As filed with the Securities and Exchange Commission on May 2, 2022
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
TREVI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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45-0834299 |
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(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification Number) |
195 Church Street, 14th Floor
New Haven, Connecticut 06510
(203) 304-2499
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Jennifer L. Good
President and Chief Executive Officer
Trevi Therapeutics, Inc.
195 Church Street, 14th Floor
New Haven, Connecticut 06510
(203) 304-2499
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Stuart M. Falber
Jeffries Oliver-Li
Wilmer Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, Massachusetts 02109
(617) 526-6000
Approximate date of commencement of proposed sale to the public: From time to time after this registration statement becomes effective.
If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ☐
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this prospectus is not complete and may be changed. The selling stockholders named in this prospectus may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and the selling stockholders named in this prospectus are not soliciting offers to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.
Subject to completion, dated May 2, 2022
PROSPECTUS
28,960,199 Shares of Common Stock
This prospectus relates to the resale from time to time of up to an aggregate of 28,960,199 shares of common stock of Trevi Therapeutics, Inc. by the selling stockholders listed on page 7 and any of their respective pledgees, assignees and successors-in-interest, which consist of 4,580,526 outstanding shares of our common stock held by the selling stockholders and 24,379,673 shares of our common stock issuable upon the exercise of outstanding pre-funded warrants to purchase shares of our common stock at an exercise price of $0.001 per share held by the selling stockholders, or the Pre-Funded Warrants. We will not receive any proceeds from the sale of the shares offered by this prospectus.
We have agreed, pursuant to a registration rights agreement that we have entered into with the selling stockholders, to bear all of the expenses incurred in connection with the registration of these shares. The selling stockholders will pay or assume discounts, commissions, fees of underwriters, selling brokers or dealer managers and similar expenses, if any, incurred for the sale of these shares of our common stock.
The selling stockholders identified in this prospectus, and any of their respective pledgees, assignees and successors-in-interest, may offer the shares from time to time on terms to be determined at the time of sale through ordinary brokerage transactions or through any other means described in this prospectus under the caption “Plan of Distribution.” The shares may be sold at fixed or negotiated prices.
We may amend or supplement this prospectus from time to time by filing amendments or supplements as required. You should read the entire prospectus and any amendments or supplements carefully before you make your investment decision.
Our common stock is traded on the Nasdaq Global Market, or Nasdaq, under the symbol “TRVI.” On April 29, 2022, the last reported closing sale price of our common stock on Nasdaq was $2.70 per share. You are urged to obtain current market quotations for our common stock.
We are an “emerging growth company” under applicable Securities and Exchange Commission rules and, as such, have elected to comply with certain reduced public company disclosure requirements for this prospectus and future filings. See “Prospectus Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”
Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 3 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2022.
TABLE OF CONTENTS
You should rely only on the information contained or incorporated by reference in this prospectus. We and the selling stockholders have not authorized any other person to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectus may only be used where it is legal to offer and sell shares of our common stock. If it is against the law in any jurisdiction to make an offer to sell these shares, or to solicit an offer from someone to buy these shares, then this prospectus does not apply to any person in that jurisdiction, and no offer or solicitation is made by this prospectus to any such person. You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus, regardless of the time of delivery of this prospectus or of any sale of common stock. Our business, financial condition, results of operations and prospects may have changed since such date.
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PROSPECTUS SUMMARY
This summary highlights, and is qualified in its entirety by, the more detailed information included elsewhere in this prospectus or incorporated by reference in this prospectus. This summary does not contain all of the information that you should consider before investing. You should read and carefully consider the entire prospectus, especially the “Risk Factors” section of this prospectus, before deciding to invest in our common stock.
Overview
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions. We are developing Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis, or IPF. We are conducting a Phase 2b/3 clinical trial of Haduvio, which we refer to as the Phase 2b/3 PRISM trial, in patients with severe pruritus associated with prurigo nodularis. We are also conducting a Phase 2 clinical trial of Haduvio for chronic cough in patients with IPF, which we refer to as the Phase 2 CANAL trial.
Corporate Information
We were incorporated under the laws of the State of Delaware on March 17, 2011 under the name Trevi Therapeutics, Inc. Our principal executive offices are located at 195 Church Street, 14th Floor, New Haven, Connecticut, 06510, and our telephone number is (203) 304-2499. Our website address is www.trevitherapeutics.com. The information contained on, or that can be accessed through, our website is not a part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.
Unless the context otherwise requires, we use the terms “Company,” “we,” “us,” “our,” “Trevi” and similar designations in this prospectus to refer to Trevi Therapeutics, Inc. and our wholly owned subsidiary.
We own or have rights to trademarks, service marks and trade names that we use in connection with the operation of our business, including our corporate name, logos and website names. We own the trademarks Trevi® and Haduvio™. Other trademarks, service marks and trade names appearing in this prospectus are the property of their respective owners. Solely for convenience, some of the trademarks, service marks and trade names referred to in this prospectus are listed without the ® and ™ symbols, but we will assert, to the fullest extent under applicable law, our rights to our trademarks, service marks and trade names. We intend to propose Haduvio as the trade name for our nalbuphine ER investigational product and therefore plan to use that name when we refer to nalbuphine ER going forward.
