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Bicycle Therapeutics(BCYC) - 2024 Q4 - Annual Report

Financial Performance - The company has incurred net losses of 169.0million,169.0 million, 180.7 million, and 112.7millionfortheyearsendedDecember31,2024,2023,and2022,respectively,withanaccumulateddeficitof112.7 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of 680.8 million as of December 31, 2024[564]. - The net loss for the year ended December 31, 2024, was 169.031million,adecreaseof169.031 million, a decrease of 11.633 million from a net loss of 180.664millionin2023[596].Thecompanydoesnotexpecttogeneraterevenuefromproductsalesfortheforeseeablefuture,relyinginsteadoncollaborationrevenue[571].Thecompanyhasnotgeneratedrevenuefromproductsalessinceinceptionandexpectstocontinueincurringsignificantoperatinglosses[605].RevenueandCollaborationThecompanyhasreceivedgrossproceedsof180.664 million in 2023[596]. - The company does not expect to generate revenue from product sales for the foreseeable future, relying instead on collaboration revenue[571]. - The company has not generated revenue from product sales since inception and expects to continue incurring significant operating losses[605]. Revenue and Collaboration - The company has received gross proceeds of 1.4 billion from the sale of ordinary shares and 236.6millionfromcollaborationagreementssinceitsinceptionin2009[563].Collaborationrevenueincreasedby236.6 million from collaboration agreements since its inception in 2009[563]. - Collaboration revenue increased by 8.3 million in the year ended December 31, 2024, compared to 2023, primarily due to increases from collaborations with Novartis (6.3million),Genentech(6.3 million), Genentech (2.9 million), and Bayer (2.2million)[597].Collaborationrevenueincreasedby2.2 million)[597]. - Collaboration revenue increased by 8.3 million to 35.3millionin2024,drivenbycontributionsfromcollaborationswithNovartis,Genentech,andBayer[596].Thecompanyhasnotrecognizedanysalesbasedroyaltyrevenuefromitscollaborationagreementstodate[643].ExpensesandOperatingCostsTotaloperatingexpensesfor2024were35.3 million in 2024, driven by contributions from collaborations with Novartis, Genentech, and Bayer[596]. - The company has not recognized any sales-based royalty revenue from its collaboration agreements to date[643]. Expenses and Operating Costs - Total operating expenses for 2024 were 245.147 million, an increase of 28.225millioncomparedto28.225 million compared to 216.922 million in 2023[596]. - Research and development expenses for the year ended December 31, 2024, were 172.966million,anincreaseof172.966 million, an increase of 16.470 million from 156.496millionin2023[596].Generalandadministrativeexpensesroseto156.496 million in 2023[596]. - General and administrative expenses rose to 72.181 million in 2024, up by 11.755millionfrom11.755 million from 60.426 million in 2023[596]. - The company anticipates substantial increases in expenses and capital requirements as it continues its development activities and seeks marketing approvals[565]. - General and administrative expenses are anticipated to rise as the company increases headcount to support research and development and potential commercialization efforts[586]. Cash and Financing - As of December 31, 2024, the company had cash and cash equivalents of 879.5million,whichisexpectedtofundoperationsforatleast12months[570].Netcashusedinoperatingactivitieswas879.5 million, which is expected to fund operations for at least 12 months[570]. - Net cash used in operating activities was 164.72 million in 2024, an increase of 104.1millioncomparedto2023,largelyduetohighercashpaymentsforongoingdevelopmentactivities[608].Netcashprovidedbyfinancingactivitieswas104.1 million compared to 2023, largely due to higher cash payments for ongoing development activities[608]. - Net cash provided by financing activities was 519.75 million in 2024, primarily from net proceeds of 544.1millionfromaprivateplacement[610].Thecompanyexpectstofinanceitscashneedsthroughequityofferings,debtfinancings,collaborations,andotherstrategictransactions,whichmaydiluteexistingshareholdersownership[622].ResearchandDevelopmentThecompanyisevaluatingmultipleproductcandidates,includingzelenectidepevedotinandBT5528,inongoingclinicaltrials[559].Thecompanyexpectsresearchanddevelopmentexpensestocontinueincreasingduetoanexpandedportfolioofproductcandidatesandongoingclinicaltrials[579].Researchanddevelopmentexpensesincreasedby544.1 million from a private placement[610]. - The company expects to finance its cash needs through equity offerings, debt financings, collaborations, and other strategic transactions, which may dilute existing shareholders' ownership[622]. Research and Development - The company is evaluating multiple product candidates, including zelenectide pevedotin and BT5528, in ongoing clinical trials[559]. - The company expects research and development expenses to continue increasing due to an expanded portfolio of product candidates and ongoing clinical trials[579]. - Research and development expenses increased by 16.5 million to 172.97millionin2024,primarilyduetoa172.97 million in 2024, primarily due to a 38.6 million increase in clinical program expenses for zelenectide pevedotin[599]. - The company incurred approximately 156.6millionindirectexternalexpensesforthedevelopmentofzelenectidepevedotinsinceitscandidatenomination[600].ObligationsandLiabilitiesTotalcontractualobligationsasofDecember31,2024,amountedto156.6 million in direct external expenses for the development of zelenectide pevedotin since its candidate nomination[600]. Obligations and Liabilities - Total contractual obligations as of December 31, 2024, amounted to 11.18 million, with 6.07millionduewithinoneyear[615].Thecompanyhasenteredintoagreementswiththirdpartiesforfuturemilestonepaymentstotaling6.07 million due within one year[615]. - The company has entered into agreements with third parties for future milestone payments totaling 166.2 million, contingent upon achieving specific milestones[618]. - Future debt financing may involve covenants that restrict the company's operations or ability to incur additional debt[622]. Economic and Market Conditions - High inflation rates and increased costs of clinical trial materials and supplies may adversely affect the company's operating results and cash flows[623]. - The company faces challenges in raising capital due to unfavorable global economic and political conditions, which may impact its development programs[621]. - The company is subject to potential downward pressure on share prices due to economic uncertainty and volatility in capital markets[623].