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Centessa Pharmaceuticals(CNTA) - 2024 Q3 - Quarterly Report
CNTACentessa Pharmaceuticals(CNTA)2024-11-12 12:16

Pipeline Development - Centessa Pharmaceuticals is developing a pipeline of high conviction programs targeting unmet medical needs in multi-billion-dollar markets[114]. - The most advanced program is ORX750, an OX2R agonist for treating sleep-wake disorders, with a favorable safety and tolerability profile observed in Phase 1 studies[115][116]. - A Phase 2a clinical study of ORX750 has been initiated to evaluate its safety, tolerability, and pharmacokinetics in patients with narcolepsy and idiopathic hypersomnia, with initial dosing set at 1.0 mg for NT1 and 2.0 mg for NT2 and IH[127]. - ORX142, a second OX2R agonist candidate, is being advanced for neurological and psychiatric disorders, with preclinical data showing efficacy in promoting wakefulness[128]. - ORX489, the third OX2R agonist candidate, is entering IND-enabling activities for additional neurological and psychiatric disorders[129]. - The LockBody technology platform is being utilized to develop LB101, a bi-specific monoclonal antibody for treating solid tumors, with a Phase 1/2a study initiated in March 2023[130]. Clinical Study Updates - Interim data from the Phase 1 study showed significant increases in wakefulness at doses of 1.0 mg and 2.5 mg compared to placebo, with mean sleep latencies of 18 minutes and 32 minutes respectively[117][120]. - The Phase 1 study has completed three single-ascending dose cohorts and demonstrated a clear dose-dependent response in wakefulness[119][120]. - The Phase 1 study of ORX750 is ongoing, with dose escalation continuing in various cohorts, and a presentation of data is planned for a medical conference in the second quarter of 2025[126]. Financial Performance - Research and development expenses for Q3 2024 were 33.9million,anincreasefrom33.9 million, an increase from 28.2 million in Q3 2023, primarily due to higher costs associated with the OX2R agonist program[150]. - General and administrative expenses for Q3 2024 were 12.5million,comparedto12.5 million, compared to 12.0 million in Q3 2023, with personnel expenses increasing by 0.8million[151].−ThenetlossforQ32024was0.8 million[151]. - The net loss for Q3 2024 was 42.6 million, compared to a net loss of 38.6millioninQ32023[148].−InterestincomeforQ32024was38.6 million in Q3 2023[148]. - Interest income for Q3 2024 was 3.3 million, up from 2.9millioninQ32023,whileinterestexpensewas2.9 million in Q3 2023, while interest expense was 2.6 million, slightly higher than 2.5millioninthesameperiod[152].−OtherincomeforQ32024wasanetgainof2.5 million in the same period[152]. - Other income for Q3 2024 was a net gain of 3.7 million, compared to a net expense of 1.7millioninQ32023[153].−Thecompanyrecordedanincometaxexpenseof1.7 million in Q3 2023[153]. - The company recorded an income tax expense of 0.6 million in Q3 2024, contrasting with an income tax benefit of 2.8millioninQ32023[154].−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,were2.8 million in Q3 2023[154]. - Research and development expenses for the nine months ended September 30, 2024, were 89.4 million, down from 94.7millionforthesameperiodin2023[155].−GeneralandadministrativeexpensesfortheninemonthsendedSeptember30,2024,were94.7 million for the same period in 2023[155]. - General and administrative expenses for the nine months ended September 30, 2024, were 37.1 million, down from 41.4millionintheprioryear,primarilyduetotheabsenceofERPsystemimplementationcosts[157].−Interestincomeincreasedto41.4 million in the prior year, primarily due to the absence of ERP system implementation costs[157]. - Interest income increased to 9.2 million for the nine months ended September 30, 2024, up 1.6millionfromthesameperiodin2023,duetointerestearnedfromcashandcashequivalents[158].−Interestexpenseroseto1.6 million from the same period in 2023, due to interest earned from cash and cash equivalents[158]. - Interest expense rose to 7.6 million in the first nine months of 2024, an increase of 0.3millioncomparedtothesameperiodin2023,attributedtoahigheraverageinterestrateontheNotePurchaseAgreement[159].−OtherincomefortheninemonthsendedSeptember30,2024,wasanetgainof0.3 million compared to the same period in 2023, attributed to a higher average interest rate on the Note Purchase Agreement[159]. - Other income for the nine months ended September 30, 2024, was a net gain of 2.3 million, compared to a net expense of 4.6millioninthesameperiodof2023,mainlyduetoforeigncurrencytransactiongains[160].CashandFinancing−AsofSeptember30,2024,thecompanyhadcash,cashequivalents,andshort−terminvestmentstotaling4.6 million in the same period of 2023, mainly due to foreign currency transaction gains[160]. Cash and Financing - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments totaling 518.4 million, expected to fund operations into mid-2027[134]. - The company completed a public offering of 17,542,372 ADSs at an offering price of 14.75perADS,resultinginnetproceedsofapproximately14.75 per ADS, resulting in net proceeds of approximately 242.7 million[166]. - Net cash used in operating activities for the nine months ended September 30, 2024, was 99.3million,animprovementfrom99.3 million, an improvement from 129.3 million in the same period of 2023[168]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was 361.8million,significantlyhigherthan361.8 million, significantly higher than 14.8 million in the prior year, primarily due to proceeds from share offerings[173]. - The company sold 1,250,000 ordinary shares under the ATM Program in the nine months ended September 30, 2024, generating net proceeds of 9.7million[165].StrategicDecisions−ThecompanyannouncedthediscontinuationoftheglobalclinicaldevelopmentofSerpinPC,reallocatingapproximately9.7 million[165]. Strategic Decisions - The company announced the discontinuation of the global clinical development of SerpinPC, reallocating approximately 200 million in net savings towards the OX2R agonist program[131]. - The company plans to explore potential strategic alternatives for SerpinPC following its discontinuation[131]. - The company expects aggregate expenses in 2024 to be similar to 2023, reflecting higher costs related to the SerpinPC registration program and increased spending on the OX2R agonist portfolio[174]. - Future expenses are anticipated to increase significantly as the company seeks to discover and develop current and future clinical and preclinical product candidates[174]. - The company will need to rely on additional financing to achieve business objectives, as commercial revenues from product candidates are not expected for the next couple of years[176]. Tax and Obligations - The company has provided a valuation allowance for the full amount of the net deferred tax assets in the U.K. due to a history of cumulative net losses[190]. - The company entered into a Note Purchase Agreement in October 2021, obligating it to pay a milestone payment equal to 30% of the aggregate principal amount upon regulatory approval of any drug candidate[183]. - The fair value of the Note Purchase Agreement is based on the present value of estimated future payments, including interest and principal[185]. - The company measures share-based awards at their grant-date fair value and records compensation expense over the vesting period[186]. - The company is classified as an emerging growth company and a smaller reporting company, allowing it to delay the adoption of new accounting standards[192][193]. - As of September 30, 2024, the company had no material contractual obligations and other commitments associated with enforceable contracts[191].