1, 2022
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Delaware | ||||
| | | 75-3175693 (I. R. S. Employer Identification No.) | |
1 Parrott Drive
Shelton, Connecticut 06484
(203) 567-1500
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Derek Chalmers, Ph.D., D.Sc.
Chief Executive Officer
Cara Therapeutics, Inc.
1 Parrott Drive
Shelton, Connecticut 06484
(203) 567-1500
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Babak Yaghmaie
Darren DeStefano
Cooley LLP
1114 Avenue of the Americas
New York, NY 10036-7798 (212) 479-6000
From time to time after the effective date of this Registration Statement
(Approximate date of commencement of proposed sale to the public)
| 4 Stamford Plaza 107 Elm Street, 9th Floor Stamford, Connecticut 06902 (203) 406-3700 | |
| Christopher Posner Chief Executive Officer Cara Therapeutics, Inc. 4 Stamford Plaza 107 Elm Street, Ninth Floor Stamford, Connecticut 06902 (203) 406-3700 | |
| Copies to: Darren DeStefano Nicolas H.R. Dumont Cooley LLP 11951 Freedom Drive, 14th Floor Reston, VA 20190-5640 (703) 456-8000 | |
| From time to time after the effective date of this Registration Statement (Approximate date of commencement of proposed sale to the public) | |
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Large accelerated filer ☒ | | Accelerated filer ☐ | ||||
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Non-accelerated filer ☐ | | Smaller reporting company ☐ | | |||
| | | Emerging Growth Company ☐ | |
CALCULATION OF REGISTRATION FEE
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Title of each class of securities to be registered | Amount to be Registered | Proposed Maximum Offering Price per Unit | Proposed Maximum Aggregate Offering Price | Amount of Registration Fee (1) | ||||
Common Stock, par value $0.001 per share | (2) | (3) | (3) | — | ||||
Preferred Stock, par value $0.001 per share | (2) | (3) | (3) | — | ||||
Debt Securities | (2) | (3) | (3) | — | ||||
Warrants | (2) | (3) | (3) | — | ||||
Total | (2) | $150,000,000 | $17,430 | |||||
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1, 2022
300,000,000
2022.
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Our most advanced product candidate, intravenous, or I.V., CR845, has demonstrated significant pain reliefCKD in adults undergoing hemodialysis in the United States. We expect commercial launch of KORSUVA injection in April 2022 and a favorable safety and tolerability profile in three Phase 2 clinical trials in patients with acute postoperative pain. We have scheduled an End of Phase 2 meeting with the FDA to be heldassociated revenues in the second quarter of 20152022.
We are also developing an oral version of CR845, or Oral CR845, for acute and chronic pain. We have successfully completed a Phase 1 trial of a capsule formulationregistrational programs of Oral CR845 that established oral bioavailability parameters. In the second quarter of 2014, we initiated a Phase 1 trial of a tablet formulation of Oral CR845, for which we announced positive top-line data in the fourth quarter of 2014.
CR845 has exhibited anti-pruritic (anti-itch) potency in standard preclinical models. In the second quarter of 2014, we filed an Investigational New Drug Application (“IND”) and in the third quarter of 2014 we initiated a proof-of-concept Phase 2 trial for I.V. CR845KORSUVA (difelikefalin) for the treatment of uremic pruritus, one in NDD-CKD and the other in AD.
2022. We believe this program could provide insight on Oral KORSUVA’s (difelikefalin) potential in other chronic neurologic pruritus conditions. In addition, we have an ongoing Phase 2 study of Oral KORSUVA (difelikefalin) for the treatment of PBC for which we currently anticipate a readout in the second half of 2022. This program could provide insight into whether Oral KORSUVA (difelikefalin) has utility in other CLDs.
Since our inception and through December 31, 2014, we have received net proceeds of $56.3 million fromKORSUVA injection was approved in the sale of 5.75 million shares of our common stockU.S. in our initial public offering, after deducting underwriting discounts and commissions and offering expenses, net proceeds of $65.9 million from the sale of various series of convertible preferred stock, $3.6 million from the issuance of convertible promissory notes and $3.8 million from the issuance of long-term debt.
In addition to our financing activities, we have received aggregate payments of $30.1 million pursuant to license agreements related to CR845 and an earlier product candidate for which development efforts ceased in 2007. Included in those aforementioned payments pursuant to license agreements,August 2021, with commercial launch expected in April 2013, we received $15.0 million as an upfront payment, and in August 2014, we received an additional $0.5 million related to achievement of a milestone in connection with the license of rights to CR845 in Japan to Maruishi Pharmaceutical Co., Ltd., or Maruishi. In 2012, we received aggregate upfront and milestone payments of $1.2 million pursuant to a license agreement with Chong Kun Dang Pharmaceutical Corporation, or CKD, in connection with the license of rights to CR845 in South Korea.
