On August 11, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the second quarter ended June 30, 2026.

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"AN2 will have three Phase 2 programs underway by the end of this year, all of which have the potential to address major unmet needs. Our near-term focus is advancing start-up activities for the Phase 2 EBO-PV-201 study in polycythemia vera. We recently held a pre-IND meeting with the FDA and are expanding the Phase 2 study to include sites in the U.S. and Australia," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Enrollment is ongoing in an investigator-initiated Phase 2 study in M. abscessus lung disease. In our chronic Chagas program, compelling non-human primate efficacy data and a favorable clinical PK and safety profile from our Phase 1 study support planned initiation of a Phase 2 trial by year-end. We are also expanding our pipeline, having declared our first development candidate for solid tumors earlier this year and expecting to advance a second development candidate by the end of 2026. Collectively, these achievements underscore the potential of our boron chemistry platform to deliver differentiated therapies across multiple disease areas."

Second Quarter & Recent Business Updates:

Polycythemia vera

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Advancing start-up activities for the global Phase 2 trial of oral epetraborole in polycythemia vera
In March 2026, the Company outlined plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera (PV). PV is a slowly progressing blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit, which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, such as burdensome periodic therapeutic phlebotomies, many patients experience uncontrolled hematocrit levels and persistent symptoms, requiring long-term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S.

The Company recently held a pre-IND meeting with the FDA and now plans to expand the Phase 2 study (EBO-PV-201) to add sites in the U.S. and Australia, with an IND filing expected in the third quarter of 2026. As a result of this expansion, Phase 2 enrollment is anticipated to commence in the fourth quarter of 2026, beginning with an open-label sentinel cohort at a sub-therapeutic dose aimed at assessing pharmacokinetics and safety in PV patients. Following successful conclusion of the sentinel group, the safety monitoring committee will advise on dose selections for Part 1, an open-label, single arm, 28-week evaluation of epetraborole’s ability to maintain hematocrit control and reduce the frequency of phlebotomy in phlebotomy-dependent PV patients. The Company anticipates releasing Part 1 data periodically throughout 2027.

M. abscessus complex lung disease

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Enrollment ongoing in Phase 2 investigator-initiated clinical trial of epetraborole in patients with M. abscessus lung disease
Building on the learnings from AN2’s prior non-tuberculous mycobacterial (NTM) study in treatment-refractory MAC, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult-to-treat NTM infections for which no FDA-approved therapy exists. M. abscessus lung disease is a serious NTM infection requiring prolonged therapy, initially often with IV-only antibiotics. People affected by this illness face limited, burdensome treatment options, and high rates of morbidity and mortality. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of whom 10-15% have infection caused by M. abscessus.

The Company is supporting an investigator-initiated trial and anticipates that data from this study, if positive, could provide clinical proof-of-concept in M. abscessus lung disease and thereby inform the design of a subsequent pivotal trial. Patient enrollment is ongoing. The 84-patient multicenter, randomized, double-blind, placebo-controlled, prospective clinical study is being led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at the Oregon Health and Sciences University, in conjunction with other investigators across an estimated 10-15 sites in the U.S. The Company anticipates reporting topline results in late 2027, subject to enrollment progress.

Chagas disease

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Announced positive enabling data from two studies of oral AN2-502998, under development for chronic Chagas disease, which support advancement to Phase 2 proof-of-concept study anticipated to start in 2026
The Company is studying AN2-502998, an oral, boron-based small molecule CPSF3 inhibitor for the treatment of chronic Chagas disease, also known as American trypanosomiasis. Chagas disease is caused by the parasite Trypanosoma cruzi (T. cruzi). Over 300,000 people are estimated to be infected in the U.S., 200,000 across Europe and Japan, and about 10 million worldwide. Left untreated, chronic T. cruzi infection is lifelong and can be life threatening. The parasite T. cruzi silently damages the heart and digestive system, with ~20-30% of people developing serious cardiac damage resulting in heart failure, stroke, or sudden death. There are no FDA-approved treatments for adults with Chagas disease.

