Silo Pharma Issues Letter to Shareholders Detailing Development Progress and Potential for Lead Assets Targeting PTSD and Chronic Pain
Silo Pharma (NASDAQ: SILO) has issued a shareholder letter highlighting progress on its lead assets. The company plans to submit an IND application for SPC-15, an intranasal PTSD treatment, in 2025, followed by Phase 1 clinical trials. SPC-15 has shown promising pre-clinical results for PTSD, stress, and potentially eating disorders.
The company is also advancing SP-26, a ketamine implant for fibromyalgia and chronic pain, with animal testing scheduled for early 2025. Both drugs could qualify for the FDA's streamlined 505(b)(2) regulatory pathway, potentially accelerating approval timelines.
Silo has exclusive global rights to commercialize SPC-15 through a collaboration with Columbia University. The company reports a strong balance sheet with minimal debt as it advances its development programs.
Silo Pharma (NASDAQ: SILO) ha emesso una lettera agli azionisti evidenziando i progressi sui suoi principali asset. L'azienda prevede di presentare una domanda di IND per SPC-15, un trattamento intranasale per il PTSD, nel 2025, seguito da prove cliniche di Fase 1. SPC-15 ha mostrato risultati preclinici promettenti per il PTSD, lo stress e potenzialmente i disturbi alimentari.
L'azienda sta anche portando avanti SP-26, un impianto di ketamina per la fibromialgia e il dolore cronico, con test sugli animali previsti per l'inizio del 2025. Entrambi i farmaci potrebbero qualificarsi per il percorso normativo semplificato 505(b)(2) della FDA, accelerando potenzialmente i tempi di approvazione.
Silo detiene diritti globali esclusivi per commercializzare SPC-15 attraverso una collaborazione con la Columbia University. L'azienda riporta un solido bilancio con debito minimo mentre avanza nei suoi programmi di sviluppo.
Silo Pharma (NASDAQ: SILO) ha emitido una carta a los accionistas destacando el progreso en sus activos principales. La compañía planea presentar una solicitud IND para SPC-15, un tratamiento intranasal para el PTSD, en 2025, seguido de ensayos clínicos de Fase 1. SPC-15 ha mostrado resultados preclínicos prometedores para el PTSD, el estrés y potencialmente los trastornos alimentarios.
La compañía también avanza en SP-26, un implante de ketamina para la fibromialgia y el dolor crónico, con pruebas en animales programadas para principios de 2025. Ambos medicamentos podrían calificar para el camino regulatorio simplificado 505(b)(2) de la FDA, lo que podría acelerar los plazos de aprobación.
Silo tiene derechos globales exclusivos para la comercialización de SPC-15 a través de una colaboración con la Universidad de Columbia. La empresa informa de un balance sólido con deuda mínima mientras avanza en sus programas de desarrollo.
사일로 제약 (NASDAQ: SILO)는 주요 자산에 대한 진행 상황을 강조한 주주 서한을 발송했습니다. 회사는 2025년에 PTSD 치료제를 위한 SPC-15의 IND 신청서를 제출할 계획이며, 이후 1상 임상시험이 진행될 예정입니다. SPC-15는 PTSD, 스트레스 및 잠재적으로 섭식 장애에 대해 유망한 전임상 결과를 보여주었습니다.
회사는 또한 섬유근육통 및 만성 통증을 위한 케타민 임플란트인 SP-26을 진행 중이며, 2025년 초에 동물 실험이 예정되어 있습니다. 두 약물 모두 FDA의 간소화된 505(b)(2) 규제 경로에 적격할 수 있어 승인 일정을 가속화할 수 있습니다.
사일로는 컬럼비아 대학교와의 협력을 통해 SPC-15의 상업화에 대한 전 세계 독점 권리를 보유하고 있습니다. 회사는 발전하는 개발 프로그램에 대한 최소한의 부채로 강력한 재무 상태를 보고하고 있습니다.
Silo Pharma (NASDAQ: SILO) a émis une lettre aux actionnaires mettant en avant les progrès de ses principaux actifs. La société prévoit de soumettre une demande IND pour SPC-15, un traitement intranasal pour le PTSD, en 2025, suivi d'essais cliniques de phase 1. SPC-15 a montré des résultats précliniques prometteurs pour le PTSD, le stress et potentiellement les troubles alimentaires.
La société avance également avec SP-26, un implant de kétamine pour la fibromyalgie et la douleur chronique, avec des essais sur animaux prévus pour début 2025. Les deux médicaments pourraient être éligibles pour la voie réglementaire simplifiée 505(b)(2) de la FDA, ce qui pourrait accélérer les délais d'approbation.
