Delaware		2834		45-1472564
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

Stuart M. Falber Joseph B. Conahan WilmerHale 60 State Street Boston, MA 02109 USA (617) 526 6000		Stephen Brady President and Chief Operating Officer 7000 Shoreline Court; Suite 275 South San Francisco, CA 94080 (415) 798-8589		Asher Rubin Frank Rahmani Rob Carlson Istvan A Hajdu Sidley Austin LLP 1001 Page Mill Road, Building 1 Palo Alto, CA 94304 USA (650) 565-7000

Large accelerated filer		☐		Accelerated filer		☐
Non-accelerated filer		☒		Smaller reporting company		☒
				Emerging growth company		☐

QUESTIONS AND ANSWERS ABOUT THE MERGER			iv
PROSPECTUS SUMMARY			1
The Companies			1
The Merger (see page 104)			4
Reasons for the Merger (see pages 113 and 116)			5
Opinion of Millendo’s Financial Advisor (see page 118)			6
Interests of Certain Directors, Officers and Affiliates of Millendo and Tempest (see pages 124 and 131)			7
Management Following the Merger (see page 131)			8
Overview of the Merger Agreement and Agreements Related to the Merger Agreement			8
Material U.S. Federal Income Tax Consequences of the Merger (see page 132)			12
Nasdaq Stock Market Listing (see page 135)			12
Anticipated Accounting Treatment (see page 135)			13
Appraisal Rights and Dissenters’ Rights (see page 135)			13
Comparison of Stockholder Rights (see page 305)			13
Risk Factors (see page 16)			13
MARKET PRICE AND DIVIDEND INFORMATION			14
Dividends			14
RISK FACTORS			16
Risks Related to the Merger			18
Risks Related to the Proposed Reverse Stock Split			23
Risks Related to the Combined Company			23
Risks Related to Tempest			52
Risks Related to Tempest’s Financial Position			52
Risks Related to Tempest’s Product Development and Regulatory Approval			55
Risks Related to Commercialization and Manufacturing			64
Risks Related to Government Regulation			71
Risks Related to Tempest’s Intellectual Property			80
Risks Related to Employee Matters, Managing Growth and Other Risks Related to Tempest’s Business			92
CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS			99
THE SPECIAL MEETING OF MILLENDO STOCKHOLDERS			100
Date, Time and Place			100
Purposes of the Millendo Special Meeting			100
Recommendation of Millendo’s Board of Directors			100
Record Date and Voting Power			101
Voting and Revocation of Proxies			101
Required Vote			102
Solicitation of Proxies			103
Other Matters			103
THE MERGER			104
Background of the Merger			104
Millendo Reasons for the Merger			113
Tempest Reasons for the Merger			116
Opinion of Millendo’s Financial Advisor			118
Interests of Millendo Directors and Executive Officers in the Merger			124
Interests of Tempest Directors and Executive Officers in the Merger			130
Effective Time of the Merger			131
Regulatory Approvals			131
Material U.S. Federal Income Tax Consequences of the Merger			132

Anticipated Accounting Treatment			135
Nasdaq Stock Market Listing			135
Appraisal Rights and Dissenters’ Rights			135
THE MERGER AGREEMENT			139
Structure			139
Completion and Effectiveness of the Merger			139
Merger Consideration			139
Exchange Ratio			140
Calculation of Millendo’s Final Net Cash			141
Treatment of Tempest Options			142
Treatment of Millendo Common Stock and Millendo Options			143
Procedures for Exchanging Tempest Stock Certificates			143
Directors and Officers of Millendo Following the Merger			144
Amendment of the Amended and Restated Certificate of Incorporation of Millendo			144
Representations and Warranties			144
Covenants; Conduct of Business Pending the Merger			145
Non-Solicitation			149
Board Recommendation Change			150
Meeting of Millendo’s Stockholders and Written Consent of Tempest’s Stockholders			152
Indemnification and Insurance for Directors and Officers			152
Additional Agreements			153
Conditions to the Completion of the Merger			153
Termination and Termination Fees			157
Amendment			160
Fees and Expenses			160
AGREEMENTS RELATED TO THE MERGER			161
Support Agreements			161
Lock-Up Agreements			162
Funding Agreements			162
MILLENDO DIRECTORS, OFFICERS AND CORPORATE GOVERNANCE			164
MILLENDO EXECUTIVE COMPENSATION			166
TEMPEST EXECUTIVE COMPENSATION			176
MATTERS BEING SUBMITTED TO A VOTE OF MILLENDO STOCKHOLDERS			185
PROPOSAL NO. 1: APPROVAL OF THE ISSUANCE OF COMMON STOCK IN THE MERGER AND THE CHANGE OF CONTROL RESULTING FROM THE MERGER			185
PROPOSAL NO. 2: APPROVAL OF THE AMENDMENT TO AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF MILLENDO TO EFFECT THE REVERSE STOCK SPLIT			186
PROPOSAL NO. 3: ADVISORY, NON-BINDING VOTE ON MERGER-RELATED EXECUTIVE COMPENSATION ARRANGEMENTS			193
PROPOSAL NO. 4: APPROVAL OF POSSIBLE ADJOURNMENT OF THE SPECIAL MEETING			194
MILLENDO’S BUSINESS			195
TEMPEST’S BUSINESS			216
MILLENDO MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			260
MANAGEMENT FOLLOWING THE MERGER			282
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS OF THE COMBINED COMPANY			288
Tempest Transactions			288
Promissory Note with Tom Dubensky			289
Equity Grants to Executive Officers and Directors			290
Director and Executive Officer Compensation			290

Employment Agreements			290
Indemnification Agreements			290
Millendo Transactions			291
PRINCIPAL STOCKHOLDERS OF MILLENDO			313
PRINCIPAL STOCKHOLDERS OF TEMPEST			316
LEGAL MATTERS			318
EXPERTS			319
WHERE YOU CAN FIND MORE INFORMATION			320
TRADEMARK NOTICE			321
OTHER MATTERS			322
Section 16(a) Beneficial Ownership Reporting Compliance			322
Stockholder Proposals			322
Householding of Proxy Statement/Prospectus			323
INDEX TO MILLENDO CONSOLIDATED FINANCIAL STATEMENTS			F-1
INDEX TO TEMPEST FINANCIAL STATEMENTS			F-1
PART II INFORMATION NOT REQUIRED IN PROXY STATEMENT/PROSPECTUS			II-1
Item 20. Indemnification of Directors and Officers			II-1
Item 21. Exhibits and Financial Statement Schedules			II-3
Item 22. Undertakings			II-3
Annex A—Agreement and Plan of Merger			A-1
Annex B—Opinion of SVB Leerink LLC			B-1
Annex C—Form of Millendo Stockholder Support Agreement			C-1
Annex D—Form of Tempest Stockholder Support Agreement			D-1
Annex E—Form of Lock-Up Agreement			E-1
Annex F—Certificate of Amendment for the Reverse Stock Split			F-1
Annex G—Appraisal Rights (Section 262 of the Delaware General Corporation Law)			G-1

.

