Nuvalent Investor Presentation Deck
January 2024, 41 slides
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overview cancer a | Nuvalent
cautionary note regarding forward looking statements this presentation contains forward looking statements within the meaning of the private securities litigation reform act of as amended including without limitation implied and express statements regarding strategy business plans and focus the period over which estimates its cash cash equivalents and marketable securities will be sufficient to fund its future operating expenses and capital expenditure requirements estimate of its cash cash equivalents and marketable securities as of the expected timing of data announcements and approvals the preclinical and clinical development programs for and the potential clinical effect of and the potential benefits of the design and enrollment of the and trials including their intended pivotal registration directed design the potential of pipeline programs including and the implications of data and presentations timing and content of potential discussions with regulators and investigators the design and timing of the planned phase portions of the and trials research and development programs for the treatment of cancer and could would should expect plan anticipate aim goa intend believe risks and uncertainties associated with drug development the words may might will expect estimate seek predict future project i continue target or the negative of these terms and similar words or expressions are intended to identify forward looking statements although not all forward looking statements contain these identifying words drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product you should not place undue reliance on these statements or the scientific data presented any forward looking statements in this presentation are based on management 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 presentation including without limitation risks that may not fully enroll the or trials or that enrollment will take longer than expected unexpected concerns that may arise from additional data analysis or results obtained during preclinical studies or clinical trials the risk that results of clinical trials may not be predictive of the results of later stage clinical trials the risk that data from our clinical trials may not be sufficient to support registration and that may be required to conduct one or more additional studies or trials prior to seeking registration of our product candidates the occurrence of adverse safety events risks that the may not approve our potential products on the we expect if at all risks of unexpected costs delays or other unexpected hurdles risks that may not be able to nominate drug candidates from its discovery programs the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of clinical trials strategy and future operations including the and trials the timing and outcome of planned interactions with regulatory authorities risks related to obtaining maintaining and protecting intellectual property and the risk that estimate of its cash cash equivalents and marketable securities as of may differ from the final amount determined upon completion of its year end closing procedures these and other risks and uncertainties are described in greater detail in the section entitled risk factors in quarterly report on form for the quarterly period ended as well as any prior and subsequent filings with the securities and exchange commission in addition any forward looking statements represent views only as of the date made and should not be relied upon as representing its views as of any subsequent date explicitly disclaims any obligation to update any forward looking statements | Nuvalent
targeted therapies for patients with cancer parallel lead programs for clinical development proven discovery capabilities and alk in global research pipeline third program for her in enabling studies active hybrid operations with offices in listed growing team cash runway expected into | Nuvalent
precisely therapies for patients with cancer the approach goal maximize patient impact | Nuvalent
track record of success resource efficient execution and value creation across an expanding portfolio wholly owned programs emergence from first clinical proof of concept second proof of concept first pivotal study disclosed parallel lead programs initiated two global phase studies demonstrated clinical proof of concept and alk for alk program presented preclinical profiles demonstrated clinical proof of concept initiated phase with supporting desired target product for program registrational intent disclosed third novel program advanced her program towards listed her ended with approximately in cash cash equivalents and marketable securities unaudited with potential to deliver multiple transformative catalysts within cash runway window into preliminary unaudited estimate only as the date this presentation subject to change following completion year end closing procedures does not present all information necessary for an understanding financial position as a | Nuvalent
coal execute on global first pivotal registrational data strategies first approved product mission bringing new potential best in class medicines to patients with cancer anticipated milestones progress phase with registrational intent initiate phase with registrational intent initiate phase trial for launch alk strategy and alk programs interim data for both her program i | Nuvalent
meet the significant experience in drug discovery development and company building board of directors scientific advisors independent independent hack bain capital life sciences flare therapeutics management anna protopapas independent james porter professor of chemistry chemical biology independent wheeler management head scientific advisor professor of chemistry chemical biology ross clinical advisor university of colorado clinical advisor memorial sloan cancer center translational research advisor mass general cancer center pasi clinical advisor cancer institute nancy kohl translational research advisor independent consultant leadership team james porter chief executive officer chief financial officer miller chief legal officer chief development turner chief medical officer officer me ruth clinical operations josh chemistry benjamin lane technical operations lin corporate strategy portfolio management human resources henry drug discovery translational development business development strategy prior approvals a a rea tablets | Nuvalent
