10-Q: BioVie Inc. Reports Q2 2025 Financial Results, Highlights Clinical Program Advancements

Sentiment:

Quarterly Report 11 February 2025 5:00 PM

BioVie Inc. announces its financial results for the quarter ended December 31, 2024, and provides updates on its clinical development programs for neurodegenerative and liver diseases.

Capital raiseThe company closed a best efforts public offering (the September 2024 Offering) of 1,360,800 shares of its common stock, par value $ 0.0001 per share, pre-funded warrants (the September Pre-funded Warrants) to purchase 600,000 shares of Common Stock, and warrants to purchase up to 1,960,800 shares of Common Stock (the September Common Warrants) at a combined public offering price of $ 1.53 per share, or September Pre-funded Warrant, and the associated September Common Warrant.In October 2024, the Company closed three registered direct offerings totaling 8,256,000 shares of its common stock, par value $ 0.0001 per share, and two concurrent private placements of warrants to purchase up to 7,110,000 shares of Common Stock (the October Common Warrants) priced at-the-market under Nasdaq rules at prices ranging from $ 1.50 to $ 2.83 per share (the October Offerings).

Better than expectedThe company's net loss decreased for both the three and six months ended December 31, 2024, compared to the same periods in 2023.

Summary

BioVie Inc., a clinical-stage biopharmaceutical company, has released its financial results for the quarter ended December 31, 2024.
The company is focused on developing therapies for chronic debilitating conditions, including neurological, neuro-degenerative disorders, and liver disease.
Key programs include Bezisterim (NE3107) for Alzheimer's and Parkinson's disease, a Long Covid program funded by a $13.1 million grant from the U.S. Department of Defense, and BIV201 for ascites due to chronic liver cirrhosis.
The net loss for the three months ended December 31, 2024, was approximately $7.1 million, compared to a net loss of $8.4 million for the same period in 2023.
Research and development expenses decreased to $4.7 million from $6.5 million year-over-year, primarily due to the completion of clinical trials.
Selling, general, and administrative expenses increased slightly to $2.5 million from $2.3 million year-over-year.
For the six months ended December 31, 2024, the net loss was approximately $11.3 million, compared to $19.1 million for the same period in 2023.
As of December 31, 2024, BioVie had approximately $24.4 million in cash and cash equivalents and working capital of approximately $23.2 million.
The company expects to commence a Phase 2 study of bezisterim (NE3107) for Parkinson's disease and a trial for Long COVID in the first calendar quarter of 2025.
The company is finalizing protocol designs for a Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While the company is still operating at a loss, the reduced losses and successful capital raising efforts are positive signs. However, the company's dependence on future financing and the ongoing legal proceedings are risks that temper the overall sentiment.

Positives

The company's net loss decreased for both the three and six months ended December 31, 2024, compared to the same periods in 2023.
Research and development expenses decreased, primarily due to the completion of clinical trials.
BioVie secured a $13.1 million clinical trial award from the U.S. Department of Defense for its Long COVID program.
The company successfully raised capital through registered direct offerings, strengthening its financial position.
The company paid off its notes payable, reducing its debt burden.
The FDA permitted the company to proceed with a new Phase 2 study of bezisterim (NE3107) as a potential first line therapy to treat patients with new onset PD.

Negatives

The company is in the pre-revenue stage and does not expect to generate revenue in the foreseeable future.
The company has an accumulated deficit of approximately $345.9 million as of December 31, 2024.
The company is dependent on raising additional capital to finance its operations, and there is no assurance that it will be successful in doing so.
The company is subject to a shareholder class action complaint and a shareholder derivative lawsuit.

Risks

The company's future operations are dependent on the success of its ongoing development and commercialization efforts.
The company's ability to obtain regulatory approval for its product candidates is uncertain.
The company faces competition from other companies developing therapies for the same indications.
The company's ability to raise additional capital is subject to market conditions and other factors.
The company is subject to the risks associated with clinical trials, including the risk of adverse events and the risk that the trials will not be successful.
The company is subject to the risks associated with intellectual property, including the risk that its patents will be challenged or that it will infringe on the patents of others.
The company is subject to the risks associated with legal proceedings, including the risk of adverse judgments and the cost of litigation.

Future Outlook

The company anticipates commencing a Phase 2 study of bezisterim (NE3107) for Parkinson's disease and a trial for Long COVID in the first calendar quarter of 2025. The company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

Industry Context

BioVie operates in the competitive biopharmaceutical industry, focusing on developing therapies for neurodegenerative diseases and liver disease, areas with significant unmet medical needs. The company's programs target Alzheimer's, Parkinson's, Long COVID, and ascites, all of which represent substantial market opportunities. The company's approach of targeting inflammation and insulin resistance in neurodegenerative diseases aligns with emerging scientific consensus.