2022.
Cara commenced operations in 2004, and our primary activities to date have been organizing and staffing our company, developing our product candidates, including conducting preclinical studies and clinical trials of CR845-based product candidates and raising capital. Additional information
solely as an inactive textual reference.
406-3700.
certificateAmended and Restated Certificate of incorporation,Incorporation, or the Restated Certificate, our board of directors has the authority, without further action by the stockholders (unless such stockholder action is required by applicable law or the rules of any stock exchange or market on which our securities are then traded), to designate up to 5,000,000 shares of preferred stock in one or more series and to determine the designations, voting powers, preferences and rights of each series of the preferred stock, as well as the qualifications, limitations or restrictions thereof, including dividend rights, conversion rights, preemptive rights, terms of redemption or repurchase, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of any series, any or all of which may be greater than the rights of the common stock. Any convertible preferred stock we may issue will be convertible into our common stock or exchangeable for our other securities. Conversion may be mandatory or at the holder’s option and would be at prescribed conversion rates.
The following table sets forth our ratio of earnings (loss) to fixed charges for each of the periods indicated. As we qualify as an emerging growth company under the JOBS Act, such ratio as ordinarily required under Item 503 of SEC Regulation S-K for the year ended December 31, 2010 has been omitted. We do not have any preferred stock outstanding as of the date of this prospectus and did not have any preferred stock with required dividend payments during any of the periods presented below. Therefore there are no preferred dividends included in our calculation of these ratios. The following table is qualified by the more detailed information appearing in the computation table set forth in Exhibit 12.1 to the registration statement of which this prospectus is part and our historical financial statements, including the notes to those financial statements, incorporated by reference in this prospectus.
Year Ended December 31, | ||||||||||||||||
2014 | 2013 | 2012 | 2011 | |||||||||||||
( in thousands) | ||||||||||||||||
Pre-tax loss | $ | (17,946 | ) | $ | (3,993 | ) | $ | (6,302 | ) | $ | (9,841 | ) | ||||
Ratio of earnings to fixed charges (1) | N/A | N/A | N/A | N/A | ||||||||||||
Coverage deficiency | $ | 17,946 | $ | 3,993 | $ | 6,302 | $ | 9,841 |
CONTENTS
We and
Demand Registration Rights
The holders of at least 20% of the registrable securities, as defined under the investor rights agreement, have the rightissued pursuant to make up to two demands that we file a registration statement to register all or a portion of their shares so long as the aggregate offering price of securities requested to be sold under such registration statement is at least $10,000,000, net of underwriting discounts and commissions and subject to specified exceptions.
Piggyback Registration Rights
If we register any securities for public sale, holders of registrable securities, as defined under the investor rights agreement, are entitled to written notice of the registration and will have the right to include their shares in the registration statement. The underwriters of any offering will have the right to limit the number of shares having registration rights to be included in the registration statement provided such registration does not include shares of any other selling stockholders, in which case any and all shares held by selling stockholders may be excluded from the offering.
Registration on Form S-3
If we are eligible to file a registration statement on Form S-3, the holders of at least 10% of the registrable securities, as defined under the investor rights agreement, have the right to demand up to twice per year that we file registration statements on Form S-3 so long as the aggregate offering price of the securities to be sold under the registration statement on Form S-3 is at least $5,000,000, net of underwriting discounts and commissions, and subject to specified exceptions.
Expenses of Registration; Indemnification
Generally, we are required to bear all registration expenses incurred in connection with the demand, Form S-3 and piggyback registrations described above, other than underwriting discounts and commissions. The investor rights agreement contains customary indemnification provisions with respect to registration rights.
Termination of Registration Rights
The demand, Form S-3 and piggyback registration rights discussed above will terminate if all of the holder’s registrable securities may be sold without restriction under Rule 144 of the Securities Act.
purchase agreement.
may be removed only for cause unless the corporation’s certificate of incorporation provides otherwise. Our Restated Certificate does not provide otherwise.provides that any director may be removed with cause by the affirmative vote of the holders of at least 66
exercise any of the powers given it by the indenture at the request of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses and liabilities that it might incur.
additional terms.
Unless we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together with specified information, and paying the required amount to the warrant agent in immediately available funds, as provided in the applicable prospectus supplement. We will set forth on the reverse side of the warrant certificate and in the applicable prospectus supplement the information that the holder of the warrant will be required to deliver to the warrant agent in connection with the exercise of the warrant.
may act as warrant agent for more than one issue of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate legal action its right to exercise, and receive the securities purchasable upon exercise of, its warrants.