In June 2026, the Company announced positive results from two studies that it believes support the planned initiation later this year of a Phase 2 trial of AN2-502998 in chronic Chagas disease. In the non-human primate (NHP) efficacy study, 28 days of treatment with AN2-502998 resulted in 100% parasitic elimination at target exposures attainable in humans, in NHP’s with naturally acquired, chronic T. cruzi infection. In the Phase 1 first-in-human study, AN2-502998 was generally well tolerated at exposure levels consistent with NHP efficacy thresholds.

AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in NHPs with long-term, naturally acquired chronic infections caused by diverse T. cruzi genetic types. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease.

The Company expects to initiate a Phase 2 proof-of-concept study in adults with chronic Chagas disease in late 2026.

Boron chemistry pipeline

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Advancing ENPP1 candidate for the potential treatment of solid tumors
The Company is prioritizing targets in oncology and bone disorders where it believes boron chemistry may offer a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds that demonstrate sub-nanomolar activity, high selectivity and excellent oral pharmacokinetic properties. Earlier this year, the Company declared a development candidate (ENPP1) for the treatment of solid tumors and expects to advance a second development candidate by the end of 2026.

Selected Second Quarter Financial Results

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Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $6.0 million, compared to $3.2 million for the same period during 2025 due to increased chemistry manufacturing and controls (CMC) expenses, other miscellaneous expenses, consulting and outside services, preclinical and research studies expenses, and clinical trial expenses. These increases were partially offset by a decrease in personnel-related expenses.
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General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $2.9 million, compared to $4.0 million for the same period in 2025 due to decreased professional and outside services expenses and personnel-related expenses.
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Interest Income: Interest income for the second quarter of 2026 was $0.7 million, compared to $0.8 million for the same period during 2025 due to lower average cash, cash equivalents, and investment balances and lower interest rates in 2026 as compared to 2025.
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Net Loss: Net loss for the second quarter of 2026 was $8.2 million, compared to $6.5 million for the same period during 2025.
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Cash Position: The Company had cash, cash equivalents and investments of $79.9 million at June 30, 2026. The Company projects that existing cash, cash equivalents, and investments will sustain operations into 2029 under the current operating plan.

(Press release, AN2 Therapeutics, AUG 11, 2026, View Source [SID1234669940])

On August 10, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, reported the opening of the investigator-initiated ("IIT") Phase 1 neoadjuvant study (NCT07671339) evaluating ELI-002 7P in combination with chemotherapy and an anti-PD1 checkpoint inhibitor in borderline resectable and resectable PDAC. The multi-center IIT is being conducted by MSK Cancer Center and is being funded by a strategic partnership between The Lustgarten Foundation and Break Through Cancer.

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"The activation of this study marks an important milestone as we prepare to evaluate the potential of ELI-002 7P across multiple stages of pancreatic cancer," said Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio. "Building on the complete responses observed in patients with metastatic PDAC treated with sequential ELI-002 7P followed by checkpoint inhibitor and chemotherapy, this study prospectively evaluates the combination beginning in the neoadjuvant setting and continuing after surgery. We hope to generate important clinical insights into ELI-002 7P’s potential to harness the immune system and improve surgical outcomes and long-term survival for patients facing this devastating disease."

Kevin Soares, MD, Assistant Attending Surgeon Hepatopancreatobiliary Service, MSK and Principal Investigator of the Phase 1 study added, "Despite advances in the treatment of pancreatic cancer, patients with resectable and borderline resectable disease continue to face a high risk of recurrence, highlighting the need for new therapeutic strategies. This trial offers an important opportunity to investigate how ELI-002 7P may reshape the tumor immune environment when initially combined with neoadjuvant therapy, while offering the potential to generate valuable translational data that could inform future treatment strategies."

The randomized, open-label Phase 1 trial aims to enroll 20 patients with resectable or borderline resectable KRAS-mutant PDAC. Participants will receive ELI-002 7P with standard chemotherapy, mFOLFIRINOX, with or without tislelizumab, an anti-PD1 checkpoint inhibitor, starting before surgery. Throughout treatment, researchers plan to collect tumor tissue and blood samples to better understand immune activation, characterize changes within the tumor microenvironment, and identify biomarkers that could guide future clinical trials.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s proprietary AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.

