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Kymera Therapeutics Announces Second Quarter 2022 Financial Results and Provides a Business UpdateInitiated dosing in patient cohort (Part C) of IRAK4 degrader KT-474 Phase 1 trial, on track for data by year end Phase 1 patient studies initiated for STAT3 (KT-333) and IRAKIMiD (KT-413) oncology programs, June 30, 2022 cash balance of $482.5 million, providing cash runway into 2025 Company to hold quarterly results call at 8:30 a.m. EST (877-317-6789 or +1 412-317-6789) WATERTOWN, Mass., Aug. 09, 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 second quarter ended June 30, 2022. “Kymera has made strong progress, dosing patients in our three first-in-class clinical programs and advancing our mission to build a fully integrated medicines company,” said Nello Mainolfi, PhD, Co-Founder, President and CEO. “We are on track to deliver clinical data before year end for all three programs, including our KT-474 Phase 1 patient cohort, where we expect to demonstrate the ability of KT-474 to degrade IRAK4 and impact disease relevant biomarkers in the skin and blood of HS and AD patients. We also plan to share initial safety and proof-of-mechanism data for our two oncology programs, KT-413 and KT-333. With a cash runway into 2025, we are well-financed and poised to deliver clinical results in the second half of this year that reinforce the exciting and broad potential of our targeted protein degradation pipeline and platform.” Business Highlights and Recent Developments IRAK4 Degrader Program (KT-474) Background. KT-474 is designed as a potent, highly selective, orally bioavailable IRAK4 degrader, in development for the treatment of IL-1R/TLR-driven autoimmune and autoinflammatory diseases with high unmet medical needs. 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 drug. 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. 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. Recent Updates. Kymera has commenced dosing patients in the Phase 1 patient cohort (Part C). Part C is an open-label study of KT-474 administered daily on an outpatient basis for 28 days. This cohort is expected to enroll up to 20 patients with moderate-to-severe hidradenitis suppurativa (HS) or atopic dermatitis (AD) to examine the safety and pharmacokinetics/pharmacodynamics (PK/PD) of KT-474 and explore early signs of clinical activity of this first-in-class degrader therapeutic. Patients will receive a daily dose of 75 mg of KT-474 with food. This dose 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. More information on the Phase 1 study can be found at www.clinicaltrials.gov, identifier NCT04772885. Expected 2022 Milestones:
STAT3 Degrader Program (KT-333) Background. 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. Recent Updates. Patient enrollment and dosing are ongoing in a 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 will explore 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 peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), large granular lymphocytic leukemia (LGL-L), and solid tumors. KT-333 was recently granted Orphan drug designation by the U.S. Food and Drug Administration for the treatment of PTCL. This designation provides incentives to encourage the development of medicines for rare diseases. Expected 2022 Milestones:
IRAKIMiD Degrader Program (KT-413) Background. 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. Recent Updates. Patient enrollment and dosing are ongoing in a 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 will explore escalating doses of single-agent KT-413 in a 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 diffuse large B cell lymphoma (DLBCL). Expected 2022 Milestones:
MDM2 Degrader Program (KT-253) Background and Update. 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. Kymera is completing IND enabling studies for KT-253 and expects to file an IND in 2H22. Expected 2022 Milestones:
Platform and Discovery Programs Background. 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. New Appointments Kymera recently announced the appointment of Leigh Morgan to its Board of Directors. Ms. Morgan is a senior executive accomplished in scaling global, high-performing organizations in the biopharmaceutical, non-profit, and public sectors. In her current role as Chief Strategy and Operating Officer for Nia Tero, she is a key architect of the firm’s growth, inclusive of strategy, finance, innovation, communications, operations, impact investments and governance. Ms. Morgan previously served as Chief Operating Officer of the Bill & Melinda Gates Foundation where she oversaw a broad portfolio, including human resources, information technology and security, facilities and the foundation’s culture transformation efforts. Her health and biotechnology leadership roles include serving as Associate Chancellor at the University of California, San Francisco, Vice President and Global Head of Human Resources for Product Development at Genentech, and HR leadership roles at GSK. She currently serves as Vice-Chair/Chair-elect of the Board at the Fred Hutch Cancer Center, is on the University of Washington Medical Center Advisory Board, and is an independent director at Curemark, a clinical-stage biotechnology company. Conference Call To access the conference call via phone, please dial 877-317-6789 (U.S.) or +1 412-317-6789 (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. Second Quarter 2022 Financial Results Collaboration Revenues: Collaboration revenues were $11.5 million for the second quarter of 2022 compared to $18.5 million the second quarter of 2021. Collaboration revenues include revenue from the Company’s Sanofi and Vertex collaborations. Research and Development Expenses: Research and development expenses were $41.3 million for the second quarter of 2022 compared to $35.2 million for the second quarter of 2021. This increase was primarily due to direct expenses related to clinical activities for our IRAK4, IRAKIMiD, and STAT3 programs, as well as increased expenses related to the investment in our MDM2 program, platform, discovery programs, and Vertex collaboration, 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 $4.8 million and $2.9 million in the second quarter of 2022 and the second quarter of 2021, respectively. General and Administrative Expenses: General and administrative expenses were $11.0 million for the second quarter of 2022, compared to $8.0 million for the second quarter of 2021. This increase was primarily due to increases 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 our growth. Stock based compensation expenses included in G&A were $4.9 million and $2.8 million in the second quarter of 2022 and the second quarter of 2021, respectively. Net Loss: Net loss was $40.3 million for the second quarter of 2022 compared to a net loss of $24.7 million for the second quarter of 2021. Cash and Cash Equivalents: As of June 30, 2022, Kymera had approximately $482.5 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 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 KYMERA THERAPEUTICS, INC.
KYMERA THERAPEUTICS, INC.
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