pipeline advancing a portfolio of potentially best in class products with complementary initial indications in lead indication product candidate discovery enabling phase phase phase anticipated milestones rights open enrolling phase portion phase trial data update at medical meeting alk open enrolling phase portion phase trial i phase initiation data update at medical meeting her phase initiation undisclosed targets additional discovery research programs ongoing | Nuvalent
alk and landscape emerging resistance mutations increasing involvement treatment related adverse events limit utility of approved therapies advanced metastatic advanced metastatic notable populations standard of care notable populations ager sees standard of care sin resistance oer mutations compound resistance mutations wild kinase domain pests lean ist no clear standard of care alternatives no clear standard of care additional alternative tee was approved not approved but in guidelines line line line central nervous system sources lung cancer jama shaw no peters shaw lancet jack cancer res sources lin precision lung cancer | Nuvalent
alk and strategy potential best in class to overcome the combined medical needs of a treating preventing brain metastases avoiding treatment limiting adverse events selective inhibition of the driver overcoming treatment emergent resistance mutations comparable resistance mutation rates after single mutation gee for activity against as at or with sources jack cancer res cancer precision with improved activity months patients with package insert intracranial eel months or significant improvement movement up the treatment paradigm months | Nuvalent
alk market opportunity meaningful commercial markets with combined sales in potential best in class profiles ana designed with the goal to supplant the current standard of care arrays clinical proof of concept demonstrated in heavily treated patient populations cee lear for patients more durable responses potential to grow the through all a global sales for standard of care months standard of care months other and generally used guidelines for for version | Nuvalent
for alk meio a brain penetrant selective inhibitor of and resistance mutations with the potential to minimize related adverse events while providing activity is | Nuvalent
alk patient journey of majority are advanced metastatic at diagnosis nee of care sales sales and are approved line agnostic was designed to address single mutations that resistance to and no clear standard of care patients may consider clinical trials or chemotherapy i key limitations single resistance mutations observed in of patients progressing on or brain penetrance present with brain metastases at diagnosis will develop brain metastases overall compound resistance activity no approved therapies have demonstrated activity after sequential to mutations observed in of patients progressing on sequential to treatment limiting off target adverse events adverse events associated with inhibition observed in of patients receiving sources chia sales and forecasts accessed guidelines for version jack cancer res cancer precis shaw a lancet package inserts cocco nat rev shaw a nature cancer illustrative image | Nuvalent
a rationally designed alk selective sparing inhibitor medical needs alk gen gen gen lin preliminary phase conclusions investigational gen alk activity alk single mutant activity alk compound mutant activity ens activity avoiding alk activity observed in patients with alk including after exhausting available therapies alk single mutant activity activity observed in patients with diverse single alk resistance mutations alk compound mutant activity activity observed in patients with diverse compound alk resistance mutations activity air avoiding activity observed in patients with history of including intracranial responses emerging safety profile was consistent with design key observed in clinical investigation source lin head to head clinical studies comparing with currently approved or investigational therapies have not been conducted | Nuvalent
preclinical characterization demonstrates desired target product profile inhibited diverse alk fusions and resistance mutations in activity in activity potent activity against alk driven cell lines including alk single and compound mutants tumor regression at well tolerated doses in alk models including alk single and compound mutants i is a eye of a a a a i i a a a a vehicle call lines alk fusion day cell viability assay no resistance mutations a a a a a a a a a i models harboring alk fusion no resistance mutations hip alk alk alk alk me alk a alk bid bid or in some cases dosing was not performed on weekends bid twice daily half maximal inhibitory concentration orally once daily variant sources lin lee a a data also reflect additional repeat testing and models | Nuvalent
preclinical characterization demonstrates desired target product profile brain penetrant with the potential to avoid related adverse events brain penetrance avoiding inhibition data similar to observations for selective inhibition of alk and alk mutants over i a a a i a han rats single dose hour more active for alk a a a a a more active for a selectivity index alk selectivity for alk over no resistance mutations a a a head to head clinical studies comparing with currently approved or investigational therapies have not been conducted central nervous system half maximal inhibitory concentration orally stimulated phosphorylation source lin a data presented here reflect updated values following additional repeat testing | Nuvalent
