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

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

Delaware						45-1472564
(State or Other Jurisdiction of Incorporation or Organization)						(I.R.S. Employer Identification No.)
110 Miller Avenue, Suite 100 Ann Arbor, Michigan						48104
(Address of Principal Executive Offices)						(Zip Code)

Title of each class			Trading Symbol(s)			Name of each exchange on which registered
Common Stock, $0.001 par value			MLND			The Nasdaq Global Market

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. ☐

						Page
			SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS			3
			SUMMARY OF SELECTED RISKS ASSOCIATED WITH OUR BUSINESS			3
			PART I — FINANCIAL INFORMATION			5
Item 1.			Financial Statements (unaudited):			5
			Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019			5
			Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2020 and 2019			6
			Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2020 and 2019			7
			Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019			9
			Notes to Unaudited Interim Consolidated Financial Statements			10
Item 2.			Management’s Discussion and Analysis of Financial Condition and Results of Operations			19
Item 3.			Quantitative and Qualitative Disclosures About Market Risk			28
Item 4.			Controls and Procedures			28
			PART II — OTHER INFORMATION			30
Item 1.			Legal Proceedings			30
Item 1A.			Risk Factors			30
Item 2.			Unregistered Sales of Equity Securities and Use of Proceeds			69
Item 3.			Defaults Upon Senior Securities			69
Item 4.			Mine Safety Disclosures			69
Item 5.			Other Information			69
Item 6.			Exhibits			70
Signatures						71

•We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.

•We have a limited operating history and have never generated any revenue from product sales, which may make it difficult to assess our future viability.

•We will require additional capital to finance our operations, which may not be available on acceptable terms, if at all. Failure to obtain capital when needed may force us to delay, limit or terminate certain of our development programs, future commercialization efforts or other operations.

•Raising additional capital by issuing equity or debt securities may cause dilution to our existing stockholders, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.

•We may be required to make payments under licenses applicable to nevanimibe and MLE-301.

•We may expend our limited resources to pursue a particular product candidate or disease and fail to capitalize on product candidates or diseases that may be more profitable or for which there is a greater likelihood of success.

•Our future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of MLE-301 and any future product candidates. If we are not able to obtain the required regulatory approvals, we will not be able to commercialize our current or future product candidates and our ability to generate revenue will be adversely affected.

•Preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of our clinical trials may not support our MLE-301 claims.

•We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

•If we are not able to obtain required regulatory approvals, we will not be able to commercialize MLE-301 or any future product candidate and our ability to generate revenue will be harmed.

•If we are unable to establish sales, marketing and distribution capabilities, either on our own or in collaboration with third-parties, we may not be successful in commercializing our product candidates, if approved.

•Even if we obtain and maintain approval for our current and future product candidates from the FDA, we may nevertheless be unable to obtain approval for our product candidates outside of the United States, which would limit our market opportunities and could harm our business.

•If we are not able to obtain orphan drug designations or exclusivity for any of our current or future product candidates for which we seek such designation, the potential profitability of any such product candidates could be limited.

•We rely on the availability of licenses for intellectual property from third-parties and these licenses may not be available to us on commercially reasonable terms, or at all.

•If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.

•We jointly own patents and patent applications with third-parties. Our ability to exploit or enforce these patent rights, or to prevent the third-party from granting licenses to others with respect to these patent rights, may be limited in some circumstances

•We do not have our own manufacturing capabilities and will rely on third-parties to produce clinical and commercial supplies of MLE-301 and any future product candidates.

•We rely on third-parties to conduct, supervise and monitor our clinical trials, and if those third-parties perform in an unsatisfactory manner, it may harm our business.

•Our business, preclinical studies and clinical development programs and timelines, our financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic.

•We are highly dependent on the services of our key executives and personnel, including Julia C. Owens, Ph.D., our chief executive officer, Christophe Arbet-Engels, M.D., Ph.D., our chief medical officer, and Ryan Zeidan, Ph.D., our chief development officer, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.

			September 30, 2020						December 31, 2019
Assets
Current assets:
Cash and cash equivalents			$	43,212					$	62,478
Short-term restricted cash			540						1,034
Prepaid expenses and other current assets			2,093						6,344
Refundable tax credit			244						1,276
Total current assets			46,089						71,132
Operating lease right-of-use assets			2,360						3,331
Other assets			389						507
Total assets			$	48,838					$	74,970
Liabilities and stockholders’ equity
Current liabilities:
Current portion of debt			$	222					$	208
Accounts payable			1,733						1,495
Accrued expenses			4,267						9,066
Operating lease liabilities — current			899						1,751
Total current liabilities			7,121						12,520
Debt, net of current portion			117						168
Operating lease liabilities			1,786						2,395
Other liabilities			—						16
Total liabilities			9,024						15,099
Commitments and contingencies (Note 6)
Stockholders’ equity:
Preferred stock, $0.001 par value: 5,000,000 shares authorized; no shares issued and outstanding			—						—
Common stock, $0.001 par value: 100,000,000 shares authorized; 18,999,701 and 18,266,545 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively			19						18
Additional paid-in capital			276,551						267,018
Accumulated deficit			(237,698)						(208,654)
Accumulated other comprehensive income			274						165
Total stockholders’ equity attributable to Millendo Therapeutics, Inc.			39,146						58,547
Equity attributable to noncontrolling interests			668						1,324
Total stockholders’ equity			39,814						59,871
Total liabilities and stockholders’ equity			$	48,838					$	74,970

