Curemark LLC

RYE BROOK, N.Y., Dec. 4, 2023 /PRNewswire/ -- Curemark today announced the publication of their long-term clinical data demonstrating disease/disorder modification in maladaptive behaviors in children as young as 3 years of age with Autism Spectrum Disorder (ASD). The paper entitled Pancreatic Replacement Therapy for Maladaptive Behaviors in Preschool Children With Autism Spectrum Disorders was published in The Journal of the American Medical Association (JAMA) Network Open. Disease/disorder modifying treatments are those that delay, slow or alter the progression or pathophysiology of a disease or disorder, in direct contrast with symptom-modifying treatments which may alter an individual symptom without sustained overall improvement in the disease or disorder. Data from the trial was collected at 32 leading autism centers across the US, then analyzed using a delayed-start approach that is increasingly utilized in neurodegenerative diseases such as Alzheimer's. "The JAMA article presents a novel approach to the analysis of treatment outcomes for children with autism," states Dr. Joan Fallon, Curemark's CEO. "With the prevalence of autism increasing globally, there is a need for multiple treatments to improve the lives of the children and their families. Autism manifests as a complex set of behaviors which are not easily evaluated in isolation and we see the long-term trajectory of improvements seen in our clinical trials as positive for the children, their families and the entire autism community. It opens the possibility for more treatments to become available." The study was led by Drs. Deborah Pearson and Robert Hendren, who have a combined 75+ years of experience in working with children with autism at their respective leading institutions. Curemark is grateful to all the physicians, researchers and families who participated in the Curemark studies. For media and interview requests, please contact [email protected] . About Curemark Founded in 2007, Curemark is a private, clinical-stage biopharmaceutical company developing novel therapies for the treatment of serious unmet needs in neuro-developmental and neurodegenerative disorders. Curemark's pipeline includes preclinical and clinical-stage programs for the treatment of autism, schizophrenia, Parkinson's disease, ADHD and addiction. For additional information, please visit our website at or follow @Curemark on Twitter. Safe Harbor This press release includes both historical facts and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. In some cases, forward-looking statements can be identified by words such as "may," "will," "should," "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," "predict," "potential," the negative of such words, variations of such words and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. These risks and uncertainties include, among other things, uncertainties inherent in (i) research and development, (ii) the building of Curemark, LLC's patent portfolio and protection of its intellectual property, (iii) the conduct of clinical trials, (iv) obtaining the requisite approval of regulatory authorities to market and sell Curemark LLC's product candidates, (v) decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Curemark LLC's product candidates, and (vi) competitive developments. Readers should not place undue reliance on any forward-looking statements, which are based on Curemark, LLC's current expectations of future events and speak only as of the date they are made. Except as may be required by law, Curemark, LLC undertakes no obligation to update any forward-looking statements contained in this press release to reflect any change in Curemark, LLC's expectations or any change in information, events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. SOURCE Curemark

RYE BROOK, N.Y., Sept. 22, 2022 /PRNewswire/ -- Curemark announced today the key addition of Dr. William R. McIntyre to the team as the Senior Vice President of Global Regulatory Affairs, effective immediately. Previously, Dr. McIntyre served as Senior Vice President of Regulatory Affairs for Endo Par and oversaw the approval of 4 NDAs for Pfizer as Associate Director of Regulatory Affairs. Dr. McIntyre earned his PhD with Distinction at New York University, was awarded a post-doctoral Research Fellowship from the National Institutes of Health and served a post-doctoral residency at NYU Medical Center's Department of Molecular Endocrinology. Curemark CEO Dr. Joan Fallon stated, "I'm excited that Dr. McIntyre is onboard as he brings a wealth of regulatory experience to our BLA filing process. He is the right person to lead our regulatory team into the future." Dr. McIntyre commented, "I'm truly grateful to Dr. Fallon for the opportunity to be a part of Curemark. Throughout my career in pharma, I've always looked towards situations where unmet medical needs are addressed. Curemark's platform technology seeks to solve problems where there is great need and little or no treatment." ABOUT CUREMARK Curemark, LLC is a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of neurological disorders. Curemark's pipeline includes preclinical and clinical-stage programs for the treatment of autism, schizophrenia and Parkinson's disease, ADHD and addiction. For additional information, please visit our website at or follow @Curemark on Twitter. SAFE HARBOR This press release includes both historical facts and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. In some cases, forward-looking statements can be identified by words such as "may," "will," "should," "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," "predict," "potential," the negative of such words, variations of such words and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. These risks and uncertainties include, among other things, uncertainties inherent in (i) research and development, (ii) the building of Curemark, LLC's patent portfolio and protection of its intellectual property, (iii) the conduct of clinical trials, (iv) obtaining the requisite approval of regulatory authorities to market and sell Curemark LLC's product candidates, (v) decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Curemark LLC's product candidates, and (vi) competitive developments. Readers should not place undue reliance on any forward-looking statements, which are based on Curemark, LLC's current expectations of future events and speak only as of the date they are made. Except as may be required by law, Curemark, LLC undertakes no obligation to update any forward-looking statements contained in this press release to reflect any change in Curemark, LLC's expectations or any change in information, events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. View original content: SOURCE Curemark, LLC