a global first in human phase clinical trial of in advanced alk positive and other solid tumors dose preliminary data presented all treated population ongoing at sites across sites north patient population harboring alk fusion or activating mutation by local testing patients with prior or alk prior chemotherapies excluded concurrent drivers met ret or valuable but non measurable disease allowed objectives selection if applicable primary overall safety tolerability characterization preliminary activity intracranial activity enrollment initiated june data cut off dose cohorts all doses dose expansion for dose optimization all treated population response evaluable population generation alk i generation alk i or generation alk i alk benefit rate i platinum based chemotherapy dor duration response maximum tolerated dose non small cell lung cancer objective response rate overall survival progression free survival recommended dose tyrosine kinase inhibitor time to response patients with concurrent drivers identified on subsequent testing patients without measurable disease are excluded from efficacy evaluation per protocol analysis plan first response evaluation is pending for patients response evaluable population prospectively defined as all patients with measurable disease without concurrent driver who undergo post response assessment or discontinue treatment due to progression death prior to the first response assessment additional patients for response no measurable disease at tumor with alternate driver met amplification a no post scan discontinued treatment for reasons than tumor pancreatic atypical carcinoid lung source lin | Nuvalent
patient population heavily alk solid tumors phase characteristic age median range female non smoker tumor type pancreatic adenocarcinoma atypical carcinoid lung history of metastases fusion secondary mutation single mutation compound i mutations single or compound all treated treatment history prior lines of anticancer treatment median range prior treatments chemotherapy received any or including and including and all treated a | Nuvalent
preliminary activity tumor response across heavily patient populations phase pete a of with alk resistance mutation i including all dose levels best evaluable metastases any single compound all at doses alk ala chiral rate criteria in solid version tyrosine kinase inhibitor of allelic configuration by central pound mutations with evidence of allelic configuration without post radiographic assessment includes patients with on three patients source lin no | Nuvalent
preliminary activity radiographic tumor response in patients with and without known alk resistance mutations phase key a a dose level cohort prior no mutation single or compound mutation a a holla a prior lines chemotherapy prior lines anticancer therapy data cut off august response evaluable four response evaluable no single or compound not shown due to incomplete or missing post assessments the setting of or symptomatic deterioration mutation as per any prior local testing or central analyses progressive disease partial once daily stable disease tyrosine kinase inhibitor evidence of allelic configuration mutation variant of unknown significance ongoing partial responses pending confirmation single not confirmed additional was including investigational therapy source lin i i | Nuvalent
time on treatment sustained duration with follow up ongoing phase i a a a a prior alk including prior alk no and subsequently confirmed pending confirmation pep all patients tumor response remain without disease progression response evaluable patients continue median range of months median range to response weeks months data as of august for response evaluable patients progressive disease partial response once daily tyrosine kinase inhibitor source lin i | Nuvalent
activity induced intracranial responses in patients with refractory alk phase refractory complete response alk fusion partial response alk fusion no known resistance mutations lines of therapy including and chemotherapy complete resolution of parietal parenchymal brain metastases after weeks treatment continues at months ongoing confirmed weeks weeks alk fusion resistance mutation lines of therapy consisting of and after weeks treatment continues at months ongoing confirmed courtesy of and hospital vall barcelona courtesy of university united states data as of august central nervous system complete response non small cell lung cancer partial response once daily tyrosine kinase inhibitor source lin i | Nuvalent
preliminary safety profile favorable and consistent with alk selective sparing design of phase has not been identified transient asymptomatic grade increase treatment related adverse events in patients all treated patients grade grade grade any grade infrequent requiring dose any modification discontinued due to dose reduced due to overall avoiding related alt increased ast increased nausea constipation fatigue peripheral edema data cut off alt alanine ast aspartate creatinine dose limiting toxicity treatment related adverse event resulting in treatment discontinuation were grade alt grade ast elevations intolerable grade constipation occurred at following dose increase from resulting in dose reduction were grade alt ast elevation grade alt ast elevation grade nausea cognitive disturbance grade elevation grade treatment continues at the reduced dose for these patients source lin i | Nuvalent
potential best in class profile for alk opportunity to both move up the treatment paradigm grow the market with deep durable responses no clear standard of care soc current soc compound mutations disease single mutations disease current soc of disease demonstrated activity where current available therapies have failed opportunity to differentiate with deep durable responses and clinical activity observed in heavily patients who likely exhausted all available therapies with single and compound mutations with history of metastasis including intracranial responses sparing clinical activity observed in patients with single and compound resistance mutations clinical activity observed in patients who are naive favorable overall preliminary safety consistent with avoiding related head to head clinical studies comparing with currently approved or investigational therapies have not been conducted sources sales and forecasts accessed and lung cancer jama shaw and no peters shaw lancet jack cancer res lin package inserts and | Nuvalent
