I am confident we are on the right path to execute a rapid transformation of our Company to clinical stage for a range of incurable diseases which can offer renewed hope for patients."

(Press release, Propanc, MAY 15, 2026, View Source [SID1234665791])