			Three Months Ended September 30,												Nine Months Ended September 30,
			2020						2019						2020						2019
Operating expenses:
Research and development			$	2,676					$	7,308					$	16,682					$	19,493
General and administrative			3,380						4,443						12,113						13,075
Loss from operations			6,056						11,751						28,795						32,568
Other expenses (income):
Interest expense (income), net			$	8					$	(238)					$	(159)					$	(866)
Other loss			310						119						408						167
Net loss			$	(6,374)					$	(11,632)					$	(29,044)					$	(31,869)
Net loss per share of common stock, basic and diluted			$	(0.34)					$	(0.87)					$	(1.54)					$	(2.38)
Weighted-average shares of common stock outstanding, basic and diluted			18,999,701						13,420,614						18,816,481						13,386,381
Other comprehensive income (loss):
Foreign currency translation adjustment			$	156					$	(17)					$	109					$	(25)
Comprehensive loss			$	(6,218)					$	(11,649)					$	(28,935)					$	(31,894)

			Three Months Ended September 30, 2020
			Common Stock												Additional Paid-in Capital						Accumulated Deficit						Accumulated Other Comprehensive Income						Total Stockholders’ Equity (Deficit) attributable to Millendo Therapeutics, Inc.						Total Equity Attributable to Noncontrolling Interests						Total Stockholders’ Equity (Deficit)
			Shares						Amount
Balance at July 1, 2020			18,999,701						$	19					$	275,463					$	(231,324)					$	118					$	44,276					$	668					$	44,944
Stock-based compensation expense			—						—						1,088						—						—						1,088						—						1,088
Foreign currency translation adjustment			—						—						—						—						156						156						—						156
Net loss			—						—						—						(6,374)						—						(6,374)						—						(6,374)
Balance at September 30, 2020			18,999,701						$	19					$	276,551					$	(237,698)					$	274					$	39,146					$	668					$	39,814

			Nine Months Ended September 30, 2020
			Common Stock												Additional Paid-in Capital						Accumulated Deficit						Accumulated Other Comprehensive Income						Total Stockholders’ Equity (Deficit) attributable to Millendo Therapeutics, Inc.						Total Equity Attributable to Noncontrolling Interests						Total Stockholders’ Equity (Deficit)
			Shares						Amount
Balance at January 1, 2020			18,266,545						$	18					$	267,018					$	(208,654)					$	165					$	58,547					$	1,324					$	59,871
Issuance of common stock, net of issuance costs			719,400						1						5,649						—						—						5,650						—						5,650
Exercise of stock options			1,449						—						2						—						—						2						—						2
Exercise/forfeiture of BSPCE warrants			12,307						—						734						—						—						734						(656)						78
Stock-based compensation expense			—						—						3,148						—						—						3,148						—						3,148
Foreign currency translation adjustment			—						—						—						—						109						109						—						109
Net loss			—						—						—						(29,044)						—						(29,044)						—						(29,044)
Balance at September 30, 2020			18,999,701						$	19					$	276,551					$	(237,698)					$	274					$	39,146					$	668					$	39,814

			Three Months Ended September 30, 2019
			Common Stock												Additional Paid-in Capital						Accumulated Deficit						Accumulated Other Comprehensive Income						Total Stockholders’ Equity (Deficit) attributable to Millendo Therapeutics, Inc.						Total Equity Attributable to Noncontrolling Interests						Total Stockholders’ Equity (Deficit)
			Shares						Amount
Balance at July 1, 2019			13,412,058						$	13					$	237,136					$	(184,323)					$	140					$	52,966					$	2,059					$	55,025
Exercise of stock options			51,278						—						194						—						—						194						—						194
Exercise/forfeiture of BSPCE warrants			9,601						—						367						—						—						367						(304)						63
Stock-based compensation expense			—						—						1,196						—						—						1,196						—						1,196
Foreign currency translation adjustment			—						—						—						—						(17)						(17)						—						(17)
Net loss			—						—						—						(11,632)						—						(11,632)						—						(11,632)
Balance at September 30, 2019			13,472,937						$	13					$	238,893					$	(195,955)					$	123					$	43,074					$	1,755					$	44,829

			Nine Months Ended September 30, 2019
			Common Stock												Additional Paid-in Capital						Accumulated Deficit						Accumulated Other Comprehensive Income						Total Stockholders’ Equity (Deficit) attributable to Millendo Therapeutics, Inc.						Total Equity Attributable to Noncontrolling Interests						Total Stockholders’ Equity (Deficit)
			Shares						Amount
Balance at January 1, 2019			13,357,999						$	13					$	234,876					$	(164,086)					$	148					$	70,951					$	2,171					$	73,122
Exercise of stock options			97,225						—						360						—						—						360						—						360
Exercise/forfeiture of BSPCE warrants			17,713						—						527						—						—						527						(416)						111
Stock-based compensation expense			—						—						3,130						—						—						3,130						—						3,130
Foreign currency translation adjustment			—						—						—						—						(25)						(25)						—						(25)
Net loss			—						—						—						(31,869)						—						(31,869)						—						(31,869)
Balance at September 30, 2019			13,472,937						$	13					$	238,893					$	(195,955)					$	123					$	43,074					$	1,755					$	44,829

			Nine Months Ended September 30,
			2020						2019
Operating activities:
Net loss			$	(29,044)					$	(31,869)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			115						52
Stock-based compensation expense			3,148						3,130
Foreign currency remeasurement loss			395						—
Amortization of right-of-use asset			748						719
Loss on disposal of equipment			6						—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			5,243						(505)
Other assets			21						175
Accounts payable			280						812
Accrued expenses and other liabilities			(4,805)						(1,204)
Operating lease liabilities			(1,239)						(841)
Cash used in operating activities			(25,132)						(29,531)
Investing activities:
Purchase of property and equipment			(26)						(364)
Proceeds from sale of marketable securities			—						4,385
Cash (used in) provided by investing activities			(26)						4,021
Financing activities:
Repayment of debt			(53)						(134)
Payment of financing costs			(197)						(245)
Proceeds from the issuance of common stock, net of issuance costs			5,650						—
Proceeds from option and BSPCE warrant exercises			78						471
Repayment of principal on finance lease			(28)						(9)
Cash provided by financing activities			5,450						83
Effect of foreign currency exchange rate changes on cash			(52)						5
Net decrease in cash, cash equivalents and restricted cash			(19,760)						(25,422)
Cash, cash equivalents and restricted cash at beginning of period			63,512						73,770
Cash, cash equivalents and restricted cash at end of period			$	43,752					$	48,348
Supplemental schedule of non-cash investing and financing activities:
Right-of-use assets acquired under operating leases			$	—					$	3,414