Each share of Millendo common stock and option to purchase Millendo common stock that is issued and outstanding at the effective time of the merger will remain issued and outstanding and such shares will be unaffected by the merger. Immediately after the merger, Millendo securityholders as of immediately prior to the merger are expected to own approximately 18.5% of the outstanding shares of the combined company and former Tempest securityholders, including shares purchased in the Tempest financing, are expected to own approximately 81.5% of the outstanding shares of the combined company, subject to certain assumptions, including, but not limited to, (a) Millendo’s net cash as of the earlier of the closing and June 30, 2021 being between $15.3 million and $18.7 million, and (b) Tempest raising $30 million in the Tempest financing.

A:

Millendo and Tempest believe that combining the two companies will result in a company with a robust pipeline, strong leadership team and substantial capital resources, positioning it to become a leading company researching, developing and commercializing therapies for cancer. For a more complete description of the reasons for the merger, please see the sections titled “ The Merger—Millendo Reasons for the Merger ” and “ The Merger—Tempest Reasons for the Merger ” beginning on pages 113 and 116, respectively, of this proxy statement/prospectus.

Votes will be counted by the inspector of election appointed for the meeting, who will separately count “FOR” and “AGAINST” votes, abstentions and any broker Abstentions and broker will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the special meeting. Abstentions will be counted towards the vote totals for each proposal, and will have the same effect as “AGAINST” votes. Broker will have no effect on Proposal Nos. 1, 3 and 4, and will have the same effect as “AGAINST” votes for Proposal No. 2.

A:

Shares of Millendo common stock are currently listed on The Nasdaq Capital Market under the symbol “MLND.” Millendo has filed an initial listing application for the combined company with Nasdaq. After completion of the merger, Millendo will be renamed “Tempest Therapeutics, Inc.” and it is expected that the common stock of the combined company will trade on The Nasdaq Capital Market under the symbol “TPST.” On April 30, 2021, the last trading day before the date of this proxy statement/prospectus, the closing sale price of Millendo common stock was $1.15 per share.

A:

You should carefully review the section titled “ Risk Factors ” beginning on page 16 of this proxy statement/prospectus and the annexes attached hereto, which set forth certain risks and uncertainties related to the merger, risks and uncertainties to which the combined company’s business will be subject, and risks and uncertainties to which each of Millendo and Tempest, as independent companies, are subject.

A:

The merger is anticipated to close promptly after the Millendo special meeting scheduled to be held on June 22, 2021, but the exact timing cannot be predicted. For more information, please see the section titled “ The Merger Agreement—Conditions to the Completion of the Merger ” beginning on page 153 of this proxy statement/prospectus.

A:

In light of the coronavirus/COVID-19 outbreak and governmental decrees that in-person gatherings be postponed or cancelled, and in the best interests of public health and the health and safety of Millendo’s board of directors and stockholders, the Millendo special meeting will be held entirely online. Stockholders of record as of May 7, 2021 will be able to attend and participate in the Millendo special meeting online by accessing www.virtualshareholdermeeting.com/MLND2021SM. To join the Millendo special meeting, you will need to have your 16-digit control number which is included on your Notice of Internet Availability of Proxy Materials and your proxy card. If your shares are held in “street name,” you should contact your bank, broker or other nominee to obtain your 16-digit control number or otherwise vote through your bank, broker or other nominee.

Broker will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Millendo special meeting. Broker will not be treated as votes cast for or against a proposal and accordingly will not have any effect with respect to the outcome of Proposal Nos. 1, 3 and 4, and will have the same effect as “AGAINST” votes for Proposal No. 2.

•

You may attend the Millendo special meeting online and vote by following the instructions at www.virtualshareholdermeeting.com/MLND2021SM. Simply attending the Millendo special meeting will not, by itself, revoke your proxy.

A:

Millendo and Tempest intend the merger to qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”). Assuming the merger constitutes a reorganization, subject to the limitations and qualifications described in the section titled “ The Merger—Material U.S.  Federal Income Tax Consequences of the Merger ,” holders of Tempest capital stock will not recognize gain or loss for U.S. federal income tax purposes on the receipt of shares of Millendo common stock issued in connection with the merger, except with respect to cash received in lieu of a fractional share of Millendo common stock. For a more detailed discussion of the material U.S. federal income tax consequences of the merger, see “ The Merger—Material U.S.  Federal Income Tax Consequences of the Merger ” beginning on page 132.

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At the effective time of the merger, outstanding shares of Tempest capital stock will be converted into shares of Millendo common stock. Applying the exchange ratio, the former Tempest securityholders immediately before the merger, including shares purchased in the Tempest financing, are expected to own approximately 81.5% of the aggregate number of shares of Millendo common stock following the merger, and Millendo securityholders immediately before the merger are expected to own approximately 18.5% of the aggregate number of shares of Millendo common stock following the merger, subject to certain assumptions, including, but not limited to, (a) Millendo’s net cash as of the earlier of the closing and June 30, 2021 being between $15.3 million and $18.7 million, and (b) Tempest raising $30 million in the Tempest financing. To the extent that Millendo’s net cash is greater than $18.7 million, Millendo securityholders immediately before the merger would own a greater percentage of the aggregate shares of Millendo common stock following the merger than stated above and, accordingly, the former Tempest securityholders immediately before the merger, including securityholders that purchased shares in the Tempest financing, would own a lesser percentage of the aggregate shares of Millendo common stock following the merger than stated above. Conversely, to the extent that Millendo’s net cash is less than $15.3 million, Millendo securityholders immediately before the merger would own a lesser percentage of the aggregate shares of Millendo common stock following the merger than stated above and, accordingly, the former Tempest securityholders immediately before the merger, including securityholders that purchased shares in the Tempest financing, would own a greater percentage of the aggregate shares of Millendo common stock following the merger than stated above.