Silo détient des droits exclusifs mondiaux pour commercialiser SPC-15 grâce à une collaboration avec l'Université de Columbia. L'entreprise indique avoir un bilan solide avec une dette minimale tout en poursuivant ses programmes de développement.
Silo Pharma (NASDAQ: SILO) hat einen Aktionärsbrief herausgegeben, der die Fortschritte bei seinen wichtigsten Vermögenswerten hervorhebt. Das Unternehmen plant, im Jahr 2025 einen IND-Antrag für SPC-15, eine intranasale PTSD-Behandlung, einzureichen, gefolgt von Phase-1-Studien. SPC-15 hat vielversprechende präklinische Ergebnisse bei PTSD, Stress und möglicherweise Essstörungen gezeigt.
Das Unternehmen arbeitet auch an SP-26, einem Ketamin-Implantat zur Behandlung von Fibromyalgie und chronischen Schmerzen, mit Tierversuchen, die für Anfang 2025 geplant sind. Beide Medikamente könnten für den vereinfachten Regulierungsweg 505(b)(2) der FDA qualifiziert werden, was potenziell die Genehmigungsfristen beschleunigen könnte.
Silo verfügt über weltweit exklusive Rechte zur Kommerzialisierung von SPC-15 in Zusammenarbeit mit der Columbia University. Das Unternehmen berichtet von einer soliden Bilanz mit minimaler Verschuldung, während es seine Entwicklungsprogramme vorantreibt.
- IND submission for SPC-15 planned for 2025 with potential fast-track 505(b)(2) approval pathway
- Exclusive global license for SPC-15 from Columbia University
- Strong balance sheet with minimal debt
- Pre-clinical data supports potential expansion of SPC-15 into eating disorders treatment
- No revenue-generating products in portfolio yet
- Clinical trials haven't started for any products
- Several years away from potential market approval
Insights
The planned IND submission for SPC-15 in 2025 represents a critical advancement in PTSD treatment development. The pre-IND meeting completion with FDA and potential 505(b)(2) pathway qualification could significantly accelerate the approval timeline and reduce development costs. The dual mechanism combining 5-HT4R agonism with NMDAR antagonism shows promising preclinical efficacy for major depressive disorder.
The SP-26 ketamine implant program entering animal studies marks another key milestone. If successful as an at-home therapeutic, it could revolutionize chronic pain management by providing an alternative to addictive opioids. The sustained-release formulation and novel delivery system could address significant unmet needs in fibromyalgia treatment.
This developmental pipeline targets substantial market opportunities. With no new PTSD drug approvals in 25 years and <percent>3.9%</percent> global prevalence, SPC-15 addresses a significant unmet need. The projected growth of the Alzheimer's treatment market to <money>$30.8B</money> by 2033 (<percent>18.8%</percent> CAGR) and multiple sclerosis market to <money>$38.9B</money> by 2032 (<percent>7.9%</percent> CAGR) indicates substantial commercial potential for Silo's neurology programs. The company's strong cash position and minimal debt provide flexibility for continued development.
The strategic licensing agreement with Columbia University for SPC-15 global commercialization rights strengthens Silo's intellectual property portfolio. The 505(b)(2) regulatory pathway could significantly reduce development costs and time-to-market, potentially accelerating revenue generation. For a company with a market cap of <money>$4M</money>, successful advancement of either SPC-15 or SP-26 through clinical trials could trigger substantial value creation, particularly given the large addressable markets and unique positioning in treatment-resistant conditions.
- IND submission for intranasal SPC-15 treatment expected in 2025; Phase 1 clinical trial to follow upon approval
- SP-26 ketamine implants nearing first animal studies
SARASOTA, FL, Jan. 02, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” “we,” “us,” “our,” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today issued a letter to shareholders highlighting the Company’s progress and potential for its lead assets SPC-15 and SP-26 as treatments for mental health and chronic pain management, respectively. The letter, in its entirety, is reprinted below.
Dear fellow Silo Pharma shareholders,
Silo Pharma is gaining momentum along its path to first-in-human trials for lead candidate SPC-15, an intranasal prophylactic targeting PTSD and stress induced anxiety disorder. We are currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study and believe this will be the final data required before we submit an investigational new drug (IND) application to the FDA. I’m proud to report that we are getting closer to in-human trials.
In addition to SPC-15, we are advancing development of our SP-26 ketamine implant and continuing studies of our other investigational drugs. Each of these novel and potentially transformative therapies are tied to exclusive collaborations with world-class medical research partners, bringing valuable IP, assets and time-to-market advantages for Silo.
