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Sonnet BioTherapuetics(SONN) - 2025 Q1 - Quarterly Report

Financial Performance - Total assets increased to 7,182,027asofDecember31,2024,comparedto7,182,027 as of December 31, 2024, compared to 2,771,030 as of September 30, 2024, representing a growth of 159%[12] - Collaboration revenue for the three months ended December 31, 2024, was 1,000,000,asignificantincreasefrom1,000,000, a significant increase from 18,626 in the same period of 2023[14] - Total operating expenses rose to 3,849,422forthethreemonthsendedDecember31,2024,comparedto3,849,422 for the three months ended December 31, 2024, compared to 1,297,497 in the prior year, marking an increase of 196%[14] - Net loss for the three months ended December 31, 2024, was 3,160,706,comparedtoanetlossof3,160,706, compared to a net loss of 1,168,509 for the same period in 2023, reflecting a 170% increase in losses[14] - Cash at the end of the period increased to 4,861,503from4,861,503 from 149,456 at the beginning of the period, indicating a net increase of 4,712,047[18]Thecompanyrecordedtotalliabilitiesof4,712,047[18] - The company recorded total liabilities of 3,145,458 as of December 31, 2024, compared to 3,256,769asofSeptember30,2024,showingadecreaseofapproximately3.43,256,769 as of September 30, 2024, showing a decrease of approximately 3.4%[12] - For the three months ended December 31, 2024, the net loss was 3.16 million, compared to a net loss of 1.17millionforthesameperiodin2023,representinga1701.17 million for the same period in 2023, representing a 170% increase in losses[18] - Net cash used in operating activities was 2.91 million for Q4 2024, slightly improved from 3.09millioninQ42023[18]Thecompanyraised3.09 million in Q4 2023[18] - The company raised 7.71 million from the issuance of common stock in Q4 2024, compared to 3.84millioninQ42023,indicatinga1013.84 million in Q4 2023, indicating a 101% increase in financing activities[18] - Cash at the end of the period was 4.86 million, up from 3.02millionattheendofQ42023,reflectinga613.02 million at the end of Q4 2023, reflecting a 61% increase in cash reserves[18] Shareholder Information - The company reported a weighted average of 2,022,818 shares outstanding for the three months ended December 31, 2024, compared to 474,699 shares in the same period of 2023[14] - The number of shares outstanding increased to 3,007,431 as of December 31, 2024, from 650,284 at the end of September 2024[12][16] - The weighted-average number of shares for diluted net loss per share remains the same as for basic net loss per share due to the anti-dilutive effect of dilutive securities[51] - The Company has a total of 5,161,565 potentially dilutive securities excluded from the computation of diluted shares as of December 31, 2024, compared to 805,931 in 2023[54] - As of December 31, 2024, the Company had a total of 5,789,600 outstanding warrants[91] Clinical Development - The company initiated a U.S. clinical trial (SB101) for its lead asset SON-1010 in oncology patients with solid tumors in Q2 2022[21] - Sonnet BioTherapeutics received FDA clearance for its Investigational New Drug (IND) application for SON-1010 in March 2022, allowing clinical development to proceed[21] - The company created a wholly-owned Australian subsidiary for conducting clinical trials, with an Australian study (SB102) of SON-1010 initiated in Q3 2022[21] - In January 2023, Sonnet announced a collaboration with Roche to evaluate SON-1010 with atezolizumab for platinum-resistant ovarian cancer, with the trial approved in June 2023[22] - Sonnet expanded its Phase 1 SB101 clinical study of SON-1010 in January 2025 to include a new cohort with trabectedin, which was approved as a second-line treatment in early 2024[23] - The Data Safety Monitoring Board cleared the Phase 1b/2a study of SON-080 in chemotherapy-induced peripheral neuropathy to proceed to Part 2 in early 2024[26] - Sonnet entered into a License Agreement with Alkem Laboratories in October 2024 to develop SON-080 for diabetic peripheral neuropathy in India[26] - SON-1210, a lead bifunctional construct, is being developed for solid tumors, with a Phase 1b/2a study in pancreatic cancer initiated by the Sarcoma Oncology Center[27] - SON-080 is advancing in clinical trials for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, with a Phase 1b/2a study approved in Q3 2022[26] Financing and Capital Structure - The Company has a committed equity facility allowing it to sell up to 25.0 million in common stock, with 24.9millionavailableasofDecember31,2024[84]TheCompanyclosedapublicofferingonOctober26,2023,raisingnetproceedsof24.9 million available as of December 31, 2024[84] - The Company closed a public offering on October 26, 2023, raising net proceeds of 3.9 million through the sale of 163,281 shares and warrants[81] - A subsequent public offering on November 7, 2024, generated net proceeds of 4.2millionfromthesaleof155,000sharesandwarrants[85]TheCompanyraisedapproximately4.2 million from the sale of 155,000 shares and warrants[85] - The Company raised approximately 3.5 million from a registered direct and PIPE offering completed on December 10, 2024[90] - The Company recorded a contract asset of 0.5millionrelatedtotheAlkemAgreement,representingunbilledcollaborationrevenue[80]TheNewLifeAgreementgenerated0.5 million related to the Alkem Agreement, representing unbilled collaboration revenue[80] - The New Life Agreement generated 1.0 million in non-refundable upfront cash payments, fully recognized by December 31, 2023[72] - Under the Alkem Agreement, the Company will receive 1.0millioninupfrontpaymentsanduptoanadditional1.0 million in upfront payments and up to an additional 1.0 million in milestone payments, along with low double-digit royalties on net sales in India[75] Expenses and Liabilities - Total accrued expenses and other current liabilities as of December 31, 2024, amounted to 1,394,520,anincreasefrom1,394,520, an increase from 942,489 as of September 30, 2024, with research and development expenses rising to 969,684from969,684 from 617,545[59] - The company has contingent milestone payments totaling 3.8milliontoXOMAuponachievingcertaindevelopmentmilestonesrelatedtoproductcommercialization[61]Thecompanyincurreda3.8 million to XOMA upon achieving certain development milestones related to product commercialization[61] - The company incurred a 0.1 million technology access fee upon execution of the Navigo Agreement, with additional contingent milestone payments of up to 1.0millionbasedonevaluationanddevelopmentmilestones[70]Thecompanyhasaonetimefeeobligationof1.0 million based on evaluation and development milestones[70] - The company has a one-time fee obligation of 1.5 million or 5% of the first upfront payment received from a third-party partnership under the SOC Agreement for the development of SON-1210[67] - The Company incurred 12,000inlicensefeesundertheBrinkAgreementduringthethreemonthsendedDecember31,2024and2023[65]ManagementandGovernanceThecompanyappointedDonaldGriffithasChiefFinancialOfficereffectiveFebruary21,2025,followingtheresignationofJayCross[100]StephenMcAndrewwasappointedasChiefBusinessOfficer,withanannualbasesalaryof12,000 in license fees under the Brink Agreement during the three months ended December 31, 2024 and 2023[65] Management and Governance - The company appointed Donald Griffith as Chief Financial Officer effective February 21, 2025, following the resignation of Jay Cross[100] - Stephen McAndrew was appointed as Chief Business Officer, with an annual base salary of 330,000 and eligibility for a performance-based cash bonus of up to 35%[101]