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Kymera Therapeutics Announces Third Quarter 2024 Financial Results and Provides a Business Update

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Kymera Therapeutics (NASDAQ: KYMR) reported Q3 2024 financial results and business updates. Key developments include FDA clearance and Phase 1 trial initiation for KT-621 (STAT6), with data expected in H1 2025. Sanofi is expanding KT-474 Phase 2 trials in HS and AD to Phase 2b studies. The company nominated KT-295 as its TYK2 degrader development candidate for Phase 1 trials in H1 2025.

The company will shift focus from oncology to immunology, seeking partners for oncology programs beyond Phase 1. Financial results show $3.7M in collaboration revenues, $62.5M net loss, and $911M in cash, providing runway into mid-2027.

Kymera Therapeutics (NASDAQ: KYMR) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. Gli sviluppi chiave includono l'approvazione della FDA e l'inizio della fase 1 della sperimentazione per KT-621 (STAT6), con i dati attesi nella prima metà del 2025. Sanofi sta espandendo gli studi di fase 2 per KT-474 in HS e AD a studi di fase 2b. L'azienda ha nominato KT-295 come il candidato per lo sviluppo di degradatori TYK2 per le sperimentazioni di fase 1 nella prima metà del 2025.

L'azienda cambierà il focus dall'oncologia all'immunologia, cercando partner per i programmi oncologici oltre la fase 1. I risultati finanziari mostrano 3,7 milioni di dollari di ricavi da collaborazioni, 62,5 milioni di dollari di perdita netta e 911 milioni di dollari in liquidità, che garantiscono un margine fino a metà 2027.

Kymera Therapeutics (NASDAQ: KYMR) informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones empresariales. Los desarrollos clave incluyen la aprobación de la FDA y el inicio del ensayo de Fase 1 para KT-621 (STAT6), con datos esperados para la primera mitad de 2025. Sanofi está ampliando los ensayos de Fase 2 para KT-474 en HS y AD a estudios de Fase 2b. La empresa nominó a KT-295 como su candidato para el desarrollo de degradadores de TYK2 para ensayos de Fase 1 en la primera mitad de 2025.

La empresa cambiará su enfoque de oncología a inmunología, buscando socios para programas de oncología más allá de la Fase 1. Los resultados financieros muestran 3,7 millones de dólares en ingresos por colaboraciones, 62,5 millones de dólares de pérdida neta y 911 millones de dólares en efectivo, lo que proporciona capital hasta mediados de 2027.

Kymera Therapeutics (NASDAQ: KYMR)는 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 주요 개발 사항으로는 KT-621 (STAT6)의 FDA 승인을 받고 1상 시험이 시작되며, 데이터는 2025년 상반기에 예상됩니다. Sanofi는 KT-474의 2상 시험을 HS 및 AD에서 2b 연구로 확장하고 있습니다. 회사는 KT-295를 2025년 상반기에 1상 시험을 위한 TYK2 분해제 개발 후보로 지명했습니다.

회사는 온콜로지에서 면역학으로 초점을 전환하고, 1상 이상의 온콜로지 프로그램 파트너를 찾고 있습니다. 재무 결과는 370만 달러의 협력 수익, 6250만 달러의 순손실 및 9억 1100만 달러의 현금을 보여 주며, 이는 2027년 중반까지의 자금을 제공합니다.

Kymera Therapeutics (NASDAQ: KYMR) a rapporté les résultats financiers du troisième trimestre 2024 et des mises à jour commerciales. Les développements clés incluent l'approbation de la FDA et le lancement de l'essai de phase 1 pour le KT-621 (STAT6), avec des données attendues au premier semestre 2025. Sanofi étend les essais de phase 2 pour le KT-474 dans le HS et l'AD à des études de phase 2b. L'entreprise a désigné le KT-295 comme son candidat développeur pour les dégradateurs TYK2 pour les essais de phase 1 dans la première moitié de 2025.