In an effort to streamline costs after discontinuing the PWS program, the Company eliminated employee positions representing approximately 30% of its prior headcount, which were completed in the second quarter of 2020. The Company recorded one-time costs of $1.1 million in the form of termination benefits related to this plan in the second quarter of 2020.

The Company had also been developing nevanimibe (ATR-101) as a potential treatment for patients with classic congenital adrenal hyperplasia, (“CAH”), a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses. The Company elected to cease investing in the development of nevanimibe as a potential treatment for CAH in June 2020 based on an interim review of data from its Phase 2b trial. All costs, including estimated closeout costs associated with the nevanimibe program for the treatment of CAH were recognized during the second quarter of 2020. The Company recorded additional expense in the third quarter of 2020 related to the nevanimibe program, which reflects changes to estimated close out costs. The Company does not expect to incur future material expenses related to this program.

With the global spread of the ongoing COVID-19 pandemic in 2020, the Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its business. The Company anticipates that the COVID-19 pandemic will continue to have an impact on clinical and preclinical development activities. The extent to which the COVID-19 pandemic impacts the Company’s business, its preclinical and clinical development and regulatory efforts, its corporate development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on the Company’s business, financial condition, results of operations and growth prospects.

			September 30,
			2020						2019
Stock options			3,754,176						2,588,235
Common stock warrants			17,125						17,125
BSA and BSPCE warrants			48,265						126,699
			3,819,566						2,732,059

In January 2020, the FASB issued ASU 2020-01, Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815). ASU 2020-01 states any equity security transitioning from the alternative method of accounting under Topic 321 to the equity method, or vice versa, due to an observable transaction

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740) - Simplifying the Accounting for Income Taxes. ASU 2019-12 simplifies the accounting for income taxes by removing exceptions within the general principles of Topic 740 regarding the calculation of deferred tax liabilities, the incremental approach for intraperiod tax allocation, and calculating income taxes in an interim period. In addition, the ASU adds clarifications to the accounting for franchise tax (or similar tax), which is partially based on income, evaluating tax basis of goodwill recognized from a business combination, and reflecting the effect of any enacted changes in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The ASU is effective for fiscal years beginning after December 15, 2020, and will be applied either retrospectively or prospectively based upon the applicable amendments. Early adoption is permitted. The Company is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures.

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820) Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. ASU 2018-13 resulted in certain modifications to fair value measurement disclosures, primarily related to level 3 fair value measurements. This standard was effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, and early adoption was permitted. The adoption of this ASU did not have a material impact on the consolidated financial statements and related disclosures.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) Measurement of Credit Losses on Financial Instruments, which replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Additionally, ASU 2016-13 requires a financial asset measured at amortized cost basis to be presented at the net amount expected to be collected through the use of an allowance of expected credit losses. In May 2019, the FASB issued ASU 2019-05, Financial Instruments - Credit Losses (Topic 326) Targeted Transition Relief, which amends ASU 2016-13 by providing entities with an option to irrevocably elect the fair value option to be applied on an instrument-by-instrument basis for eligible financial instruments that are within the scope of Topic 326. The fair value option election does not apply to held-to-maturity debt securities. In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842), which finalized effective date delays for private companies, not-for-profit organizations, and certain smaller reporting companies applying the credit losses, leases, and hedging standards. Also, in November 2019, the FASB issued ASU 2019-11, Codification Improvements to Topic 326, Financial Instruments - Credit Losses, which provides clarity about certain aspects of the amendments in ASU 2016-13. ASU 2016-13, as amended, is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, and requires a modified retrospective approach. The Company is in the process of evaluating the impact of this new guidance on its consolidated financial statements and related disclosures.

			September 30, 2020
			(Level 1)						(Level 2)						(Level 3)
Assets
Money market funds (included in cash and cash equivalents)			$	37,635					$	—					$	—

			December 31, 2019
			(Level 1)						(Level 2)						(Level 3)
Assets
Money market funds (included in cash and cash equivalents)			$	59,382					$	—					$	—

			September 30, 2020						December 31, 2019
Compensation and related benefits			$	1,602					$	2,042
Professional fees			1,198						2,929
Preclinical and clinical costs			1,002						1,820
Insurance premiums			119						1,423
Other			346						852
Total			$	4,267					$	9,066

2020 (excluding the nine months ended September 30, 2020)			$	354
2021			760
2022			783
2023			806
2024			302
Thereafter			—
Total			$	3,005
Present Value Adjustment			(320)
Lease liability at September 30, 2020			$	2,685

			Three Months Ended September 30,												Nine Months Ended September 30,
			2020						2019						2020						2019
Research and development			$	258					$	180					$	731					$	981
General and administrative			830						1,016						2,417						2,149
Total			$	1,088					$	1,196					$	3,148					$	3,130

			Shares						Weighted average exercise price per share						Weighted-average remaining contractual life (years)
Outstanding at December 31, 2019			2,498,606						$	17.18					7.7
Granted			1,824,375						4.77
Exercised			(1,449)						1.08
Forfeited			(567,356)						13.81
Outstanding at September 30, 2020			3,754,176						$	11.67					8.0
Vested and exercisable at September 30, 2020			1,358,519						$	20.83					6.0
Vested and expected to vest at September 30, 2020			3,754,176						$	11.67					8.0

			Three Months Ended September 30, 2020						Three Months Ended September 30, 2019						Nine Months Ended September 30, 2020						Nine Months Ended September 30, 2019
Expected term (in years)			6.08						6.08						5.75						6.02
Expected volatility			77%						81%						77%						80%
Risk-free interest rate			0.36%						1.51%						0.87%						2.23%
Expected dividend yield			0%						0%						0%						0%

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

In an effort to streamline costs after discontinuing our PWS program, we eliminated employee positions representing approximately 30% of our prior headcount, which were completed in the second quarter of 2020.