ELI-002 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Elicio continues to evaluate pre-specified subgroups, including the R0 resected population, to further inform a refined Phase 3 development strategy. Elicio intends to initiate a Phase 1 study in metastatic PDAC designed to provide a rapid assessment of clinical activity using an open label design to assess the objective response rate including partial and complete radiographic responses. Elicio plans to use the study findings to further evaluate checkpoint inhibitor combinations and help inform future development strategies in metastatic PDAC and the adjuvant PDAC Phase 3 trial. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

(Press release, Elicio Therapeutics, AUG 10, 2026, View Source [SID1234669923])

On August 10, 2026 Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a clinical-stage biotechnology company developing small-molecule therapeutics targeting epigenetic and metabolic drivers of cancer, reported the peer-reviewed publication of preclinical data of Telomir-Zn suppressing tumor growth in prostate and triple-negative breast cancer (TNBC) models through selective modulation of intracellular iron and copper.

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The manuscript, titled "Telomir-Zn Modulates Intracellular Iron and Copper to Inhibit JmjC Histone Demethylases and Suppress Tumor Growth in Prostate and Triple-Negative Breast Cancer," has been published in the Journal of Oncology Research and Therapy, Volume 11, Issue 3. These preclinical findings provide the scientific foundation supporting advancement of Telomir-Zn toward the Company’s planned Phase 1/2 clinical trial in TNBC.

Publication Highlights

KDM Inhibition: The Target at the Core

Histone demethylases, or KDMs, specifically the KDM2, KDM5, and KDM6 families, are often overexpressed in aggressive cancers, where they can promote tumorigenesis by either silencing tumor-suppressor genes or activating oncogenic programs, depending on their substrate specificity and cellular context. Telomir-Zn targets these KDM enzymes by depleting the intracellular iron they require for catalytic activity. This study demonstrates that this KDM-targeting approach translates to meaningful anti-cancer activity.

Iron-Dependent Mechanism Proved

The study’s most critical finding was direct proof that Telomir-Zn’s anti-cancer activity depends on iron depletion. When researchers added iron back to treated TNBC cells, the compound’s killing effect was significantly reversed. This iron-rescue result eliminates alternative explanations and demonstrates the mechanism is real and specific, not a general toxin or off-target effect.

Selective Targeting of Cancer Over Normal Cells

Telomir-Zn killed iron-dependent TNBC cancer cells at low concentrations while leaving normal cells unharmed at concentrations more than 50-fold higher. This selectivity window demonstrates the compound preferentially targets cancer cells with elevated iron dependence, a hallmark of aggressive malignancies like TNBC.

Tumor Suppressor Gene Reactivation

In a prostate cancer model, oral Telomir-Zn suppressed tumor growth and reactivated silenced tumor-suppressor genes (STAT1, GSTP1, RASSF1A, CDKN2A, and MASPIN). In TNBC and prostate cancer, both elevated KDM activity and abnormal DNA methylation can silence tumor-suppressor genes through distinct but complementary epigenetic mechanisms. The compound works through an upstream mechanism distinct from approved drugs that target downstream epigenetic machinery.

Anti-Tumor and Anti-Metastatic Activity

In TNBC human xenograft models, Telomir-Zn reduced primary tumor size across several cell lines. In HCC1806 xenografts, the compound also significantly reduced metastatic dissemination, a critical finding, as most TNBC patients die from spread disease, not the primary tumor. In BT-549 xenografts, Telomir-Zn combined with paclitaxel produced significantly greater tumor reduction than either drug alone, a finding that suggests potential for combination therapy approaches in the clinic and positions Telomir-Zn as both a monotherapy and a chemotherapy partner. Notably, MDA-MB-231 xenografts did not respond, indicating heterogeneous sensitivity based on tumor-specific iron-metabolism features. It tells us that in the future we could be able to stratify patients based on personalized iron-handling signatures and potentially enrich for responders in future clinical development.

Why This Matters for Clinical Development

Triple-negative breast cancer remains a significant clinical challenge. Most patients receive chemotherapy as a backbone, with limited options for targeted or precision-based approaches. Current approved therapies and those in development address symptoms of epigenetic dysregulation but do not target the underlying metabolic drivers, specifically, the dysregulated iron homeostasis that fuels overactive KDM enzymes in iron-addicted cancers.