L'entreprise va changer son axé de l'oncologie vers l'immunologie, recherchant des partenaires pour des programmes d'oncologie au-delà de la phase 1. Les résultats financiers montrent 3,7 millions de dollars de revenus de collaboration, 62,5 millions de dollars de perte nette et 911 millions de dollars en liquidités, offrant une marge jusqu'à mi-2027.

Kymera Therapeutics (NASDAQ: KYMR) hat die finanziellen Ergebnisse des dritten Quartals 2024 und Unternehmensupdates veröffentlicht. Zu den wichtigsten Entwicklungen gehören die FDA-Zulassung und der Beginn der Phase-1-Studie für KT-621 (STAT6), wobei Daten im ersten Halbjahr 2025 erwartet werden. Sanofi erweitert die Phase-2-Studien für KT-474 in HS und AD auf Phase-2b-Studien. Das Unternehmen hat KT-295 als seinen Entwickler für TYK2-Degrader für Phase-1-Studien im ersten Halbjahr 2025 nominiert.

Das Unternehmen wird den Fokus von der Onkologie auf die Immunologie verlagern und sucht Partner für Onkologie-Programme über Phase 1 hinaus. Die finanziellen Ergebnisse zeigen 3,7 Millionen Dollar an Einnahmen aus Kooperationen, 62,5 Millionen Dollar Nettoverlust und 911 Millionen Dollar an Bargeld, was bis Mitte 2027 Spielraum bietet.

Positive
  • Strong cash position of $911M providing runway into mid-2027
  • FDA clearance and initiation of KT-621 Phase 1 trial
  • Sanofi's expansion of KT-474 Phase 2 trials indicates strong program potential
  • Successful equity offering raising $247M in net proceeds
Negative
  • Net loss increased to $62.5M from $52.9M year-over-year
  • Collaboration revenues decreased to $3.7M from $4.7M year-over-year
  • R&D expenses increased to $60.4M from $48.1M year-over-year
  • Strategic shift away from oncology programs requiring partnership for advancement

Insights

The Q3 results reveal significant financial positioning with $911 million in cash, providing runway into mid-2027. Revenue declined to $3.7 million from $4.7 million year-over-year, while R&D expenses increased to $60.4 million from $48.1 million. Net loss widened to $62.5 million. The strategic shift to immunology and partnership-only approach for oncology programs beyond Phase 1 demonstrates prudent resource allocation. The successful $247 million equity offering strengthens the balance sheet, supporting multiple clinical programs through key milestones.

The pipeline developments show strategic focus on immunology with three key programs: KT-621 (STAT6 degrader) entering Phase 1 with data expected H1 2025, KT-474 expansion in Phase 2b trials for HS and AD with partner Sanofi and KT-295 (TYK2 degrader) advancing to Phase 1 in H1 2025. The expansion of KT-474 trials suggests strong preliminary efficacy signals. The shift away from oncology programs indicates confidence in the immunology pipeline's commercial potential, particularly in large markets like atopic dermatitis and hidradenitis suppurativa.

KT-621 (STAT6) IND cleared by FDA and dosing in the Phase 1 clinical trial initiated, with data expected in the first half of 2025

Sanofi expanding KT-474/SAR444656 (IRAK4) Phase 2 clinical trials in HS and AD to dose ranging Phase 2b studies to accelerate overall development timelines; completion of both expanded trials expected by mid-2026

KT-295, a new TYK2 degrader, selected as the development candidate to advance into Phase 1 clinical trial in the first half of 2025, in line with prior program guidance

Company to shift focus and resources from oncology to its expanding immunology pipeline, and will only advance KT-333 (STAT3) and KT-253 (MDM2) beyond Phase 1 with a partner

Well-capitalized with $911 million in cash as of September 30, 2024, and runway into mid-2027

Company to hold call and webcast today at 8:30 a.m. ET

WATERTOWN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today reported financial results for the third quarter ended September 30, 2024, and provided business highlights and updates on its pipeline of first- and best-in-class protein degraders.

“This has been an important year for Kymera with an increased focus on the exciting opportunities we have in immunology and programs that have the potential to transform the treatment landscape for millions of patients around the globe,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “We are particularly excited about the initiation of the Phase 1 trial for KT-621, our first-in-class STAT6 degrader. This is a target that perfectly fits the value proposition of oral degraders with biologics-like activity, and we are excited and proud to be the first company to advance a drug candidate for this mechanism into the clinic. The preclinical profile of KT-621 is compelling, particularly its ability to replicate the biology of upstream biologics like dupilumab, which we look forward to translating in the clinic with an initial Phase 1 data readout in the first half of 2025. In addition, Sanofi’s decision to expand both the HS and AD studies with KT-474 into dose ranging Phase 2b studies is a testament to their strong interest in exploring even more comprehensively the IRAK4 degradation mechanism and this drug candidate given all the supporting data generated so far.”

Dr. Mainolfi added, “Given the significant progress and potential of our immunology pipeline, we have made the decision to shift our resources toward our discovery and development efforts in immunology. As a result, we will advance our clinical stage oncology programs beyond Phase 1 only in the context of a partnership. Focusing our resources and efforts on our work in immunology reflects our financial discipline around program prioritization to address large patient populations with significant need and clear substantial commercial opportunities.”

Business Highlights, Recent Developments and Upcoming Milestones

STAT6 Degrader Program

KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of TH2 inflammation, currently in Phase 1 testing. In preclinical studies, KT-621 was well tolerated with exquisite selectivity and fully blocked IL-4/IL-13 functions in key human TH2 cellular assays and in in vivo models of TH2 inflammation with comparable or superior activity to dupilumab. KT-621 has the potential to address numerous TH2 diseases including atopic dermatitis, asthma and COPD, among others.

  • In October, Kymera initiated dosing in the Phase 1 healthy volunteer clinical trial evaluating single and multiple ascending doses of KT-621, a potent and selective oral degrader of STAT6. The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT-621 compared to placebo. The Company expects to report Phase 1 data in the first half of 2025. More information on the KT-621 Phase 1 study will be available on www.clinicaltrials.gov.
  • The Company presented preclinical data at the European Academy of Dermatology and Venereology (EADV) Congress and the American College of Asthma, Allergy, and Immunology (ACAAI) Annual Meeting. The new findings showed strong degradation of STAT6 in human sensory neurons resulted in inhibition of IL-13-induced itch- and pain-related gene transcripts, highlighting the potential of KT-621 to alleviate these symptoms in atopic dermatitis patients by effectively targeting and modulating the STAT6 pathway.

IRAK4 Degrader Program
KT-474 (SAR444656) is an investigational, first-in-class, once daily, oral degrader of IRAK4, a key protein involved in inflammation. Phase 2 clinical trials for hidradenitis suppurativa (HS) and atopic dermatitis (AD), in collaboration with Sanofi, are currently ongoing. In the Phase 1 study, KT-474 demonstrated robust degradation of IRAK4 in the blood and skin of healthy volunteers and patients with HS and AD, demonstrating a systemic anti-inflammatory effect and preliminary evidence of clinical activity.