We had also been developing nevanimibe (ATR-101) as a potential treatment for patients with classic congenital adrenal hyperplasia (“CAH”), a rare, monogenic adrenal disease that requires lifelong treatment with exogenous cortisol, often at high doses. As we previously announced, we elected to cease investing in the development of nevanimibe as a potential treatment for CAH in June 2020. The decision to cease investment in the CAH program was based on the interim review of results from the Phase 2b clinical study and the changing competitive environment. Results from 10 subjects, nine from cohort 1 and one from cohort 2, with at least 12 weeks of treatment with nevanimibe in this open-label, continuous dose escalation study showed that one patient (10%) met the primary endpoint of achieving 17-hydroxyprogesterone (17-OHP) levels less than or equal to 2-times the upper limit of normal. Treatment under the amended protocol with dose titration starting at 500 mg BID improved tolerability of nevanimibe. We are currently exploring the option of out-licensing nevanimibe. We do not expect to incur future material expenses related to our nevanimibe program for the treatment of CAH.

With respect to clinical development, we are prepared to take measures as needed to implement remote and virtual approaches, including remote patient monitoring and home delivery of drug treatments where possible, to maintain patient safety and trial continuity and to preserve study integrity. As the COVID-19 pandemic continues, it is possible that there will be an impact on our ability to initiate trial sites, enroll and assess patients and maintain patient enrollment, including in the ongoing Phase 1 clinical trial of MLE-301. We could also see an impact on our ability to acquire supplies of study drug, report trial results or interact with regulators, ethics committees or other important agencies due to limitations in regulatory authority employee resources or otherwise. In addition, we rely on contract research organizations or other third-parties to assist us with clinical trials, and we cannot guarantee that they will continue to perform their contractual duties in a timely and satisfactory manner as a result of the COVID-19 pandemic. If the COVID-19 pandemic continues and persists for an extended period of time, we could experience significant disruptions to our clinical development timelines, which would adversely affect our business, financial condition, results of operations and growth prospects.

•personnel expenses, including salaries, benefits and stock-based compensation expense;

•costs of funding research performed by third-parties, including pursuant to agreements with contract research organizations, (“CROs”), as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;

•expenses incurred under agreements with contract manufacturing organizations (“CMOs”), including manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical study and clinical trial materials;

•payments made under our third-party licensing agreements;

•consultant fees and expenses associated with outsourced professional scientific development services;

•expenses for regulatory activities, including filing fees paid to regulatory agencies; and

•allocated expenses for facility costs, including rent, utilities, depreciation and maintenance.

			Three Months Ended September 30,												Nine Months Ended September 30,
			2020						2019						2020						2019
			(dollars in thousands)												(dollars in thousands)
Livoletide expenses			$	83					$	3,850					$	8,053					$	9,881
Nevanimibe expenses			145						867						882						2,595
MLE-301 expenses			1,312						838						2,739						1,282
Personnel expenses			1,006						1,529						4,515						5,054
Other expenses			130						224						493						681
Total			$	2,676					$	7,308					$	16,682					$	19,493

•the ongoing COVID-19 pandemic, including the potential impact on various aspects and stages of the clinical development process;

•the number of clinical sites included in the trials;

•the length of time required to enroll suitable patients;

•the number of patients that ultimately participate in the trials;

•the number of doses patients receive;

•the duration of patient follow-up and number of patient visits;

•the results of our clinical trials;

•the establishment of commercial manufacturing capabilities;

•the receipt of marketing approvals; and

•the commercialization of product candidates.

			Three Months Ended September 30,
			2020						2019						Change
			(dollars in thousands)
Operating expenses:
Research and development			$	2,676					$	7,308					$	(4,632)					(63.4)		%
General and administrative			3,380						4,443						(1,063)						(23.9)
Loss from operations			6,056						11,751						(5,695)						(48.5)
Other expenses (income):
Interest expense (income), net			8						(238)						246						(103.4)
Other loss			310						119						191						160.5
Net loss			$	(6,374)					$	(11,632)					$	5,258					(45.2)		%

			Three Months Ended September 30,
			2020						2019						Change
			(dollars in thousands)
Preclinical and clinical development expense			$	1,540					$	5,555					$	(4,015)					(72.3)		%
Compensation expense, other than stock-based compensation			748						1,349						(601)						(44.6)
Stock-based compensation expense			258						180						78						43.3
Other expenses			130						224						(94)						(42.0)
Total research and development expense			$	2,676					$	7,308					$	(4,632)					(63.4)		%

•a $4.0 million decrease in preclinical and clinical development expense primarily related to decreased spend due to discontinuing our development of the livoletide program and ceasing investment in the nevanimibe programs offset by increased spend on MLE-301;

•a $0.6 million decrease in compensation expense, other than stock-based compensation primarily due to the reduction in force completed in the second quarter of 2020, as a result of the discontinuance of our livoletide program; and

•a $0.1 million increase in stock-based compensation expenses primarily related to additional options granted in 2020.