Additional financing may not be available to the combined company when it is needed or may not be available on favorable terms. To the extent that the combined company raises additional capital by issuing equity securities, such financing will cause additional dilution to all securityholders of the combined company, including Millendo’s securityholders and Tempest’s former securityholders. It is also possible that the terms of any new equity securities may have preferences over the combined company’s common stock. Any debt financing the combined company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the combined company’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to the combined company.

Directors and executive officers of Millendo and Tempest may have interests in the merger that are different from, or in addition to, the interests of other Millendo stockholders generally. These interests with respect to Millendo’s directors and executive officers may include, among others, acceleration of stock option vesting, retention bonus payments, extension of exercisability periods of previously issued stock option grants, severance payments if employment is terminated in a qualifying termination in connection with the merger and rights to continued indemnification, expense advancement and insurance coverage. A current member of the Millendo board of directors will continue as a director of the combined company after the effective time of the merger, and, following the closing of the merger, will be eligible to be compensated as director of the combined company pursuant to the Millendo director compensation policy that is expected to remain in place following the effective time of the merger. These interests with respect to Tempest’s directors and executive officers may include, among others, that certain of Tempest’s directors and executive officers have options, subject to vesting, to purchase shares of Tempest common stock which, after the effective time of the merger, will be converted into and become options to purchase shares of the common stock of the combined company; Tempest’s executive officers are expected to continue as executive officers of the combined company after the effective time of the merger; and all of Tempest’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. Further, certain current members of Tempest’s board of directors will continue as directors of the combined company after the effective time of the merger, and, following the closing of the merger, will be eligible to be compensated as directors of the combined company pursuant to the Millendo director compensation policy that is expected to remain in place following the effective time of the merger. The directors and executive officers own options to purchase the shares of their respective companies.

After the completion of the merger, the current stockholders of Millendo and Tempest will own a smaller percentage of the combined company than their ownership of their respective companies prior to the merger. Immediately after the merger, Millendo securityholders as of immediately prior to the merger are expected to own approximately 18.5% of the outstanding shares of the combined company and former Tempest securityholders, including shares purchased in the Tempest financing are expected to own approximately 81.5% of the outstanding shares of the combined company, subject to certain assumptions, including, but not limited to, (a) Millendo’s net cash as of the earlier of the closing and June 30, 2021 being between $15.3 million and $18.7 million, and (b) Tempest raising $30 million in the Tempest financing. The President and Chief Operating Officer of Tempest will serve as the Chief Executive Officer of the combined company following the completion of the merger.

Covenants in the Merger Agreement impede the ability of Millendo and Tempest to make acquisitions during the pendency of the merger, subject to specified exceptions. As a result, if the merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, proposing, seeking or knowingly encouraging, facilitating or supporting any inquiries, indications of interest, proposals or offers that constitute or may reasonably be expected to lead to certain transactions involving a third party, including a merger, sale of assets or other business combination, subject to specified exceptions. Any such transactions could be favorable to such party’s stockholders, but the parties may be unable to pursue them. For more information, see the section titled “ .”

The terms of the Merger Agreement prohibit each of Millendo and Tempest from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances as described in further detail in the section titled “.” In addition, if the MergerAgreement is terminated under specified circumstances, Millendo would be required to pay Tempest a termination fee of $1.4 million and reimburse up to $1.0 million of expenses. This termination fee may discourage third parties from submitting competing proposals to Millendo or its stockholders, and may cause the Millendo board of directors to be less inclined to recommend a competing proposal.

Millendo and Tempest intend for the merger to qualify as a “reorganization” within the meaning of Section 368(a) of the Code, as described in the section titled “” in this proxy statement/prospectus. In the event that the merger does not qualify as a “reorganization,” the merger would result in taxable gain or loss for each Tempest stockholder, with the amount of such gain or loss determined by the amount that each Tempest stockholder’s adjusted tax basis in the Tempest capital stock surrendered is less or more than the fair market value of the Millendo common stock and any cash in lieu of a fractional share received in exchange therefor. Each holder of Tempest capital stock is urged to consult with his, her or its own tax advisor with respect to the tax consequences of the merger.

The principal purpose of the reverse stock split is to increase the market price of Millendo’s common stock above the minimum bid price requirement under the Nasdaq rules so that the listing of Millendo and the shares of Millendo common stock being issued in the merger on Nasdaq will be approved. It cannot be assured, however, that the reverse stock split will accomplish this objective for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of Millendo’s common stock, it cannot be assured that the reverse stock split will increase the market price of its common stock by a multiple of the reverse stock split ratio mutually agreed by Millendo and Tempest, or result in any permanent or sustained increase in the market price of Millendo’s common stock, which is dependent upon many factors, including Millendo’s business and financial performance, general market conditions and prospects for future success. Thus, while the stock price of Millendo might meet the listing requirements for Nasdaq initially, it cannot be assured that it will continue to do so.

Should the market price of the combined company’s common stock decline after the reverse stock split, the percentage decline may be greater, due to the smaller number of shares outstanding, than it would have been prior to the reverse stock split. A reverse stock split is often viewed negatively by the market and, consequently, can lead to a decrease in the combined company’s overall market capitalization. If the per share market price does not increase in proportion to the reverse stock split ratio, then the value of the combined company, as measured by its stock capitalization, will be reduced. In some cases, the stock price of companies that have effected reverse stock splits subsequently declined back to split levels, and accordingly, it cannot be assured that the total market value of the combined company’s common stock will remain the same after the reverse stock split is effected, or that the reverse stock split will not have an adverse effect on the combined company’s stock price due to the reduced number of shares outstanding after the reverse stock split.