Implications of Being an Emerging Growth Company and a Smaller Reporting Company
As a company with less than $1.07 billion of revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We may remain an emerging growth company until December 31, 2024 or until such earlier time as we have more than $1.07 billion in annual revenue, the market value of our stock held by non-affiliates is more than $700 million as of the last business day of our most recently completed second fiscal quarter or we issue more than $1 billion of non-convertible debt over a three-year period. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure and other requirements that are applicable to other public companies that are not emerging growth companies.
We are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates was less than $700 million measured on the last business day of our most recently completed second fiscal quarter, and our annual revenue was less than $100 million during our most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. For so long as we remain a smaller reporting company, we are permitted and intend to rely on exemptions from certain disclosure and other requirements that are applicable to other public companies that are not smaller reporting companies.
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THE OFFERING
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Common stock offered by the selling stockholders |
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28,960,199 shares, consisting of an aggregate of 4,580,526 outstanding shares of our common stock and an aggregate of 24,379,673 shares of our common stock issuable upon the exercise of outstanding Pre-Funded Warrants. |
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Use of proceeds |
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We will not receive any proceeds from the sale of shares in this offering. |
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Risk factors |
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You should read the “Risk Factors” section on page 3 of this prospectus for a discussion of factors to consider carefully before deciding to invest in shares of our common stock. |
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Nasdaq Global Market symbol |
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“TRVI” |
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RISK FACTORS
Investing in our common stock involves a high degree of risk. Before you decide to invest in our common stock, you should carefully consider the risks described in the section captioned “Risk Factors” in our most recent Annual Report on Form 10-K, our most recent Quarterly Report on Form 10-Q and other filings we make with the Securities and Exchange Commission, or the SEC, from time to time, which are incorporated by reference herein in their entirety, together with the other information in this prospectus and documents incorporated by reference in this prospectus. The risks described in our most recent Annual Report on Form 10-K, our most recent Quarterly Report on Form 10-Q and the other filings incorporated by reference herein are not the only ones facing our company. Additional risks and uncertainties may also impair our business operations. If any of the risks described in our most recent Annual Report on Form 10-K, our most recent Quarterly Report on Form 10-Q and the other filings incorporated by reference herein occurs, our business, financial condition, results of operations and future growth prospects could be harmed. In these circumstances, the market price of our common stock could decline, and you may lose all or part of your investment.
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This prospectus and the information incorporated by reference in this prospectus include “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this prospectus or the information incorporated by reference in this prospectus, including statements regarding our strategy, future operations, future financial position, future revenues and profitability, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “could,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The forward-looking statements in this prospectus and the information incorporated by reference herein include, among other things, statements about:
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our ongoing clinical trials, including our Phase 2b/3 PRISM trial of Haduvio (nalbuphine ER) for the treatment of pruritus associated with prurigo nodularis and our Phase 2 CANAL trial for the treatment of chronic cough in patients with IPF; |
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our plans to develop and, if approved, subsequently commercialize Haduvio for the treatment of pruritus associated with prurigo nodularis, for the treatment of chronic cough in patients with IPF, or for other serious neurologically mediated conditions; |
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our expectations regarding the timing for the initiation of clinical trials and the reporting of data from such trials; |
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the timing of and our ability to submit applications for and to obtain and maintain regulatory approvals for Haduvio; |
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our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and cash equivalents and to continue as a going concern; |
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our estimates regarding expenses, future revenue, timing of any future revenue, capital requirements and needs for additional financing; |
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the impact of government laws and regulations; |
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our competitive position; |
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our ability to establish and maintain collaborations; and |
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the impact of the pandemic caused by the novel coronavirus, or COVID-19, which pandemic we refer to as the COVID-19 pandemic, on our clinical trials, business and operations and our response to the COVID-19 pandemic. |
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included or incorporated by reference in this prospectus, particularly in the section titled “Risk Factors”, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
This prospectus incorporates by reference statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties as well as our own estimates. All of the market data incorporated by reference in this prospectus involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for Haduvio include several key assumptions based on our industry knowledge, industry publications, third-party research and other surveys, which may be based on a small sample size and may fail to accurately reflect
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market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions.
You should read this prospectus, the documents incorporated by reference herein and the documents that we have filed as exhibits to the registration statement of which this prospectus is a part completely and with the understanding that our actual future results may differ materially from what we expect. The forward-looking statements contained in this prospectus and incorporated by reference herein are made as of the date hereof, and we do not assume any obligation to update any forward-looking statements except as required by applicable law.
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USE OF PROCEEDS
We are filing the registration statement of which this prospectus forms a part to permit the selling stockholders to resell the shares of our common stock described in the section entitled “Selling Stockholders.” We are not selling any securities under this prospectus and we will not receive any proceeds from the sale or other disposition of shares of our common stock held by the selling stockholders.