planned clinical development for alk pronged strategy supports goal of moving up the treatment paradigm previously treated naive and treated global open label cohort phase with registrational intent strategy naive head to head phase study with registrational intent phase opportunity accelerated approval in cohort tumor type prior prior i detail a prior or lines prior or or lines registrational intent ale prior with in of therapy male line or eons any solid tumor prior or systemic therapy or whom no satisfactory standard therapy exists an exploratory cohort phase objectives primary by blinded independent central review secondary additional efficacy measures dor intracranial activity overall safety and tolerability confirmation of profile line line line benefit rate dor duration of response objective response rate overall survival progression free survival tyrosine kinase inhibitor time to response | Nuvalent
for sane a brain penetrant selective inhibitor of and resistance mutations with the potential to minimize related adverse events while providing activity | Nuvalent
patient journey of majority are advanced metastatic at diagnosis of care sales no clear standard of care and are approved line agnostic in addition to options is included in guidelines as an option following included in guidelines as an alternative option patients may consider clinical trials or chemotherapy i key brain penetrance activity in experienced patients limitations present with brain metastases at diagnosis has been studied in patients with prior and no prior i of patients progressing on have brain metastases with of treatment limiting off target adverse events coverage of resistance mutations of patients progressing on have resistance mutation adverse events associated with inhibition observed in of patients receiving sources a nat rev jordan cancer discovery a sales and forecasts accessed guidelines for version i and lung cancer precision prescribing information cocco nat rev shaw a illustrative image | Nuvalent
a rationally designed selective sparing inhibitor medical needs preliminary phase conclusions approved approved approved investigational by activity mutant activity activity key observed in clinical investigation activity observed in patients with including after exhausting approved and investigational therapies such as and activity observed in patients with resistance mutations activity mutant activity activity activity observed in patients with history of metastases including intracranial responses avoiding emerging safety profile was consistent with design with no dose reductions or treatment discontinuations due to adverse events source head to head clinical studies comparing with currently approved or investigational therapies have not been conducted | Nuvalent
preclinical characterization demonstrates desired target product profile in activity wild type mutant brain penetrance avoiding inhibition sub activity in day cell viability assays data similar to observations for selectivity for and over i no i a a a i a expressing or mutant fusion wild type han rats single dose hour more active for more active for selectivity index on head to head clinical studies comparing with currently approved or investigational therapies have not been conducted above data from studies bid twice daily half maximal inhibitory concentration patient derived cell line orally stimulated phosphorylation sources a cancer a a | Nuvalent
a global first in human phase clinical trial of in advanced positive and other solid tumors dose preliminary data presented all treated population enrollment completed august updated data to be presented at medical meeting patient population harboring fusions by local testing prior for no limit to number prior chemotherapies or excluded concurrent drivers alk met ret or evaluable but non measurable disease allowed objectives enrollment initiated data as for patients treated by dose cohorts all doses dose expansion for dose optimization tit all treated population response evaluable population selection if applicable primary overall safety tolerability characterization preliminary activity intracranial activity central nervous system dose limiting toxicities milligram maximum tolerated dose non small cell lung cancer once daily recommended dose tyrosine kinase inhibitor patients with concurrent drivers identified on subsequent testing patients without measurable disease are excluded from efficacy evaluation per protocol analysis plan first response evaluation is pending for patients response evaluable population prospectively defined as all patients with measurable disease without concurrent driver who undergo post response assessment or discontinue treatment due to progression death prior to the first response assessment additional patients for response no measurable disease at tumor with alternate driver met amplification voluntarily discontinued study treatment prior to first response assessment tumor pancreatic cancer source | Nuvalent
patient population heavily solid tumors phase characteristic age median range female tumor type pancreatic adenocarcinoma non smoker history of metastases measurable lesions data as of for patients treated by all data shown as unless otherwise ire eon includes patients with untreated lesions categories are not mutually exclusive source a treatment history prior lines of anticancer treatment median range prior treatments without chemotherapy and chemotherapy without chemotherapy and chemotherapy received other a | Nuvalent
preliminary activity phase induced tumor response across heavily patient populations radiographic tumor regression observed across all dose levels data as of for response evaluable patients with treated by central nervous system not evaluable objective response rate progressive disease partial response once daily response evaluation criteria in solid version stable disease tyrosine kinase inhibitor footnotes for waterfall two patients and dose cohorts both with prior therapies consisting of and chemotherapy not shown due to incomplete or missing post tumor assessments in the setting of and symptomatic deterioration not confirmed ongoing partial responses pending confirmation best response due to residual disease additional prior was including and investigational therapy patients with across all dose levels best response all response evaluable resistance mutation history of metastases prior and chemotherapy prior or includes ongoing partial responses pending confirmation includes ongoing partial response pending confirmation patient discontinued treatment due to clinical progression without post radiographic assessment these prior were discontinued due to progressive disease in patients key a a source a prior lines anticancer therapy i a a dose level cohort prior prior lines chemotherapy a | Nuvalent
