10-Q
--12-31false0001658551Q20001658551us-gaap:CollateralizedDebtObligationsMember2022-06-300001658551us-gaap:RetainedEarningsMember2022-01-012022-03-310001658551us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-06-300001658551us-gaap:AdditionalPaidInCapitalMember2021-12-3100016585512021-01-012021-12-310001658551us-gaap:RetainedEarningsMember2021-06-300001658551us-gaap:SeriesCPreferredStockMemberamlx:TwoThousandTwentyOneNotesMember2021-07-310001658551srt:MinimumMember2022-01-012022-06-3000016585512021-01-012021-03-310001658551amlx:SpecialPurposeAcquisitionCorpMembersrt:MaximumMemberamlx:TwoThousandTwentyOneNotesMember2021-01-310001658551us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-3100016585512022-01-012022-06-300001658551us-gaap:EmployeeStockOptionMember2022-06-300001658551us-gaap:AdditionalPaidInCapitalMember2022-06-300001658551us-gaap:CommonStockMember2021-06-300001658551amlx:TwoThousandTwentyTwoStockOptionAndIncentivePlanMember2022-01-052022-01-0500016585512022-03-310001658551us-gaap:RestrictedStockUnitsRSUMember2022-04-012022-06-3000016585512020-12-310001658551us-gaap:EmployeeStockOptionMember2021-01-012021-12-310001658551srt:MaximumMemberamlx:TwoThousandTwentyOneNotesMember2021-01-012021-01-310001658551us-gaap:FairValueInputsLevel1Memberamlx:RestrictedCashMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:CommonStockMember2022-01-012022-03-310001658551us-gaap:FairValueInputsLevel2Memberus-gaap:CommercialPaperMemberus-gaap:ShortTermInvestmentsMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:FairValueInputsLevel1Memberus-gaap:ShortTermInvestmentsMemberus-gaap:USTreasuryAndGovernmentMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551amlx:TwoThousandTwentyOneNotesInJanuaryAndFebruaryTwoThousandTwentyOneMember2021-01-012021-02-280001658551amlx:ALSAssociationAndALSFindingCureMemberus-gaap:RoyaltyAgreementTermsMember2016-08-012019-02-280001658551amlx:TwoZeroOneSevenNotesMemberamlx:SeriesARedeemableConvertiblePreferredSharesMember2020-06-170001658551us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001658551amlx:SeriesC1RedeemableConvertiblePreferredSharesMember2021-07-310001658551us-gaap:AdditionalPaidInCapitalMember2021-06-300001658551us-gaap:FairValueInputsLevel2Memberus-gaap:CommercialPaperMemberus-gaap:ShortTermInvestmentsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:ShortTermInvestmentsMemberus-gaap:USTreasuryAndGovernmentMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551amlx:RestrictedCashMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551amlx:SeriesARedeemableConvertiblePreferredSharesMember2021-03-310001658551amlx:SeriesC2RedeemableConvertiblePreferredSharesMember2021-07-010001658551us-gaap:CommonStockMember2020-12-310001658551us-gaap:AdditionalPaidInCapitalMember2020-12-310001658551amlx:TwoThousandTwentyOneNotesMember2022-01-012022-06-300001658551amlx:TwoZeroOneSevenNotesMemberamlx:SeriesBRedeemableConvertiblePreferredSharesMember2021-06-300001658551us-gaap:StockCompensationPlanMember2022-06-300001658551amlx:TwoZeroOneSevenNotesMemberamlx:SeriesARedeemableConvertiblePreferredSharesMember2020-06-180001658551us-gaap:CommercialPaperMemberus-gaap:ShortTermInvestmentsMember2021-12-310001658551us-gaap:CommonStockMember2021-04-012021-06-300001658551us-gaap:EmployeeStockOptionMember2021-04-012021-06-300001658551us-gaap:ShortTermInvestmentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:ShortTermInvestmentsMember2022-06-300001658551amlx:TwoThousandTwentyOneNotesMember2021-06-300001658551us-gaap:CommercialPaperMemberus-gaap:ShortTermInvestmentsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:EmployeeStockOptionMember2022-01-012022-06-300001658551amlx:IncentiveStockOptionsMemberamlx:TwoThousandTwentyTwoStockOptionAndIncentivePlanMember2022-01-050001658551amlx:SeriesC2RedeemableConvertiblePreferredSharesMemberamlx:TwoThousandTwentyOneNotesMember2021-07-312021-07-310001658551us-gaap:ShortTermInvestmentsMemberus-gaap:USTreasurySecuritiesMember2022-06-300001658551us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:RetainedEarningsMember2022-03-310001658551us-gaap:RetainedEarningsMember2021-04-012021-06-300001658551amlx:TwoThousandTwentyTwoStockOptionAndIncentivePlanMember2022-06-300001658551us-gaap:ShortTermInvestmentsMemberus-gaap:USTreasuryAndGovernmentMember2022-06-300001658551amlx:SeriesC1RedeemableConvertiblePreferredSharesMember2021-07-010001658551us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-06-300001658551amlx:SeriesC1RedeemableConvertiblePreferredSharesMember2021-12-310001658551us-gaap:RestrictedStockUnitsRSUMember2022-06-3000016585512021-12-310001658551amlx:TwoZeroOneSevenNotesMemberamlx:SeriesBRedeemableConvertiblePreferredSharesMember2021-07-310001658551us-gaap:ShortTermInvestmentsMemberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551amlx:TwoThousandFifteenStockOptionAndRestrictedStockPlanMember2022-01-062022-01-0600016585512022-04-012022-06-300001658551us-gaap:CommercialPaperMemberus-gaap:ShortTermInvestmentsMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551amlx:SeriesC1RedeemableConvertiblePreferredSharesMember2022-01-012022-03-310001658551us-gaap:RetainedEarningsMember2020-12-310001658551us-gaap:CommonStockMember2022-03-310001658551us-gaap:GeneralAndAdministrativeExpenseMember2021-01-012021-06-300001658551amlx:SeriesC2RedeemableConvertiblePreferredSharesMember2022-06-300001658551amlx:TwoThousandTwentyOneNotesMember2022-06-300001658551us-gaap:EmployeeStockOptionMember2021-12-310001658551amlx:SeriesARedeemableConvertiblePreferredSharesMember2020-12-310001658551amlx:SeriesBRedeemableConvertiblePreferredSharesMember2021-03-310001658551us-gaap:FairValueInputsLevel2Memberus-gaap:ShortTermInvestmentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551amlx:SeriesBRedeemableConvertiblePreferredSharesMember2021-12-310001658551srt:MaximumMemberamlx:NonemployeeDirectorMemberamlx:TwoThousandTwentyTwoStockOptionAndIncentivePlanMember2022-01-052022-01-0500016585512021-03-310001658551amlx:TwoThousandFifteenStockOptionAndRestrictedStockPlanMember2022-01-052022-01-050001658551us-gaap:AccountingStandardsUpdate201811Member2022-01-0100016585512022-01-012022-01-310001658551us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551srt:DirectorMemberamlx:MorningsideVenturesInvestmentsLimitedMemberamlx:TwoThousandTwentyOneNotesMember2021-01-310001658551us-gaap:RetainedEarningsMember2022-06-300001658551amlx:SeriesARedeemableConvertiblePreferredSharesMember2021-12-3100016585512022-01-3100016585512022-01-012022-03-310001658551us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-03-310001658551us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-06-300001658551amlx:TwoThousandTwentyTwoStockOptionAndIncentivePlanMember2022-01-050001658551amlx:SeriesC2RedeemableConvertiblePreferredSharesMemberamlx:TwoThousandTwentyOneNotesMember2021-07-3100016585512021-04-012021-06-300001658551amlx:SeriesBRedeemableConvertiblePreferredSharesMember2020-12-310001658551us-gaap:CorporateDebtSecuritiesMemberus-gaap:ShortTermInvestmentsMember2021-12-310001658551amlx:SeriesBRedeemableConvertiblePreferredSharesMember2022-01-012022-03-310001658551amlx:SeriesBRedeemableConvertiblePreferredSharesMember2021-06-300001658551us-gaap:EmployeeStockOptionMember2022-01-012022-06-300001658551us-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-300001658551us-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:CommercialPaperMemberus-gaap:ShortTermInvestmentsMember2022-06-300001658551us-gaap:AdditionalPaidInCapitalMember2021-01-012021-03-310001658551us-gaap:CommonStockMember2022-06-300001658551us-gaap:RetainedEarningsMember2021-12-310001658551amlx:SeriesC1RedeemableConvertiblePreferredSharesMember2022-06-300001658551us-gaap:ShortTermInvestmentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:AdditionalPaidInCapitalMember2021-03-310001658