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Silo Pharma Selects Veloxity Labs for Bioanalytical IND-Enabling Study for our Novel Intranasal PTSD Therapy, SPC-15

Key Takeaway: Silo Pharma announced the selection of Veloxity Labs for bioanalytical support in the IND-enabling study of its intranasal PTSD therapy, SPC-15. The company expects to start the FDA IND process in 2025, leading to a Phase 1 clinical trial upon approval. This move highlights Silo's commitment to advancing its innovative treatment for PTSD as well as its collaborations with leading laboratories and universities.

Market Sentiment Analysis

POSITIVE FACTORS

  • Silo Pharma has partnered with Veloxity Labs, indicating a proactive approach to bioanalytical studies.
  • The company is moving forward with its IND application process for SPC-15, signifying progress in its development pipeline.
  • SPC-15 aims to address an underserved condition, PTSD, potentially benefiting many patients.

CONCERNS & RISKS

  • The FDA's acceptance of the IND application is uncertain, posing a risk to progress.
  • There is a possibility that the FDA may require changes to the IND, which could delay clinical trials.
  • The actual timeline for FDA approval of SPC-15 is unpredictable.

Full Press Release Details

SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has engaged Veloxity Labs, LLC for bioanalysis supporting the ongoing investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
“We look forward to working with Veloxity Labs for GLP sample analysis in our current safety study of SPC-15,” said Eric Weisblum, CEO of Silo. “We expect Veloxity to provide fast turnaround times and precise, high-quality data, and we believe their team will play an important role in delivering preclinical data we need to open an IND for SPC-15.”
Silo expects to begin the FDA IND process for SPC-15 in 2025. Upon approval of the IND, Silo will proceed to a first-in-human Phase 1 clinical trial.
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company’s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer’s disease and multiple sclerosis. Silo’s research is conducted in collaboration with leading universities and laboratories. silopharma.com
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 the Company’s ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve SPC-15 on the Company’s expected timeline, or at all, 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 press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.

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IntranasalPTSDTherapy

Frequently Asked Questions

What is Silo Pharma focused on?

Silo Pharma is focused on developing novel therapeutics for underserved conditions.

What is SPC-15 used to treat?

SPC-15 is an intranasal treatment for post-traumatic stress disorder (PTSD).

Who is supporting Silo Pharma's bioanalysis?

Silo has engaged Veloxity Labs for bioanalysis in their safety study.

When does Silo expect to start the IND process?

Silo anticipates beginning the FDA IND process for SPC-15 in 2025.

What are Silo's other programs besides SPC-15?

Other programs include SP-26 for chronic pain and assets for Alzheimer's and MS.

Last updated: May 14, 2025