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the combined company’s common stock. In addition, a recession, depression or other sustained adverse market event resulting from the spread of or otherwise could materially and adversely affect the combined company’s business and the value of its common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies. Furthermore, market volatility may lead to increased shareholder activism if the combined company experiences a market valuation that activists believe is not reflective of its intrinsic value. Activist campaigns that contest or conflict with the combined company’s strategic direction or seek changes in the composition of its board of directors could have an adverse effect on its operating results and financial condition.

Developing cancer therapies, including conducting studies and clinical trials and establishing manufacturing capabilities, is expensive. The combined company has not generated any revenues from the commercial sale of products and will not be able to generate any product revenues until, and only if, the combined company receives approval to sell its product candidates from the FDA or other regulatory authorities. The cash expected from both Millendo and Tempest at closing, including the net proceeds of the Tempest financing, are expected to fund the further development of the combined company’s three oncology programs and operate the combined company into early 2023. However, as the combined company has not generated any revenue from commercial sales to date and does not expect to generate any revenue for several years, if ever, the combined company will need to raise substantial additional capital in order to fund its general corporate activities and to fund its research and development, including its currently planned clinical trials and plans for new clinical trials and product development.

Given the combined company’s capital constraints, it will need to prioritize spending on its clinical and programs. If the combined company is unable to raise sufficient funds to support its current and planned operations, it may elect to discontinue certain of its ongoing activities or programs. The combined company’s inability to raise additional funds could also prevent it from taking advantage of opportunities to pursue promising new or existing programs in the future.

Provisions that will be included in the combined company’s certificate of incorporation and may discourage, delay or prevent a merger, acquisition or other change in control of the combined company that stockholders may consider favorable, including transactions in which its common stockholders might otherwise receive a premium price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of the combined company’s common stock, thereby depressing the market price of its common stock. In addition, because the combined company’s board of directors will be responsible for appointing the members of the combined company’s management team, these provisions may frustrate or prevent any attempts by the combined company’s stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of the combined company’s board of directors. Among other things, these provisions:

Under Section 382 and Section 383 of the Code and corresponding provisions of state law, if a corporation undergoes an “ownership change,” its ability to use its NOL carryforwards and other tax attributes (such as research tax credits) to offset its post-change income may be limited. A Section 382 “ownership change” is generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period. Millendo believes that it has experienced an ownership change in the past, and may experience ownership changes in the future due to subsequent shifts in its stock ownership (some of which are outside of its control). Tempest may have experienced ownership changes in the past, may experience an ownership change as a result of the merger, and may experience ownership changes in the future due to subsequent shifts in the combined company’s stock ownership (some of which are outside of its control). Furthermore, the merger, if consummated, will constitute an ownership change (within the meaning of Section 382 of the Code) of Millendo which could eliminate or otherwise substantially limit the combined company’s ability to use Millendo’s federal and state NOLs to offset its future taxable income. Consequently, even if the combined company achieves profitability, it may not be able to utilize a material portion of Tempest’s, Millendo’s or the combined company’s NOL carryforwards and other tax attributes, which could have a material adverse effect on cash flow and results of operations. Similar provisions of state tax law may also apply to limit the combined company’s use of accumulated state tax attributes. There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs, or other unforeseen reasons, the combined company’s existing NOLs could expire or otherwise be unavailable to offset future income tax liabilities.

If existing securityholders of Millendo and Tempest sell, or indicate an intention to sell, substantial amounts of the combined company’s common stock in the public market after legal restrictions on resale discussed in this proxy statement/prospectus lapse, the trading price of the common stock of the combined company could decline. Based on shares outstanding as of March 31, 2021, the shares to be issued in the Tempest financing and shares expected to be issued upon completion of the merger the combined company is expected to have outstanding a total of approximately 111,559,188 shares of common stock immediately following the completion of the merger. Of the shares of common stock, approximately 55,961,483 shares will be available for sale in the public market beginning 180 days after the closing of the merger as a result of the expiration of agreements between Millendo and Tempest on the one hand and certain securityholders of Millendo and Tempest on the other hand. All other outstanding shares of common stock, other than shares held by affiliates of the combined company, will be freely tradable, without restriction, in the public market. In addition, shares of common stock that are subject to outstanding options of Tempest will become eligible for sale in the public market to the extent permitted by the provisions of various vesting agreements and Rules 144 and 701 under the Securities Act. If these shares are sold, the trading price of the combined company’s common stock could decline.

Upon the completion of the merger, and giving effect to the issuance of the shares of common stock of Tempest prior to the closing of the merger pursuant to the Tempest financing, it is anticipated that the combined company’s executive officers, directors and principal stockholders will, in the aggregate, beneficially own approximately 54.4% of the combined company’s outstanding shares of common stock, subject to certain assumptions, including, but not limited to, (a) Millendo’s net cash as of the earlier of the closing and June 30, 2021 being between $15.3 million and $18.7 million, and (b) Tempest raising $30 million in the Tempest financing. As a result, if these stockholders were to choose to act together, they would be able to

The combined company will have broad discretion over the use of the cash and cash equivalents of the combined company and the proceeds from the Tempest financing. You may not agree with the combined company’s decisions, and its use of the proceeds may not yield any return on your investment. The combined company’s failure to apply these resources effectively could compromise its ability to pursue its growth strategy and the combined company might not be able to yield a significant return, if any, on its investment of these net proceeds. You will not have the opportunity to influence its decisions on how to use the combined company’s cash resources.

In 2020, Millendo undertook a strategic review process, which was intended to result in an actionable plan that leverages its assets, capital and capabilities to maximize stockholder value. Following an extensive process of evaluating strategic alternatives and identifying and reviewing potential candidates for a strategic acquisition or other transaction, on March 29, 2021, Millendo entered into a merger agreement with Tempest, under which the privately held Tempest will merge with a wholly owned subsidiary of Millendo. Millendo shareholders will own approximately 18.5% of the combined company and Tempest stockholders will own approximately 81.5% of the combined company (assuming the Tempest financing results in gross proceeds of approximately $30 million). Millendo is devoting substantially all of its time and resources to consummating this transaction, however, there can be no assurance that such activities will result in the consummation of this transaction or that such transaction will deliver the anticipated benefits or enhance stockholder value.

