Sonnet BioTherapeutics Reports Fiscal Year 2024 Financial Results and Provides Corporate Update
Sonnet BioTherapeutics (NASDAQ: SONN) reported fiscal year 2024 results with significant operational improvements. The company achieved a 37% reduction in total operating expenses compared to fiscal year 2023, with 43% of expenses covered by non-dilutive funding. Key developments include progress in clinical trials for SON-1010 in solid tumors and Platinum-Resistant Ovarian Cancer, and a licensing agreement for SON-080 in Diabetic Peripheral Neuropathy.
Financial results show R&D expenses decreased to $5.7M from $11.8M, and G&A expenses reduced to $6.1M from $7.1M year-over-year. The company had $0.1M cash on hand as of September 30, 2024, but secured additional funding through stock sales and tax incentives, projecting operations funded through July 2025.
Sonnet BioTherapeutics (NASDAQ: SONN) ha riportato i risultati dell'anno fiscale 2024 mostrando significativi miglioramenti operativi. L'azienda ha ottenuto una riduzione del 37% delle spese operative totali rispetto all'anno fiscale 2023, con il 43% delle spese coperte da finanziamenti non diluitivi. Sviluppi chiave includono progressi negli studi clinici per SON-1010 nei tumori solidi e nel cancro ovarico resistente al platino, oltre a un accordo di licenza per SON-080 nella neuropatia periferica diabetica.
I risultati finanziari mostrano che le spese per R&S sono scese a 5,7 milioni di dollari da 11,8 milioni, e le spese generali e amministrative sono diminuite a 6,1 milioni da 7,1 milioni rispetto all'anno precedente. L'azienda aveva 0,1 milioni di dollari in cassa al 30 settembre 2024, ma ha ottenuto finanziamenti aggiuntivi tramite vendite di azioni e incentivi fiscali, prevedendo operazioni finanziate fino a luglio 2025.
Sonnet BioTherapeutics (NASDAQ: SONN) reportó resultados del año fiscal 2024 con importantes mejoras operativas. La compañía logró una reducción del 37% en los gastos operativos totales en comparación con el año fiscal 2023, con un 43% de los gastos cubiertos por financiamiento no dilutivo. Los desarrollos clave incluyen avances en ensayos clínicos para SON-1010 en tumores sólidos y cáncer de ovario resistente al platino, así como un acuerdo de licencia para SON-080 en neuropatía periférica diabética.
Los resultados financieros muestran que los gastos en I+D disminuyeron a 5,7 millones de dólares desde 11,8 millones, y los gastos generales y administrativos se redujeron a 6,1 millones desde 7,1 millones año tras año. La compañía tenía 0,1 millones de dólares en efectivo al 30 de septiembre de 2024, pero aseguró financiamiento adicional a través de ventas de acciones e incentivos fiscales, proyectando operaciones financiadas hasta julio de 2025.
Sonnet BioTherapeutics (NASDAQ: SONN)는 2024 회계연도의 결과를 보고하며 상당한 운영 개선을 달성했습니다. 이 회사는 2023 회계연도와 비교하여 총 운영 비용을 37% 줄였습니다, 그리고 비용의 43%는 비희석 자금으로 충당되었습니다. 주요 개발 사항으로는 SON-1010의 고형 종양 및 백금 내성 난소암에 대한 임상 시험에서의 진전과 SON-080의 당뇨병성 말초신경병증에 대한 라이센스 계약이 포함됩니다.
재무 결과는 연구개발비가 5.7백만 달러에서 11.8백만 달러로 감소했으며, 일반관리비는 6.1백만 달러에서 7.1백만 달러로 감소했음을 보여줍니다. 이 회사는 2024년 9월 30일 기준으로 0.1백만 달러의 현금을 보유하고 있었지만, 주식 판매 및 세금 인센티브를 통해 추가 자금을 확보하여 2025년 7월까지 운영 자금을 계획하고 있습니다.
Sonnet BioTherapeutics (NASDAQ: SONN) a annoncé les résultats de l'exercice fiscal 2024 avec des améliorations opérationnelles significatives. La société a réussi à réaliser une réduction de 37% des dépenses opérationnelles totales par rapport à l'exercice fiscal 2023, avec 43% des dépenses couvertes par un financement non dilutif. Les développements clés incluent des progrès dans les essais cliniques pour SON-1010 dans les tumeurs solides et le cancer de l'ovaire résistant au platine, ainsi qu'un accord de licence pour SON-080 dans la neuropathie périphérique diabétique.