551us-gaap:GeneralAndAdministrativeExpenseMember2021-04-012021-06-300001658551us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-04-012022-06-3000016585512022-01-100001658551us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-06-300001658551amlx:TwoZeroTwoOneNotesMemberamlx:SeriesC2RedeemableConvertiblePreferredSharesMember2021-07-310001658551us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-06-300001658551amlx:TwoThousandTwentyOneNotesInDecemberTwoThousandTwentyMember2020-12-012020-12-3100016585512021-01-012021-06-3000016585512022-06-300001658551us-gaap:FairValueInputsLevel2Memberus-gaap:ShortTermInvestmentsMemberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:StockCompensationPlanMember2021-12-310001658551amlx:SeriesC2RedeemableConvertiblePreferredSharesMember2022-01-012022-03-310001658551us-gaap:ResearchAndDevelopmentExpenseMember2021-04-012021-06-300001658551us-gaap:EmployeeStockOptionMember2021-01-012021-06-300001658551us-gaap:RetainedEarningsMember2021-01-012021-03-310001658551us-gaap:EmployeeStockOptionMember2022-04-012022-06-300001658551amlx:RestrictedCashMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:FairValueInputsLevel1Memberus-gaap:ShortTermInvestmentsMemberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551amlx:TwoThousandTwentyTwoStockOptionAndIncentivePlanMember2022-01-012022-06-300001658551amlx:TwoThousandTwentyOneNotesMember2021-01-310001658551amlx:SeriesARedeemableConvertiblePreferredSharesMember2021-06-300001658551us-gaap:CommonStockMember2021-12-310001658551amlx:TwoThousandTwentyOneNotesMember2021-12-310001658551us-gaap:GeneralAndAdministrativeExpenseMember2022-01-012022-06-300001658551amlx:AlzheimersDrugDiscoveryFoundationAlzheimersAssociationAndCureAlzheimersFundMemberus-gaap:RoyaltyAgreementTermsMember2019-02-280001658551amlx:SeriesC2RedeemableConvertiblePreferredSharesMember2021-12-310001658551us-gaap:RedeemableConvertiblePreferredStockMember2021-01-012021-12-310001658551us-gaap:RetainedEarningsMember2022-04-012022-06-300001658551us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-03-310001658551us-gaap:RetainedEarningsMember2021-03-310001658551amlx:SeriesBRedeemableConvertiblePreferredSharesMember2022-06-300001658551us-gaap:CommonStockMember2021-03-310001658551amlx:SeriesARedeemableConvertiblePreferredSharesMember2022-01-012022-03-3100016585512021-06-300001658551us-gaap:ShortTermInvestmentsMember2021-12-310001658551us-gaap:ResearchAndDevelopmentExpenseMember2022-04-012022-06-300001658551us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2022-06-300001658551amlx:TwoThousandTwentyOneNotesMember2021-01-012021-01-310001658551us-gaap:AdditionalPaidInCapitalMember2022-03-310001658551us-gaap:GeneralAndAdministrativeExpenseMember2022-04-012022-06-300001658551us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:CorporateDebtSecuritiesMemberus-gaap:ShortTermInvestmentsMember2022-06-300001658551amlx:SeriesBRedeemableConvertiblePreferredSharesMember2022-01-012022-06-300001658551us-gaap:CollateralizedCreditCardSecuritiesMember2022-06-300001658551us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-300001658551srt:DirectorMemberamlx:TwoThousandTwentyTwoStockOptionAndIncentivePlanMember2022-01-052022-01-0500016585512022-08-080001658551amlx:AlzheimersDrugDiscoveryFoundationAlzheimersAssociationAndCureAlzheimersFundMemberus-gaap:RoyaltyAgreementTermsMember2016-08-012019-02-280001658551us-gaap:FairValueInputsLevel1Memberamlx:RestrictedCashMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:RoyaltyAgreementTermsMember2016-08-012019-02-280001658551us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001658551us-gaap:CommonStockMember2021-01-012021-03-310001658551us-gaap:CommonStockMemberus-gaap:IPOMember2022-01-012022-03-310001658551amlx:SeriesARedeemableConvertiblePreferredSharesMember2022-06-30utr:Ratexbrli:pureamlx:LeaseAgreementxbrli:sharesamlx:Voteiso4217:USDiso4217:USDxbrli:shares

