What changed in this filing

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Item 1A. Risk Factors

2023-05-12 compared with 2023-02-10 · 46 added, 306 removed, 28 unchanged (93% of the section changed)

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that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.

Relating to Our Business and Industry

the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing

approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions

of our products, the sales of our products could be adversely affected.

a new drug application (“NDA”) is approved, the product covered thereby becomes a “reference listed drug” or

RLD, in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as

the Orange Book.

Other manufacturers may seek approval of generic versions of reference listed drugs through submission of abbreviated

new drug applications (“ANDAs”) in the United States.

In support of an ANDA, a generic manufacturer need not conduct clinical

Rather, the applicant generally must show that its product has the same active ingredient(s), dosage form, strength, route of

administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference

listed drug, meaning it is absorbed in the body at the same rate and to the same extent as the RLD.

Generic products may be significantly

less costly to bring to market than the reference listed drug and companies that produce generic products are generally able to offer

them at lower prices.

Moreover, generic versions of RLDs are often automatically substituted for the RLD by pharmacies when dispensing

a prescription written for the RLD.

Thus, following the introduction of a generic drug, a significant percentage of the sales of any

branded product or reference listed drug is typically lost to the generic product.

FDA may not approve an ANDA for a generic product until any applicable period of non-patent exclusivity for the RLD has expired.

federal Food, Drug, and Cosmetic Act (“FDCA”) provides a period of five years of non-patent exclusivity for a new drug

containing a new chemical entity (“NCE”).

An NCE is an active ingredient that has not previously been approved by FDA alone

or in combination with other substances.

Specifically, in cases where such exclusivity has been granted, an ANDA may not be submitted

to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV Certification that a patent covering

the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its

application four years following approval of the reference listed drug.

If an ANDA is submitted to FDA with a Paragraph IV Certification,

the generic applicant must also provide a Paragraph IV Notification to the holder of the NDA for the RLD and to the owner of the listed

patent(s) being challenged by the ANDA applicant, providing a detailed written statement of the basis for the ANDA applicant’s

position that the relevant patent(s) is invalid or would not be infringed.

If the patent owner brings a patent infringement lawsuit against

the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA will be automatically stayed for 30 months,

or until 7-1/2 years after the NDA approval if the generic application was filed between 4 years and 5 years after the NDA approval.

Any such stay will be terminated earlier if the court rules that the patent is invalid or would not be infringed.

that our products may face from generic versions of our products could materially and adversely impact our future revenue, profitability

and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity, and

on our intellectual property rights, which may reduce the length of time that we can prevent competitors from selling generic versions

have obtained Orphan Drug Designation for BIV201 (terlipressin) in the U.S.

for the treatment of hepatorenal syndrome (received November

21, 2018) and treatment of ascites due to all etiologies except cancer (received September 8, 2016).

Under the Orphan Drug Act, the FDA

may designate a product as an Orphan Drug if it is a drug intended to treat a rare disease or condition, defined, in part, as a patient

population of fewer than 200,000 in the U.S.

In the EU, Orphan Drug designation may be granted to drugs intended to treat, diagnose or

prevent a life-threatening or chronically debilitating disease having a prevalence of no more than five in 10,000 people in the EU, and

which meet other specified criteria.

The company that first obtains FDA approval for a designated Orphan Drug for the associated rare

disease may receive a seven-year period of marketing exclusivity during which time FDA may not approve another application for the same

drug for the same orphan disease or condition.

Orphan Drug Exclusivity does not prevent FDA approval of another application for the same

drug for a different disease or condition, or of an application for a different drug for the same rare disease or condition.

exclusive marketing rights may be lost under several circumstances, including a later determination by the FDA that the request for designation

was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug.

Similar regulations are available

in the EU with a ten-year period of market exclusivity.

though BioVie has obtained two Orphan Drug Designations for its lead product candidate, terlipressin, for treatment of ascites and for

treatment of HRS, and may seek other Orphan Drug Designations for BIV201, and Orphan Drug Designation for other product candidates, there

is no assurance that BioVie will be the first to obtain marketing approval for any particular rare indication.

Further, even though BioVie

has obtained Orphan Drug Designations for its lead product candidate, or even if BioVie obtains Orphan Drug Designation for other potential

product candidates, such designation may not effectively protect BioVie from competition because different drugs can be approved for

the same condition and the same drug can be approved for different conditions and potentially used off-label in the Orphan indication.

