Foghorn Therapeutics Q2 2024 Financial and Corporate Update

Foghorn Therapeutics Inc., a clinical-stage biotechnology firm, has provided a financial and corporate update timed with the company's 10-Q filing for the quarter ending June 30, 2024. Based in Cambridge, Massachusetts, the company is at the forefront of developing a new class of medicines that address severe diseases by correcting abnormal gene expression, primarily focusing on oncology.

CEO Adrian Gottschalk highlighted significant milestones, including anticipated topline data from a Phase 1 trial combining FHD-286 with decitabine for relapsed or refractory acute myeloid leukemia (AML) patients, expected in late 2024. FHD-286, an inhibitor of SMARCA2 and SMARCA4, has shown promising mutation-agnostic effects in preclinical studies, and its combination with existing treatments aims to enhance efficacy in challenging AML cases.

Foghorn is also preparing to dose the first patient in a Phase 1 trial of FHD-909, an oral SMARCA2 selective inhibitor, by the second half of 2024. This trial targets non-small cell lung cancer (NSCLC) patients with SMARCA4 mutations. The investigational new drug (IND) application for FHD-909 was approved by the FDA in May 2024, marking a significant step towards clinical testing.

Additionally, the company plans to initiate IND-enabling studies for its Selective CBP degrader program by the end of 2024. This program aims at tumors with EP300 mutations, prevalent in cancers like bladder, gastric, and endometrial. Preclinical data presented earlier in 2024 demonstrated the potential of these selective degraders to inhibit tumor growth effectively.

Financially, Foghorn has bolstered its balance sheet by securing $110 million through a registered direct offering in May 2024. This financing round included new investors alongside existing ones, extending the company's cash runway into 2027, providing financial stability and supporting ongoing and future research and development activities.

In April 2024, Foghorn presented preclinical data at the American Association for Cancer Research (AACR) annual meeting, showcasing advancements across multiple potential first-in-class medicines. The event reinforced the potential of Foghorn’s platform to develop innovative cancer treatments by targeting historically challenging drug targets within the chromatin regulatory system.

The company also hosted the inaugural Future of Disease and Chromatin Regulation Summit in April 2024, featuring discussions and presentations from leading experts on therapeutic opportunities in chromatin regulatory biology.

Foghorn has made significant strides in enhancing its executive team, appointing Kristian Humer as Chief Financial Officer in April 2024. Humer brings over 14 years of experience in financial strategy and business development within the life sciences sector.

Key recent updates on Foghorn’s programs include progress on FHD-286 and FHD-909. The ongoing Phase 1 trial for FHD-286 is examining its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in combination with decitabine for AML patients. Early data indicate that FHD-286 may help overcome resistance in tumors with EGFR/KRAS mutations, further explored in additional preclinical studies.

FHD-909 has shown significant preclinical efficacy in SMARCA4-mutant lung tumor models. The strategic partnership with Lilly, initiated in December 2021, continues to evolve, focusing on developing novel oncology medicines. This collaboration includes co-development and co-commercialization agreements and leverages Foghorn’s proprietary Gene Traffic Control platform.

Foghorn is also advancing its Selective CBP and EP300 degrader programs, aiming to address tumors harboring specific mutations. These programs have shown promising preclinical results, indicating potential for robust anti-tumor activity and manageable side effects.

Financial highlights for the second quarter of 2024 include collaboration revenues of $6.9 million, an increase from $5.6 million in the same period in 2023. Research and development expenses decreased to $23.8 million, reflecting lower personnel costs and reduced spending on halted clinical studies. General and administrative expenses also saw a reduction, marking an efficient financial management approach.

Overall, Foghorn Therapeutics is making substantial progress in developing groundbreaking therapies for cancer, supported by a solid financial foundation and strategic collaborations. The company's advancements in clinical trials and preclinical studies highlight its commitment to transforming cancer treatment through innovative approaches within the chromatin regulatory system.