This publication establishes dysregulated KDM-driven epigenetic silencing as a fundamental cancer vulnerability that can be targeted through selective iron modulation. Unlike conventional epigenetic drugs that broadly inhibit methylation-modifying enzymes (DNMT or HDAC inhibitors), Telomir-Zn targets the upstream metabolic dependency, excess intracellular iron, that fuels KDM overactivity. By depleting labile iron and disabling KDM enzymes, the compound disrupts epigenetic silencing at its root, enabling tumor-suppressor reactivation. This mechanistically distinct approach addresses a therapeutic gap in the current TNBC treatment landscape.

The iron-rescue experiments provide the strongest possible proof that this mechanism is real and specific, enabling clinical strategies for patient selection based on iron-metabolism biomarkers. The preclinical anti-metastatic activity in HCC1806 xenografts is particularly noteworthy, as it suggests potential to address both primary tumor control and disseminated disease, a key unmet need in TNBC.

Management Commentary

"In several cancer types, cancer cells silence critical tumor-suppressor genes through abnormal DNA methylation, essentially turning off the cell’s brakes," said Dr. Itzchak Angel, Chief Scientific Advisor of Telomir. "Overactive KDM enzymes also play a role as important drivers of this epigenetic silencing. Current TNBC treatments address downstream consequences of this dysregulation but do not target the KDM-driven mechanism itself. Our data implicates that by reversing the abnormal methylation and by KDM inhibition, Telomir-Zn can reactivate these silenced tumor-suppressor genes, promoting cell killing. We’re seeing tumor suppression and, in some models, reduced metastatic spread. This is a mechanistically different approach to TNBC, and we believe it addresses a fundamental vulnerability that existing therapies don’t. We’re encouraged by the preclinical evidence and eager to test it in patients."

"Triple-negative breast cancer represents one of oncology’s most significant unmet needs," said Erez Aminov, CEO of Telomir. "Most patients with advanced disease have limited treatment options and poor survival outcomes. We’re excited to advance Telomir-Zn into our Phase 1/2 program under our active IND to test whether this approach can meaningfully improve outcomes for TNBC patients."

(Press release, Telomir Pharmaceutical, AUG 10, 2026, View Source [SID1234669922])

On August 10, 2026 NeOnc Technologies (NASDAQ: NTHI) reported one of its most closely watched weeks of 2026, with the clinical-stage CNS oncology company scheduled to unveil topline Phase 2a results for NEO100 on Wednesday, August 12, putting the spotlight squarely on data from the fully enrolled study evaluating intranasal NEO100 in patients with recurrent IDH1-mutant high-grade glioma. For a small-cap biotechnology company, a clinical readout of this significance can become a powerful near-term catalyst, particularly when investors are already positioning around a defined event.

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The company is developing NEO100, its proprietary formulation of purified perillyl alcohol, as an investigational treatment for central nervous system cancers. The upcoming presentation will focus on the topline analysis of an open-label Phase 2a study evaluating intranasal NEO100 in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma.

The August 12 presentation represents a major near-term catalyst, as NeOnc’s management team is expected to discuss efficacy and safety observations from the Phase 2a portion of the study, along with planned regulatory next steps.

Attention has also focused on insider activity and institutional ownership. Recent SEC filings show Chairman, President and CEO Amir Heshmatpour has invested more than $500,000 through open-market purchases, with insider buying approaching $1 million over the past year. Public filings also identify institutions including Bank of America, State Street, Barclays, and BlackRock among shareholders. Combined with previously disclosed financing facilities and multiple anticipated regulatory milestones during 2026, NeOnc remains closely watched within the CNS oncology sector.

The company has already positioned NEO100 within multiple expedited FDA development pathways, including Orphan Drug, Fast Track and Rare Pediatric Disease designations, adding further significance to the forthcoming clinical update if the topline results are supportive.

NeOnc has also expanded internationally after receiving a second Investigational New Drug (IND) authorization from the Department of Health – Abu Dhabi, allowing additional studies evaluating NEO100 for recurrent high-grade gliomas. The authorization complements the company’s previously announced UAE approval for NEO212, further expanding its international clinical footprint.

