TMCnet News
Kymera Therapeutics Announces Third Quarter 2022 Financial Results and Provides a Business UpdateCompleted patient cohort portion (Part C) of the IRAK4 degrader KT-474 Phase 1 trial Patient data from KT-474 and clinical oncology pipeline to be presented in December, 2022 Raised $150 million through private placement equity financing; September 30, 2022, cash balance of $596 million Company to hold quarterly results call at 8:30 a.m. EST (800-715-9871) WATERTOWN, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today reported business highlights and financial results for the third quarter ended September 30, 2022. “We’ve made important progress with our three clinical stage programs, recently completing the patient cohort of our KT-474 Phase 1 clinical trial, the first study of a degrader in patients with hidradenitis suppurativa and atopic dermatitis, and actively recruiting for our two clinical stage oncology programs, KT-333 and KT-413. We look forward to gaining insights into the potential clinical impact that our unique approach to targeted protein degradation can have on patients, and to sharing updates on our clinical programs in December,” said Nello Mainolfi, PhD, Co-Founder, President and CEO. “Looking ahead, the timing of our IND for KT-253, a highly potent MDM2 degrader, remains on track. Additionally, our recent financing will enable us to continue to invest in our clinical programs and discovery pipeline while maintaining a strong cash runway and enabling our vision to build a global, fully integrated biopharma company.” Business Highlights and Recent Developments
Anticipated Upcoming Milestones
Program Background Information IRAK4 Degrader Program (KT-474) KT-474 is a potent, highly selective, orally bioavailable IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven autoimmune and autoinflammatory diseases where there is an opportunity to significantly advance the standard of care in a broad variety of diseases. In 2021, Kymera completed dose escalation in the single ascending dose (SAD) and multiple ascending dose (MAD) portions of its KT-474 Phase 1 trial, the industry’s first randomized, placebo-controlled trial in healthy adult volunteers for a heterobifunctional degrader. The data demonstrated near complete IRAK4 degradation in peripheral blood mononuclear cells (PBMC) and skin, robust inhibition of multiple ex vivo-stimulated disease-relevant cytokines, and a favorable safety profile. In the recently completed patient cohort of the Phase I trial, patients received a daily dose of 75 mg of KT-474 in the fed state. The dose being explored is expected to provide a plasma exposure that is approximately equivalent to that achieved with the 100 mg per day dose in the fasted state in healthy volunteers in the MAD portion of the trial, which showed maximal or close to maximal degradation in blood and skin and broad disease relevant cytokine inhibition ex vivo. Kymera is collaborating with Sanofi on the development of degrader candidates targeting IRAK4, including KT-474 (SAR444656), outside of the oncology and immuno-oncology fields. More information on the Phase 1 study can be found at www.clinicaltrials.gov, identifier NCT04772885. STAT3 Degrader Program (KT-333) A target long considered “undruggable,” STAT3 is a transcriptional regulator that has been linked to numerous cancers and other inflammatory and autoimmune diseases. Kymera is developing selective STAT3 degraders for the treatment of hematological malignancies and solid tumors, as well as autoimmune and fibrotic diseases. The Company’s STAT3 degraders have the potential to provide a transformative solution to address multiple STAT3-dependent pathologies. The company is currently dosing patients in the Phase 1 clinical trial of KT-333 evaluating the safety, tolerability, PK/PD and clinical activity of KT-333 in adult patients with relapsed and/or refractory lymphomas and solid tumors. The first stage of the study is exploring escalating doses of KT-333 in a broad variety of tumor types. The second stage is expected to consist of expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-333 in relapsed and/or refractory PTCL, CTCL, large granular lymphocytic leukemia (LGL-L), and solid tumors. IRAKIMiD Degrader Program (KT-413) Kymera is developing novel heterobifunctional degraders that target degradation of both IRAK4 and IMiD substrates, Ikaros and Aiolos, with a single small molecule. KT-413 is designed to address both the IL-1R/TLR and the Type 1 IFN pathways