Even after an Orphan Drug is approved, the FDA can subsequently approve another competing drug with the same active ingredient for the

same condition for several reasons, including, if the FDA concludes that the later drug is clinically superior due to being safer or

more effective or because it makes a major contribution to patient care.

Orphan Drug Designation neither shortens the development time

or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

fact, Mallinckrodt recently received an NDA approval for its terlipressin product for the hepatorenal syndrome (“HRS”) indication

in September 2022, which is the same indication for which we had received an Orphan Designation.

FDA granted Mallinckrodt and its approved

drug a new chemical entity exclusivity.

Similarly, if another company with an Orphan Drug designation for the same drug as ours for the

same proposed disease or condition receives FDA approval and orphan drug exclusivity before our product is approved, approval of our

drug(s) for the orphan indication may be blocked for seven years by the other company’s orphan drug exclusivity and they may obtain

a competitive advantage even after the exclusivity period expires associated with being the first to market.

may face business disruption and related risks if there is another surge ofCOVID-19 or if there is another pandemic caused by other bacteria

or viruses, which could have a material adverse effect on our business plan.

emergencies or pandemics, whether from COVID-19 or other viruses or bacteria, may lead to regional quarantines, business shutdowns, labor

shortages, disruptions to supply chains, and overall economic instability, which could materially and adversely affect the clinical trials,

supply chain, financial condition and financial performance of our company.

The duration and spread of a pandemic and its long-term impact

on the financial markets and the overall economy are highly uncertain and cannot be predicted.

If the financial markets and/or the overall

economy are impacted for an extended period, the Company’s ability to raise funds may be materially adversely affected.

such health emergencies or pandemics may create a widespread labor shortage, including a shortage of medical professionals, and may impact

potential patient participation in our studies which may adversely impact our ability to continue or complete our clinical trials in

the planned timeline.

can provide no assurance that our product candidates will obtain regulatory approval or that the results of clinical studies will be

business plan we have developed through June 2024 for the liver disease program is to complete the Phase 2b clinical development program

for our lead new product candidate BIV201 for treatment of ascites, conduct a single pivotal Phase 3 trial of BIV201 for ascites, and

to pursue other key milestones such as additional patent issuances.

For NE3107, we have commenced a potentially pivotal 18-month Phase

3 trial in Alzheimer’s disease, commenced a Phase 2 study of NE3017 in Parkinson’s disease.

Due to our financial constraints,

we do not have the resources necessary to complete all of these clinical studies.

Subject to FDA guidance, we plan to commence additional

Phase 2 and potentially Phase 3 clinical trials upon receipt of a successful capital raise.

There is no guarantee the FDA will approve

the commencement of a Phase 3 trial for BIV201, and even if it does, our financial constraints may prevent us from undertaking clinical

rely and will continue to rely on third parties to conduct our clinical trials.

If these third parties do not successfully carry out

their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product

depend, and will continue to depend, on contract research organizations (“CROs”), clinical trial sites and clinical trial

principal investigators, contract laboratories, and other third parties to conduct our clinical trials.

We rely heavily on these third

parties over the course of our clinical trials, and we control only certain aspects of their activities.

Nevertheless, we are responsible

for ensuring that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards

and regulations, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and these third parties

are required to comply with current good clinical practices (“cGCPs”), which

are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct of clinical trials on

product candidates in clinical development.

Regulatory authorities enforce cGCPs through periodic inspections and for-cause inspections

of clinical trial principal investigators and trial sites.

If we or any of these third parties fail to comply with applicable cGCPs or

fail to enroll a sufficient number of patients, we may be required to conduct additional clinical trials to support our marketing applications,

which would delay the regulatory approval process.

Moreover, our business may be implicated if any of these third parties violates federal,

state, or foreign fraud and abuse or false claims laws and regulations or healthcare privacy and security laws, or provide us or government

agencies with inaccurate, misleading, or incomplete data.

we design the clinical trials for our product candidates, our CROs will facilitate and monitor our clinical trials.

As a result, many

important aspects of our clinical development programs, including site and investigator selection, and the conduct and timing and monitoring

of the study, will be partly or completely outside our direct control.