NEO100 comprises a patented composition of a proprietary synthesis of Perillyl Alcohol (POH) that our research suggests has several beneficial actions for Central Nervous System (CNS)-based disease applications, including:

Regulates neurologic pathways associated with tumor cell growth.
Bypasses the BBB via its small molecular size when delivered intranasally.
Creates a temporary BBB opening when delivered intra-arterially, enabling larger molecule therapeutics to pass.
Acts as an effective therapeutic for brain cancers in high concentrations.
Serves as a solvent for traditional large-molecule therapeutics at low concentrations, allowing them to bypass the BBB.
Can be conjugated with other CNS therapeutics to create compound formulations with higher BBB penetration and greater effect on brain cancer.
Perillyl Alcohol (POH) is a naturally occurring substance found in the essential oils of plants, such as citrus. It is already FDA-approved as a flavoring food agent.

POH has been shown to have antitumor activity against various cancer types including gliomas. POH induces apoptosis in tumor cells without affecting normal cells and can revert tumor cells to a differentiated state.

In the NEO100 Phase 1/2a trial, NEO100 has been shown to potentially positively impact the treatment of Grade IV gliomas. Grade IV gliomas are among the most aggressive and deadly forms of brain cancers, and patients with this form of cancer face a grim prognosis. Only a quarter of newly diagnosed Glioblastoma patients survive for 24 months, and fewer than 10 percent survive more than five years.

Because of its small lipophilic molecular size, NEO100 can permeate the Blood-Brain-Barrier and therefore allow delivery of itself or a combinatorial therapeutic directly to a tumor site.

Since our clinical trial and research has demonstrated that NEO100 potentially permeates across the Blood Brain Barrier (BBB), three forms of delivery can be used to administer NEO100 or any of its conjugates.

Internasal Delivery – NEO100 can be delivered intranasal through the trigeminal pathway to bypass the BBB. This ability allows NEO100 to be used for local targeted delivery to the brain eliminating the issues associated with oral and intravenous delivery methods.

Permeable BBB Delivery – Since NEO100 is a small, lipophilic (fat-soluble) molecule, it can permeate the BBB which primarily targets the restriction of entry for large molecule substances (pathogens, viruses) and water-soluble compounds.

Intra-Arterial Delivery – NEO100 can be delivered intrathecally through a catheter positioned in the arterial pathway which feeds the tumor and is injected into the tumor site where it would be absorbed through the BBB into the tumor.

The upcoming readout should therefore provide a much clearer view of where NEO100 stands clinically and what the next stage of development could look like.

Investor Conference Call Details

Date: Wednesday, August 12, 2026
Time: 5:30 a.m. Pacific Time / 8:30 a.m. Eastern Time
Webcast: Live Webcast
Investor Relations: NeOnc Technologies Investor Relations

A replay will be available on the company’s investor relations website shortly after the presentation.

Featured Participants

Amir Heshmatpour — Executive Chairman, President and Chief Executive Officer
Thomas C. Chen, MD, PhD — Founder, Chief Medical Officer and Chief Scientific Officer
Josh Neman, PhD — Chief Clinical Officer
Keithly Garnett — Chief Financial Officer
With topline Phase 2a data now just days away, August 12 is shaping up as one of the most closely watched dates on NeOnc’s 2026 calendar.

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(Press release, Neonc, AUG 10, 2026, View Source [SID1234669921])

On August 10, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding its New Drug Application (NDA) for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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The CRL stated that the FDA is unable to approve the NDA in its present form and cited CMC- and third-party commercial facility-related items that must be addressed before the application can be approved.

The FDA did not identify any concerns regarding the clinical or nonclinical data package or safety profile of ITM-11. ITM is reviewing the agency’s feedback and assessing the appropriate next steps with the relevant external parties.

The Company remains confident in the potential of ITM-11 and is reviewing the FDA’s feedback to determine the most appropriate path forward. The Company intends to resubmit to complete the review of the NDA.

"Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL," said Dr. Andrew Cavey, chief executive officer of ITM. "Our pivotal COMPETE trial data package stands, and our goal remains unchanged as we work toward bringing ITM-11 to patients living with advanced GEP-NETs."

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, AUG 10, 2026, View Source [SID1234669920])