BioVie’s Upcoming Parkinson’s Disease Clinical Trial is Fully Funded

Rhea-AI Summary

BioVie (NASDAQ: BIVI) has secured full funding for its upcoming PD-202 Parkinson's Disease clinical trial through recent secondary offerings raising over $15 million. The double-blind, randomized, placebo-controlled study of bezisterim in early Parkinson's Disease patients is scheduled to begin in early 2025, with topline results expected by late 2025. The company's lead asset, bezisterim, has shown promising results in clinical studies, demonstrating reduced inflammation, improved motor function, and decreased non-motor symptoms in PD patients. BioVie's strategic plans include launching Phase 2 trials for PD and Long Covid in early 2025, followed by a Phase 3 trial for Alzheimer's Disease in late 2025.

Positive

• Secured over $15 million in funding through secondary offerings
• PD-202 clinical trial fully funded and scheduled to begin in early 2025
• DOD grant funding secured for Long Covid Phase 2 trial

Negative

• Secondary offerings may lead to shareholder dilution

Insights

Medical Research Analyst

The $15 million funding secured for BioVie's Phase 2 Parkinson's Disease trial represents a significant milestone. The trial design as a double-blind, randomized, placebo-controlled study follows gold-standard methodology. Previous clinical data for bezisterim showing improvements in motor function, non-motor symptoms and inflammation markers provides encouraging scientific rationale. The company's pipeline diversification across Parkinson's, Long Covid (DOD-funded) and Alzheimer's indicates strong development potential.

The planned trial initiation in early 2025 with topline results expected by late 2025 provides a clear catalyst timeline. The company's multi-pronged strategy including geographic partnering discussions and development of a once-daily formulation demonstrates sound clinical development planning. However, investors should note that early-stage clinical trials carry inherent risks of failure.

Financial Analyst

The successful secondary offering raising over $15 million significantly strengthens BioVie's financial position and removes near-term funding uncertainty for their lead program. With a market cap of $45.5 million, this capital injection represents about 33% of the company's value. The Department of Defense grant funding for the Long Covid trial provides additional financial flexibility. The company's partnering strategy for geographic rights and BIV201 could potentially bring in non-dilutive capital. However, the need for future capital raises remains likely, especially for the planned Phase 3 Alzheimer's trial in late 2025.

CARSON CITY, Nev., Nov. 04, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, is pleased to announce that the upcoming PD-202 A Double-Blind, Randomized, Placebo-controlled, Study of Bezisterim in Subjects with Early Parkinson’s Disease is now fully funded.

Favorable capital market conditions last week enabled the company to raise over $15 million from secondary offerings, and the proceeds allow the Company to fund fully the costs of this upcoming clinical trial. The trial is expected to start in early 2025, and topline results are expected by late 2025.

BioVie's lead asset, bezisterim (formerly NE3107), binds ERK and selectively modulates NFkB activation and TNFα production, which are believed to be responsible for significant clinical improvements in several disease indications. In clinical studies, patients treated with bezisterim experienced reduced inflammation and insulin resistance, significantly improved motor function after withholding PD medications and decreased non-motor symptoms in patients that had measurable symptoms at baseline in PD, and improved cognition and regional connectivity measured by brain imaging in AD as well as altered DNA methylation directionally consistent with decreased AD pathophysiology. The Company's strategic priorities include launching a Phase 2 trial for PD in early 2025, launching an exploratory Long Covid Phase 2 trial that has been fully funded by a grant from the U.S. Department of Defense (DOD) in early 2025 and initiating a Phase 3 trial for AD in late 2025 with a new once-daily formulation of bezisterim. The Company is also continuing partnering discussions for bezisterim's geographic rights and plans to commence an ascites Phase 3 trial for BIV201 (continuous infusion terlipressin) upon identifying a suitable partner.

BioVie will be presenting in a webinar on November 7, 204; to register for the free webinar, please visit: https://redchip.zoom.us/webinar/register/WN_v1NL71qkR8W-fNfWM4YLCg#/registration

Questions can be pre-submitted to BIVI@redchip.com or online during the live event.

About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Long COVID, Alzheimer's disease and Parkinson’s disease) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor, Nuclear factor- kB, and the associated neuroinflammation and insulin resistance but not ERK and NFkB homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are drivers of AD and PD. Persistent systematic inflammation and neuroinflammation are key features in patients with neurological symptoms of Long COVID. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com

Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.

Contact:

Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
BIVI@redchip.com  

For Investor Relations Inquiries: 

Contact: 
Bruce Mackle 
Managing Director 
LifeSci Advisors, LLC 
bmackle@lifesciadvisors.com

For Media Inquiries:
Contact:
Melyssa Weible
Managing Partner
Elixir Health Public Relations 
Ph: +1 201-723-5705
mweible@elixirhealthpr.com

FAQ

When will BioVie (BIVI) start its PD-202 Parkinson's Disease clinical trial?

BioVie's PD-202 clinical trial is scheduled to begin in early 2025.

How much funding did BioVie (BIVI) raise for its Parkinson's Disease trial?

BioVie raised over $15 million through secondary offerings to fully fund the PD-202 clinical trial.

When are the topline results expected for BioVie's (BIVI) PD-202 trial?

Topline results for the PD-202 trial are expected by late 2025.

What are BioVie's (BIVI) strategic priorities for 2025?

BioVie plans to launch Phase 2 trials for Parkinson's Disease and Long Covid in early 2025, and initiate a Phase 3 trial for Alzheimer's Disease in late 2025.