Our reliance on third parties to conduct clinical trials will

also result in less direct control over the collection, management, and quality of data developed through clinical trials than would

be the case if we were relying entirely upon our own employees.

Communicating with third parties can also be challenging, potentially

leading to mistakes as well as difficulties in coordinating activities.

third parties conducting our clinical trials are not, and will not be, our employees and, except for remedies available to us under our

agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing preclinical,

clinical, and nonclinical programs.

These third parties may also have relationships with other commercial entities, including our competitors,

for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our

If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if the

quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory

requirements, or if there are other difficulties with such third parties, such as staffing difficulties, changes in priorities, or financial

distress, our clinical trials may be extended, delayed, or terminated.

As a result, we may not be able to complete development of, obtain

regulatory approval of, or successfully commercialize our product candidates.

As a result, our financial results and the commercial prospects

for our product candidates will be harmed, our costs could increase, and our ability to generate revenue could be delayed.

any of our relationships with trial sites, or any CRO that we may use in the future, terminates, we may not be able to timely enter into

arrangements with alternative trial sites or CROs, or do so on commercially reasonable terms.

Switching or adding clinical trial sites

or CROs to conduct our clinical trials involves substantial cost and requires extensive management time, training, and focus.

there is a natural transition lag when a new third party must learn about our product candidates and protocols, which can result in delays

that may materially impact our ability to meet our desired clinical development timelines.

may be unable to obtain or protect intellectual property rights relating to our product candidates, and we may be liable for infringing

upon the intellectual property rights of others, which could have a materially adverse effect on our business.

ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies.

We cannot assure investors

that we will continue to innovate and file new patent applications, or that if filed any future patent applications will result in granted

patents with respect to the technology owned by us or licensed to us.

Further, we cannot predict how long it will take for such patents

to issue, if at all.

The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves

complex legal and factual considerations and, therefore, validity and enforceability cannot be predicted with certainty.

be challenged, deemed unenforceable, invalidated or circumvented.

has also filed a PCT (“Patent Cooperation Treaty”) application covering our novel liquid formulations of terlipressin (international

patent application PCT/US2020/034269 published as WO2020/237170) and we are seeking patent protection in the United States, Europe, China,

Japan and eight other jurisdictions.

As of December 31, 2022, we have fifteen (15) issued U.S.

patents, one (1) pending U.S.

patent application,

one (1) pending PCT application and six (6) issued foreign patents directed to protecting NE3107 and related compounds and methods of

making and using thereof.

However, there can be no assurance that our pending patent applications will result in issued patents, or that

any issued patent claims from pending or future patent applications will be sufficiently broad to protect BIV201, NE3107, or any other

product candidates or to provide us with competitive advantages.

patents we do obtain may be challenged by re-examination or otherwise invalidated or eventually found unenforceable.

Both the patent

application process and the process of managing patent disputes can be time consuming and expensive.

If we were to initiate legal proceedings

against a third party to enforce a patent related to one of our products, the defendant in such litigation could counterclaim that our

patent is invalid and/or unenforceable.

In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability

are commonplace, as are validity challenges by the defendant against the subject patent or other patents before the United States Patent

and Trademark Office (the “USPTO”).

Grounds for a validity challenge could be an alleged failure to meet any of several statutory

requirements, including lack of novelty, obviousness or non-enablement, failure to meet the written description requirement, indefiniteness,

and/or failure to claim patent eligible subject matter.

Grounds for an unenforceability assertion could be an allegation that someone

connected with prosecution of the patent intentionally withheld material information from the USPTO, or made a misleading statement,

during prosecution.

Additional grounds for an unenforceability assertion include an allegation of misuse or anticompetitive use of patent

rights, and an allegation of incorrect inventorship with deceptive intent.

Third parties may also raise similar claims before the USPTO

even outside the context of litigation.

The outcome is unpredictable following legal assertions of invalidity and unenforceability.

respect to the validity question, for example, we cannot be certain that no invalidating prior art existed of which we and the patent

examiner were unaware during prosecution.

These assertions may also be based on information known to us or the Patent Office.

If a defendant

or third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all,

of the claims of the challenged patent.

Such a loss of patent protection would or could have a material adverse impact on our business.

standards that the United States Patent and Trademark Office (and foreign countries) use to grant patents are not always applied predictably

or uniformly and can change.

