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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 8, 2022

Seelos Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

 

Nevada   000-22245   87-0449967
(State or Other Jurisdiction of Incorporation)   (Commission File Number)   (I.R.S. Employer Identification No.)

 

300 Park Avenue, 2nd Floor, New York, NY   10022
(Address of principal executive offices)   (Zip Code)

Registrant's telephone number, including area code: (646) 293-2100

Not Applicable
(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

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

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company      ☐     

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.      ☐     

Item 1.01. Entry into a Material Definitive Agreement.

 

On April 8, 2022, Seelos Corporation (“STI”), a wholly-owned subsidiary of Seelos Therapeutics, Inc. (the “Company”), and Phoenixus AG f/k/a Vyera Pharmaceuticals AG (“Vyera”), entered into an amendment (the “Amendment”) to the Asset Purchase Agreement by and between STI and Vyera, dated March 6, 2018 (as amended by a first amendment thereto entered into on May 18, 2018, a second amendment thereto entered into on December 31, 2018, a third amendment thereto entered into on October 15, 2019 and a fourth amendment thereto entered into on February 15, 2021, the “Purchase Agreement”). Pursuant to the Purchase Agreement, STI acquired the assets and liabilities of Vyera related to a product candidate currently referred to as SLS-002 (intranasal ketamine) (the “Vyera Assets”) and agreed, among other things, to make certain development and commercialization milestone payments and royalty payments related to the Vyera Assets (the “Milestone and Royalty Payment Obligations”) and further agreed that in the event that the Company sold, directly or indirectly, all or substantially all of the Vyera Assets to a third party, then the Company would pay Vyera an amount equal to 4% of the net proceeds actually received by the Company as an upfront payment in such sale (the “Change of Control Payment Obligation”).

 

Pursuant to the Purchase Agreement, as amended by the Amendment, STI agreed to (i) make a cash payment to Vyera in the aggregate amount of $4,000,000 on or before April 8, 2022; (ii) issue to Vyera on or before April 11, 2022 500,000 shares of the Company’s common stock, par value $0.001 per share (“Common Stock”) (as adjusted for stock splits, stock dividends, combinations, recapitalizations and the like) (the “Initial Shares”); (iii) issue to Vyera on or before July 11, 2022 an additional 500,000 shares of Common Stock (as adjusted for stock splits, stock dividends, combinations, recapitalizations and the like) (the “July 2022 Shares”); and (iv) issue to Vyera on or before January 11, 2023 an additional number of shares of Common Stock equal to $1,000,000 divided by the volume weighted average closing price of the Common Stock for the ten consecutive trading days ending on the fifth trading day prior to the applicable date of issuance of the shares of Common Stock (the “January 2023 Shares”, and together with the Cash Payment, the Initial Shares and the July 2022 Shares, “Final Payments”). In consideration for the Final Payments, all of STI’s contingent payment obligations under the Purchase Agreement, including the Milestone and Royalty Payment Obligations and the Change of Control Payment Obligation, as well as all commercialization covenants of STI under the Purchase Agreement, will terminate in full upon the date that all of the Final Payments have been made.

 

The foregoing summary of the Amendment does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Amendment, a copy of which is filed as Exhibit 10.1 hereto and is incorporated herein by reference.

 

Item 3.02. Unregistered Sales of Equity Securities.

 

The Initial Shares were issued to Vyera on April 11, 2022. The Initial Shares were offered and issued to Vyera, and the July 2022 Shares and the January 2023 Shares were offered and will be issued to Vyera, in a transaction exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on Section 4(a)(2) thereof and Rule 506(b) of Regulation D thereunder. Accordingly, the Initial Shares, the July 2022 Shares and the January 2023 Shares have not been registered under the Securities Act and these shares may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.

 

Neither this Current Report on Form 8-K nor the exhibits attached hereto is an offer to sell or the solicitation of an offer to purchase shares of Common Stock or any other securities of the Company.

 

Item 8.01.    Other Events.

 

On April 11, 2022, the Company issued a press release regarding the entry into the Amendment. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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Item 9.01.    Financial Statements and Exhibits.

(d) Exhibits.

NumberDescription

10.1

Amendment No. 5 to Asset Purchase Agreement, dated April 8, 2022, by and between Seelos Corporation and Phoenixus AG.

 99.1Press Release, dated April 11, 2022.
 104Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  Seelos Therapeutics, Inc.
   
