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Kymera Therapeutics Announces Fourth Quarter and Full Year 2022 Financial Results and Provides a Business UpdatePartner Sanofi plans to initiate Phase 2 trial of IRAK4 degrader KT-474 (SAR444656) in 2023 Phase 1 trials for STAT3 (KT-333) and IRAKIMiD (KT-413) degraders ongoing, Phase 1 clinical trial for MDM2 degrader (KT-253) expected to be initiated in early 2023 Year-end 2022 cash balance of approximately $560 million with cash runway into second half of 2025 Company to hold quarterly results call at 8:30 a.m. ET WATERTOWN, Mass., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2022. “2022 was a significant year for Kymera, with our clinical data validating critical aspects of our approach to drug discovery and development, moving us forward toward becoming a fully integrated global biopharmaceutical company. Our lead program, KT-474, demonstrated the first clinical impact of a degrader outside of oncology in complex inflammatory diseases, and also showed the superior clinical potential of an IRAK4 degrader compared to a small molecule inhibitor, confirming our platform and target selection strategy. In addition, we are excited that programs from our oncology pipeline continue to show fidelity of translation of PK, PD and tolerability from preclinical models to human patients, validating our proprietary molecular design and translational capabilities,” said Nello Mainolfi, PhD, Co-Founder, President and CEO. “Looking ahead, we plan to share important data from our oncology programs this year, including clinical data evaluating anti-tumor activity with our STAT3 (KT-333) and IRAKIMiD (KT-413) programs. With four clinical stage programs, a proprietary discovery engine designed to enable us to add one new program to our clinical pipeline each year, and a strong financial position that will enable us to continue to invest in our platform and pipeline, we are well-positioned to deliver on our goals and improve patients’ lives with a new generation of medicines.” Recent Business Highlights and Developments
Kymera’s 2023 Objectives The Company’s recent data, generated in healthy volunteers and patients with HS, AD, hematological malignancies and solid tumors, demonstrated its industry leading, proprietary know-how in TPD and its progress in developing medicines in areas of significant patient and commercial opportunity. In January, the Company outlined its strategic objectives for 2023:
Program Background Information IRAK4 Degrader Program (KT-474/SAR444656) In the recently completed patient cohort of the Phase 1 trial, KT-474 showed evidence of robust IRAK4 degradation in the blood and active skin lesions of HS and AD patients and was generally well tolerated. Treatment with KT-474 was associated with a systemic anti-inflammatory response and meaningful improvement in skin lesions and symptoms in both HS and AD patients, with internal consistency between the effect on inflammatory biomarkers and impact on clinical endpoints. KT-474 was generally safe and well-tolerated, with no serious adverse events, no drug-related infections, and no dose interruptions or discontinuations due to adverse events. Sanofi, which is collaborating with Kymera on the development of KT-474 (SAR444656) outside of the oncology and immune-oncology fields, will advance KT-474 into Phase 2 clinical studies in HS and AD, with the first study initiating in 2023. STAT3 Degrader Program (KT-333) KT-333 is designed as a potent degrader of STAT3, a transcriptional regulator that has been linked to numerous cancers and inflammatory and autoimmune diseases. KT-333 is being developed for the treatment of STAT3-dependent hematological malignancies and solid tumors. The Phase 1 clinical trial of KT-333 is designed to evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 dosed weekly in adult patients with relapsed and/or refractory lymphomas, leukemias and solid tumors. The Phase 1a dose escalation portion of the trial is ongoing. In December 2022 Kymera announced that Dose Level (DL) 1 had been completed with a total of 4 patients enrolled. All patients were heavily pretreated with multiple prior regimens and included 3 with solid tumors and 1 with cutaneous T-cell lymphoma. Plasma PK and PD translated as expected in humans, with mean maximum STAT3 degradation in PBMC following the first 2 doses averaging 66%, with maximum STAT3 knockdown of up to 86% as measured by mass spectrometry. There were no dose-limiting toxicities or treatment-related serious adverse events reported at this dose. KT-333 has been granted orphan drug designation by the U.S. Food and Drug Administration for both the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). More information on the Phase 1 study can be found at www.clinicaltrials.gov, identifier NCT05225584. IRAKIMiD Degrader Program (KT-413) KT-413 is a novel heterobifunctional degrader targeting both IRAK4 and the IMiD substrates Ikaros and Aiolos. Designed to address both the IL-1R/TLR and Type 1 IFN pathways synergistically with a