  • In July, Kymera announced that Sanofi had communicated to Kymera the intent to expand the ongoing KT-474 Phase 2 trials in HS and AD following an interim review of KT-474/SAR444656 safety and efficacy data by an independent data monitoring committee. The expansion of the ongoing HS and AD Ph2 studies to larger dose-ranging Phase 2b studies is intended to accelerate overall development timelines and enable a subsequent transition into registrational Phase 3 trials.
    • Hidradenitis Suppurativa (ZEN trial): The study has been expanded from 99 to 156 patients. Previously, the trial included one active dose of KT-474 as well as placebo. The study will now include an additional dose. The estimated primary completion date for the ZEN trial is now in the first half of 2026.
    • Atopic Dermatitis (ADVANTA Trial): The study has been expanded from 115 to 200 patients. Previously, the trial included two active doses of KT-474 as well as placebo. The study will now include an additional dose. The estimated primary completion date for the ADVANTA trial is now in the middle of 2026.
  • In July, results from the Company’s non-interventional trial evaluating IRAK4 expression in patients with HS were published in the Journal of Investigative Dermatology. The results support the role of IRAK4 signaling in HS and the potential of IRAK4 degradation to impact the clinical manifestations of HS, AD, and potentially other TLR/IL-1R-driven immuno-inflammatory diseases.
  • In August, the Company published on the discovery of KT-474 in the Journal of Medicinal Chemistry highlighting the exploration of structure–activity relationships that ultimately led to the identification of the first-in-class oral IRAK4 degrader, KT-474, and reinforcing Kymera’s innovative molecular design strategies.

TYK2 Degrader Program

KT-295 is an investigational, first-in-class, once daily, oral degrader of TYK2, a member of the Janus kinase (JAK) family required for Type I IFN, IL-12 and IL-23 signaling. In preclinical studies, unlike traditional small molecule inhibitors, KT-295 has demonstrated picomolar degradation potency and potent inhibition of the IL-23, IL-12 and Type I IFN pathways while sparing IL-10, showing its potential to recapitulate the biology of human TYK2 loss-of-function mutations. KT-295 has the potential to be the first oral therapy to deliver biologics-like activity in diseases such as IBD and psoriasis, among others.

  • The Company nominated a new TYK2 development candidate, KT-295, a potent, selective, once daily oral degrader, and has prioritized this compound for clinical evaluation. KT-295 has picomolar potency and is highly selective for TYK2, while also demonstrating greater in vivo activity in preclinical animal models compared to KT-294, the Company’s previously identified TYK2 degrader.
  • Kymera intends to advance KT-295 into Phase 1 clinical testing in the first half of 2025, which is consistent with prior program guidance. The Company expects to report Phase 1 data later that year.

Oncology Degrader Programs

  • Dose escalation and enrollment have been completed for both the KT-333 and KT-253 Phase 1 trials. Based on an overall assessment of its clinical oncology programs, and given progress across the immunology pipeline, the Company has made the strategic decision not to continue development of KT-333 (STAT3) and KT-253 (MDM2) beyond Phase 1. Kymera plans to present STAT3 Phase 1 data at a poster presentation at ASH in December. The Company is evaluating partnership opportunities to advance the oncology pipeline beyond its current stage.

Corporate Updates

  • In August, the Company announced the closing of an upsized underwritten equity offering, resulting in net proceeds of approximately $247 million. With these proceeds, the Company extended its cash runway into mid-2027.

Program Background Information

For more information on Kymera’s pipeline visit our website.

Financial Results

Collaboration Revenues: Collaboration revenues were $3.7 million for the third quarter of 2024, compared to $4.7 million for the same period of 2023. Collaboration revenues in the third quarter of 2024 were all attributable to the Company’s Sanofi collaboration.

Research and Development Expenses: Research and development expenses were $60.4 million for the third quarter of 2024, compared to $48.1 million for the same period of 2023. This increase was primarily due to increased expenses related to the investment in the Company’s STAT6 degrader 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 $7.6 million for the third quarter of 2024, compared to $5.8 million for the same period in 2023.

General and Administrative Expenses: General and administrative expenses were $15.5 million for the third quarter of 2024, compared to $14.1 million for the same period of 2023. The increase was primarily due to an increase in legal and professional service fees in support of the Company’s growth and an increase in personnel, facility, occupancy, and other expenses to support growth as a public company. Stock based compensation expenses included in G&A were $7.3 million for the third quarter of 2024 compared to $5.9 million for the same period in 2023.

Net Loss: Net loss was $62.5 million for the third quarter of 2024 compared to a net loss of $52.9 million for the same period of 2023.