General and administrative expense decreased by $1.1 million to $3.4 million for the three months ended September 30, 2020 from $4.4 million for the three months ended September 30, 2019. The decrease was primarily due to lower professional fees and compensation expenses, including stock-based compensation. Professional fees decreased $0.8 million as a result of lower accounting fees and consulting fees incurred as compared to the prior period. The decrease in these fees was due to decreased expenditure on preparations for certain public reporting requirements in 2020 as compared to 2019, as well as lower consulting fees incurred related to assessing market opportunities for previous product candidates. Compensation and stock-based compensation decreased by $0.3 million as a result of a decrease in our general and administrative headcount and changes to compensation arrangements related to our reduction in force in the second quarter of 2020.

			Nine Months Ended September 30,
			2020						2019						Change
			(dollars in thousands)
Operating expenses:
Research and development			$	16,682					$	19,493					$	(2,811)					(14.4)		%
General and administrative			12,113						13,075						(962)						(7.4)
Loss from operations			28,795						32,568						(3,773)						(11.6)
Other expenses (income):
Interest income, net			(159)						(866)						707						(81.6)
Other loss			408						167						241						144.3
Net loss			$	(29,044)					$	(31,869)					$	2,825					(8.9)		%

			Nine Months Ended September 30,
			2020						2019						Change
			(dollars in thousands)
Preclinical and clinical development expense			$	11,674					$	13,758					$	(2,084)					(15.1)		%
Compensation expense, other than stock-based compensation			3,784						4,073						(289)						(7.1)
Stock-based compensation expense			731						981						(250)						(25.5)
Other expenses			493						681						(188)						(27.6)
Total research and development expense			$	16,682					$	19,493					$	(2,811)					(14.4)		%

•a $2.1 million decrease in preclinical and clinical development expense primarily related to decreased spend due to discontinuing our development of the livoletide and nevanimibe programs offset by increased spend on MLE-301;

•a $0.3 million decrease in compensation expense, other than stock-based compensation primarily due to the reduction in force completed in the second quarter of 2020, as a result of the discontinuance of the livoletide program; and

•a $0.3 million decrease in stock-based compensation expenses primarily related to the reduction in force completed in the second quarter of 2020.

			Nine Months Ended September 30,
			2020						2019
			(in thousands)
Net cash used in operating activities			$	(25,132)					$	(29,531)
Net cash (used in) provided by investing activities			(26)						4,021
Net cash provided by financing activities			5,450						83
Effect of foreign currency exchange rate changes on cash			(52)						5
Net decrease in cash, cash equivalents and restricted cash			$	(19,760)					$	(25,422)

•the scope, progress, results and costs of preclinical studies and clinical trials;

•the scope, prioritization and number of our research and development programs;

•the costs, timing and outcome of regulatory review of our product candidates;

•our ability to establish and maintain collaborations on favorable terms, if at all;

•the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under collaboration agreements, if any;

•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

•the extent to which we acquire or in-license other product candidates and technologies;

•the costs of securing manufacturing arrangements for commercial production; and

•the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates.

Item 3.  Quantitative and Qualitative Disclosures about Market Risk

Item 4.  Controls and Procedures

Item 1.  Legal Proceedings

Item 1A.  Risk Factors

•continue our ongoing and planned development of MLE-301 for the treatment of vasomotor symptoms (“VMS”) in menopausal women, including our Phase 1 clinical trial of MLE-301;

•initiating preclinical studies and clinical trials for any additional diseases for our current product candidates and any future product candidates that we may pursue;

•building a portfolio of product candidates through acquisition or in-licensing;

•developing, maintaining, expanding and protecting our intellectual property portfolio;

•manufacturing, or having manufactured, clinical and commercial supplies of our product candidates;

•seeking marketing approvals for our current and future product candidates that successfully complete clinical trials;

•establishing a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval;

•hiring additional administrative, clinical, regulatory and scientific personnel; and

•continuing to incur additional costs associated with operating as a public company.

•timely and successful completion of development activities of our current product candidates;

•obtaining and maintaining regulatory and marketing approvals for MLE-301 and any future product candidates for which we successfully complete clinical trials;

•launching and commercializing any product candidates for which we obtain regulatory and marketing approval by establishing a sales force, marketing and distribution infrastructure or, alternatively, collaborating with a commercialization partner;

•qualifying for coverage and adequate reimbursement by government and third-party payors for our current or any future product candidates, if approved, both in the United States and internationally, and reaching acceptable agreements with such government and third-party payors on pricing terms;

•developing, validating and maintaining a commercially viable, sustainable, scalable, reproducible and transferable manufacturing process for MLE-301 or any future product candidates that are compliant with current good manufacturing practices (“cGMP”);

•establishing and maintaining supply and manufacturing relationships with third-parties that can provide an adequate amount and quality of our product candidates and services to support our planned clinical development, as well as the market demand for MLE-301 and any future product candidates, if approved;

•obtaining market acceptance, if and when approved, of MLE-301 or any future product candidates as a viable treatment option by physicians, patients, third-party payors and others in the medical community;

•effectively addressing any competing technological and market developments;

•implementing additional internal systems and infrastructure, as needed;

•negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter, and performing our obligations pursuant to such arrangements;

•maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how;

•avoiding and defending against third-party interference or infringement claims; and

•attracting, hiring and retaining qualified personnel.