The selling stockholders will pay any underwriting discounts and commissions and expenses incurred by the selling stockholders for brokerage, accounting, tax or legal services or any other expenses incurred by the selling stockholders in disposing of these shares. We will bear all other costs, fees and expenses incurred in effecting the registration of the shares covered by this prospectus, including, without limitation, all registration and filing fees, Nasdaq listing fees and fees and expenses of our counsel and our accountants.
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SELLING STOCKHOLDERS
On April 6, 2022, we entered into a securities purchase agreement, or the Purchase Agreement, with the selling stockholders, pursuant to which we issued and sold to the selling stockholders in a private placement, or the Private Placement, an aggregate of 4,580,526 shares of our common stock and Pre-Funded Warrants to purchase up to an aggregate of 24,379,673 shares of our common stock. Under the Purchase Agreement, each share of common stock was sold at a price of $1.90 per share and each Pre-Funded Warrant was sold at a price of $1.899 per warrant share, for aggregate gross proceeds of approximately $55.0 million. The Private Placement closed on April 11, 2022.
Each Pre-Funded Warrant has an exercise price of $0.001 per share, became exercisable immediately upon issuance and will be exercisable until the Pre-Funded Warrant is exercised in full. Under the terms of each Pre-Funded Warrant, a selling stockholder will not be entitled to exercise any portion of any such warrant, and the Company may not effect the exercise of any such warrant, if, upon giving effect to such exercise, the aggregate number of shares of common stock beneficially owned by such selling stockholder (together with its affiliates, any other persons acting as a group together with such selling stockholder or any of such selling stockholder’s affiliates, and any other persons whose beneficial ownership of common stock would or could be aggregated with such selling stockholder’s for purposes of Section 13(d) or Section 16 of the Exchange Act) would exceed 9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of such warrant, which percentage may be increased or decreased at such selling stockholder’s election upon 61 days’ notice to us subject to the terms of such warrants, provided that such percentage may in no event exceed 19.99%. We refer to such percentage limitations as the Beneficial Ownership Limitations.
The shares issuable upon exercise of the Pre-Funded Warrants will become eligible for sale by the selling stockholders under this prospectus only when the Pre-Funded Warrants are exercised. We cannot predict when or whether the selling stockholders will exercise the Pre-Funded Warrants.
On April 6, 2022, in connection with the Private Placement, we entered into a registration rights agreement, or the Registration Rights Agreement, with the selling stockholders, pursuant to which we agreed to register for resale the shares of common stock sold in the Private Placement, as well as the shares of common stock issuable upon exercise of the Pre-Funded Warrants. Under the Registration Rights Agreement, we agreed to file a registration statement covering the resale by the selling stockholders of the shares of common stock and the shares of common stock issuable upon exercise of the Pre-Funded Warrants within 30 days following the date the Registration Rights Agreement was entered into. We have granted the selling stockholders customary indemnification rights in connection with the registration statement, including for liabilities arising under the Securities Act of 1933, as amended, or the Securities Act. The selling stockholders have also granted us customary indemnification rights in connection with the registration statement. The registration statement of which this prospectus forms a part has been filed in accordance with the Registration Rights Agreement.
The foregoing summary descriptions of the Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of such documents, which are filed as exhibits to the registration statement of which this prospectus forms a part and are incorporated by reference herein.
This prospectus covers the sale or other disposition by the selling stockholders of up to the total number of shares of our common stock that were issued to the selling stockholders pursuant to the Purchase Agreement, plus the total number of shares of our common stock issuable upon exercise of the Pre-Funded Warrants issued to the selling stockholders. The information in the table below with respect to the selling stockholders has been obtained from the selling stockholders and sets forth, to our knowledge, information concerning the beneficial ownership of shares of our common stock by the selling stockholders. When we refer to the “selling stockholders” in this prospectus, or, if required, a post-effective amendment to the registration statement of which this prospectus is a part, we mean the selling stockholders, as well as any of their respective pledgees, assignees and successors-in-interest. The selling stockholders may sell all, some or none of the shares of common stock subject to this prospectus. See “Plan of Distribution” below as it may be supplemented and amended from time to time.
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Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to our common stock. Generally, a person “beneficially owns” shares of our common stock if the person has or shares with others the right to vote those shares or to dispose of them, or if the person has the right to acquire voting or disposition rights with respect to such shares within 60 days. In computing the number of shares of our common stock beneficially owned by each selling stockholder and the percentage ownership of each selling stockholder, we excluded any shares for which the Pre-Funded Warrants held by a selling stockholder may not be exercised due to the Beneficial Ownership Limitations of such Pre-Funded Warrants because such shares may not be acquired by such selling stockholders within 60 days of April 25, 2022. The percentage ownership of each selling stockholder is calculated based on 38,685,600 shares of common stock outstanding as of April 25, 2022 plus the shares of common stock for which such selling stockholder’s Pre-Funded Warrants were exercisable as of April 25, 2022, after giving effect to the applicable Beneficial Ownership Limitation. The inclusion of any shares in this table does not constitute an admission of beneficial ownership by the selling stockholders.