synergistically to broaden activity against MYD88-mutant B cell malignancies. The company is currently dosing patients in the Phase 1 clinical trial of KT-413 evaluating the safety, tolerability, PK/PD and antitumor activity of KT-413 in patients with relapsed and/or refractory B-cell non-Hodgkin's lymphomas. The first stage is exploring escalating doses of single-agent KT-413 in broad B-cell lymphoma population. The second stage is expected to consist of expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-413 in relapsed/refractory MYD88-mutant lymphomas including diffuse large B cell lymphoma (DLBCL). MDM2 Degrader Program (KT-253) MDM2 is the crucial regulator of the most common tumor suppressor, p53, which remains intact (WT) in more than 50% of cancers. Kymera is developing a highly potent MDM2 degrader that, unlike small molecule inhibitors, has been shown preclinically to have the ability to suppress the MDM2 feedback loop and rapidly induce apoptosis, even with brief exposures. KT-253 has the potential to be effective in a wide range of hematological malignancies and solid tumors with functioning (WT) p53. The company is preparing to initiate, upon FDA clearance of the IND, a Phase 1 clinical trial evaluating the safety, tolerability, PK/PD and antitumor activity of KT-253 in patients with liquid and solid tumors. Platform and Discovery Programs Kymera is leveraging the Company’s proprietary E3 Ligase Whole-Body Atlas, including the differential expression profile of known E3 ligases, to pursue targets and indications that may benefit from tissue-restricted or -selective degradation. Kymera has also expanded the Company’s platform to develop a new generation of molecular glue degraders for high value undrugged and non-ligandable targets. Multiple programs are approaching development stage in 2022 from its discovery pipeline with at least one using a tissue restricted E3 ligase. Conference Call To access the conference call via phone, please dial (800) 715-9871 (U.S.) or +1 (646) 307-1963 (International) and ask to join the Kymera Therapeutics call. A live webcast of the event will be available under “Events and Presentations” in the Investors section of the Company’s website at www.kymeratx.com. A replay of the webcast will be archived and available for one month following the event. Third Quarter 2022 Financial Results Collaboration Revenues: Collaboration revenues were $9.6 million for the third quarter of 2022 compared to $20.3 million the third quarter of 2021. Collaboration revenues include revenue from the Company’s Sanofi and Vertex collaborations. Research and Development Expenses: Research and development expenses were $43.9 million for the third quarter of 2022 compared to $38.3 million for the third quarter of 2021. This increase was primarily due to increased expenses related to the investment in our MDM2 program, platform and discovery programs, as well as an increase in occupancy and related costs due to continued growth in the research and development organization. Stock based compensation expenses included in R&D were $4.9 million and $3.4 million in the third quarter of 2022 and the third quarter of 2021, respectively. General and Administrative Expenses: General and administrative expenses were $10.6 million for the third quarter of 2022, compared to $10.7 million for the third quarter of 2021. This decrease was primarily due to a decrease in legal and professional service fees, partially offset by an increase in personnel, facility, occupancy, and other expenses from an increase in headcount to support our growth. Stock based compensation expenses included in G&A were $4.2 million and $4.0 million in the third quarter of 2022 and the third quarter of 2021, respectively. Net Loss: Net loss was $43.0 million for the third quarter of 2022 compared to a net loss of $28.6 million for the third quarter of 2021. Cash and Cash Equivalents: As of September 30, 2022, Kymera had approximately $595.6 million in cash, cash equivalents, and investments. Kymera expects that its cash, cash equivalents, excluding any future potential milestones from collaborations, will enable the Company to fund its operational plans at least into 2025 while the Company continues to identify opportunities to accelerate growth and expand its pipeline, technologies, and clinical indications. About Kymera Therapeutics About Kymera’s Pegasus™ Platform Cautionary Note Regarding Forward-Looking Statements
Investor Contacts: Chris Brinzey Media Contact: |