If Millendo was to seek to continue its business, it would need to determine whether to acquire one or more other product candidates. Millendo would also need to raise funds to support continued operations and its workforce requirements in consideration of its reduced workforce.

Since inception, Millendo has incurred significant operating losses and negative operating cash flows and there is no assurance that Millendo will ever achieve or sustain profitability. Millendo’s net loss was $36.4 million and $44.6 million and for the years ended December 31, 2020 and 2019, respectively. As of December 31, 2020, Millendo had an accumulated deficit of $245.1 million and expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. Millendo has devoted substantially all of its efforts to the acquisition of and preclinical and clinical development of in which it decided to discontinue its investment in January 2021, nevanimibe, in which Millendo ceased investing in June 2020, and livoletide, of which Millendo discontinued development in April 2020, as well as to building its management team and infrastructure. The net losses Millendo incurs may fluctuate significantly from quarter to quarter and year to year. Millendo anticipates that expenses may increase if it resumes drug development activities. Millendo’s failure to become and remain profitable would decrease its value and could impair its ability to raise capital, continue its operations. A decline in its value also could cause Millendo stockholders to lose all or part of their investment.

If the merger is not completed, Millendo may require substantial additional capital to fund any research and development and expenses related to its business. Millendo had cash, cash equivalents and restricted cash of $38.7 million at December 31, 2020. In the event that the merger is not completed, Millendo may pursue a liquidation, dissolution or or may seek to complete an alternate strategic transaction or may elect to resume investment in other product candidates. Based on the current operating plan, Millendo believe that its existing cash, cash equivalents and restricted cash will be sufficient to allow it to fund its current operating plan for at least the next 12 months.

Millendo expects its expenses to increase in connection with ongoing activities and expects to continue to incur additional costs associated with operating as a public company. As of December 31, 2020, Millendo’s cash, cash equivalents and restricted cash were $38.7 million. Millendo’s existing cash, cash equivalents and restricted cash are currently expected to be sufficient to fund its current operating plans through at least the next 12 months. This cash runway guidance is based on Millendo’s current operational plans and excludes any additional funding that may be received and business development activities that may be undertaken. In addition, the operating plans may change as a result of many factors currently unknown to Millendo, including the short- and long-term effects of the pandemic, and Millendo may need to seek additional funds sooner than planned, through public or private equity or debt financings, third-party funding, and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or a combination of these approaches. In any event, Millendo will require additional capital to pursue preclinical and clinical activities, regulatory approval and the commercialization of its current and future product candidates. Even if Millendo believes it has sufficient capital for its current operating plans, Millendo may seek additional capital if market conditions are favorable or if it has specific strategic considerations. If Millendo elects to do so, additional capital may not be available to it on acceptable terms, if at all. Millendo’s ability to access additional capital, and as a result its operating results and liquidity needs, could be negatively affected by market fluctuations and economic downturn. The pandemic has already resulted in a significant disruption of global financial markets. If the disruption persists and deepens, Millendo could experience an inability to access additional capital, which could negatively affect its business. Any additional capital raising efforts may divert its management from its activities, which may adversely affect Millendo’s ability to develop and commercialize its current and future product candidates.

Millendo has never obtained marketing approval for a product candidate. It is possible that the FDA may refuse to accept for substantive review any NDAs that Millendo submits for any future candidates Millendo may choose to develop or may conclude after review of the data that Millendo’s application is insufficient to obtain marketing approval of its product candidates. If the FDA does not accept or approve Millendo’s NDAs for any of Millendo’s future product candidates, it may require that Millendo conduct additional clinical trials, preclinical studies or manufacturing validation studies and submit that data before it will reconsider Millendo’s applications. Depending on the extent of these or any other trials or studies, approval of any New Drug Application, or NDA, or application that Millendo submits may be delayed by several years or may require Millendo to expend more resources than it has available. It is also possible that additional trials or studies, if performed and completed, may not be considered sufficient by the FDA to approve Millendo’s NDAs.

the GDPR will introduce numerous privacy-related changes for companies operating in the EU, including greater control over personal subjects (e.g., the “right to be forgotten”), increased data portability for EU consumers, data breach notification requirements, and increased fines. The GDPR requirements apply not only to third-party transactions, but also to transfers of information between Millendo and its subsidiaries, including employee information. However, despite the ongoing efforts to bring Millendo’s practices into compliance before the effective date of the GDPR, Millendo may not be successful either due to various factors within its control, such as limited financial or human resources, or other factors outside its control. It is also possible that local data protection authorities may have different interpretations of the GDPR, leading to potential inconsistencies amongst various EU member states. Any failure or alleged failure (including as a result of deficiencies in its policies, procedures, or measures relating to privacy, data security, marketing, or communications) by Millendo to comply with laws, regulations, policies, legal or contractual obligations, industry standards, or regulatory guidance relating to privacy or data security, may result in governmental investigations and enforcement actions, litigation, fines and penalties, additional regulatory oversight and reporting obligations or adverse publicity. Further, because of the work-from-home policies Millendo implemented due to information that is normally protected, including company confidential information, may be less secure.

Moreover, Millendo may be subject to a third-party submission of prior art to the USPTO or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging its patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, Millendo’s patent rights, allow third-parties to commercialize its technology or product candidates and compete directly with Millendo, without payment to Millendo, or result in Millendo’s inability to manufacture or commercialize product candidates without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by Millendo’s patents and patent applications is threatened, it could dissuade companies from collaborating with Millendo to license, develop or commercialize current or future product candidates.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and Millendo’s owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit its ability to stop others from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection of Millendo’s technology and product candidates. Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years from the earliest filing date of a patent application. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for Millendo’s current or future product candidates, it may be open to competition from generic versions of such drugs. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, Millendo’s owned and licensed patent portfolio may not provide it with sufficient rights to exclude others from commercializing drugs similar or identical to that of us.