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Shares of
Common Stock
to be Beneficially
Owned After
Offering(2) |
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Shares of
Common Stock
Beneficially Owned
Prior to Offering |
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Number of
Shares of
Common Stock
Being Offered(1) |
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Name of Selling Stockholder |
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Number |
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Percentage |
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Number |
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Percentage |
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Entities affiliated with New Enterprise Associates(3) |
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15,074,080 |
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35.56% |
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6,580,526 |
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11,493,554 |
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27.11% |
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Entities affiliated with Frazier Life Sciences(4) |
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4,182,636 |
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9.99% |
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10,531,332 |
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— |
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— |
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Entities affiliated with Venrock Healthcare Capital Partners(5) |
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4,021,704 |
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9.99% |
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8,425,487 |
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2,450,000 |
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6.33% |
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Entities affiliated with Fairmount Funds Management LLC(6) |
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4,125,689 |
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9.99% |
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3,422,854 |
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1,513,100 |
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3.91% |
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The number of shares of our common stock in the column “Number of Shares of Common Stock Being Offered” represents all of the shares of our common stock that the selling stockholders may offer and sell from time to time under this prospectus. |
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We do not know when or in what amounts the selling stockholders may offer shares for sale. The selling stockholders might not sell any or might sell all of the shares offered by this prospectus. Because the selling stockholders may offer all or some of the shares pursuant to this offering, and because there are currently no agreements, arrangements or understandings with respect to the sale of any of the shares, we cannot estimate the number of shares that will be held by the selling stockholders after completion of the offering. However, for purposes of this table, we have assumed that, after completion of the offering, none of the shares covered by this prospectus will be held by the selling stockholders, including common stock issuable upon exercise of the Pre-Funded Warrants issued in the Private Placement. |
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Shares held by New Enterprise Associates 16, L.P, or NEA 16, and NEA 18 Venture Growth Equity, L.P., or NEA 18, which we refer to collectively as the NEA Entities, consist of: (i) 10,421,428 shares of our common stock and warrants to purchase 3,703,704 shares of common stock held by NEA 16, and (ii) 948,948 shares of our common stock and Pre-Funded Warrants to purchase 3,000,000 shares of common stock held by NEA 18. The ability of NEA 18 to exercise its Pre-Funded Warrants is subject to the Beneficial Ownership Limitations, which prevent NEA 18 from exercising any portion of such Pre-Funded Warrants to the extent such exercise would result in the NEA Entities exceeding the applicable Beneficial Ownership Limitation. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” consist of (i) the 11,370,376 shares of common stock held by the NEA Entities and (ii) the 3,703,704 shares of common stock issuable to NEA 16 upon exercise of its warrants. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” do not include the 3,000,000 shares of common stock issuable to NEA 18 upon the exercise of its Pre-Funded Warrants due to the application of the applicable Beneficial Ownership Limitation. The shares reported under “Number of Shares of Common Stock Being Offered” do not give effect to the Beneficial Ownership Limitations and consist of the following: (i) 3,580,526 shares of common stock, and (ii) 3,000,000 shares of common stock issuable upon the exercise of the Pre-Funded Warrants. The shares directly held by NEA 16 are indirectly |
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held by (i) NEA Partners 16, L.P., or NEA Partners 16, the sole general partner of NEA 16, (ii) NEA 16 GP, LLC, or NEA 16 LLC, the sole general partner of NEA Partners 16, and (iii) each of the individual Managers of NEA 16 LLC, which we refer to as the NEA 16 Managers. The NEA 16 Managers are Forest Baskett, Ali Behbahani, Carmen Chang, Anthony A. Florence, Jr., Mohamad Makhzoumi, Peter Sonsini, Paul Walker and Scott D. Sandell. NEA Partners 16, NEA 16 LLC and the NEA 16 Managers share voting and dispositive power with regard to the shares directly held by NEA 16. The shares directly held by NEA 18 are indirectly held by (i) NEA Partners 18 VGE, L.P., or NEA Partners 18, the sole general partner of NEA 18, (ii) NEA 18 VGE GP, LLC, or NEA 18 LLC, the sole general partner of NEA Partners 18, and (iii) each of the individual Managers of NEA 18 LLC. The individual Managers of NEA 18 LLC, collectively, the NEA 18 Managers, are Liza