Les résultats financiers montrent que les dépenses en R&D ont diminué à 5,7 millions de dollars contre 11,8 millions, et les dépenses générales et administratives ont été réduites à 6,1 millions de dollars contre 7,1 millions d'une année sur l'autre. La société avait 0,1 million de dollars en liquidités au 30 septembre 2024, mais a sécurisé un financement supplémentaire par le biais de ventes d'actions et d'incitations fiscales, projetant des opérations financées jusqu'en juillet 2025.
Sonnet BioTherapeutics (NASDAQ: SONN) berichtete über die Ergebnisse des Geschäftsjahres 2024 und bedeutende betriebliche Verbesserungen. Das Unternehmen erzielte eine Reduzierung der Gesamtkosten um 37% im Vergleich zum Geschäftsjahr 2023, wobei 43% der Kosten durch nicht verwässerndes Kapital gedeckt wurden. Wichtige Entwicklungen umfassen Fortschritte in klinischen Studien für SON-1010 bei soliden Tumoren und platinresistentem Ovarialkarzinom sowie eine Lizenzvereinbarung für SON-080 bei diabetischer peripherer Neuropathie.
Die finanziellen Ergebnisse zeigen, dass die F&E-Ausgaben von 11,8 Millionen auf 5,7 Millionen Dollar gesenkt wurden und die allgemeinen Verwaltungsaufwendungen von 7,1 Millionen auf 6,1 Millionen Dollar sanken. Das Unternehmen hatte zum 30. September 2024 0,1 Millionen Dollar Bargeld, sicherte jedoch zusätzliche Finanzierung durch Aktienverkäufe und Steueranreize, wobei die Betriebe bis Juli 2025 finanziert werden sollen.
- 37% reduction in total operating expenses year-over-year
- 43% of operating expenses covered by non-dilutive funding
- R&D expenses decreased by 51.7% to $5.7M from $11.8M
- G&A expenses reduced by 14.1% to $6.1M from $7.1M
- Secured approximately $7.7M through stock and warrant sales in Nov-Dec 2024
- Low cash position of $0.1M as of September 30, 2024
- cash runway only extending to July 2025
- Ongoing need for additional financing through stock sales causing potential dilution
Insights
The fiscal year 2024 results show significant cost optimization, with total operating expenses reduced by
The clinical progress of SON-1010 represents meaningful advancement with completed dose escalation in Phase 1 for solid tumors and ongoing Phase 1b/2a trial in combination with atezolizumab. Key data readouts expected in 2025 could validate the FHAB platform technology. The expansion into pancreatic cancer with SON-1210 through the Sarcoma Oncology Center collaboration and the Alkem partnership for SON-080 in diabetic peripheral neuropathy demonstrate pipeline diversification. The published mechanism of action data in Frontiers in Immunology and new patent coverage for SON-1411 and SON-1400 strengthen the company's intellectual property position.
Continued progress with both clinical trials of lead program, SON-1010, for solid tumors and Platinum-Resistant Ovarian Cancer (PROC)
Executed licensing agreement to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral Neuropathy (DPN)
Multiple value-driving milestones expected throughout calendar year 2025 as well as pipeline expansion opportunities across the solid tumor market
Total annual operating expenses reduced by an approximate
Approximately
PRINCETON, NJ, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported today financial results for the fiscal year ended September 30, 2024 and provided a corporate update.