Through our ongoing commitment to developing novel therapeutics that address underserved conditions, Silo has created a robust platform of innovative solutions for mental health, chronic pain, and neurology.
SPC-15 | Intranasal PTSD Treatment
For our lead program, SPC-15, we completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in September 2024 regarding our development plan. The primary purpose of the meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 as we prepare for an expected IND submission in 2025, followed by a Phase 1 clinical trial in PTSD upon approval of our IND. This would be a significant milestone for Silo.
While the initial indications for SPC-15 are PTSD and stress, our pre-clinical data could also support a possible Phase 1 trial of SPC-15 as a treatment for eating disorders and anorexia. Additionally, promising results from another pre-clinical study showed that a dual-action approach of combining SPC-15, a 5-HT4R agonist, with an NMDA receptor (NMDAR) antagonist enhanced efficacy as compared to either agent alone for the treatment of major depressive disorder (MDD) and other severe stress-related conditions.
Columbia University, our collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide.
SP-26 | Ketamine-Loaded Implants
We continued our progress in the development and formulation of our novel SP-26 ketamine implants targeting fibromyalgia and chronic pain during 2024, and animal testing is scheduled to begin in early 2025. The unique design and development of the subcutaneous insertion device is expected to support sustained relief of chronic pain using a viable alternative to highly addictive opioid treatments.
Preclinical research to date has focused on ensuring that the safety profile of SP-26 aligns with FDA requirements for potential at-home therapeutic designation. If approved, SP-26 could become the first at-home injectable ketamine-based therapeutic.
We have initiated our first animal study to evaluate dosage, time release, and absorption of the drug, and we expect to share these results in early 2025.
Approval Pathways
If clinically successful, both SCP-15 and SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Under Section 505(b)(2) of the Federal Food, Drug, and Cosmetics Act (FDCA), drug developers can use publicly available data on active ingredients in a compound for a new drug application (NDA). This streamlined pathway allows for significantly shortened clinical timelines and reduced clinical development costs as compared to the conventional full NDA process.
We believe this strategy could simplify our clinical plans and allow for a faster approval process, potentially accelerating our delivery of effective solutions for patients with access to few, if any, proven therapeutics.
Market Trends
The blood-brain barrier (BBB) is a major hurdle for the development of systemically delivered drugs targeting diseases of the central nervous system (CNS). Because of this barrier there is a huge unmet need for the treatment of these diseases, despite years of clinical research efforts across the pharmaceutical industry.1
For PTSD, there have been no new drug approvals in nearly 25 years for a condition that affects an estimated
Each of our neurology programs, SPC-14 for the treatment of Alzheimer’s disease and SPU-15 for the treatment of multiple sclerosis, address very large and growing markets. The Alzheimer’s disease treatment market shows projected growth to
Creating Value
In closing, we believe our progress in 2024 sets us up for exciting developments and milestones for Silo in 2025. Our current balance sheet, with cash on hand and minimal debt, offers financial flexibility as we move forward with ongoing research and development of therapies with the potential to transform patient care.
Silo Pharma is committed to delivering compelling catalysts for value creation for our existing and future shareholders. We are enthusiastic about the future and grateful for your interest and continued support.
Sincerely,
Eric Weisblum
Chief Executive Officer
December 2024
About SPC-15
SPC-15 is a serotonin 5-HT4 receptor agonist designed to treat stress-induced disorders such as PTSD and anxiety. Delivered via an intranasal formulation, SPC-15 may qualify for the FDA’s streamlined 505(b)(2) regulatory pathway, potentially accelerating its approval process. Currently, Silo Pharma is collaborating with Columbia University on preclinical studies and holds exclusive rights to develop and commercialize SPC-15 globally.
About SP-26
SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment. If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with universities and independent laboratories. For more information, visit www.silopharma.com and connect on social media at LinkedIn, X, and Facebook.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Contact
800-705-0120
investors@silopharma.com
1 MDPI journals, Pharmaceutics, Novel Developments to Enable Treatment of CNS Diseases with Targeted Drug Delivery, March 2023.
2 FT Specialist, Endpoints in Focus, Lykos’ pain is others’ gain…., June 2024.
3 WebMD, Fibromyalgia: Treatment and Medications. February 2024.
4 Market.us, Alzheimer’s Disease Therapeutics Market Value to Reach USD 30.8 Billion by 2033 | Driven by the Advancements in Neurological Research. January 2024.
5 Fortune Business Insights, Multiple Sclerosis Drugs Market Size, Share & Industry Analysis… July 2024.
FAQ
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