 Date: April 11, 2022 By: /s/ Raj Mehra, Ph.D.  
    Name: Raj Mehra, Ph.D.  
    Title: Chief Executive Officer and President

 

 

 

 

 

 
Exhibit 10.1

 

 

Amendment No. 5 to Asset Purchase Agreement

This Amendment No. 5 (this “Amendment”) to the Asset Purchase Agreement, dated as of March 6, 2018, by and between Phoenixus AG f/k/a Vyera Pharmaceuticals AG and Turing Pharmaceuticals AG, a stock corporation organized under the laws of Switzerland (“Seller”), and Seelos Corporation f/k/a Seelos Therapeutics, Inc., a Delaware corporation (“Buyer”), as amended by that certain Amendment to Asset Purchase Agreement, dated as of May 18, 2018, by and between Buyer and Seller, that certain Amendment No. 2 to Asset Purchase Agreement, dated as of December 31, 2018, by and between Buyer and Seller, that certain Amendment No. 3 to Asset Purchase Agreement, dated as of October 15, 2019, by and between Buyer and Seller, and that certain Amendment No. 4 to Asset Purchase Agreement, dated as of February 15, 2021, by and between Buyer and Seller (as amended, the “Purchase Agreement”), is made as of April 8, 2022, by and between Buyer and Seller. Capitalized terms used but not otherwise defined herein shall have the meanings attributed to such terms in the Purchase Agreement.

RECITALS

WHEREAS, Section 10.10 of the Purchase Agreement provides that any amendment, modification or waiver of the Purchase Agreement shall only be valid if made in writing and signed by each of the Parties; and

WHEREAS, the Parties desire to enter into this Amendment and amend the Purchase Agreement as set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and with reference to the above recitals, the parties hereby agree as follows:

ARTICLE 1
AMENDMENTS

1.1              AMENDMENT TO SECTION 3. Section 3 of the Purchase Agreement shall be amended by adding the following as a new Section 3.4 to the Purchase Agreement:

“3.4 Final Payments. Buyer shall (i) make a cash payment to Seller in the aggregate amount of $4,000,000 on or before April 8, 2022, (ii) issue to Seller 500,000 shares of Parent Stock (as adjusted for stock splits, stock dividends, combinations, recapitalizations and the like) on or before April 11, 2022, (iii) issue to Seller an additional 500,000 shares of Parent Stock (as adjusted for stock splits, stock dividends, combinations, recapitalizations and the like) on or before July 11, 2022, and (iv) issue to Seller an additional number of shares of Parent Stock equal to $1,000,000 divided by the Value (rounded down to the nearest whole share) on or before January 11, 2023 (collectively, the “Final Payments”). For purposes of this Section 3.4, “Value” means the volume weighted average closing price of the Parent Stock, as reported on Principal Trading Market, for the ten (10) consecutive Trading Days ending on the fifth (5th) Trading Day prior to the applicable date of issuance of the shares of Parent Stock by Parent. Seller acknowledges and agrees that, effective upon the payment by Buyer to Seller of all of the Final Payments, (A) Buyer shall have no further payment obligations to the Seller or covenants with respect to the commercialization of the Product, and, (B) for avoidance of doubt, each of Section 3.2, Section 8.2, Section 8.4 and Section 8.5 shall terminate and be of no further force or

 

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effect. Notwithstanding anything to the contrary contained in this Agreement, the aggregate number of shares of Parent Stock issuable to Seller pursuant to this Section 3.4 shall not exceed the lesser of: (I) 21,107,595 shares (as adjusted for stock splits, stock dividends, combinations, recapitalizations and the like after April 8, 2022), or (II) the maximum number of shares of Parent Stock that Parent may issue without having to obtain approval of its stockholders pursuant to the rules of The Nasdaq Stock Market LLC; provided that if Buyer is unable to issue any shares of Parent Stock to Seller as a result of the limitation in this sentence then, in lieu of issuing any such shares of Parent Stock, Buyer shall pay to Seller on the applicable date an amount in cash equal to the Value of all shares of Parent Stock that cannot be issued as of the applicable date as a result of the foregoing limitation.”

1.2              AMENDMENT TO SECTION 3.2. Effective upon the payment by Buyer to Seller of all of the Final Payments (as defined in Section 1.1 above) (the “Satisfaction Time”), Section 3.2 of the Purchase Agreement shall be deleted and replaced to read in its entirety as follows:

“Reserved.”

1.3              AMENDMENT TO SECTION 8.2. Effective as of the Satisfaction Time, Section 8.2 of the Purchase Agreement shall be deleted and replaced to read in its entirety as follows:

“8.2 Reserved.”