There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable

in pharmaceutical or biotechnology patents.

Accordingly, we do not know the degree of future protection for our proprietary rights or

the breadth of claims that will be allowed in any patents issued to us or to others.

we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures

to protect our rights in the technology.

If any trade secret, know-how or other technology not protected by a patent were to be disclosed

to or independently developed by a competitor, our business and financial condition could be materially adversely affected.

of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant

problems in protecting our proprietary rights in these countries.

do not believe that either BIV201 or NE3107, the product candidates we are currently developing, infringe upon the rights of any third

parties nor are they infringed upon by third parties.

However, there can be no assurance that our technology will not be found in the

future to infringe upon the rights of others or be infringed upon by others.

Moreover, patent applications are in some cases maintained

in secrecy until patents are issued.

The publication of discoveries in the scientific or patent literature frequently occurs substantially

later than the date on which the underlying discoveries were made and patent applications were filed.

Because patents can take many years

to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products

or product candidates infringe.

For example, pending applications may exist that provide support or can be amended to provide support

for a claim that results in an issued patent that our product infringes.

In such a case, others may assert infringement claims against

us, and should we be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be

forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’ patent

In addition to any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual

We may fail to obtain any of these licenses or intellectual property rights on commercially reasonable terms.

Even if we are

able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

that event, we may be required to expend significant time and resources to develop or license replacement technology.

If we are unable

to do so, we may be unable to develop or commercialize the affected products, which could materially harm our business and the third

parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales,

an obligation on our part to pay royalties and/or other forms of compensation.

Conversely, we may not always be able to successfully

pursue our claims against others that infringe upon our technology.

Thus, the proprietary nature of our technology or technology licensed

by us may not provide adequate protection against competitors.

pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights.

the cost to us of any litigation or other proceeding relating to our patents and other intellectual property rights, even if resolved

in our favor, could be substantial, and the litigation would divert our management’s efforts.

We may not have sufficient resources

to bring any such action to a successful conclusion.

Uncertainties resulting from the initiation and continuation of any litigation could

limit our ability to continue our operations and you could lose all of your investment.

may be conflicts of interest among our officers, directors and stockholders.

of our executive officers and directors and their affiliates are engaged in other activities and have interests in other entities on

their own behalf or on behalf of other persons.

Neither we nor any of our stockholders will have any rights in these ventures or their

income or profits.

In particular, our executive officers or directors or their affiliates may have an economic interest in or other business

relationship with partner companies that invest in us or are engaged in competing drug development.

Our executive officers or directors

may have conflicting fiduciary duties to us and third parties.

The terms of transactions with third parties may not be subject to arm’s

length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations.

Developments Affecting the Financial Services Industry and Concentration of Risk

of March 31, 2023 and December 31, 2022, the Company had cash deposited in certain financial institutions in excess of federally insured

The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to

any significant credit risk in cash and cash equivalents.

However, in March and April 2023, certain U.S.

government banking regulators

took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened

uncertainties in financial markets.

While these events have not had a material direct impact on the Companys operations, if further

liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions,

the Companys ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse

effect on its business, financial condition and results of operations.

Relating To Our Common Stock

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or exchangeable for our common stock, including under the Controlled Equity Offering Sales Agreement (the Sales Agreement),

dated as of August 31, 2022, by and among the Company, Cantor Fitzgerald & Co.

Riley Securities, Inc.

(collectively, the “Agents”),

pursuant to which the Company may issue and sell from time to time shares of common stock through the Agents.

dated as of August 31, 2022, with Cantor Fitzgerald & Co.

(the Agent),

pursuant to which the Company may issue and sell from time to time shares of common stock through the Agent.

We may sell shares or other

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for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained within those

addition, as of December 31, 2022, there were warrants outstanding to purchase an aggregate of 7,770,285 shares of common

stock at exercise prices ranging from $1.82 to $12.50 per share and 3,448,797 shares issuable upon exercise of outstanding

options at exercise prices ranging from $1.69 to $42.09 per share.

Our Loan Agreement entered into on November 30, 2021

contains a conversion feature whereby at the option of lender, up to $5 million of the outstanding loan amount may be converted into

shares of common stock at a conversion price of $6.98 per share.