Success in preclinical testing and early clinical trials does not ensure that later and/or pivotal clinical trials will generate the same results, or otherwise provide adequate data to demonstrate the safety and efficacy of a product candidate. Frequently, product candidates that have shown promising results in early clinical trials have subsequently suffered significant setbacks in later or pivotal clinical trials. Failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. For example, we expended substantial time and resources on a previous product candidate, MLE4901, an NK3R antagonist, which we ceased developing in 2017 due to concerns relating to elevated liver enzymes observed in clinical trials. Similarly, at least one of our competitors has publicly announced similar concerns in one of their clinical trials of an NK3R antagonists; however, they have indicated that they are continuing development of that product candidate with revised dosing for their Phase 3 trial. We are currently developing MLE-301, an NK3R antagonist, and there can be no assurance that we will not face similar development challenges with regard to this product candidate. We also discontinued our development of livoletide as a potential treatment of patients with PWS after receiving results from the Phase 2b trial in April 2020. In addition, we do not currently plan to make further investment in the development of nevanimibe for the treatment of CAH, based on the interim data review of the Phase 2b trial completed in June 2020. Further, we may encounter challenges in the clinical development of product candidates for reasons unrelated to the observed safety or efficacy of such product candidates in prior clinical trials. For example, in our Phase 2 clinical trial for the treatment of Cushing’s syndrome ("CS"), we experienced slower than anticipated enrollment, which could have made impractical further development of nevanimibe for the treatment of CS. As a result of the difficulty in enrolling this trial, we discontinued this Phase 2 clinical trial in August 2019 and discontinued development of nevanimibe for the treatment of CS. In addition, because we may at times pursue the treatment of multiple indications for a single product candidate, setbacks or failures in, or termination of, clinical development for one indication may have a negative impact on the clinical development for the treatment of other indications.

•direct and indirect effects of the ongoing COVID-19 pandemic on various aspects and stages of the clinical development process;

•significant reprioritization and diversion of healthcare resources away from the conduct of clinical trials as a result of the ongoing COVID-19 pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

•failure to obtain regulatory approval to commence a trial;

•unforeseen safety issues;

•determination of dosing issues;

•lack of effectiveness during clinical trials;

•inability to reach agreement on acceptable terms with prospective contract research organizations (“CROs”), and clinical trial sites;

•slower than expected rates of patient recruitment, failure to recruit adequate numbers of suitable patients to participate in our clinical trials or failure to maintain participation of recruited patients in clinical trials;

•interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel, quarantines or social distancing protocols imposed or recommended by federal or state governments, employers and others in connection with the ongoing COVID-19 pandemic;

•failure to manufacture sufficient quantities of a product candidate for use in clinical trials;

•inability to monitor patients adequately during or after treatment; and

•inability or unwillingness of medical investigators to follow our clinical protocols.

•the FDA or the applicable foreign regulatory agency’s disagreement with the design or implementation of our clinical trials;

•negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory agencies for approval;

•serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates;

•our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory body that our product candidates are safe and effective for the proposed indication;

•the FDA’s or the applicable foreign regulatory agency’s disagreement with the interpretation of data from preclinical studies or clinical trials;

•our inability to demonstrate the clinical and other benefits of our product candidates outweigh any safety or other perceived risks;

•the FDA’s or the applicable foreign regulatory agency’s requirement for additional preclinical studies or clinical trials;

•the FDA’s or the applicable foreign regulatory agency’s disagreement regarding the formulation, labeling or the specifications of our product candidates;

•the FDA’s or the applicable foreign regulatory agency’s failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract, including failure of such manufacturers to pass the required pre-approval inspections; or

•the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.

•be delayed in obtaining marketing approval for MLE-301, if at all;

•obtain approval for indications or patient populations that are not as broad as intended or desired;

•obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

•be subject to additional post-marketing testing requirements;

•be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

•have regulatory authorities withdraw, or suspend, their approval of the drug or impose restrictions on its distribution in the form of REMS;

•be subject to the addition of labeling statements, such as warnings or contraindications;

•be sued; or

•experience damage to our reputation.

•issue a warning letter asserting that we are in violation of the law;

•seek an injunction or impose administrative, civil or criminal penalties or monetary fines;

•suspend or withdraw regulatory approval;

•suspend any ongoing clinical trials;

•refuse to approve a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic partners;

•restrict the marketing or manufacturing of the drug;

•seize or detain the drug or otherwise require the withdrawal of the drug from the market;

•refuse to permit the import or export of product candidates; or

•refuse to allow us to enter into supply contracts, including government contracts.

•the efficacy and potential advantages compared to alternative treatments;

•the success of our efforts to educate physicians, patients, third-party payors and others in the medical community on the benefits of our products;

•effectiveness of sales and marketing efforts;

•the cost of treatment in relation to alternative treatments, including any similar generic treatments;

•our ability to offer our drugs, once approved, for sale at competitive prices;

•the convenience and ease of administration compared to alternative treatments;

•the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

•the strength of marketing and distribution support;

•the availability of third-party coverage and adequate reimbursement, and patients’ willingness to pay out-of-pocket in the absence third-party coverage or adequate reimbursement;

•the prevalence and severity of any side effects; and

•any restrictions on the use of our drugs, once approved, together with other medications.

•our inability to raise additional capital through equity or debt financings or through lending and licensing arrangements;

•our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

•the inability of sales personnel to obtain access to educate adequate numbers of physicians as to the benefits or our drug products;

•the inability of reimbursement professionals to negotiate arrangements, for formulary access, reimbursement, and other acceptance by payors;

•restricted or closed distribution channels that make it difficult to distribute our products to segments of the patient population;

•the lack of complementary medicines to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

•unforeseen costs and expenses associated with creating an independent sales and marketing organization.

•different regulatory requirements for approval of therapies in foreign countries;

•reduced protection for intellectual property rights;

•unexpected changes in tariffs, trade barriers and regulatory requirements;

•economic weakness, including inflation, or political instability in particular foreign economies and markets;

•compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

•foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;

•foreign reimbursement, pricing and insurance regimes;

•workforce uncertainty in countries where labor unrest is more common than in the United States;

•changes in diplomatic and trade relationships;

•anti-corruption laws, including the FCPA, and its equivalent in foreign jurisdictions, such as the UK Bribery Act;

•production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

•business interruptions resulting from pandemics and public health emergencies, including those related to the COVID-19 pandemic, geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods and fires.