1.4              AMENDMENT TO SECTION 8.4. Effective as of the Satisfaction Time, Section 8.4 of the Purchase Agreement shall be deleted and replaced to read in its entirety as follows:

“8.4 Reserved.”

1.5              AMENDMENT TO SECTION 8.5. Effective as of the Satisfaction Time, Section 8.5 of the Purchase Agreement shall be deleted and replaced to read in its entirety as follows:

“8.5 Reserved.”

ARTICLE 2
GENERAL PROVISIONS

2.1              Full Force and Effect. Except as expressly set forth herein, the Purchase Agreement remains unchanged and in full force and effect. This Amendment shall be deemed an amendment to the Purchase Agreement and shall become effective when executed and delivered by the parties hereto. Upon the effectiveness of this Amendment, all references in the Purchase Agreement to “the Agreement” or “this Agreement,” as applicable, shall refer to the Purchase Agreement, as modified by this Amendment.

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2.2              Counterparts. This Amendment may be executed in counterparts, each of which shall be deemed an original and all of which shall constitute a single document. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

2.3              Governing Law; Forum. This Amendment and the relationship of the Parties shall be governed by and construed and interpreted in accordance with the laws of the State of New York irrespective of the choice of laws principles of the State of New York. Any disputes relating to the transactions contemplated by this Amendment shall be heard in the State and Federal courts located in the County of New York in the State of New York.

2.4              Amendment. Any amendment, modification or waiver of this Amendment shall only be valid if made in writing and signed by each of the Parties.

[SIGNATURE PAGE FOLLOWS]

 

 

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IN WITNESS WHEREOF, the Parties, intending to be bound hereby, have executed this Amendment as of the date first written above.

SELLER:

PHOENIXUS ag


By: /s/ Lukas Däscher
Name: Lukas Däscher
Title: Country Head of Switzerland


BUYER:

seelos CORPORATION


By: /s/ Raj Mehra, Ph.D.
Name: Raj Mehra, Ph.D.
Title: Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Seelos Therapeutics Announces Amendment of SLS-002 Agreement to Repurchase the Remaining Royalties Payable to Phoenixus AG for SLS-002 (Intranasal Racemic Ketamine Program), All Future Success and Commercial Based Milestones and the Change of Control Fee

 

NEW YORK, April 11, 2022 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today an amendment of the agreement with Phoenixus AG, formerly known as Vyera Pharmaceuticals AG (“Vyera”), for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash and stock the remaining royalties payable on any future net sales of SLS-002, all future success and commercial based milestones and the change of control fee in the event SLS-002 is acquired.

On March 6, 2018, Seelos entered into an asset purchase agreement (the “Purchase Agreement”) with Vyera, currently known as Phoenixus AG, to acquire the assets and liabilities of Vyera’s intranasal racemic ketamine program, which Seelos now calls SLS-002. As additional consideration to certain upfront cash and equity payments and success-based milestone payments contemplated under the prior agreement, Seelos agreed to pay a mid-teens percentage royalty on any future net sales of SLS-002. In February 2021, Seelos amended the asset purchase agreement, for three additional cash payments, agreeing to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002. Seelos completed those payments in February, June, and September of 2021. Under the amendment entered into on April 8, 2022, for additional cash and stock payments due by April 2022, July 2022 and January 2023, the parties have agreed to terminate in full all contingent payment obligations to Vyera and its related entities under the Purchase Agreement, effective upon the payment and issuance of all cash and stock payments.

“We believe this repurchase of the remaining financial obligations owed or that may become payable on SLS-002 has the potential to return meaningful future value to Seelos’ stockholders, assuming we are successful in the clinical development, regulatory approval processes, and commercialization of the intranasal ketamine program,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos.

“This amendment removes all future royalties due to Vyera, nearly $100 million of potential future milestones and a change of control fee in the event this program were to be acquired as a standalone transaction or as part of a larger transaction,” said Michael Golembiewski, CFO of Seelos.

 

 
 

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment

of Acute Suicidal Ideation and Behavior in Major Depressive Disorder or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 looks to address an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I) and is being followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for depression and suicidality.

 

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), spinocerebellar ataxia (SCA), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.

 

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the ability of the royalty repurchase to return meaningful future value to Seelos stockholders, and Seelos' ability to succeed in the clinical development, regulatory approval processes and commercialization of its intranasal ketamine program (SLS-002). These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated

 
 

 

with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

 

Contact Information
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer

Managing Director

LifeSci Advisors, LLC

250 West 55th St., Suite 3401

New York, NY 10019

(617) 308-4306

mmoyer@lifesciadvisors.com