Millendo jointly owns certain patents and patent applications with third-parties. In the absence of an agreement with each of jointly owned patent rights, Millendo will be subject to default rules pertaining to joint ownership. Some countries require the consent of all joint owners to exploit, license or assign jointly owned patents, and if Millendo is unable to obtain that consent from the joint owners, it may be unable to exploit the invention or to license or assign its rights under these patents and patent applications in those countries. For example, Millendo secured exclusive rights from the University of Michigan for certain patents and patent applications that they jointly own with Millendo related to nevanimibe. Additionally, in the United States, each may be required to be joined as a party to any claim or action Millendo may wish to bring to enforce these patent rights, which may limit its ability to pursue third-party infringement claims.

Millendo has certain patents and patent applications from third-parties. In the absence of an agreement with each patent rights owner, Millendo will be subject to default rules pertaining to ownership. Some countries require the consent of all owners to exploit, license or assign owned patents, and if Millendo is unable to obtain that consent from the owners, it may be unable to exploit the invention or to license or assign its rights under these patents and patent applications in those countries. For example, Millendo secured exclusive rights from Roche for certain patents and patent applications that Roche owns related to Additionally, in the United States, each owner may be required to be joined as a party to any claim or action Millendo may wish to bring to enforce these patent rights, which may limit its ability to pursue third-party infringement claims.

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on patents and/or applications will be due to be paid to the USPTO and various government patent agencies outside of the United States in several stages over the lifetime of Millendo’s owned and licensed patents and/or applications and any patent rights it may own or license in the future. Millendo relies on its outside counsel or its licensing partners to pay these fees due to patent agencies. The USPTO and various government patent agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. Millendo employs reputable law firms and other professionals to help it comply and is also dependent on its licensors to take the necessary action to comply with these requirements with respect to its licensed intellectual property. In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules.

There are situations, however, in which can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Millendo has in the past sought, and in the future may seek, extensions of patent terms in the United States and, if available, in other countries where it is prosecuting patents. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits extension of the term of one U.S. patent that includes at least one claim covering the composition of matter of an drug, an method of treatment using the drug. The extended patent term cannot exceed the shorter of five years beyond the expiration of the patent or 14 years from the date of the FDA approval of the drug. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with Millendo’s assessment of whether such extensions are available, and may refuse to grant extensions to Millendo’s patents, or may grant more limited extensions than it requests. Further, Millendo may not elect to extend the most beneficial patent to it or the claims underlying the patent that it chooses to extend could be invalidated. If any of the foregoing occurs, Millendo’s competitors may be able to take advantage of Millendo’s investment in development and clinical trials by referencing its clinical and preclinical data and launch their drug earlier than might otherwise be the case.

The biotechnology and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual property rights. Millendo may in the future become party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to any future product candidates and technology, including interference proceedings, post grant review and inter partes review before the USPTO. Third-parties may assert infringement claims against Millendo based on existing patents or patents that may be granted in the future, regardless of their merit. There is a risk that third-parties may choose to engage in litigation with Millendo to enforce or to otherwise assert their patent rights against Millendo. Even if Millendo believes such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a material adverse effect on its ability to commercialize any future product candidates. In order to successfully challenge the validity of any such U.S. patent in federal court, Millendo would need to overcome a presumption of validity. As this burden is a high one requiring Millendo to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If Millendo is found to infringe a third-party’s valid and enforceable intellectual property rights, Millendo could be required to obtain a license from such third-party to continue developing, manufacturing and marketing its product candidate and technology. However, Millendo may not be able to obtain any required license on commercially reasonable terms or at all. Even if Millendo was able to obtain a license, it could be thereby giving its competitors and other third-parties access to the same technologies licensed to Millendo, and it could require Millendo to make substantial licensing and royalty payments. Millendo could be forced, including by court order, to cease developing, manufacturing and commercializing the infringing technology or product candidate. In addition, Millendo could be found liable for monetary damages, including treble damages and

Competitors may infringe or otherwise violate Millendo’s patents, the patents of its licensors or its other intellectual property rights. To counter infringement or unauthorized use, Millendo may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of Millendo or its licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that its patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of Millendo’s patents at risk of being invalidated or interpreted narrowly and could put Millendo’s patent applications at risk of not issuing. The initiation of a claim against a third-party may also cause the third-party to bring counter claims against Millendo such as claims asserting that Millendo’s patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third-parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Millendo cannot be certain that there is no invalidating prior art, of which Millendo and the patent examiner were unaware during prosecution. For the patents and patent applications that it has licensed, it may have a limited or no right to participate in the defense of any licensed patents against challenge by a third-party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, Millendo would lose at least part, and perhaps all, of any future patent protection on its current or future product candidates. Such a loss of patent protection could have material adverse effect on its business.

The United States has recently enacted and implemented wide-ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to Millendo’s ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by the U.S. Congress, federal courts, USPTO, and the relevant bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken Millendo’s ability to obtain new patents or to enforce patents that it has licensed or that it might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken Millendo’s ability to obtain new patents or to enforce patents that it has licensed or that it may obtain in the future.

Certain of Millendo’s employees, consultants or advisors are currently, or were previously, employed at universities or other biotechnology or pharmaceutical companies, including Millendo’s competitors or potential competitors. Although Millendo tries to ensure that its employees, consultants and advisors do not use the proprietary information or of others in their work for Millendo, Millendo may be subject to claims that these individuals or Millendo has used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims. If Millendo fails in defending any such claims, in addition to paying monetary damages Millendo may lose valuable intellectual property rights or personnel. Even if Millendo is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

Millendo may enter into collaborations with third-parties in the future. It may in the future determine to collaborate with other pharmaceutical and biotechnology companies for development and potential commercialization of its product candidates. These relationships, or those like them, may require Millendo to incur and other charges, increase Millendo’s near- and long-term expenditures, issue securities that dilute Millendo’s existing stockholders or disrupt its management and business. In addition, Millendo could face significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex. Millendo’s ability to reach a definitive collaboration agreement will depend, among other things, upon its assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of several factors. If Millendo licenses rights to its product candidates, it may not be able to realize the benefit of such transactions if it is unable to successfully integrate them with its existing operations and company culture.