•decreased demand for any product candidate that we may develop;

•loss of revenue;

•substantial monetary awards to trial participants or patients;

•significant time and costs to defend the related litigation;

•withdrawal of clinical trial participants;

•the inability to commercialize any product candidate that it may develop;

•injury to our reputation and significant negative media attention; and

•increased marketing costs to attempt to overcome any injury to our reputation or negative media attention.

•the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, in return for the purchase, recommendation, leasing or furnishing of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand, and prescribers, purchasers, formulary managers, and others on the other hand. In addition, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively PPACA, amended the intent requirement of the federal Anti-Kickback Statute, establishing that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation;

•federal civil and criminal false claims laws, including the federal civil False Claims Act, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid or other government payors that are false or fraudulent. PPACA provides, and recent government cases against pharmaceutical and medical device manufacturers support the view, that federal Anti-Kickback Statute violations and certain marketing practices, including off-label promotion, may implicate the federal civil False Claims Act;

•the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal civil and criminal statutes that prohibit a person from knowingly and willfully executing a scheme or from making false or fraudulent statements to defraud any healthcare benefit program, regardless of the payor (e.g., public or private);

•HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as

health plans, health care clearinghouses and certain health care providers, known as covered entities, and their business associates, as well as their subcontractors, who create, use or disclose individually identifiable health information on their behalf;

•federal transparency laws, including the federal Physician Payments Sunshine Act, that require certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information related to: (i) payments or other “transfers of value” made to physicians, as defined by such law, and teaching hospitals and (ii) ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding its relationships with physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives during the previous year;

•state and foreign law equivalents of each of the above federal laws, such as state anti-kickback, self-referral, and false claims laws which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers; state laws that require pharmaceutical manufacturers to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers; state laws that require pharmaceutical manufacturers to file reports with states regarding marketing information, such as the tracking and reporting of gifts, compensation and other remuneration and items of value provided to healthcare professionals and entities; state laws that require the reporting of information related to drug pricing; and state and local laws requiring the registration of pharmaceutical sales representatives; and

•state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

We expect that PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we are able to charge for any approved drug in the United States. For example, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for drugs. At the federal level, the Trump administration’s budget proposal for fiscal year 2021 includes a $135 billion allowance to support legislative proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic and biosimilar drugs. On March 10, 2020, the Trump administration sent “principles” for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases. Moreover, the Trump administration previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers. The Department of Health and Human Services (“HHS”), has solicited feedback on some of these measures and has implemented others under its existing authority. On July 24, 2020, the Trump administration announced four executive orders related to prescription drug pricing that attempt to implement several of the administration's proposals, including a policy that would tie Medicare Pare B drug prices to international drug prices; one that directs HHS to finalize the Canadian drug importation proposed rule previously issued by HHS and makes other changes allowing for personal importation of drugs from Canada; one that directs HHS to finalize the rulemaking process on modifying the anti-kickback law safe harbors for discounts for plans, pharmacies, and pharmaceutical benefit managers; and one the reduces costs of insulin and epipens to patients of federally qualified health centers. Although a number of these and other measures may require additional authorization to become effective, Congress and the Trump administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, such measures are designed to encourage importation from other countries and bulk purchasing. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our drugs. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

In addition, other legislative changes have been adopted since PPACA was enacted. These changes include aggregate reductions in Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and, following passage of the Bipartisan Budget Act of 2018, among other legislative amendments, will remain in effect through 2030 unless additional Congressional action is taken. The Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), which was signed into law in March 2020 and is designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030. The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and, accordingly, our financial operations.

•lose our rights to develop and market our current and any future product candidates;

•lose our rights to patent protection for our current or any future product candidates;

•experience significant delays in the development or commercialization of our current or any future product candidates;

•not be able to obtain any other licenses on acceptable terms, if at all; or

•incur liability for damages.

•others may be able to make compounds or formulations that are similar to our MLE-301 formulation but that are not covered by the claims of the patents that we own or control;

•we or any strategic partners might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or control;

•we might not have been the first to file patent applications covering certain of our inventions;

•others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

•it is possible that our pending patent applications will not lead to issued patents;

•issued patents that we own or control may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;

•our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive drugs for sale in our major commercial markets;

•we may not develop additional proprietary technologies that are patentable; and

•the patents of others may have an adverse effect on our business.

•inability to meet our product specifications and quality requirements consistently;

•delay or inability to procure or expand sufficient manufacturing capacity;

•issues related to scale-up of manufacturing;

•costs and validation of new equipment and facilities required for scale-up;

•failure to comply with cGMP and similar foreign standards;

•inability to negotiate manufacturing agreements with third-parties under commercially reasonable terms;

•termination or nonrenewal of manufacturing agreements with third-parties in a manner or at a time that is costly or damaging to us;

•reliance on a limited number of sources, and in some cases, single sources for product components;

•lack of qualified backup suppliers for those materials that are currently purchased from a sole or single source supplier;

•operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including public health emergencies, such as the COVID-19 pandemic, natural disasters, such as earthquakes, fires or floods, or the bankruptcy of the manufacturer or supplier;

•inability to find replacement manufacturers or suppliers, if necessary, on terms favorable to us, in a timely manner, or at all;

•carrier disruptions or increased costs that are beyond our control; and

•failure to deliver our products under specified storage conditions and in a timely manner.

•diversion of management attention from ongoing business concerns to integration matters;

•coordinating clinical and preclinical development plans;

•consolidating and rationalizing information technology and accounting platforms and administrative infrastructures;

•complexities associated with managing the geographic separation of the combined businesses and consolidating multiple physical locations;

•reconciling different corporate cultures; and

•retaining scientific and other key employees.

We are highly dependent on the services of our key executives and personnel, including Julia C. Owens, Ph.D., our chief executive officer, Christophe Arbet-Engels, M.D., Ph.D., our chief medical officer, and Ryan Zeidan, Ph.D., our chief development officer, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.

We are highly dependent on Drs. Owens, Arbet-Engels, and Zeidan. The employment agreements we have with these officers do not prevent such persons from terminating their employment with us at any time. Further, these officers may be unable to perform their duties or have limited availability due to COVID-19 or other health emergencies. The temporary or permanent loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

To succeed, we must recruit, develop, retain, manage and motivate qualified clinical, scientific, technical, general and administrative and management personnel while facing significant competition for experienced personnel. In April 2020, we announced our decision to discontinue the development of livoletide as a potential treatment for PWS. In connection with the discontinuation of the livoletide program in PWS, we eliminated employee positions representing approximately 30% of our prior headcount (the “restructuring”). The restructuring could harm our ability to attract and retain qualified personnel. The restructuring could also result in reduced morale and productivity among our remaining personnel. Our inability or failure to successfully attract and retain qualified personnel, particularly at the management level, could adversely affect our ability to execute our business plan and harm our operating results. In particular, the loss of one or more of our executive officers could be detrimental if we cannot recruit suitable replacements in a timely manner. The competition for qualified personnel in the pharmaceutical field is intense and we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.

•the commencement, enrollment or results of our clinical trials or changes in the development status of our product candidates;

•any delay in our regulatory filings for any product candidate we may develop, and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

•adverse results from, delays in or termination of clinical trials;

•adverse regulatory decisions, including failure to receive regulatory approval of our product candidates;

•unanticipated serious safety concerns related to the use of our product candidates;

•changes in financial estimates by us or by any securities analysts who might cover our stock;

•conditions or trends in our industry;

•changes in the structure of healthcare payment systems;

•changes in the market valuations of similar companies;

•stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

•publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;

•announcements by us or our competitors of significant acquisitions, strategic partnerships or divestitures;

•announcements of investigations or regulatory scrutiny of our operations or lawsuits filed against us;

•investors’ general perception of our company and our business;

•recruitment or departure of key personnel;

•overall performance of the equity markets;

•trading volume of our common stock;

•disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

•significant lawsuits, including patent or stockholder litigation;

•general political and economic conditions; and

•other events or factors, many of which are beyond our control.

•establish a classified board of directors such that not all members of the board are elected at one time;

•allow the authorized number of our directors to be changed only by resolution of our board of directors;

•limit the manner in which stockholders can remove directors from the board;

•establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and for nominations to our board of directors;

•limit who may call stockholder meetings;

•prohibit actions by our stockholders by written consent;

•require that stockholder actions be effected at a duly called stockholders meeting;

•authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and

•require the approval of the holders of at least 75 percent of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our certificate of incorporation or by-laws.

We are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the rules and regulations of the stock market on which our common stock is listed. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting and that we furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting. However, due to recent changes in SEC rules related to smaller reporting companies, we do not expect to be required to have our auditors formally attest to the effectiveness of our internal control over financial reporting in connection with our Annual Report on Form 10-K for the year ending December 31, 2020. For the year ended December 31, 2018, we were unable to conduct the required assessment primarily due to the Merger occurring in the fourth quarter of 2018 and the substantial change in operational focus, management and the internal control environment following the Merger. As a result, we provided our first internal control assessment with our Annual Report on Form 10-K for the year ended December 31, 2019.

New tax laws or regulations could be enacted at any time, and existing tax laws or regulations could be interpreted, modified or applied in a manner that is adverse to us, which could adversely affect our business and financial condition. For example, legislation enacted in 2017, informally titled the Tax Act, enacted many significant changes to the U.S. tax laws, including changes in corporate tax rates, the utilization of our NOLs and other deferred tax assets, the deductibility of expenses, and the taxation of foreign earnings. Future guidance from the Internal Revenue Service and other tax authorities with respect to the Tax Act may affect us, and certain aspects of the Tax Act could be repealed or modified in future legislation. For example, the CARES Act modified certain provisions of the Tax Act. In addition, it is uncertain if and to what extent various states will conform to the Tax Act, the CARES Act, or any newly enacted federal tax legislation. The impact of changes under the Tax Act, the CARES Act, or future reform legislation could increase our future U.S. tax expense and could have a material adverse impact on our business and financial condition.

Item 6. Exhibits

Exhibit Number						Description
3.1						Restated Certificate of Incorporation of the Registrant, as amended (incorporated by reference from Exhibit 3.1 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2019 File No. 001-35890)
3.2						Third Amended and Restated Bylaws, as Amended, of the Registrant (incorporated by reference from Exhibit 3.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on August 9, 2018 File No. 001-35890)
31.1*						Certification of Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002
31.2*						Certification of Chief Financial Officer (Principal Financial Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002
32.1+						Certification of Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002
101.INS						Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH						Inline XBRL Taxonomy Extension Schema Document
101.CAL						Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF						Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB						Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE						Inline XBRL Taxonomy Extension Presentation Linkbase Document
104						Cover Page Interactive Data File - the cover page interactive data is embedded within the Inline XBRL document or included within the Exhibit 101 attachments.

*    Filed herewith.

+    This certification is being furnished solely to accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

			MILLENDO THERAPEUTICS, INC.
			By:			/s/ Julia C. Owens, Ph.D.
						Julia C. Owens, Ph.D. President and Chief Executive Officer (Principal Executive Officer)
			By:			/s/ Louis Arcudi III
						Louis Arcudi III Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
Date: November 9, 2020