 

lb

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2022

OR

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

For the transition period from ___________________ to ___________________

Commission File Number: 001-41199

 

Amylyx Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

46-4600503

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

43 Thorndike St.

Cambridge, Massachusetts

02141

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 682-0917

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

AMLX

 

Nasdaq Global Select Stock Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

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.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of August 8, 2022, the registrant had 58,533,226 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

 


 

AMYLYX PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022

 

Table of Contents

 

 

 

Page

 

 

 

PART I.

FINANCIAL INFORMATION

3

 

 

 

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Consolidated Balance Sheets

3

 

Condensed Consolidated Statements of Operations

4

 

Condensed Consolidated Statements of Comprehensive Loss

5

 

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

6

 

Condensed Consolidated Statements of Cash Flows

8

 

Notes to Condensed Consolidated Financial Statements

9

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

34

 

 

 

PART II.

OTHER INFORMATION

35

 

 

 

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

93

Item 3.

Defaults Upon Senior Securities

93

Item 4.

Mine Safety Disclosures

93

Item 5.

Other Information

93

Item 6.

Exhibits

94

Signatures

95

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q ("Quarterly Report") contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended ("the Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended ("the Exchange Act"). All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “should,” “would” or the negative of these terms or other comparable terminology. These statements are not guarantees of future results or performance and involve substantial risks and uncertainties. Forward-looking statements in this Quarterly Report include, but are not limited to, express or implied statements about:

our ability to obtain and maintain regulatory approval of AMX0035 (also known as ALBRIOZA in Canada) and any future product candidates;
our ability to successfully commercialize and market AMX0035 and any future product candidates, if approved, and the timing of any commercialization and marketing efforts;
our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately and to produce sufficient quantities of clinical and commercial supplies;
the potential market size, opportunity and growth potential for AMX0035 and any future product candidates, if approved;
our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize AMX0035 and any future product candidates, if approved;
our ability to obtain funding for our operations;
the initiation, timing, progress and results of our preclinical studies and clinical trials, including our Phase 3 clinical trial of AMX0035 for the treatment of ALS, known as the PHOENIX trial, and our research and development activities;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
our ability to advance AMX0035 and any future product candidates into, and successfully complete, clinical trials;
our ability to successfully recruit and enroll suitable patients in our clinical trials;
the timing or likelihood of the accomplishment of various scientific, clinical, regulatory filings and approvals and other product development objectives;
the pricing and reimbursement of AMX0035 in Canada and in any other jurisdictions in which AMX0035 is approved, if any, and of any other product candidates, if approved;
the rate and degree of market acceptance AMX0035 and any future product candidates by physicians, patients, third-party payors and others in the medical community;
the implementation of our business model, strategic plans for our business, product candidates and technology;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
developments relating to our competitors and our industry, including any regulatory developments;
our estimates regarding expenses, capital requirements, cash runway and future and needs for additional financing;
our financial performance; and
other statements about future events, including those made in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 ("Annual Report").

Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events and with respect to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report, as well as in Part I, Item 1A. and elsewhere in our Annual Report. Given these uncertainties, you should not place undue reliance on these

1


 

forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

All of our forward-looking statements are as of the date of this Quarterly Report only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the Securities and Exchange Commission ("SEC"), could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report that modify or impact any of the forward-looking statements contained in this Quarterly Report will be deemed to modify or supersede such statements in this Quarterly Report.

We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this Quarterly Report. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.

 

TRADEMARKS

Solely for convenience, our trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that we will not assert, to the fullest extent under applicable law, our rights thereto.

 

2


 

 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(Unaudited)

 

 

 

June 30,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

67,440

 

 

$

50,191

 

Short-term investments

 

 

139,241

 

 

 

45,927

 

Prepaid expenses and other current assets

 

 

9,458

 

 

 

5,392

 

Deferred offering costs

 

 

 

 

 

3,441

 

Total current assets

 

 

216,139

 

 

 

104,951

 

Property and equipment, net

 

 

1,857

 

 

 

474

 

Restricted cash

 

 

419

 

 

 

189

 

Operating lease right-of-use assets

 

 

6,369

 

 

 

 

Other assets

 

 

456

 

 

 

 

Total assets

 

$

225,240

 

 

$

105,614

 

Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

8,117

 

 

$

4,372

 

Accrued expenses and other current liabilities

 

 

17,260

 

 

 

13,024

 

Operating lease liabilities, current portion

 

 

1,787

 

 

 

 

Total current liabilities

 

 

27,164

 

 

 

17,396

 

Operating lease liabilities, net of current portion

 

 

5,287

 

 

 

 

Deferred rent

 

 

 

 

 

35

 

Total liabilities

 

 

32,451

 

 

 

17,431

 

Commitments and contingencies (Note 13)

 

 

 

 

 

 

Series A redeemable convertible preferred stock, $0.0001 par value; 0 and 6,289,609
   shares authorized, issued and outstanding as of June 30, 2022 and December 31, 2021,
   respectively

 

 

 

 

 

7,675

 

Series B redeemable convertible preferred stock, $0.0001 par value; 0 and 15,100,000
   shares authorized as of June 30, 2022 and December 31, 2021, respectively;
0 and 14,496,835 
   shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

 

 

 

 

 

64,387

 

Series C-1 redeemable convertible preferred stock, $0.0001 par value; 0 and 13,150,430
   shares authorized, issued and outstanding as of June 30, 2022 and December 31, 2021,
   respectively

 

 

 

 

 

134,791

 

Series C-2 redeemable convertible preferred stock, $0.0001 par value; 0 and 3,170,585
   shares authorized, issued and outstanding as of June 30, 2022 and December 31, 2021,
   respectively

 

 

 

 

 

32,498

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 and 0 shares authorized as of
   June 30, 2022 and December 31, 2021, respectively;
0 shares issued
   or outstanding as of June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 and 56,500,000 shares authorized
   as of June 30, 2022 and December 31, 2021, respectively;
58,533,226 and 7,020,487 
   shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

 

 

6

 

 

 

1

 

Additional paid-in capital

 

 

450,739

 

 

 

4,667

 

Accumulated deficit

 

 

(257,760

)

 

 

(155,845

)

Accumulated other comprehensive (loss) income

 

 

(196

)

 

 

9

 

Total stockholders’ equity (deficit)

 

 

192,789

 

 

 

(151,168

)

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

 

$

225,240

 

 

$

105,614

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


 

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

24,259

 

 

$

10,929

 

 

$

45,723

 

 

$

17,793

 

General and administrative

 

 

29,994

 

 

 

7,658

 

 

 

56,344

 

 

 

13,662

 

Total operating expenses

 

 

54,253

 

 

 

18,587

 

 

 

102,067

 

 

 

31,455

 

Loss from operations

 

 

(54,253

)

 

 

(18,587

)

 

 

(102,067

)

 

 

(31,455

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

402

 

 

 

1

 

 

 

533

 

 

 

3

 

Change in fair value of convertible notes

 

 

 

 

 

(3,310

)

 

 

 

 

 

(5,228

)

Other (expense) income, net

 

 

(42

)

 

 

(26

)

 

 

(61

)

 

 

235

 

Total other income (expense), net

 

 

360

 

 

 

(3,335

)

 

 

472

 

 

 

(4,990

)

Loss before income taxes

 

 

(53,893

)

 

 

(21,922

)

 

 

(101,595

)

 

 

(36,445

)

Provision for income taxes

 

 

174

 

 

 

 

 

 

320

 

 

 