A novel strain of coronavirus, causing has been declared a pandemic by the World Health Organization. The pandemic has resulted in travel and other restrictions in order to reduce the spread of the disease, including state and local orders across the country, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease operations at physical locations, prohibit certain gatherings, and order cessation of travel. In response to these public health directives and orders, Millendo has implemented work-from-home policies for certain employees. The effects of the executive orders, the orders and the work-from-home policies may negatively impact productivity, disrupt Millendo’s business and delay its clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on Millendo’s ability to conduct its business in the ordinary course. These and similar, and perhaps more severe, disruptions in Millendo’s operations could negatively impact its business, operating results and financial condition.

Quarantines, and similar government orders related to may adversely impact Millendo’s business operations and the business operations of its contract research organizations conducting its clinical trials and its third-party manufacturing facilities in the United States and other countries. In particular, some of Millendo’s third-party manufacturers which it uses for the supply of materials for product candidates or other materials necessary to manufacture product to conduct preclinical studies and clinical trials are located in countries affected by and should they experience disruptions, such as temporary closures or suspension of services, Millendo would likely experience delays in advancing these tests and trials.

The spread of which has caused a broad impact globally, may materially affect Millendo economically. While the potential economic impact brought by, and the duration of, may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing Millendo’s ability to access capital, which could in the future negatively affect Millendo’s liquidity. In addition, a recession or market correction resulting from the spread of could materially affect Millendo’s business and the value of its common stock.

The global pandemic of continues to rapidly evolve. The extent to which the pandemic impacts Millendo’s business, Millendo’s clinical development and regulatory efforts will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, travel restrictions, quarantines, social distancing requirements and business closures in the United States and other countries, and business disruptions, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. Accordingly, Millendo does not yet know the full extent of potential delays or impacts on its business, its clinical and regulatory activities, healthcare systems or the global economy as a whole. However, these impacts could adversely affect Millendo’s business, financial condition, results of operations and growth prospects.

In addition, to the extent the ongoing pandemic adversely affects Millendo’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties described in this ‘‘Risk Factors’’ section.

In January 2021, Millendo began the implementation of a reduction in force that will reduce the number of its employees by up to 85 percent. The reduction in force, and the attrition thereafter, resulted in the loss of longer-term employees, the loss of institutional knowledge and expertise and the reallocation and combination of certain of roles and responsibilities across the organization, all of which could adversely affect Millendo’s operations. Millendo anticipates that its workforce will no longer be employed at the closing of the merger. However, if the merger is not consummated, given the complexity and nature of Millendo’s business, it must continue to implement and improve its managerial, operational and financial systems, manage its facilities and continue to recruit and retain qualified personnel. This will be made more challenging given the reduction in force described above and additional measures Millendo may take to reduce costs. As a result, Millendo’s management may need to divert a disproportionate amount of its attention away from its strategic and operational activities, and devote a substantial amount of time to managing these organizational changes. Further, the restructuring and possible additional cost containment measures may yield unintended consequences, such as attrition beyond Millendo’s intended reduction in force and reduced employee morale. In addition, employees who were not affected by the reduction in force may seek alternate employment which would result in Millendo seeking contract support at unplanned additional expense. In addition, Millendo may not achieve anticipated benefits from the reduction in force. Due to Millendo’s limited resources, it may not be able to effectively manage its operations or recruit and retain qualified personnel, which may result in weaknesses in its infrastructure and operations, risks that it may not be able to comply with legal and regulatory requirements, loss of business opportunities, loss of employees and reduced productivity among remaining employees. If Millendo’s management is unable to effectively manage this transition and reduction in force and additional cost containment measures, Millendo’s expenses may be more than expected, and it may not be able to implement its business strategy.

As a French technology company, Alizé historically benefited from certain tax advantages, including the French research tax credit () (“CIR”). The CIR is a French tax credit aimed at stimulating research and development and can offset French corporate income tax due. Alizé has historically received CIR reimbursements promptly following filing for such reimbursements with applicable French taxing authorities. For the year ended December 31, 2018, claims were made totaling $1.3 million, which Millendo received in the third quarter of 2019. For the year ended December 31, 2019, claims were made totaling $1.3 million, which Millendo received in the second quarter of 2020. In the future, Millendo may no longer qualify as a French small or medium size enterprise, and, accordingly, it may be subject to a three-year waiting period for reimbursement of CIRs, which could adversely affect the combined business’s results of operations and cash flows. In addition, the amount of CIR received is, among other factors, dependent upon incurring qualified research and development expenses and maintaining a certain level of employee salaries and other personnel costs in France. The number of Millendo’s research and development employees in France decreased during the year ended December 31, 2020 and it experienced a decrease in qualified research and development expenses for the year ended December 31, 2020 due to the discontinuation of its livoletide program. Millendo plans to dissolve its subsidiary in France.

Millendo incurs portions of its expenses, and may in the future derive revenue, in currencies other than the U.S. dollar, in particular, the euro. As a result, it is exposed to foreign currency exchange risk as its results of operations and cash flows are subject to fluctuations in foreign currency exchange rates. Any fluctuation in the exchange rate of these foreign currencies may negatively impact Millendo’s business, financial condition and operating results. Global economic events, such as the pandemic, have and may continue to significantly impact local economies and the foreign exchange markets, which may increase the risks associated with sales denominated in foreign currencies. Millendo currently does not engage in hedging transactions to protect against uncertainty in future exchange rates between particular foreign currencies and the euro. Therefore, for example, an increase in the value of the euro against the U.S. dollar could be expected to have a negative impact on its operating expenses as euro denominated expenses, if any, would be translated into U.S. dollars at an increased value. Millendo cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect its financial condition, results of operations and cash flows.

It is possible that Millendo may not have fully anticipated the extent of the risks associated with the OvaScience Merger Millendo completed with OvaScience in 2018. After the OvaScience Merger, OvaScience’s historic business was discontinued, but prior to the transaction OvaScience had a significant operating history. As a consequence, Millendo may be subject to claims, demands for payment, regulatory issues, costs and liabilities that were not and are not currently expected or anticipated. Notwithstanding Millendo’s exercise of due diligence and winding down of the OvaScience business post-transaction, the risks involved with taking over a business with a significant operating history and the costs and liabilities associated with these risks may be greater than anticipated. Millendo may not be able to contain or control the costs or liabilities associated with OvaScience’s historic business, which could materially and adversely affect its business, liquidity, capital resources or results of operation.