We may grant additional options, warrants or stock awards.

extent such shares are issued, the interest of holders of our common stock will be diluted.

addition, as of March 31, 2023, there were warrants outstanding to purchase an aggregate of 7,770,285 shares of common stock

at exercise prices ranging from $1.82 to $12.50 per share and 3,443,997 shares issuable upon exercise of outstanding options at

exercise prices ranging from $1.69 to $42.09 per share and restricted stock units totaling 527,549.

Our Loan Agreement entered into

on November 30, 2021 contains a conversion feature whereby at the option of lender, up to $5 million of the outstanding loan amount may

be converted into shares of common stock at a conversion price of $6.98 per share.

We may grant additional options, warrants or equity

To the extent such shares are issued, the interest of holders of our common stock will be diluted.

we are obligated to issue shares of common stock upon achievement of certain clinical, regulatory and commercial milestones with respect

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and Acuitas, as amended on May 9, 2021.

The achievement of these milestones could result in the issuance of up to 18 million shares of our common stock, further diluting the

interest of holders of our common stock.

The achievement of these milestones could result

in the issuance of up to 18 million shares of our common stock, further diluting the interest of holders of our common stock.

stockholders who are also officers and directors of the Company may have significant control over our management.

of December 31, 2022, our directors and executive officers currently own an aggregate 24,431,826 shares of our common stock, which

currently constitutes 67.9% of our issued and outstanding common stock.

As a result, directors and executive officers may have a significant

influence on our affairs and management, as well as on all matters requiring member approval, including electing and removing members

of our board of directors, causing us to engage in transactions with affiliated entities, causing or restricting our sale or merger,

and certain other matters.

Our Chairman, Mr.

Terren Peizer, may be deemed to beneficially own the shares held by Acuitas.

Such concentration

of ownership and control could have the effect of delaying, deferring or preventing a change in control of us even when such a change

of control would be in the best interests of our stockholders.

is a limited trading market for our common stock, which could make it difficult to liquidate an investment in our common stock, in a

timely manner.

common stock is currently traded on the Nasdaq Capital Market.

Because there is a limited public market for our common stock, investors

may not be able to liquidate their investment whenever desired.

We cannot assure that there will be an active trading market for our

common stock and the lack of an active public trading market could mean that investors may be exposed to increased risk.

if we failed to meet the criteria set forth in SEC regulations, various requirements would be imposed by law on broker dealers who sell

our securities to persons other than established customers and accredited investors.

Consequently, such regulations may deter broker-dealers

from recommending or selling our common stock, which may further affect its liquidity.

of March 31, 2023, our directors and executive officers and affiliate currently own an aggregate 24,431,826 shares of our common

stock, which currently constitutes 65% of our issued and outstanding common stock.

As a result, directors and executive officers may

have a significant influence on our affairs and management, as well as on all matters requiring member approval, including electing and

removing members of our board of directors, causing us to engage in transactions with affiliated entities, causing or restricting our

sale or merger, and certain other matters.

Our majority shareholder, Mr.

Terren Peizer, may be deemed to beneficially own the shares

held by Acuitas.

Such concentration of ownership and control could have the effect of delaying, deferring or preventing a change in control

of us even when such a change of control would be in the best interests of our stockholders.

may, in the future, issue additional common stock, which would reduce investors percent of ownership and may dilute our share

of December 31, 2022 our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of common stock, and we

had 34,504,332 shares of common stock outstanding.

Accordingly, we may issue up to an additional 753,719,062 shares of common

The future issuance of common stock may result in substantial dilution in the percentage of our common stock held by our then

existing stockholders.

of March 31, 2023, our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of common stock, and we had 36,153,911

shares of common stock issued and 36,131,311 issued and outstanding.

Accordingly, we may issue up to an additional 752,147,919 shares

of common stock.

The future issuance of common stock may result in substantial dilution in the percentage of our common stock held by

our then existing stockholders.

We may value any common stock in the future on an arbitrary basis.

The issuance of common stock for future services

or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our investors, might have

an adverse effect on any trading market for our common stock and could impair our ability to raise capital in the future through the

sale of equity securities.

The issuance of common stock for future

services or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our investors, might

have an adverse effect on any trading market for our common stock and could impair our ability to raise capital in the future through

the sale of equity securities.

Unregistered sales of equity securities

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors