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Humacyte(HUMA) - 2025 Q1 - Quarterly Report
HUMAHumacyte(HUMA)2025-05-13 21:11
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Financial Performance - Total revenue for Q1 2025 was 517,000,comparedto517,000, compared to 0 in Q1 2024, with product revenue of 147,000andcontractrevenueof147,000 and contract revenue of 370,000[17]. - The net income for Q1 2025 was 39.1million,asignificantimprovementfromanetlossof39.1 million, a significant improvement from a net loss of 31.9 million in Q1 2024[17]. - For the three months ended March 31, 2025, the net income attributable to common stockholders was 36,765,000,comparedtoanetlossof36,765,000, compared to a net loss of 31,896,000 for the same period in 2024, representing a significant turnaround[61]. - Basic and diluted net income per share attributable to common stockholders for Q1 2025 was 0.28,comparedtoalossof0.28, compared to a loss of 0.29 per share in Q1 2024[61]. - The company incurred operating losses of approximately 23.2millionforthethreemonthsendedMarch31,2025,comparedto23.2 million for the three months ended March 31, 2025, compared to 26.6 million for the same period in 2024[214]. Cash and Liquidity - Cash and cash equivalents increased to 62.8millionasofMarch31,2025,upfrom62.8 million as of March 31, 2025, up from 44.9 million at the end of 2024[16]. - The accumulated deficit decreased to 646.9millionasofMarch31,2025,from646.9 million as of March 31, 2025, from 686.0 million at the end of 2024[26]. - The company raised 47millionfromapublicofferinginQ12025,contributingtoanetincreaseincashandcashequivalents[22].−AsofMarch31,2025,thecompanyhadavailablecashandcashequivalentsof47 million from a public offering in Q1 2025, contributing to a net increase in cash and cash equivalents[22]. - As of March 31, 2025, the company had available cash and cash equivalents of 62.8 million, with an additional 72.6millionremainingundertheATMFacility[31][32].−Totalcash,cashequivalents,andrestrictedcashamountedto72.6 million remaining under the ATM Facility[31][32]. - Total cash, cash equivalents, and restricted cash amounted to 113.2 million as of March 31, 2025, up from 95.3 million as of December 31, 2024[58]. Operating Expenses and R&D - Operating expenses decreased to 23.7 million in Q1 2025 from 26.6millioninQ12024,primarilyduetoareductioninresearchanddevelopmentcosts[17].−TotalresearchanddevelopmentexpensesforthethreemonthsendedMarch31,2025,were26.6 million in Q1 2024, primarily due to a reduction in research and development costs[17]. - Total research and development expenses for the three months ended March 31, 2025, were 15.4 million, a decrease of 27.0% compared to 21.3millionforthesameperiodin2024[44].−Thecompanyimplementedacostreductionactiontoreduceitsworkforcebyapproximately31employeestoimprovecashrunway[32].AssetsandLiabilities−Thetotalassetsincreasedto21.3 million for the same period in 2024[44]. - The company implemented a cost reduction action to reduce its workforce by approximately 31 employees to improve cash runway[32]. Assets and Liabilities - The total assets increased to 162.6 million as of March 31, 2025, compared to 137.9millionattheendof2024[16].−ThecompanyrecordedarevenueinterestliabilityrelatedtothePurchaseAgreement,netofadebtdiscounttotaling137.9 million at the end of 2024[16]. - The company recorded a revenue interest liability related to the Purchase Agreement, net of a debt discount totaling 4.6 million, reflecting the contractual repayment obligation based on future revenue estimates[99]. - As of March 31, 2025, the revenue interest liability was 66.4million,upfrom66.4 million, up from 64.2 million as of December 31, 2024, reflecting an increase of approximately 3.4%[100]. Strategic Partnerships and Agreements - The company has a strategic partnership with Fresenius Medical Care to distribute its 6 millimeter ATEV for specific indications outside the United States, which is crucial for market expansion[65]. - The distribution agreement with Fresenius Medical Care includes a 150millionfinancingtransactionanda150 million financing transaction and a 25 million investment as part of a private placement offering[192]. - The Company entered into a JDRF Agreement on April 1, 2023, with funding up to 0.8 million based on achieving specific R&D milestones related to the BVP product candidate[179]. Regulatory and Product Development - The FDA granted full approval for the ATEV under the brand name Symvess on December 19, 2024, for use in adults as a vascular conduit for extremity arterial injury[210]. - The company commenced commercial shipments of Symvess in March 2025 following FDA authorization[212]. - The company plans to submit a supplemental BLA for the ATEV for AV access for hemodialysis in the second half of 2026, depending on interim results from the ongoing V012 Phase 3 trial[213]. Stock and Equity - The weighted-average common shares outstanding increased to 131,496,877 in Q1 2025 from 108,246,008 in Q1 2024, indicating a 21.5% increase in shares[61]. - The Company has 47.5 million remaining available for sales of Common Stock under the Common Stock Purchase Agreement as of March 31, 2025[110]. - The Company sold 500,000 shares to Lincoln Park for aggregate gross proceeds of $2.5 million through the Common Stock Purchase Agreement[110]. Risks and Future Outlook - The company expects to continue incurring substantial operating losses and negative cash flows as it advances its product candidates[26]. - The company believes it has the ability to fund operations at least into the second half of 2026 based on current cash and management plans[32]. - The company is subject to various risks, including successful commercialization of its product candidates and the ability to secure additional capital for operations[63].