Landsman, Edward T. Mathers, Rick Yang, Mr. Behbahani, Ms. Chang, Mr. Florence, Mr. Makhzoumi, Mr. Sonsini, Mr. Walker and Mr. Sandell. NEA Partners 18, NEA 18 LLC and the NEA 18 Managers share voting and dispositive power with regard to our shares directly held by NEA 18. Mr. Mathers, a member of our Board of Directors, a General Partner of New Enterprise Associates, Inc., an entity affiliated with NEA 16, and an NEA 18 Manager, has no voting or investment control over any of the shares held by NEA 16 or NEA 18 and disclaims beneficial ownership of all shares owned by such entities, except to the extent of any pecuniary interest therein. All indirect holders of the above referenced shares disclaim beneficial ownership of the above referenced shares except to the extent of their pecuniary interests therein. The address of the above referenced entities and persons is 1954 Greenspring Drive, Suite 600, Timonium MD, 21093. |
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Shares held by Frazier Life Sciences Public Fund, L.P., Frazier Life Sciences X, L.P. and Frazier Life Sciences XI, L.P., which we refer to collectively as the Frazier Life Sciences Entities, consist of: (i) 684,000 shares of our common stock and Pre-Funded Warrants to purchase 6,519,431 shares of common stock held by Frazier Life Sciences Public Fund, L.P., (ii) 153,000 shares of our common stock and Pre-Funded Warrants to purchase 1,458,294 shares of common stock held by Frazier Life Sciences X, L.P., and (iii) 163,000 shares of our common stock and Pre-Funded Warrants to purchase 1,553,607 shares of common stock held by Frazier Life Sciences XI, L.P. The ability of the Frazier Life Sciences Entities to exercise their Pre-Funded Warrants is subject to the Beneficial Ownership Limitations, which prevent the Frazier Life Sciences Entities from exercising any portion of the warrants to the extent such exercise would result in the Frazier Life Sciences Entities exceeding the applicable Beneficial Ownership Limitation. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” consist of (i) 1,000,000 shares of our common stock held by the Frazier Life Sciences Entities, and (ii) 3,182,636 shares of common stock issuable to the Frazier Life Sciences Entities upon exercise of the Pre-Funded Warrants. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” do not include the remaining 6,348,696 shares of common stock issuable to the Frazier Life Sciences Entities upon the exercise of the Pre-Funded Warrants due to the application of the applicable Beneficial Ownership Limitation. The shares reported under “Number of Shares of Common Stock Being Offered” do not give effect to the Beneficial Ownership Limitations and consist of the following: (i) 1,000,000 shares of common stock, and (ii) 9,531,332 shares of common stock issuable upon the exercise of the Pre-Funded Warrants. FHMLSP, L.P. is the general partner of Frazier Life Sciences Public Fund, L.P. and FHMLSP, L.L.C. is the general partner of FHMLSP, L.P. Patrick Heron, James Topper, Albert Cha and James Brush are the members of FHMLSP, L.L.C. and therefore share voting and investment power over the shares held by Frazier Life Sciences Public Fund, L.P. FHMLS X, L.P. is the general partner of Frazier Life Sciences X, L.P. and FHMLS X, L.L.C. is the general partner of FHMLS X, L.P. Mr. Heron and Mr. Topper are the members of FHMLS X, L.L.C. and therefore share voting and investment power over the shares held by Frazier Life Sciences X, L.P. FHMLS XI, L.P. is the general partner of Frazier Life Sciences XI, L.P. and FHMLS XI, L.L.C. is the general partner of FHMLS XI, L.P. Mr. Heron, Mr. Topper and Daniel Estes are the members of FHMLS XI, L.L.C. and therefore share voting and investment power over the shares held by Frazier Life Sciences XI, L.P. The address of each of Frazier Life Sciences X, L.P., Frazier Life Sciences XI, L.P., Frazier Life Sciences Public Fund, L.P. and their affiliated entities and persons, is 601 Union Street, Suite 3200, Seattle, Washington 98101. |
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(5) |
Shares held by Venrock Healthcare Capital Partners EG, L.P., Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners II, L.P. and VHCP Co-Investment Holdings II, LLC, which we refer to collectively as the Venrock Entities, consist of: (i) 958,692 shares of our common stock and Pre-Funded Warrants to purchase 3,296,893 shares of common stock held by Venrock Healthcare Capital Partners EG, L.P., (ii) 852,109 shares of our common stock and Pre-Funded Warrants to purchase 2,930,384 shares of common stock held by Venrock Healthcare Capital |
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Partners III, L.P, (iii) 85,259 shares of our common stock and Pre-Funded Warrants to purchase 293,207 shares of common stock held by VHCP Co-Investment Holdings III, LLC, (iv) 394,206 shares of our common stock and Pre-Funded Warrants to purchase 1,355,661 shares of common stock held by Venrock Healthcare Capital Partners II, L.P., and (v) 159,734 shares of our common stock and Pre-Funded Warrants to purchase 549,342 shares of common stock held by VHCP Co-Investment Holdings II, LLC. The ability of the Venrock Entities to exercise their Pre-Funded Warrants is subject to the Beneficial Ownership Limitations, which prevent the Venrock Entities from exercising any portion of the warrants to the extent such exercise would result in the Venrock Entities exceeding the applicable Beneficial Ownership Limitation. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” consist of 2,450,000 shares of our common stock and 1,571,704 shares of common stock issuable to the Venrock Entities upon exercise of the Pre-Funded Warrants. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” do not include the remaining 6,853,783 shares of common stock issuable to the Venrock Entities upon exercise of the Pre-Funded Warrants due to the application of the applicable Beneficial Ownership Limitation. The shares reported under “Number of Shares of Common Stock Being Offered” do not give effect to the Beneficial Ownership Limitations and consist of 8,425,487 shares of common stock issuable upon the exercise of the Pre-Funded Warrants. VHCP Management EG, LLC is the sole general partner of Venrock Healthcare Capital Partners EG, L.P. VHCP Management III, LLC is the sole general partner of Venrock Healthcare Capital Partners III, L.P. and the sole manager of VHCP Co-Investment Holdings III, LLC. VHCP Management II, LLC is the sole general partner of Venrock Healthcare Capital Partners II, L.P. and the sole manager of VHCP Co-Investment Holdings II, LLC. Nimish Shah and Bong Koh are the voting members of VHCP Management II, LLC, VHCP Management III, LLC and VHCP Management EG, LLC. Dr. Koh, Mr. Shah, VHCP Management II, LLC, VHCP Management III, LLC and VHCP Management EG, LLC disclaim beneficial ownership over all shares held by Venrock Healthcare Capital Partners EG, L.P., Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners II, L.P. and VHCP Co-Investment Holdings II, LLC, except to the extent of their respective indirect pecuniary interests therein. The address of the above referenced entities and persons is 7 Bryant Park, 23rd Floor, New York, NY 10018. |
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(6) |
Shares held by Fairmount Healthcare Fund L.P. and Fairmount Healthcare Fund II L.P., which we refer to collectively as the Fairmount Entities, consist of: (i) 54,687 shares of our common stock and Pre-Funded Warrants to purchase 123,907 shares of common stock held by Fairmount Healthcare Fund L.P., and (ii) 1,458,413 shares of our common stock and Pre-Funded Warrants to purchase 3,298,947 shares of common stock held by Fairmount Healthcare Fund II L.P. The ability of the Fairmount Entities to exercise their Pre-Funded Warrants is subject to the Beneficial Ownership Limitations, which prevent the Fairmount Entities from exercising any portion of the warrants to the extent such exercise would result in the Fairmount Entities exceeding the applicable Beneficial Ownership Limitation. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” consist of (i) 1,513,100 shares of our common stock held by the Fairmount Entities, and (ii) 2,612,589 shares of common stock issuable to the Fairmount Entities upon exercise of the Pre-Funded Warrants. The shares reported under “Shares of Common Stock Beneficially Owned Prior to Offering” do not include the remaining 810,265 shares of common stock issuable upon the exercise of the Pre-Funded Warrants by the Fairmount Entities due to the application of the applicable Beneficial Ownership Limitation. The shares reported under “Number of Shares of Common Stock Being Offered” do not give effect to the Beneficial Ownership Limitations and consist of 3,422,854 shares of common stock issuable upon the exercise of the Pre-Funded Warrants. Fairmount Funds Management LLC, of which Peter Harwin and Tomas Kiselak are controlling persons, is the investment adviser of Fairmount Healthcare Fund L.P. and Fairmount Healthcare Fund II L.P. Fairmount Healthcare Fund GP LLC is the general partner of Fairmount Healthcare Fund L.P. and Fairmount Healthcare Fund II GP LLC is the general partner of Fairmount Healthcare Fund II L.P. Fairmount Funds Management LLC, Mr. Harwin, and Mr. Kiselak may be deemed indirect beneficial owners of the shares held by Fairmount Healthcare Fund L.P. and Fairmount Healthcare Fund II L.P. Fairmount Funds Management LLC, Mr. Harwin, and Mr. Kiselak expressly disclaim beneficial ownership over such shares except to the extent of their pecuniary interest therein. The address of the above referenced entities and persons is 2001 Market Street, Suite 2500, Philadelphia, PA 19103. |
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PLAN OF DISTRIBUTION
The selling stockholders of the shares of common stock and their respective pledgees, assignees and successors-in-interest may, from time to time, sell any or all of the shares of common stock covered hereby on the Nasdaq Global Market or any other stock exchange, market or trading facility on which the shares are traded or in private transactions. These sales may be at fixed or negotiated prices. The selling stockholders may use any one or more of the following methods when selling the shares:
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ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
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block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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an exchange distribution in accordance with the rules of the applicable exchange; |
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privately negotiated transactions; |
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distributions to members, partners, stockholders or other equityholders of the selling stockholders; |
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settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part; |
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in transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share; |
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through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
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a combination of any such methods of sale; or |
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any other method permitted pursuant to applicable law. |
The selling stockholders may also sell the shares under Rule 144 or any other exemption from registration under the Securities Act, if available, rather than under this prospectus. A selling stockholder that is an entity may elect to make an in-kind distribution of common stock to its members, partners, stockholders or other equityholders pursuant to the registration statement of which this prospectus forms a part by delivering a prospectus. To the extent that such members, partners, stockholders or other equityholders are not affiliates of ours, such members, partners, stockholders or other equityholders would thereby receive freely tradable shares of common stock pursuant to a distribution pursuant to the registration statement of which this prospectus forms a part.