Initiated 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,initial data to be shared by year end 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: Present clinical data from patient cohort in HS and AD patients (4Q22)Deliver data package to Sanofi for decision to proceed to Phase 2 (4Q22) 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: Present KT-333 clinical patient data, including initial safety and proof-of-mechanism (4Q22) 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: Present KT-413 clinical patient data, including initial safety and proof-of-mechanism (4Q22) 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: File IND for KT-253 (2H22)Present preclinical translational data to inform long-term clinical strategy (2H22) 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 TherapeuticsKymera is a biopharmaceutical company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera’s Pegasus platform is a powerful drug discovery engine, advancing novel small molecule therapies candidates designed to harness the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutic candidates designed to address the most intractable of pathways and provide new treatments for patients. Kymera’s initial programs target IRAK4, IRAKIMiD, and STAT3 within the IL-1R/TLR or JAK/STAT pathways, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors. For more information, visit www.kymeratx.com. About Kymera’s Pegasus™ PlatformKymera’s Pegasus platform is a powerful drug discovery engine that enables the discovery of novel small molecule protein degrader medicines designed to target and disrupt specific protein complexes and full signaling cascades in disease, placing once elusive disease targets within reach. The key components of the platform combine Kymera’s broad understanding of the localization and expression levels of the hundreds of E3 ligases in the human body with the Company’s proprietary E3 Ligase Binders Toolbox, and advanced chemistry, biology, and computational capabilities to develop protein degraders that address significant, unmet medical needs. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements by Kymera Therapeutics regarding its: strategy, business plans and objectives for the IRAK4, IRAKIMiD,STAT3 and MDM2 degrader programs; plans and timelines for the clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing, success and data announcements of current ongoing clinical trials; the ability to initiate new clinical programs; and cash position and expected runway. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics' drug candidates; the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with future clinical trials; Kymera Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera Therapeutics' planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; and Kymera Therapeutics' relationships with its existing and future collaboration partners. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the Annual Report on Form 10-K for the period ended December 31, 2021 and most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics' subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. KYMERA THERAPEUTICS, INC.Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) June 30,2022 December 31,2021Assets Cash, cash equivalents and marketable securities $482,491 $567,605Property and equipment, net 12,748 11,881Other assets 28,182 26,419Total assets $523,421 $605,905Liabilities and Stockholders’ Equity Deferred revenue $83,531 $101,034Other liabilities 41,939 45,233Total liabilities 125,470 146,267Total stockholders’ equity 397,951 459,638Total liabilities and stockholders’ equity $523,421 $605,905 KYMERA THERAPEUTICS, INC.Consolidated Statements of Operations(In thousands, except share and per share amounts)(Unaudited) Three Months Ended June 30, Six Months EndedJune 30, 2022 2021 2022 2021 Collaboration Revenue—from related parties $11,514 $18,519 $21,136 $37,221 Operating expenses: Research and development $41,293 $35,220 $77,238 $61,181 General and administrative 11,031 8,029 21,642 13,939 Total operating expenses 52,324 43,249 98,880 75,120 Loss from operations (40,810) (24,730) (77,744) (37,899)Other income (expense): Interest and other income 594 98 884 217 Interest and other expense (41) (28) (81) (53)Total other income 553 70 803 164 Net loss attributable to common stockholders $(40,257) $(24,660) $(76,941) $(37,735)Net loss per share attributable to common stockholders, basic and diluted $(0.78) $(0.55) $(1.49) $(0.84)Weighted average common stocks outstanding, basic and diluted 51,772,440 45,094,238 51,712,081 44,873,083 Investor Contacts:Bruce JacobsChief Financial Officerinvestors@kymeratx.com857-285-5300 Chris BrinzeyManaging Director, Westwickechris.brinzey@westwicke.com339-970-2843 Media Contact:Todd CooperSenior Vice President, Corporate Affairstcooper@kymeratx.com