Enliven Therapeutics Q1 2024 Financial Results and Business Update

Enliven Therapeutics, Inc. has announced significant progress in its clinical and business endeavors for the first quarter of 2024. The Boulder, Colorado-based company, which focuses on developing small molecule kinase inhibitors for cancer treatment, shared updates on its financial health and pipeline developments.

Enliven released promising data from its Phase 1 clinical trial of ELVN-001, a small molecule kinase inhibitor aimed at treating chronic myeloid leukemia (CML). By the 12-week mark, 44% (7 out of 16) of response-evaluable patients achieved a cumulative major molecular response (MMR). This milestone is particularly noteworthy as it includes patients who were heavily pre-treated or resistant to other treatments like asciminib. Tolerability was also a highlight, with no severe non-hematologic adverse events reported. These results stand out when compared to existing BCR::ABL1 tyrosine kinase inhibitors, making ELVN-001 a potentially best-in-class treatment option. More comprehensive data from this trial is anticipated in 2025, covering between 60 to 100 patients across various therapy lines.

The company also advanced its ELVN-002 program, designed to target HER2 mutations in cancers. Following the approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration, Enliven launched the first site to evaluate ELVN-002 in combination with trastuzumab for treating HER2+ metastatic breast cancer and colorectal cancer. The combination trial's first patient dosing is expected in the second quarter of 2024. Initial data from the ongoing monotherapy trial show encouraging responses in both HER2+ and HER2 mutant tumors at well-tolerated doses. ELVN-002 has demonstrated significant target coverage, surpassing that of tucatinib, a current HER2 treatment.

On the financial front, Enliven is in a strong position, boasting a balance sheet with $321 million in cash, cash equivalents, and marketable securities, projected to sustain operations into late 2026. The company also secured $90 million from a private investment in public equity (PIPE) financing, further extending its financial runway. This capital injection will support ongoing trials and significant milestones for both ELVN-001 and ELVN-002.

The first quarter of 2024 saw a rise in Enliven's research and development (R&D) expenses, which amounted to $20.0 million, up from $11.9 million in the same period in 2023. General and administrative (G&A) expenses also increased to $6.0 million from $4.5 million. The net loss for the quarter was reported at $22.7 million, compared to $14.7 million for the previous year. Despite these losses, the company's financial health remains robust, with substantial assets and a strong stockholders' equity position.

In corporate developments, Enliven appointed Lori Kunkel, MD, to its Board of Directors. Dr. Kunkel brings a wealth of experience in corporate strategy, clinical development, and commercialization, making her a valuable addition to the team.

Enliven Therapeutics continues to make strides in precision oncology, aiming to address critical unmet needs in cancer treatment. With a solid financial foundation and promising clinical data, the company is well-positioned to advance its pipeline and bring innovative therapies to patients in need.