<?xml version="1.0"?>
<ownershipDocument>

    <schemaVersion>X0306</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2020-07-15</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0001509261</issuerCik>
        <issuerName>Rezolute, Inc.</issuerName>
        <issuerTradingSymbol>RZLT</issuerTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001798101</rptOwnerCik>
            <rptOwnerName>HANDOK, INC.</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>132, TEHERAN-RO</rptOwnerStreet1>
            <rptOwnerStreet2>GANGMAN GU</rptOwnerStreet2>
            <rptOwnerCity>SEOUL</rptOwnerCity>
            <rptOwnerState>M4</rptOwnerState>
            <rptOwnerZipCode>06235</rptOwnerZipCode>
            <rptOwnerStateDescription>KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF</rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>0</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>1</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle></officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Shares</value>
            </securityTitle>
            <transactionDate>
                <value>2020-07-15</value>
            </transactionDate>
            <deemedExecutionDate></deemedExecutionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>P</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>250000</value>
                    <footnoteId id="F1"/>
                </transactionShares>
                <transactionPricePerShare>
                    <value>0.1574</value>
                    <footnoteId id="F2"/>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>92277587</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">The purchases reported in this Form 4 were effected pursuant to a Rule 10b5-1 trading plan adopted by the reporting person on July 6, 2020.</footnote>
        <footnote id="F2">The price reported in Column 4 is a weighted average price.  These shares were purchased in multiple transactions at prices ranging from $0.157 to $0.167, inclusive. The reporting person undertakes to provide to Rezolute, Inc., any security holder of Rezolute, Inc., or the staff of the Securities and Exchange Commission, upon request, full information regarding the number of shares purchased at each separate price within the ranges set forth in this footnote (2).</footnote>
    </footnotes>

    <ownerSignature>
        <signatureName>Handok, Inc. by Hyeon Cheol Lee as CFO of Handok, Inc.</signatureName>
        <signatureDate>2020-07-16</signatureDate>
    </ownerSignature>
</ownershipDocument>