Broker-dealers engaged by the selling stockholders may arrange for other brokers dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the purchaser of the shares, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission, in compliance with the Financial Industry Regulatory Authority, Inc., or FINRA, Rule 2440; and in the case of a principal transaction, a markup or markdown in compliance with FINRA IM-2440.
In connection with the sale of the shares or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the shares in the course of hedging the positions they assume. The selling stockholders may also sell shares short and deliver these shares to close out its short positions, or loan or pledge the shares to broker-dealers that in turn may sell these shares. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or
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other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The selling stockholders and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. The selling stockholders have informed us that they do not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the shares.
We are required to pay certain fees and expenses incurred by us incident to the registration of the shares. We have agreed to indemnify the selling stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We agreed to keep this prospectus effective until the earlier of (i) the date on which the shares may be resold by the selling stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for us to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect or (ii) the date on which all of the shares have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale shares will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale shares covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.
Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale shares may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the selling stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the shares by the selling stockholders or any other person. We will make copies of this prospectus available to the selling stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).
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LEGAL MATTERS
The validity of the shares of our common stock offered by this prospectus has been passed upon by Wilmer Cutler Pickering Hale and Dorr LLP.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements) which is incorporated by reference in this prospectus and elsewhere in this registration statement. Our financial statements are incorporated by reference in reliance on Ernst & Young LLP’s report, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other documents with the SEC. Our SEC filings are available to the public over the Internet at the SEC’s website at http://www.sec.gov. Copies of certain information filed by us with the SEC are also available on our website at http://www.trevitherapeutics.com. Our website is not a part of this prospectus and is not incorporated by reference in this prospectus.
This prospectus is part of a registration statement we filed with the SEC. This prospectus omits some information contained in the registration statement in accordance with SEC rules and regulations. You should review the information and exhibits in the registration statement for further information about us and our consolidated subsidiary and the securities offered under this prospectus. Statements in this prospectus concerning any document we filed as an exhibit to the registration statement or that we otherwise filed with the SEC are not intended to be comprehensive and are qualified by reference to these filings. You should review the complete document to evaluate these statements.
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference much of the information we file with the SEC, which means that we can disclose important information to you by referring you to those publicly available documents. The information that we incorporate by reference in this prospectus is considered to be part of this prospectus. Any statement contained in a previously filed document incorporated by reference will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus modifies or replaces that statement. This prospectus incorporates by reference the documents listed below (File No. 001-38886) and any future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus and prior to the sale of all the shares covered by this prospectus, other than the portions of those documents not deemed to be filed.
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(1) |
Our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 17, 2022, including the information specifically incorporated by reference into such Annual Report on Form 10-K from our definitive proxy statement for our 2022 Annual Meeting of Stockholders filed with the SEC on April 29, 2022; |
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Our Current Reports on Form 8-K filed with the SEC on January 5, 2022, January 14, 2022, February 1, 2022, February 24, 2022, March 16, 2022 and April 7, 2022; |
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The description of our common stock contained in our Registration Statement on Form 8-A filed on April 29, 2019, including any amendments or reports filed for the purpose of updating such description; and |
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Any other filings we make pursuant to the Exchange Act after the date of filing the registration statement of which this prospectus is a part and prior to effectiveness of the registration statement. |
A statement contained in a document incorporated by reference into this prospectus shall be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus, any prospectus supplement or in any other subsequently filed document which is also incorporated in this prospectus modifies or replaces such statement. Any statements so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
You may request a copy of these filings, at no cost, by writing or calling us at the following address or telephone number:
Trevi Therapeutics, Inc.
195 Church Street, 14th Floor
New Haven, Connecticut, 06510
(203) 304-2499
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28,960,199 Shares of
Common Stock
PROSPECTUS
, 2022
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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the various expenses to be incurred in connection with the sale and distribution of the securities being registered hereby, all of which will be borne by us (except any underwriting discounts and commissions and expenses incurred by the selling stockholders for brokerage, accounting, tax or legal services or any other expenses incurred by the selling stockholders in disposing of the shares). All amounts shown are estimates except the SEC registration fee.
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Amount |
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SEC registration fee |
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7,328.99 |
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Accounting fees and expenses |
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15,000 |
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Legal fees and expenses |
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25,000 |
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Printing agent fees and expenses |
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8,000 |
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Total |
$ |
55,328.99 |
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Item 15. Indemnification of Directors and Officers.
Section 102 of the Delaware General Corporation Law, or the DGCL, permits a corporation to eliminate the personal liability of its directors to the corporation or its stockholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his or her duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our certificate of incorporation provides that no director shall be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability, except to the extent that the DGCL prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty.