key subgroups a a i induced rapid responses in resistant patients reduction in tumor burden in cancers with resistance mutations subgroup with known resistance mutation with tumor shrinkage one patient with with ongoing pending confirmation activity intracranial in patients with measurable metastases of patients with history of metastases in response evaluable no progression observed in any of the treated patients source a reduction in allele complete clearance in patients i a i a a a i a a months weeks induced responses in intracranial lesions weeks intracranial response in year old female with fusion previously treated with chemotherapy and with progression and no known resistance mutations patient continues at months with ongoing response images courtesy of lin general hospital each unique color indicates data from the same patient across both figures due to new lesions and or progression of lesions prior treatments include best response on data as of for patients treated by central nervous system circulating tumor acid non small cell lung cancer objective response rate progressive disease partial response once daily stable disease tyrosine kinase inhibitor includes ongoing partial response pending confirmation central analysis by guardant includes patients with detectable at and at least one on treatment follow up assessment bar represents week result week results are pending one patient with an ongoing intracranial pending confirmation includes ongoing partial responses pending confirmation | Nuvalent
preliminary safety profile favorable and consistent with the highly selective sparing design of in no no treatment related no aes leading to dose eduction or or discontinuation ion no treatment related dizziness treatment related adverse events in patient all treated patients fatigue alt increased ast increased myalgia grade grade grade any grade data as for patients treated by adverse event alt alanine ast aspartate dose limiting toxicity including source a a | Nuvalent
of met all desired clinical characteristics phase favorable tolerability was observed in preliminary profile presented patients enrolled across six dose levels as may was not reached no clinically significant exposure response relationships for safety and efficacy were observed wide therapeutic window was consistent with selective sparing design the dose level daily maintained steady state plasma levels above target efficacy thresholds i a a a a a a target target wild type target periphery target wild type periphery data as for patients treated by data for cohort are not shown due to immaturity central nervous system hours once daily standard deviation based on tumor regression in in models bearing and respectively values for a and divided by predicted human brain to plasma ratio respectively source data on file a i | Nuvalent
potential best in class profile for opportunity to both move up the treatment paradigm grow the market with deep durable responses no clear standard of care soc mutation disease current soc of disease demonstrated activity where current available therapies have failed opportunity to supplant standard of care with a differentiated clinical activity observed in heavily patients with who likely exhausted all available therapies including after or with resistance mutations with history of metastasis including intracranial responses to address combined medical needs mutation coverage activity avoiding off target adverse events opportunity to drive deep durable responses favorable preliminary safety consistent with selective sparing design sources sales and forecasts accessed lin precision and lung cancer a | Nuvalent
clinical development strategy for ongoing phase supports goal of moving up the treatment paradigm naive and treated ongoing global open label cohort phase with registrational intent enrollment planned across north and all patients receive at primary objective by blinded independent central review secondary objectives additional efficacy measures dor intracranial activity overall safety and tolerability confirmation of profile pros phase opportunity approval in both and cohort tumor type treatment status prior prior i a positive naive none none positive treated any positive solid tumor any prior therapy registrational intent exploratory cohort an any line line benefit rate dor duration of response objective response rate overall survival progression free survival pro patient reported outcomes once daily tyrosine kinase inhibitor time to response approximate cohort size subject to change either or platinum based chemotherapy with or without with initial of either or includes who do not qualify any of the other cohorts | Nuvalent
for her a brain penetrant her selective inhibitor with to minimize related adverse events activity against mutations and the potential | Nuvalent
preclinical characterization demonstrates desired target product profile potent inhibition of her and her mutations in cell based phosphorylation and viability assays greater selectivity for her mutations over than pan inhibitors data similar to observations for i assays viability assays assay her her her her exon insertion mutations such as her and her induce constitutive kinase activation more active for her to more active for selectivity index ion i a a a i a han rats single dose hour no head to head clinical studies have been conducted for currently approved or investigational therapies versus above data from studies her her exon insertion half maximal inhibitory concentration orally source | Nuvalent
the path to patient impact ams program status first approved and pivotal data study for phase ongoing with registrational intent for patients with execute on global registrational strategies additional discovery research programs ongoing product study for alk demonstrated clinical proof of concept in phase with mission bringing new best in class medicines to patients with cancer planned development in both and alk planned phase initiation in for her i | Nuvalent
| Nuvalent
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