In compliance with guidelines of
Unless otherwise indicatedunderwriters, dealers or agents, by counsel that we will name in the applicable prospectus supplement, certain legal matterssupplement.
Ernst & Young LLP, independent registered public accounting firm, has audited our financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2014, as set forth in their report, which isreports therein and incorporated herein by reference in this prospectus and elsewhere in the registration statement. Ourreference. Such financial statements are incorporated by referenceherein in reliance onupon the reports of Ernst & Young LLP’s report,LLP pertaining to such financial statements and the effectiveness of our internal control over financial reporting as of the respective date (to the extent covered by consents filed with the Securities and Exchange Commission) given on theirthe authority of such firm as experts in accounting and auditing.
406-3700.
SECURITIES ACT LIABILITY
InsofarCONTENTS
$150,000,000
a criminal offense.
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| Assumed public offering price per share | | | | | | | | | | $ | 10.46 | | |
| Net tangible book value per share as of December 31, 2021 | | | | $ | 4.25 | | | | | | | | |
| Increase in net tangible book value per share attributable to this offering | | | | $ | 0.74 | | | | | | | | |
| As adjusted net tangible book value per share as of December 31, 2021, after giving effect to this offering | | | | | | | | | | $ | 4.99 | | |
| Dilution per share to investors purchasing our common stock in this offering | | | | | | | | | | $ | 5.47 | | |
Preferred Stock
Debt Securities
Warrants
2022
SEC registration fee | $ | 17,430 | ||
FINRA filing fee (if applicable) | 22,500 | |||
Accounting fees and expenses | 50,000 | |||
Legal fees and expenses | 100,000 | |||
Transfer agent fees and expenses | 5,000 | |||
Trustee fees and expenses | 15,000 | |||
Printing and miscellaneous expenses | 40,070 | |||
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Total | $ | 250,000 | ||
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| SEC registration fee | | | | $ | 27,810 | | |
| Accounting fees and expenses | | | | | * | | |
| Legal fees and expenses | | | | | * | | |
| Transfer agent fees and expenses | | | | | * | | |
| Trustee fees and expenses | | | | | * | | |
| Printing and miscellaneous expenses | | | | | * | | |
| Total | | | | $ | * | | |
II-1
such person may be made a party by reason of the fact that such person is or was a director or officer of us or any of our affiliates, provided such person acted in good faith and in a manner such person reasonably believed to be in, or not opposed to, our best interests. The indemnification agreements also
Exhibit Number | | ||||
| Description of Document | | |||
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1.1(1) | | | Form of Underwriting Agreement | | |
| 1.2 | | | Open Market Sale AgreementSM, dated March 1, 2022, between the Registrant and Jefferies LLC | |
| 3.1(2) | | | | |
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3.2(3) | | | | ||
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4.1(4) | | | | ||
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4.2 | | | | ||
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4.3(1) | | | Form of Note | | |
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4.4 | | | | ||
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4.5 | | | | ||
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4.6 | | | | ||
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4.7(1) | | | Form of Specimen Preferred Stock Certificate and Certificate of Designations of Preferred Stock | | |
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4.8(5) | | | |||
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5.1 | | | | ||
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23.1 | | | | ||
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23.2 | | | | ||
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24.1 | | | | ||
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25.1(1) | | | Statement of Eligibility of Trustee under the Debt Indenture | | |
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(i)
(ii)
II-3
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(6)
(7) That for purposes of determining any liability under the Securities Act, (i) the information omitted from the form of prospectus filed as part of the registration statement in reliance upon Rule 430A and contained in the form of prospectus filed by the registrant pursuant to Rule 424(b)(l) or (4) or 497(h) under the Securities Act shall be deemed to be a part of the registration statement as of the time it was declared effective; and (ii) each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offing of such securities at that time shall be deemed to be the initialbona fide offering thereof.
(8) To file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed by the Commission under Section 305(b)(2) of the Trust Indenture Act.
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| CARA THERAPEUTICS, INC. | ||||||
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| | | | By: | | | /s/ |
CHRISTOPHER POSNER Christopher Posner Chief Executive Officer | |
| Signature | | | Title | | | Date | |
| /s/
Christopher Posner | | | President, Chief Executive Officer and | | | March | |
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/s/
Thomas Reilly | | | Chief Financial Officer(Principal Financial and Accounting Officer) | | | March | | |
| /s/ MARTIN VOGELBAUM Martin Vogelbaum | | | Director | | | March 1, 2022 | |
| /s/ HARRISON M. BAINS, JR. Harrison M. Bains,
| | | Director | | | March | |
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/s/ JEFFREY IVES Jeffrey
| | | Director | | | March | | |
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/s/
Susan Shiff | | | Director | | | March | ||
1, 2022 | ||||||||
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INDEX TO EXHIBITS
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