“We are very pleased with the progress we have made across all facets of the company’s operations. On the financial front, we have delivered on our stated objective of cutting costs through an approximate
Recent Highlights
- Announced topline safety data following successful completion of SON-1010 monotherapy dose escalation in the Phase 1 SB101 trial;
- Announced the publication of extensive discovery, development, and preclinical data regarding SON-1010, demonstrating its mechanism of action in a paper entitled, “SON-1010: an albumin-binding IL-12 fusion protein that improves cytokine half-life, targets tumors, and enhances therapeutic efficacy,” in Frontiers in Immunology;
- Granted U.S. Patent No. 12,134,635 covering two of its novel drug candidates, SON-1411 (IL-18BPR-FHAB-IL12) and SON-1400 (IL-18BPR-FHAB), each containing a modified version of recombinant human interleukin-18 (BPR = Binding Protein Resistant);
- Entered into a licensing agreement with Alkem Laboratories Limited for the research, development, manufacturing, marketing, and commercialization of the SON-080 molecule for the treatment of DPN in India;
- Received preliminary approval for the sale of tax credits from the New Jersey Technology Business Tax Certificate Transfer Program administered by the New Jersey Economic Development Authority (NJEDA); and
- Entered into a Master Clinical Collaboration Agreement with the Sarcoma Oncology Center to advance the development of SON-1210 in combination with chemotherapy for the treatment of metastatic pancreatic cancer.
Lead Clinical Programs Update
SON-1010: Targeted Immune Activation Cancer Therapy, Turning ‘Cold’ Tumors ‘Hot’, Initially Targeting Solid Tumors and Platinum-Resistant Ovarian Cancer (PROC)
Phase 1 Trial (SB101 Trial): Advanced Solid Tumors (Monotherapy)
This first-in-human study is primarily designed to evaluate the safety, tolerability, PK, and PD of multiple ascending doses of SON-1010 in cancer patients and is being conducted at several sites across the United States. The Company recently completed enrollment and dose escalation in the Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. Additionally, the Company reported that results of SON-1010 at the highest dose have been formally evaluated by the Safety Review Committee. The study has enrolled 24 subjects to date. Primary outcome measures for the study were to evaluate the safety and tolerability of SON-1010 and establish the MTD.
For more information about the SB101 clinical trial, visit clinicaltrials.gov and reference identifier NCT05352750.
Phase 1b/2a Trial (SB221 Trial): Advanced Solid Tumors and PROC (Combo with Atezolizumab)
The second trial is a global Phase 1b/2a multicenter, dose-escalation and randomized proof-of-concept study to assess the safety, tolerability, PK, PD, and efficacy of SON-1010 administered subcutaneously (SC) in combination with atezolizumab given intravenously (IV) (in collaboration with Genentech, a member of the Roche Group). This study was recently expanded to include the MTD of SON-1010 from SB101. Enrollment remains ongoing and an update on safety at the MTD in that trial is expected in Q1 2025.
For more information about the SB221 clinical trial, visit clinicaltrials.gov and reference identifier NCT05756907.
SON-1010 Upcoming Milestones
- Phase 1: Solid Tumors (Monotherapy)
- H1 calendar year 2025: Topline Efficacy Data
- Phase 1b/2a: PROC (Combo with Atezolizumab)
- Q1 calendar year 2025: Additional Safety Data
- H2 calendar year 2025: RP2D & Topline Efficacy Data
SON-1210: Proprietary, Bifunctional Version of Human Interleukins 12 (IL-12) and 15 (IL-15), Configured Using Sonnet's Fully Human Albumin Binding (FHAB®) platform, in Combination with Chemotherapy for the Treatment of Advanced Solid Tumors and Metastatic Pancreatic Cancer
As previously announced, the Company successfully completed two IND-enabling toxicology studies of SON-1210 in non-human primates (NHPs), which demonstrated no overt toxicity in the GLP study apart from the expected and mild, on-target changes in hematology and clinical chemistry parameters that resolved completely within 14 to 21 days post-dosing. A significant increase in interferon gamma (IFNγ), which was controlled and prolonged, was noted as early as one day following administration, with no apparent increase in other proinflammatory cytokines. IFNγ is a well-known pharmacodynamic biomarker that is required for anti-tumor efficacy in preclinical models. Other signs of cytokine imbalance, or uncontrolled increase of pro-inflammatory cytokines (including TNF-α, IL-1β, and IL-6) were notably absent from all dose levels tested in the study.
In August 2024, the Company entered into a Master Clinical Collaboration Agreement with the Sarcoma Oncology Center, to conduct an investigator-initiated Phase 1/2a clinical study to evaluate SON-1210 in combination with several chemotherapeutic agents including but not limited to NALIRIFOX (the combination of liposomal irinotecan, 5-fluorouracil/leucovorin, and oxaliplatin) for the specific treatment of metastatic pancreatic cancer. The NALIRIFOX regimen is U.S. FDA-approved for the treatment of metastatic pancreatic cancer in the front-line and refractory settings.
