BioVie Inc. Announces Proposed Public Offering

Rhea-AI Summary

BioVie Inc. (NASDAQ: BIVI), a clinical-stage company focused on developing innovative drug therapies for advanced liver disease and neurological disorders, has announced its intention to conduct a public offering of common stock shares and accompanying purchase warrants. The company may also offer pre-funded warrants in lieu of common stock. ThinkEquity is acting as the sole placement agent for this best efforts offering.

The offering's proceeds are intended primarily for working capital and general corporate purposes. The securities will be offered under a shelf registration statement filed with the SEC. A preliminary prospectus supplement and accompanying prospectus will be available from ThinkEquity and the SEC's website. The offering's completion is subject to market conditions, with no guarantees regarding its execution or terms.

Positive

• Potential influx of capital for working capital and corporate purposes
• Offering conducted under an effective shelf registration statement, streamlining the process

Negative

• Potential dilution of existing shareholders' equity
• Uncertainty regarding the offering's completion and terms
• Best efforts offering, which doesn't guarantee full subscription

Insights

Financial Analyst

BioVie's proposed public offering of common stock and warrants is a significant move to raise capital, likely aimed at funding ongoing clinical trials and operations. This type of offering can be dilutive to existing shareholders, potentially impacting the stock price negatively in the short term. However, for a clinical-stage biotech company with a $17.3 million market cap, securing additional funding is important for advancing their drug development pipeline.

The use of pre-funded warrants alongside common stock offers flexibility to investors and may help the company attract a broader range of institutional investors. The "best efforts" nature of the offering suggests some uncertainty about the final amount raised. Investors should closely monitor the pricing and total amount raised, as these factors will influence the company's financial runway and ability to reach key clinical milestones.

While necessary for growth, this capital raise highlights BioVie's current cash burn and dependence on external financing, which is typical for early-stage biotech firms. The market's reaction to this offering will be a key indicator of investor confidence in BioVie's long-term prospects and the perceived value of its drug candidates targeting liver disease and neurological disorders.

Legal Expert

The proposed public offering by BioVie Inc. is structured under a shelf registration statement, which provides the company with flexibility to issue securities quickly when market conditions are favorable. This approach is common for small-cap biotech companies needing to raise capital periodically.

Key legal points to consider:

• The offering is made pursuant to an effective S-3 registration statement, ensuring compliance with SEC regulations.
• The use of a preliminary prospectus supplement indicates that the terms of the offering are not yet finalized, allowing for adjustments based on market response.
• The inclusion of a disclaimer about the offer not being made in certain jurisdictions is a standard legal precaution to avoid regulatory issues in states where the offering may not be registered.

Investors should be aware that while the registration is effective, the actual terms and success of the offering are subject to market conditions. The company's ability to use this shelf registration for future offerings will depend on maintaining its eligibility under SEC rules, which is tied to factors like public float and timely filing of reports.

CARSON CITY, Nev., Sept. 23, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof) and accompanying common stock purchase warrants in a best efforts public offering. All of the shares of common stock (and/or Pre-Funded Warrants) and accompanying common stock purchase warrants are to be sold by the Company.

ThinkEquity is acting as sole placement agent for the offering.

The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-274083), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 18, 2023 and declared effective on August 28, 2023. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41^st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of Alzheimer’s and Parkinson’s diseases. The Company conducted and reported efficacy data from its randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer's disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer’s Disease annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) has completed, and data presented at the International Conference on Alzheimer's and Parkinson's Disease and Related Neurological Disorders conference in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of NE3107 and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with U.S Food and Drug Administration (“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 treatment of ascites due to chronic liver cirrhosis. 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 http://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.

For Investor Relations Inquiries:
Bruce Mackle
Managing Director, LifeSci Advisors, LLC
bmackle@lifesciadvisors.com

For Media Relations Inquiries:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com

FAQ

What is the purpose of BioVie's (BIVI) proposed public offering?

BioVie (BIVI) intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.

What securities is BioVie (BIVI) offering in its proposed public offering?

BioVie (BIVI) is offering shares of its common stock, potentially pre-funded warrants, and accompanying common stock purchase warrants.

Who is the placement agent for BioVie's (BIVI) proposed public offering?

ThinkEquity is acting as the sole placement agent for BioVie's (BIVI) proposed public offering.

Is BioVie's (BIVI) proposed public offering guaranteed to be completed?

No, the offering is subject to market conditions, and there is no assurance as to whether or when it may be completed, or its actual size or terms.