single molecule, KT-413 is in development for the treatment of MYD88-mutant B cell malignancies. The Phase 1 clinical trial of KT-413 is designed to evaluate the safety, tolerability, PK/PD and clinical activity of KT-413 administered as an IV infusion once every 3 weeks to adult patients with relapsed and/or refractory B-cell non-Hodgkin's lymphomas. The Phase 1a dose escalation portion of the trial is ongoing. In December 2022, Kymera announced that the first two dose levels had been completed. Patients were heavily pretreated with multiple prior regimens and included follicular lymphoma and DLBCL, which were both wild-type for MYD88. Plasma PK and PD translated as expected in humans with both dose levels showing dose-dependent degradation of IRAK4, Ikaros and Aiolos in PBMC, with up to 95/100% knockdown of Ikaros/Aiolos and 40% knockdown of IRAK4 at the second dose level. Serial tumor biopsies at Cycle 3/Day 4 in the patient treated at DL1 showed comparable knockdown of Ikaros/Aiolos and IRAK4 as in plasma. There were no dose-limiting toxicities or treatment-related serious adverse events and no neutropenia observed in the two patient cohorts. More information on the Phase 1 study can be found at www.clinicaltrials.gov, identifier NCT05233033. MDM2 Degrader Program (KT-253) The FDA has cleared the IND for KT-253, an investigational degrader that targets MDM2, the crucial regulator of the most common tumor suppressor, p53, which remains intact (Wild Type) in close to 50% of cancers. Unlike small molecule inhibitors, KT-253 has been shown preclinically to have the ability to overcome the MDM2 feedback loop and rapidly induce apoptosis, even with brief exposures. Kymera plans to commence the KT-253 Phase 1a dose escalation study in early 2023, with IV doses of KT-253 administered every 3 weeks to patients with solid tumors and hematological malignancies, including AML. 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 2023. Conference Call To access the conference call via phone, please dial +1 (833) 630-2127 (U.S.) or +1 (412) 317-1846 (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 following the event. Fourth Quarter 2022 Financial Results Collaboration Revenues: Collaboration revenues were $16.1 million for the fourth quarter of 2022 and $46.8 million for the year ended December 31, 2022 compared to $15.3 million and $72.8 million, respectively, for the same periods of 2021. Collaboration revenues include revenue from the Company’s Sanofi and Vertex collaborations. Research and Development Expenses: Research and development expenses were $43.1 million for the fourth quarter of 2022 and $164.2 million for the year ended December 31, 2022, compared to $37.5 million and $137.0 million, respectively, for the same periods 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 $4.5 million for the fourth quarter of 2022 and $18.0 million for the year ended December 31, 2022, compared to $3.7 million and $11.7 million, respectively, for the same periods in 2021. General and Administrative Expenses: General and administrative expenses were $11.6 million for the fourth quarter of 2022 and $43.8 million for the year ended December 31, 2022, compared to $11.7 million and $36.3 million, respectively, for the same periods of 2021. The increase in annual expense was primarily due to increase in legal and professional service fees in support of the Company’s growth and an increase in personnel, facility, occupancy, and other expenses from an increase in headcount to support growth as a public company. Stock based compensation expenses included in G&A were $4.4 million for the fourth quarter of 2022 and $17.5 million for the year ended December 31, 2022, compared to $5.0 million and $13.2 million, respectively, for the same periods in 2021. Net Loss: Net loss was $34.9 million for the fourth quarter of 2022 and $154.8 million for the year ended December 31, 2022 compared to a net loss of $33.9 million and $100.2 million, respectively, for the same periods of 2021. Cash and Cash Equivalents: As of December 31, 2022, Kymera had approximately $559.5 million in cash, cash equivalents, and investments. Kymera expects that its cash and cash equivalents will provide the company with an anticipated cash runway into the second half of 2025 that is expected to take the company past the proof-of-concept Phase 2 data for KT-474, as well as early proof-of-concept data for KT-413, KT-333 and KT-253, while Kymera continues to identify opportunities to accelerate growth and expand its pipeline, technologies, and clinical indications. About Kymera Therapeutics Founded in 2016, Kymera is headquarteed in Watertown, Mass. Kymera has been named a “Fierce 15” company by Fierce Biotech and has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces. For more information about our people, science, and pipeline, please visit www.kymeratx.com or follow us on Twitter or LinkedIn. About Kymera’s Pegasus™ Platform Cautionary Note Regarding Forward-Looking Statements
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