Cash and Cash Equivalents: As of September 30, 2024, Kymera had $911 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 mid-2027. Its existing cash is expected to take the Company beyond the Phase 2 data for KT-474 and several clinical inflection points for its STAT6 and TYK2 programs while Kymera continues to identify opportunities to accelerate growth and expand its pipeline, technologies and clinical indications.

Conference Call

Kymera will host a conference call and webcast today, October 31, 2024, at 8:30 a.m. ET. To access the conference call via phone, please dial +1 (833) 630-2127 or +1 (412) 317-1846 (International) and ask to join the Kymera Therapeutics call. A live webcast of the event will be available under News and Events 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 for three months.

About Kymera Therapeutics
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
This 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 about our expectations regarding strategy, business plans and objectives on the clinical development of clinical and preclinical pipeline, Sanofi’s   expansion of the Phase 2 clinical trials of KT-474/SAR444656, the initiation of a Phase 1 clinical trial of KT-621 and expected initial data readout of KT-621 in the first half of 2025, the declaration of KT-295 as a development candidate and the decision not to advance KT-333 and KT-253 beyond Phase 1 without a partner and Kymera’s financial condition and expected cash runway into mid-2027. 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 any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results of early clinical trials will be indicative of the results of later clinical trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim 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)
 
  September 30,
2024
 December 31,
2023
Assets    
Cash, cash equivalents and marketable securities $911,005 $436,315 
Property and equipment, net  51,244  48,134 
Right-of-use assets, operating lease  48,065  52,945 
Other assets  24,528  38,365 
Total assets $1,034,842 $575,759 
Liabilities and Stockholders’ Equity    
Deferred revenue $20,024 $54,651 
Operating lease liabilities  85,144  82,096 
Other liabilities  36,744  44,041 
Total liabilities  141,912  180,788 
Total stockholders’ equity  892,930  394,971 
Total liabilities and stockholders’ equity $1,034,842 $575,759 
 


KYMERA THERAPEUTICS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
        
 Three Months Ended  
September 30,
Nine Months Ended 
September 30,
  2024   2023   2024   2023 
Collaboration Revenue$3,741  $4,728  $39,678  $30,707 
        
Operating expenses:       
Research and development$60,410  $48,117  $168,431  $136,111 
General and administrative 15,455   14,120   47,202   40,814 
Impairment of long-lived assets       4,925    
Total operating expenses 75,865   62,237   220,558   176,925 
Loss from operations (72,124)  (57,509)  (180,880)  (146,218)
Other income (expense):       
Interest and other income 9,697   4,683   27,964   13,768 
Interest and other expense (60)  (41)  (190)  (144)
Total other income 9,637   4,642   27,774   13,624 
Net loss attributable to common stockholders$(62,487) $(52,867) $(153,106) $(132,594)
Net loss per share attributable to common  
stockholders, basic and diluted
$(0.82) $(0.90) $(2.09) $(2.27)
Weighted average common stock outstanding,  
basic and diluted
 76,125,975   58,421,859   73,330,338   58,312,813 
 

Investor & Media Contact:

Justine Koenigsberg
investors@kymeratx.com
media@kymeratx.com
857-285-5300  


FAQ

What were Kymera Therapeutics (KYMR) Q3 2024 financial results?

Kymera reported $3.7M in collaboration revenues, a net loss of $62.5M, and $911M in cash and investments as of September 30, 2024.

When will Kymera (KYMR) report KT-621 Phase 1 trial data?

Kymera expects to report Phase 1 data for KT-621 in the first half of 2025.

What is the cash runway for Kymera Therapeutics (KYMR)?

Kymera's current cash position of $911M is expected to provide runway into mid-2027.

When will Sanofi complete the expanded KT-474 Phase 2b trials for Kymera (KYMR)?

The expanded Phase 2b trials are expected to be completed by mid-2026.

Kymera Therapeutics, Inc.

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Biotechnology
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