Section 145 of the DGCL provides that a corporation has the power to indemnify a director, officer, employee or agent of the corporation and certain other persons serving at the request of the corporation in related capacities against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlements actually and reasonably incurred by the person in connection with an action, suit or proceeding to which he or she is or is threatened to be made a party by reason of such position, if such person acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation, no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnification for such expenses which the Court of Chancery or such other court shall deem proper.
Our certificate of incorporation provides that we will indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of us), by reason of the fact that he or she is or was, or has agreed to become, our director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (all such persons being referred to as an Indemnitee), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with such action, suit or
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proceeding and any appeal therefrom if such Indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, our best interests, and, with respect to any criminal action or proceeding, he or she had no reasonable cause to believe his or her conduct was unlawful.
Our certificate of incorporation also provides that we will indemnify any Indemnitee who was or is a party to an action or suit by or in the right of us to procure a judgment in our favor by reason of the fact that the Indemnitee is or was, or has agreed to become, our director or officer, or is or was serving, or has agreed to serve, at our request as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise, or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred in connection with such action, suit or proceeding, and any appeal therefrom, if the Indemnitee acted in good faith and in a manner he or she reasonably believed to be in, or not opposed to, our best interests, except that no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to us, unless a court determines that, despite such adjudication but in view of all of the circumstances, he or she is entitled to indemnification of such expenses. Notwithstanding the foregoing, to the extent that any Indemnitee has been successful, on the merits or otherwise, he or she will be indemnified by us against all expenses (including attorneys’ fees) actually and reasonably incurred by him or her or on his or her behalf in connection therewith. If we do not assume the defense, expenses must be advanced to an Indemnitee under certain circumstances.
In addition, we have entered into indemnification agreements with all of our directors and executive officers. In general, these agreements provide that we will indemnify the executive officer or director to the fullest extent permitted by law for claims arising in his or her capacity as an executive officer or director of our company or in connection with his or her service at our request for another corporation or entity. The indemnification agreements also provide for procedures that will apply in the event that an executive officer or director makes a claim for indemnification and establish certain presumptions that are favorable to the executive officer or director.
We maintain a general liability insurance policy that covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors or officers.
Insofar as the foregoing provisions permit indemnification of directors, executive officers, or persons controlling us for liability arising under the Securities Act we have been informed that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
Item 16. Exhibits
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Item 17. Undertakings.
The undersigned Registrant hereby undertakes:
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(a)(1) |
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
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To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended (the “Securities Act”); |
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To reflect in the prospectus any facts or events arising after the effective date of this registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this registration statement. Notwithstanding the foregoing, any increase or decrease in the volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and |
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To include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement; |
provided, however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are incorporated by reference in this registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of this registration statement.
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That, for the purposes of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at the time shall be deemed to be the initial bona fide offering thereof. |
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To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
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That, for the purpose of determining liability under the Securities Act to any purchaser: |
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Each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
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(ii) |
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
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(b) |
The Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the Registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
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(c) |
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the indemnification provisions described herein, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. |
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New Haven, State of Connecticut, on this 2nd day of May, 2022.
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By: |
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/s/ Jennifer Good |
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Name: Jennifer Good |
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Title: President and Chief Executive Officer |
SIGNATURES AND POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Jennifer Good, Lisa Delfini and Christopher Galletta, and each of them, as his or her true and lawful attorney-in-fact and agent with full power of substitution, for him or her in any and all capacities, to sign any and all amendments to this registration statement (including post-effective amendments or any abbreviated registration statement and any amendments thereto filed pursuant to Rule 462(b) increasing the number of securities for which registration is sought), and to file the same, with all exhibits thereto and other documents in connection therewith, with the SEC, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully for all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
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/s/ Jennifer Good
Jennifer Good |
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President and Chief Executive Officer and Director (principal executive officer) |
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May 2, 2022 |
|
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|
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/s/ Lisa Delfini
Lisa Delfini |
|
Chief Financial Officer (principal financial officer) |
|
May 2, 2022 |
|
|
|
|
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/s/ Christopher Galletta
Christopher Galletta |
|
Controller (principal accounting officer) |
|
May 2, 2022 |
|
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|
|
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/s/ David Meeker, M.D.
David Meeker, M.D. |
|
Chairman of the Board |
|
May 2, 2022 |
|
|
|
|
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/s/ James Cassella, Ph.D.
James Cassella, Ph.D. |
|
Director |
|
May 2, 2022 |
|
|
|
|
|
/s/ Dominick Colangelo
Dominick Colangelo |
|
Director |
|
May 2, 2022 |
|
|
|
|
|
/s/ Michael Heffernan
Michael Heffernan |
|
Director |
|
May 2, 2022 |
|
|
|
|
|
/s/ Edward Mathers
Edward Mathers |
|
Director |
|
May 2, 2022 |
|
|
|
|
|
/s/ Anne VanLent
Anne VanLent |
|
Director |
|
May 2, 2022 |
Trevi Therapeutics (NASDAQ:TRVI)
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From Mar 2024 to Apr 2024
Trevi Therapeutics (NASDAQ:TRVI)
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From Apr 2023 to Apr 2024