 

Net loss

 

$

(54,067

)

 

$

(21,922

)

 

$

(101,915

)

 

$

(36,445

)

Net loss per share attributable to common stockholders —basic and diluted

 

$

(0.93

)

 

$

(3.41

)

 

$

(1.85

)

 

$

(5.75

)

Weighted-average shares used in computing net loss per share attributable to common stockholders—basic and diluted

 

 

58,275,903

 

 

 

6,433,889

 

 

 

54,958,537

 

 

 

6,334,813

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


 

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(54,067

)

 

$

(21,922

)

 

$

(101,915

)

 

$

(36,445

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

58

 

 

 

 

 

 

(10

)

 

 

 

Net unrealized loss on investments held

 

 

(103

)

 

 

 

 

 

(195

)

 

 

 

Other comprehensive loss

 

 

(45

)

 

 

 

 

 

(205

)

 

 

 

Comprehensive loss

 

$

(54,112

)

 

$

(21,922

)

 

$

(102,120

)

 

$

(36,445

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5


 

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(in thousands, except share data)

(Unaudited)

 

 

 

 

Series A
Redeemable
Convertible
Preferred Stock

 

 

Series B
Redeemable
Convertible
Preferred Stock

 

 

Series C-1
Redeemable
Convertible
Preferred Stock

 

 

Series C-2
Redeemable
Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Deficit

 

Balance as of
   December 31, 2021

 

 

6,289,609

 

 

$

7,675

 

 

 

14,496,835

 

 

$

64,387

 

 

 

13,150,430

 

 

$

134,791

 

 

 

3,170,585

 

 

$

32,498

 

 

 

 

7,020,487

 

 

$

1

 

 

$

4,667

 

 

$

9

 

 

$

(155,845

)

 

$

(151,168

)

Conversion of preferred stock into common stock upon initial public offering

 

 

(6,289,609

)

 

 

(7,675

)

 

 

(14,496,835

)

 

 

(64,387

)

 

 

(13,150,430

)

 

 

(134,791

)

 

 

(3,170,585

)

 

 

(32,498

)

 

 

 

39,474,330

 

 

 

4

 

 

 

239,347

 

 

 

 

 

 

 

 

 

239,351

 

Issuance of common stock upon initial public offering, net of issuance costs of $19,639

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11,369,369

 

 

 

1

 

 

 

196,378

 

 

 

 

 

 

 

 

 

196,379

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,392

 

 

 

 

 

 

 

 

 

4,392

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(160

)

 

 

 

 

 

(160

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(47,848

)

 

 

(47,848

)

Balance as of March 31, 2022

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

57,864,186

 

 

$

6

 

 

$

444,784

 

 

$

(151

)

 

$

(203,693

)

 

$

240,946

 

Issuance of common stock upon exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

669,040

 

 

 

 

 

 

248

 

 

 

 

 

 

 

 

 

248

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,707

 

 

 

 

 

 

 

 

 

5,707

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(45

)

 

 

 

 

 

(45

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(54,067

)

 

 

(54,067

)

Balance as of June 30, 2022

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

58,533,226

 

 

$

6

 

 

$

450,739

 

 

$

(196

)

 

$

(257,760

)

 

$

192,789

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

6


 

 

AMYLYX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(in thousands, except share data)

(Unaudited)

 

 

 

 

Series A
Redeemable
Convertible
Preferred Stock

 

 

Series B
Redeemable
Convertible
Preferred Stock

 

 

Series C-1
Redeemable
Convertible
Preferred Stock

 

 

Series C-2
Redeemable
Convertible
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Deficit

 

Balance as of December 31, 2020

 

 

6,289,609

 

 

$

7,675

 

 

 

14,496,835

 

 

$

64,387

 

 

 

 

 

$

-

 

 

 

 

 

$

-

 

 

 

 

6,137,206

 

 

$

1

 

 

$

1,188

 

 

$

-

 

 

$

(67,914

)

 

$

(66,725

)

Issuance of common stock upon exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

290,032

 

 

 

 

 

 

31

 

 

 

 

 

 

 

 

 

31

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

586

 

 

 

 

 

 

 

 

 

586