8-K

UNITED

STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549

FORM

8-K

CURRENT

REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported) August 5, 2021

BioVie Inc.****(Exact Name of Registrant as Specified in Its Charter)

Nevada	000-55292	46-2510769
(State<br> or Other Jurisdiction<br><br> of Incorporation)	(Commission<br> File Number)	(I.R.S.<br> Employer Identification No.)
2120 Colorado Avenue, #230 Santa Monica, California	90404
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(Address of Principal Executive Offices)	(Zip<br> Code)

(310)444-4300(Registrant’s Telephone Number, Including Area Code)

11601 Wilshire Blvd Suite 1100
Los Angeles, CA 90025

(Former Name or Former Address, if Changed Since Last Report)

Securities

registered pursuant to Section 12(b) of the Act:

Title<br> of each class	Trading<br> Symbol(s)	Name<br> of each exchange on which<br><br> registered
Class A Common Stock, par value $0.0001 per share	BIVI	The NASDAQ Stock Market, LLC

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written<br>communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐	Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐	Pre-commencement<br>communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01	Regulation FD Disclosure.

On August 5, 2021, BioVie Inc., a Nevada corporation (the “Company”), issued a press release announcing that it had initiated patient trials regarding its Phase III clinical study testing NE3107 for the treatment of Alzheimer’s Disease. A copy of that press release is attached as Exhibit 99.1 to this Current Report and incorporated by reference into this Item 7.01.

By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.

The information presented in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act.

Item 9.01	Financial Statements and Exhibits

(a) Exhibits

	Description
99.1	Press Release dated August 5, 2021

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: August 5, 2021

BIOVIE INC.
By:	/s/<br> Joanne Wendy Kim
Name:	Joanne<br> Wendy Kim
Title:	Chief<br> Financial Officer

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BioVieAnnounces First Patient Enrolled in Phase 3 Studyof NE3107 in Alzheimer’s Disease

SANTA MONICA, Calif., August 5, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or “Company”), a clinical-stage company developing innovative drug candidates for the treatment of neurological and neurodegenerative disorders, liver disease and certain cancers, today announced that the Company has enrolled the first patient into the NM101 Phase III clinical study testing NE3107 for the treatment of Alzheimer’s Disease (AD).

The NM101 study (NCT04669028) is a potentially pivotal Phase 3, randomized, double blind, placebo-controlled, US multicenter study of NE3107 in 316 subjects with mild to moderate AD. In addition to conventional cognition, memory, functional, behavioral and imaging end points, NM101 will assess measures of glycemic control, brain glucose utilization and systems dysregulation. The mechanistic basis for the study design was recently published in a peer-reviewed article in Neurodegenerative Disease Management (https://doi.org/10.2217/nmt-2021-0022). This study design and pathophysiology and mechanism data were also presented as Poster 55458 entitled “Rationale for an Anti-inflammatoryInsulin Sensitizer in a Phase 3 Alzheimer’s Disease Trial” by Christopher L Reading, PhD, BioVie’s Executive Vice President for Neuroscience Research & Development at the 2021 Alzheimer’s Association International Conference (AAIC), July 28, 2021. The study aims to have data readout by the end of 2022.

“NM101 is the first randomized, double blind, placebo-controlled Phase 3 trial conducted by any company to test a potentially disease modifying anti-inflammatory insulin sensitizer compound in subjects with mild to moderate AD,” said Cuong Do, Chief Executive Officer of BioVie. “In prior animal studies and Phase 1 and 2 human clinical studies, NE3107 generated data supporting reduced neuroinflammation and insulin resistance, both of which are recognized as important players in AD pathology.”

Neuroinflammation and insulin resistance are associated with cognitive decline associated with Alzheimer’s. NE3107’s potential to inhibit neuroinflammation and insulin resistance forms the basis for the hypothesis that it may impact cognitive decline in Alzheimer’s patients.

Inflammation is increasingly recognized as an important mechanism in AD. Inflammation drives activation of the Extracellular Signal-Regulated Kinase (ERK) signaling molecule and Nuclear Factor kappa-B (NFκB). NFκB is the central regulator of proinflammatory cytokines and chemokines important in neurodegeneration. Furthermore, NFκB activation in the brain is triggered by Amyloid Beta (Aβ) and phosphorylated tau (P-tau), and by the very proinflammatory mediators that NFκB stimulates, leading to perpetual low-grade chronic inflammation.

Inflammation also triggers inhibitory phosphorylation of Insulin Receptor Substrate 1/2, leading to insulin resistance (IR) and the inhibition of insulin signaling. As insulin is the master regulator of energy and metabolism, neuroinflammation’s disruption of insulin signaling is believed to contribute to AD pathology. The Mayo Clinic estimates that up to 81% of AD subjects have impaired glucose tolerance or type 2 diabetes mellitus.

NE3107 is an oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK- and NFκB-stimulated inflammation. No major safety signals have been observed in preclinical and clinical studies to date.

AboutBioVie

BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing potentially transformative therapies to overcome unmet medical needs in chronic debilitating conditions. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a US Phase 2 study for the treatment of refractory ascites with top-line results expected in early 2022. The Company is also planning a Phase 3 study of BIV201 in the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI) in 2022. BIV201 is administered as a patent-pending liquid formulation. The active agent is approved in about 40 countries for related complications of advanced liver cirrhosis but is not approved or available in the U.S. or Japan. In neuro-degenerative disease, BioVie recently acquired the assets of NeurMedix Inc., including NE3107 that inhibits inflammatory activation of ERK and NFκB (e.g. TNF transcription) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g. insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are thought to be drivers of Alzheimer’s and Parkinson’s diseases. The Company is conducting a Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028). An estimated six million Americans suffer from Alzheimer’s. BioVie has initiated this study and is targeting primary completion in late 2022. A Phase 2 study of NE3107 in Parkinson’s Disease is planned for later this year, and related compounds have additional potential to treat certain cancers. NE3107 and related compounds are globally patented, potentially first-in-class molecules. For more information, visit http://www.biovieinc.com/.

Forward-LookingStatements

Thispress 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 reasonableassumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressedor 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 tocomplete our clinical studies and to obtain approval for our product candidates, 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 outof the Company’s control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterlyreports 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 statementscontained herein (including any forward-looking statements), except as required by law.

Contact:

Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com