On March 25, 2025 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the fourth quarter and year ended December 31, 2024 (Press release, AN2 Therapeutics, MAR 25, 2025, View Source [SID1234651439]).

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"Epetraborole demonstrated potential proof-of-concept in Phase 2, achieving nominal statistical significance on two patient-reported outcome measures in patients with treatment-refractory MAC lung disease. Building on these encouraging findings, we updated our statistical analysis plan to select QOL-B as the primary efficacy endpoint for the Phase 3 part of the study, for which we plan to unblind and announce topline results in the second quarter. Should the Phase 3 data support the findings from Phase 2, we plan to engage with the FDA to explore potential registrational pathways for this highly refractory population with limited treatment options," said Eric Easom Co-Founder, Chairman, President and Chief Executive Officer. "Our robust pipeline, including upcoming clinical trials in Chagas disease and melioidosis, highlights our commitment to advancing innovative treatments. We also anticipate our first oncology development candidate later this year and are excited about the potential of our pipeline to address unmet medical needs and improve patient outcomes."

Fourth Quarter & Recent Business Updates:

Epetraborole Phase 2/3 Clinical Study in TR-MAC Lung Disease

In February 2025, the Company submitted an amended statistical analysis plan to the FDA selecting the Quality of Life – Bronchiectasis (QOL-B) respiratory domain patient reported outcome (PRO) instrument as the primary efficacy endpoint for the Phase 3 part of the EBO-301 trial. The Company believes that this approach aligns with current FDA Guidance for Industry on NTM drug development regarding the use of a symptom-focused clinical outcome measure as the sole primary endpoint and it also follows the precedent established by Insmed’s ongoing confirmatory study of Arikayce in treatment-naïve patients, where Insmed has reported the same QOL-B instrument as the primary efficacy measure.

The Company intends to announce topline Phase 3 results in the second quarter of 2025, subject to the timing of any potential FDA feedback with respect to the trial or amended statistical analysis plan. Ninety-seven subjects had completed treatment in Phase 3 when the trial was terminated in August 2024 (2:1 epetraborole+optimized background regimen (OBR) vs. placebo+OBR), the data for which remains blinded and available for analysis as a Phase 3 dataset. If the Phase 3 data align with the potential efficacy signal observed in Phase 2, the Company plans to review both Phase 2 and Phase 3 results with the FDA and discuss potential registrational pathways.

Chagas Disease

During the quarter, the Company conducted Phase 1-enabling activities for AN2-502998, a candidate for chronic Chagas disease, which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S., and can cause severe cardiac disease and death. The Company plans to initiate a Phase 1 clinical study in mid-2025.

Melioidosis

The Company completed enrollment in a 200-patient observational trial in acute melioidosis in October 2024. These data will inform a potential Phase 2 proof of concept study of epetraborole that is planned to initiate start up activities in the second half of 2025. Melioidosis is a deadly bacterial infection and global bioterrorism threat with a 90-day mortality rate of approximately 50% using standard of care drugs ceftazidime or meropenem. The aim of the program is to meaningfully lower the expected mortality rate by dosing epetraborole on top of standard of care.

Boron Chemistry Pipeline

Additional development programs are underway and focused on targets in infectious diseases and oncology with high unmet needs. The Company anticipates delivering development compound(s) in 2025, including the first oncology targets using its boron chemistry platform.

Global Health

In October 2024, the Company announced that it received a second-year continuation of a research grant from the Gates Foundation to discover novel boron containing small molecules for the treatment of tuberculosis and malaria. The Company will continue its efforts to tackle global health disease through non-dilutive funding.

Selected Fourth Quarter and Full Year 2024 Financial Results

Research and Development (R&D) Expenses: R&D expenses for the full year 2024 were $40.5 million, compared to $54.9 million in the prior year. R&D expenses for the fourth quarter of 2024 were $5.4 million, compared to $14.9 million for the same period during 2023 due to decreased clinical trial expenses, personnel-related expenses, consulting and outside services, chemistry manufacturing and controls expenses, and allocated facilities and miscellaneous expenses, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities, and a decrease in licensing fees, partially offset by an increase in preclinical and research expenses.
General and Administrative (G&A) Expenses: G&A expenses for the full year 2024 were $14.1 million, compared to $14.8 million in the prior year. G&A expenses for the fourth quarter of 2024 were $3.2 million, compared to $3.9 million for the same period during 2023 due to decreased personnel-related expenses, professional services expenses and allocated facilities and miscellaneous expenses, partially offset by increased D&O insurance expenses.
Restructuring Charges: Restructuring charges for the full year 2024 were $2.2 million due to severance payments and other employee termination expenses.
Interest Income: Interest income for the full year 2024 was $5.5 million, compared to $4.9 million in the prior year. Interest income for the fourth quarter of 2024 was $1.1 million, compared to $1.9 million for the same period in 2023 due to higher interest rates despite lower cash, cash equivalents and investment balances in 2024 as compared to 2023.
Net loss: Net loss for the full year 2024 was $51.3 million, compared to $64.7 million in the prior year. Net loss for the fourth quarter of 2024 was $7.5 million, compared to $16.9 million for the same period during 2023.
Cash Position: The Company had cash, cash equivalents and investments of $88.6 million at December 31, 2024.