Comparison to Industry Standards

BioVie's R&D spending as a percentage of revenue cannot be compared to industry standards as the company is pre-revenue.
However, its cash burn rate and capital raising activities can be compared to similar stage biopharmaceutical companies.
For example, companies like Cassava Sciences (SAVA) and Annovis Bio (ANVS), which are also focused on Alzheimer's disease, have similar cash burn rates and have also raised capital through equity offerings.
The $13.1 million grant from the U.S. Department of Defense for the Long COVID program is a significant achievement and demonstrates the potential of the company's approach.
The company's focus on BIV201 for ascites due to chronic liver cirrhosis addresses a significant unmet medical need, as there are currently no FDA-approved drugs for this indication.

Legal Proceedings

The company is subject to a shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, filed in the U.S. District Court for the District of Nevada.
The company is also subject to a shareholder derivative lawsuit filed in the United States District Court for the District of Nevada by putative stockholder Andrew Hulm.

Related Party Transactions

On July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC (Acuitas), the Company's largest stockholder.
During the three months ended December 31, 2024, the Company paid a Director of the Company $ 50,000 for consulting services which are reflected as a component of selling, general and administrative expenses on the accompanying condensed statement of operations and comprehensive loss .

Stakeholder Impact

Shareholders: The company's financial performance and clinical development progress will impact shareholder value.
Employees: The company's ability to secure funding and advance its programs will impact job security and opportunities.
Patients: The company's success in developing new therapies will impact the availability of treatment options for various diseases.
Creditors: The company's financial stability will impact its ability to meet its obligations to creditors.

Next Steps

Commence Phase 2 study of bezisterim (NE3107) for Parkinson's disease in Q1 2025.
Commence trial for Long COVID in Q1 2025.
Finalize protocol designs for Phase 3 study of BIV201 for ascites due to chronic liver cirrhosis.

Key Dates

Date	Description
2016-04-11	BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program.
2021-04-27	Date of the asset purchase agreement by and among the Company, NeurMedix and Acuitas, as amended on May 9, 2021.
2021-06	The Company acquired the biopharmaceutical assets of NeurMedix, Inc.
2021-06	The Company initiated a Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment cycles) combined with standard-of-care (SOC), compared to SOC alone, for the treatment of refractory ascites.
2021-08-01	The Company began sponsoring an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the 401K Plan).
2021-11-30	The Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together, the Loan Agreement) with Avenue Venture Opportunities Fund, L.P. (AVOPI) and Avenue Venture Opportunities Fund II, L.P. (AVOPII, and together with AVOPI, Avenue) for growth capital loans in an aggregate commitment amount of up to $20 million (the Loan).
2022-07-15	The Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC (Acuitas), the Company's largest stockholder.
2022-08-31	The Company entered into a Controlled Equity Offering Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc.
2022-12	The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), completed.
2023-03	The Company announced enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment.
2023-04-06	The Company and B. Riley Securities, Inc. mutually agreed to terminate B. Riley Securities, Inc.'s role as a sales agent under the Sales Agreement.
2023-06	The Company requested and subsequently received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis.
2023-11-29	The Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
2024-01-19	A purported shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada.
2024-02-22	A second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al., No. 2:24-cv-00361.
2024-04	The Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (DOD).
2024-04-15	The court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation, No. 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel.
2024-06-21	The lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company's business, operations, compliance, and prospects.
2024-07	The Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with the study.
2024-08	U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO) approved the Company's plan to evaluate bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID.
2024-08-12	The Company awarded 15,000 shares of Common Stock to a vendor as part of their fees in exchange for services.
2024-08-21	The defendants filed a motion to dismiss the amended complaint.
2024-09-25	The Company closed a best efforts public offering (the September 2024 Offering).
2024-09-25	The Company filed a prospectus supplement to suspend sales under the Controlled Equity Offering Sales Agreement.
2024-10	The Company closed three registered direct offerings (the October Offerings).
2024-10-21	Plaintiffs filed their opposition.
2024-11-20	The Company issued equity awards as part of the board of directors annual compensation.
2024-12-01	The Loan was paid in full on its maturity date of December 1, 2024 along with a final payment equal to 4.25% of the Loan commitment amount, or $850,000, the (Loan Premium).
2024-12-05	The defendants reply brief was filed.
2024-12-20	The Company issued to employees and directors stock options to purchase 208,902 and 113,055 shares of common stock, respectively; at an exercise price of $ 1.90 , the Company's stock price at the close on December 20, 2024.
2024-12-30	A shareholder derivative lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder Andrew Hulm.
2025 Q1	The trial is anticipated to commence during the first calendar quarter of 2025.
2025 Q1	The Company anticipates the trial to commence by first calendar quarter of 2025.
2025-02-07	There were 18,451,981 shares of the Registrant's Class A Common Stock, $0.0001 par value per share, outstanding as of February 7, 2025.

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