The market price of Millendo’s common stock has been and is likely to continue to be highly volatile and could be subject to wide fluctuations in price in response to various factors. A number of factors could influence the volatility in the trading price of Millendo’s common stock, including changes in the economy or in the financial markets, including recently in connection with the ongoing pandemic, industry-related developments, and the impact of material events and changes in its operations, including as a result of its recent announcements that Millendo has discontinued its livoletide program in PWS and ceased investing in its nevanimibe program and its program. Worsening economic conditions and other adverse effects or developments relating to Millendo’s business or the ongoing pandemic may negatively affect the market price of its common stock. The market price for Millendo’s common stock is likely to continue to be volatile, particularly due to the ongoing pandemic, and subject to significant price and volume fluctuations in response to market, industry and other factors, including the risk factors described in this “Risk Factors” section. As a result of this

Provisions in Millendo’s certificate of incorporation and may discourage, delay or prevent a merger, acquisition or other change in control of Millendo that stockholders may consider favorable, including transactions in which its common stockholders might otherwise receive a premium price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of Millendo’s common stock, thereby depressing the market price of its common stock. In addition, because the Millendo board of directors is responsible for appointing the members of Millendo’s management team, these provisions may frustrate or prevent any attempts by Millendo stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of the Millendo board of directors. Among other things, these provisions:

In the past, securities class action litigation has often been brought against a company following a decline in the market price of Millendo’s securities. This risk is especially relevant for Millendo because biopharmaceutical companies have experienced significant stock price volatility in recent years. Millendo remains the subject of various securities class action lawsuits and shareholder derivative lawsuits that were filed against OvaScience and certain of its officer and directors, as described in more detail in the section titled “” of this proxy statement/prospectus. These lawsuits, as well as any similar lawsuits initiated in the future, could result in substantial cost and a diversion of management’s attention and resources, which could harm Millendo’s business.

Millendo is subject to the reporting requirements of 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 Millendo’s common stock is listed. The Sarbanes-Oxley Act requires, among other things, that Millendo maintains effective disclosure controls and procedures and internal control over financial reporting and that it furnish a report by management on, among other things, the effectiveness of its internal control over financial reporting. This assessment includes disclosure of any material weaknesses identified by Millendo’s management in its internal control over financial reporting. However, due to recent changes in SEC rules related to smaller reporting companies, Millendo is not required to have its auditors formally attest to the effectiveness of its internal control over financial reporting. For the year ended December 31, 2018, Millendo was unable to conduct the required assessment primarily due to the OvaScience Merger occurring in the fourth quarter of 2018 and the substantial change in operational focus, management and the internal control environment following the OvaScience Merger. As a result, Millendo provided its first internal control assessment with its Annual Report on Form for the year ended December 31, 2019.

Under Section 382 and Section 383 of the Code and corresponding provisions of state law, if a corporation undergoes an “ownership change,” its ability to use its NOL carryforwards and other tax attributes (such as research tax credits) to offset its post-change income may be limited. A Section 382 “ownership change” is generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period. Millendo believes that it has experienced an ownership change in the past, and may experience ownership changes in the future due to subsequent shifts in its stock ownership (some of which are outside of its control). Furthermore, the merger, if consummated, will constitute an ownership change (within the meaning of Section 382 of the Code) of Millendo which could eliminate or otherwise substantially limit the combined company’s ability to use its federal and state NOLs to offset its future taxable income. Consequently, even if the combined company achieves profitability, it may not be able to utilize a material portion of Millendo’s NOL carryforwards and other tax attributes, which could have a material adverse effect on cash flow and results of operations. Similar provisions of state tax law may also apply to limit Millendo’s use of accumulated state tax attributes. There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs, or other unforeseen reasons, Millendo’s existing NOLs could expire or otherwise be unavailable to offset future income tax liabilities.

Tempest will require substantial future capital in order to complete planned and future preclinical and clinical development for its product candidates and potentially commercialize these product candidates. Based upon Tempest’s current operating plan, Tempest believes that its existing cash and cash equivalents as of December 31, 2020, along with the net cash held by Millendo upon consummation of the transaction, including the expected proceeds from the Tempest financing, will enable Tempest to fund its operating expenses and capital expenditure requirements through into early 2023. Tempest expects Tempest’s spending levels to increase in connection with Tempest’s preclinical studies and clinical trials of Tempest’s product candidates. In addition, if Tempest obtains marketing approval for any of Tempest’s product candidates, Tempest expects to incur significant expenses related to commercial launch, product sales, medical affairs, marketing, manufacturing and distribution. Furthermore, Tempest expects to incur additional costs associated with operating as a public company. Accordingly, Tempest will need to obtain substantial additional funding in connection with its continuing operations before any commercial revenue may occur.

Tempest is actively recruiting additional accounting personnel with appropriate experience, certification, education and training as a component of its plans to remediate the material weaknesses. Tempest also plans to design and implement controls related to review of clinical trial expenses to properly evaluate progress of expense incurred in clinical trial contracts. To the extent that Tempest is not able to hire and retain suchindividuals, or is unable to successfully design and implement such controls, the material weaknesses identified may not be remediated and management may be required to record additional adjustments to its financial statements in the future.

Tempest plans to invest a substantial amount of its efforts and financial resources in its current lead product candidates, TPST-1495, a dual EP2/EP4 prostaglandin (PGE2) receptor antagonist, and TPST-1120, a peroxisome proliferator-activated receptor alpha (PPARα) antagonism for the treatment of various cancers. Tempest has initiated phase 1 clinical trials of TPST-1495 and TPST-1120 for the treatment of advanced solid tumors. In addition, Tempest plans to advance its inhibitor program and select a development candidate for this program by the end of 2021. Tempest’s ability to generate product revenue will depend heavily on the successful development and eventual commercialization of TPST-1495 and TPST-1120 and Tempest’s other product candidates, which may never occur. Tempest currently generates no revenue from sales of any product and Tempest may never be able to develop or commercialize a marketable product.