On March 25, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported it will present a poster highlighting preclinical anti-tumor activity of OP-3136, a novel small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), in prostate, ovarian, and non-small cell lung cancer models in a late-breaking session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 25-30 in Chicago, Illinois (Press release, Olema Oncology, MAR 25, 2025, View Source [SID1234651465]).

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Poster Presentation Details
Title: OP-3136, a selective KAT6 inhibitor, demonstrates anti-tumor activity in prostate, ovarian, and non-small cell lung cancer preclinical models
Poster/Abstract: LB166
Session: Late-Breaking Research: Tumor Biology 2
Date/Time: April 28, 2025, from 9:00am-12:00pm CT / 10:00am-1:00pm ET
Presenter: Dr. Gopinath S. Palanisamy, DVM, PhD

Additional information can be found on the AACR (Free AACR Whitepaper) Annual Meeting website.

About OP-3136
OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies, including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical trial.

On March 25, 2025 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that company scientists will present preclinical data from its proprietary DEL-AI platform and several degrader programs in two oral presentations and two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting, which will be held from April 25-30, 2025, in Chicago, IL (Press release, Nurix Therapeutics, MAR 25, 2025, View Source [SID1234651409]).

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Oral Presentation Details:

Title: DEL-AI: Proteome-wide in silico screening of multi-billion compound libraries using machine learning foundation models
Presenting author: Paul Novick, Ph.D.
Session title: Innovative Approaches in Drug Discovery: Novel Leads, Degraders, and AI-Driven Solutions
Session date and time: Monday, April 28, 2025, 2:30 PM – 4:30 PM CST
Abstract ID: 3762

Title: Identification of selective, orally bioavailable Aurora A degraders for treatment of pediatric and adult cancers
Presenting author: Ryan Rountree, Ph.D.
Session title: Degraders and Glues
Session date and time: Tuesday, April 29, 2025, 2:30 PM – 4:30 PM CST
Abstract ID: 6379

Poster Presentation Details:

Title: NRX-0305: a pan-mutant BRAF degrader with broad preclinical efficacy, brain penetrance, and synergistic potential with MEKi across class 1/2/3 BRAF-mutant cancers
Presenting authors: Alexandra ‘Sasha’ Borodovsky, Ph.D.
Session title: Degraders and Glues 2
Session date and time: Monday, April 28, 2025, 9:00 AM – 12:00 PM CST
Abstract ID: 1651

Title: NX-5948 is a CNS-penetrant catalytic Bruton’s tyrosine kinase (BTK) degrader that breaks established design rules for CNS drugs
Presenting authors: Wylie Palmer, Ph.D.
Session title: Targeted Protein Degradation
Session date and time: Wednesday, April 30, 2025, 9:00 AM – 12:00 PM CST
Abstract ID: 7003

About DEL-AI
DEL-AI is Nurix’s discovery platform which employs advanced machine learning to enable all aspects of Nurix’s discovery engine, starting with DNA encoded library (DEL) hit-finding and degrader design, followed by automated chemistry synthesis and direct-to-biology screening and optimization, to rapidly generate degraders and degrader antibody conjugates (DACs) as new chemical entity drug candidates. By leveraging hundreds of billions of DEL compound binding signatures derived from thousands of DEL affinity screens collected from a diverse set of highly validated protein targets, our DEL-AI platform can prospectively identify binders as starting points for drug discovery for virtually any pharmaceutically relevant target.

About Bexobrutideg (NX-5948)
Bexobrutideg is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. Bexobrutideg is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022).