SON-1210 Upcoming Milestones
- Q1 calendar year 2025: IND Submission
- H1 calendar year 2025: 1st Patient Dosed in Investigator-Initiated Phase 1/2a Study
SON-080: Low dose of rhIL-6 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN)
In October 2024, the Company entered into a licensing agreement (the “Licensing Agreement”) with Alkem Laboratories Limited (“Alkem”) for the research, development, manufacturing, marketing, and commercialization of its SON-080 molecule for the treatment of DPN in India and the manufacturing, marketing, and commercialization of SON-080 for chemotherapy induced neuropathy (CIPN) and autonomic neuropathy in India. Alkem will conduct all clinical trials it believes appropriate to obtain regulatory approval in India of SON-080 for the treatment of DPN.
Summary of Financial Results for the Fiscal Year 2024
As of September 30, 2024, Sonnet had
Research and development expenses were
General and administrative expenses were
About Sonnet BioTherapeutics Holdings, Inc.
Sonnet BioTherapeutics is an oncology-focused biotechnology company with a proprietary platform for innovating biologic drugs of single or bifunctional action. Known as FHAB (Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the outcome of the Company’s clinical trials, the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
JTC Team, LLC
Jenene Thomas
908-824-0775
SONN@jtcir.com
Sonnet BioTherapeutics Holdings, Inc.
Consolidated Balance Sheets
September 30, | ||||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 149,456 | $ | 2,274,259 | ||||
Prepaid expenses and other current assets | 1,206,409 | 1,677,396 | ||||||
Incentive tax receivable | 762,078 | 786,574 | ||||||
Total current assets | 2,117,943 | 4,738,229 | ||||||
Property and equipment, net | 20,523 | 33,366 | ||||||
Operating lease right-of-use asset | 123,417 | 193,689 | ||||||
Deferred offering costs | 15,000 | 49,988 | ||||||
Other assets | 494,147 | 414,206 | ||||||
Total assets | $ | 2,771,030 | $ | 5,429,478 | ||||
Liabilities and stockholders’ deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,183,416 | $ | 2,201,999 | ||||
Accrued expenses and other current liabilities | 942,489 | 3,230,922 | ||||||
Current portion of operating lease liability | 84,291 | 73,048 | ||||||
Deferred income | — | 18,626 | ||||||
Total current liabilities | 3,210,196 | 5,524,595 | ||||||
Operating lease liability, net of current portion | 46,573 | 130,863 | ||||||
Total liabilities | 3,256,769 | 5,655,458 | ||||||
Commitments and contingencies (Note 5) | ||||||||
Stockholders’ deficit: | ||||||||
Preferred stock, | — | — | ||||||
Common stock, | 65 | 22 | ||||||
Additional paid-in capital | 117,195,181 | 110,017,751 | ||||||
Accumulated deficit | (117,680,985 | ) | (110,243,753 | ) | ||||
Total stockholders’ deficit | (485,739 | ) | (225,980 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 2,771,030 | $ | 5,429,478 |
Sonnet BioTherapeutics Holdings, Inc.
Consolidated Statements of Operations
Years ended September 30, | ||||||||
2024 | 2023 | |||||||
Collaboration revenue | $ | 18,626 | $ | 147,805 | ||||
Operating expenses: | ||||||||
Research and development | 5,737,252 | 11,814,690 | ||||||
General and administrative | 6,130,845 | 7,125,732 | ||||||
Total operating expense | 11,868,097 | 18,940,422 | ||||||
Loss from operations | (11,849,471 | ) | (18,792,617 | ) | ||||
Foreign exchange gain (loss) | 84,293 | (40,077 | ) | |||||
Other income | 4,327,946 | — | ||||||
Net loss | $ | (7,437,232 | ) | $ | (18,832,694 | ) | ||
Per share information: | ||||||||
Net loss per share, basic and diluted | $ | (11.35 | ) | $ | (145.13 | ) | ||
Weighted average shares outstanding, basic and diluted | 655,240 | 129,760 |
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