About NRX-0305
NRX-0305 is a potent, selective, and orally bioavailable mutant-specific BRAF degrader that Nurix is exploring for use in oncology. Nurix has reported preclinical data demonstrating potent anti-tumor activity in multiple cell line-derived and patient-derived xenograft disease models representing Class I, Class II and Class III B-RAF mutations. Anti-tumor activity was also observed in the setting of CNS disease and treatment-resistance, suggesting the potential for utility across a broad range of solid tumor types

About Aurora A Kinase
Aurora A kinase (AURKA) is an oncogene frequently overexpressed in adult solid tumors, hematologic malignancies, and pediatric cancers. Several AURKA inhibitors are effective in preclinical tumor models, but this activity has failed to translate into clinical efficacy. To address the limitations of inhibitors, Nurix has designed bifunctional targeted protein degraders of AURKA that enable removal of both enzymatic and scaffolding functions.

On March 25, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that it will present preclinical data for its novel HER3 ADC, EO-1022, in a late-breaking poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, being held April 25-30 in Chicago, Illinois (Press release, Elevation Oncology, MAR 25, 2025, View Source [SID1234651424]).

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EO-1022 is an antibody drug conjugate (ADC) containing seribantumab, a fully human IgG2 anti-HER3 monoclonal antibody (mAb), which is site-specifically conjugated at glycan to the monomethyl auristatin E (MMAE) payload with a drug-to-antibody ratio (DAR) of 4. Elevation Oncology designed EO-1022, leveraging the advanced site-specific conjugation technology platform licensed from Synaffix B.V. Elevation Oncology is developing EO-1022 for the treatment of solid tumors that express HER3, including breast cancer and non-small cell lung cancer, and expects to file an IND application in 2026.

"We are eager to share the first preclinical data for EO-1022 at the AACR (Free AACR Whitepaper) Annual Meeting," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "With EO-1022, we are combining the most advanced site-specific conjugation technology platform with the clinically validated MMAE payload, which is widely used across ADC programs but has yet to be introduced into a HER3-targeting ADC in the clinic. We believe this unique combination will enable us to provide a new treatment option to patients with HER3-expressing solid tumors, including those who are refractory to other HER3-targeting agents in development. We look forward to advancing EO-1022 into clinical development next year."

Details of the poster presentation at AACR (Free AACR Whitepaper) 2025 are as follows:

Title: Preclinical discovery and characterization of EO-1022, a site-specific glycan-conjugated anti-HER3 vc-MMAE ADC for treating solid tumors

Abstract Presentation Number: LB004
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 1
Session Date and Time: Sunday, April 27, from 2 p.m. to 5 p.m. CT (3 p.m. to 6 p.m. ET)
Location: Poster Section 50
The late-breaking abstract will become available on the AACR (Free AACR Whitepaper) website beginning at 12:00 noon CT (1:00 p.m. ET) on April 25, 2025, and published in an online-only supplement to Cancer Research.

About EO-1022

Elevation Oncology is developing EO-1022, a potentially differentiated HER3 ADC for the treatment of HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer. EO-1022 consists of seribantumab, a fully human IgG2 anti-HER3 antibody, site-specifically conjugated at glycan to the MMAE payload with a DAR of 4. It leverages seribantumab’s desirable internalization properties and advanced site-specific ADC technology which makes possible the use of the potent cytotoxic MMAE payload. Elevation Oncology expects to file an IND application in 2026.

On March 25, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that an abstract detailing a potential predictive biomarker for THIO treatment was selected for poster presentation at the European Lung Cancer Congress 2025 (ELCC 2025) taking place, March 26-29, in Paris, France (Press release, MAIA Biotechnology, MAR 25, 2025, View Source [SID1234651440]). ELCC is a program of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper).

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"We are proud to join ELCC 2025, a premier conference focused directly on the science of thoracic oncology," said Vlad Vitoc, M.D., CEO of MAIA. "Our poster features our latest findings on cytokine Interleukin-6 (IL-6) as a potential predictive immune response biomarker for THIO sequenced with a checkpoint inhibitor. Predictive biomarkers can further illuminate THIO’s unique mechanisms of action which have shown exceptional efficacy in our Phase 2 clinical trial."

Presentation details:

Title:

Phase 2 Study of Telomere-Targeting Agent THIO Sequenced by Cemiplimab in Immune Checkpoint Inhibitor-Resistant Advanced NSCLC: Interleukin-6 as a Potential Predictive Biomarker

Abstract number:

997

Date:

March 28, 2025

Time:

12:00 p.m. CET

Presenter:

Tomasz Jankowski, M.D., Ph.D. – Lead investigator for THIO-101 Phase 2 clinical trial

Poster access:

MAIA’s poster will be available at maiabiotech.com/publications on March 28, 2025

The European Lung Cancer Congress is a collaborative effort of the most important multidisciplinary societies representing thoracic oncology specialists, working together to advance science, disseminate education and improve the practice of lung cancer specialists worldwide.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.