SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15 (d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): 6/1/2021
SESEN BIO, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction|
245 First Street, Suite 1800
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (617) 444-8550
(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))|
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock, par value $0.001||SESN||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 June 1, 2021, Sesen Bio, Inc. (the “Company”) entered into Amendment No. 3 (the “Third Amendment”) to the Open Market Sale AgreementSM, dated November 29, 2019, as amended by Amendment No. 1 to the Open Market Sale AgreementSM, dated October 30, 2020, and Amendment No. 2 to the Open Market Sale AgreementSM, dated February 17, 2021 (the “Sale Agreement”) with Jefferies LLC, as sales agent (“Jefferies”). The Third Amendment reflects that the Company may issue and sell additional shares of the Company’s common stock, par value $0.001 per share (“Common Stock”), from time to time through Jefferies under the Sale Agreement.
This description of the Third Amendment does not purport to be complete and is qualified in its entirety by reference to the Third Amendment, which is attached hereto as Exhibit 1.1 and incorporated by reference herein.
The Common Stock to be sold under the Sale Agreement, if any, will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-255943) filed with the Securities and Exchange Commission (“SEC”) on May 10, 2021 and declared effective by the SEC on May 14, 2021. On June 1, 2021, the Company filed a prospectus supplement (the “Prospectus Supplement”) with the SEC in connection with the offer and sale of up to $100 million of Common Stock pursuant to the Sale Agreement. The Company may sell this amount efficiently from time to time over the coming months. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock nor shall there be any sale of the Common Stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
The legal opinion of Hogan Lovells US LLP relating to the legality of the issuance and sale of the Common Stock is attached as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 8.01 – Other Information.
On June 1, 2021, the Company issued a press release announcing the appointment of Patricia M. Drake as Chief Commercial Officer as well as the appointments of several other key senior leaders. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, the Company’s intentions or ability to sell shares of Common Stock efficiently pursuant to the Sale Agreement. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. A further description of the risks and uncertainties relating to the business of the Company is contained in the Company’s most recent annual report on Form 10-K and the Company’s quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. The Company undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in its expectations.
Item 9.01 - Financial Statements and Exhibits.
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.
Date: June 1, 2021
|Sesen Bio, Inc.|
|By:||/s/ Thomas R. Cannell, D.V.M.|
|Thomas R. Cannell, D.V.M.|
|President and Chief Executive Officer|
AMENDMENT NO. 3 TO THE OPEN MARKET SALE AGREEMENTSM June 1, 2021 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: This Amendment No. 3 to the Open Market Sale AgreementSM (this “Amendment”) is entered into as of the date first written above by Sesen Bio, Inc., a Delaware corporation (the “Company”), and Jefferies LLC (“Agent”), that are parties to that certain Open Market Sale AgreementSM, dated November 29, 2019, (the “Original Agreement”), as amended by Amendment No. 1, dated October 30, 2020 and Amendment No. 2, dated February 17, 2021. All capitalized terms not defined herein shall have the meanings ascribed to them in the Original Agreement. The parties, intending to be legally bound, hereby amend the Original Agreement as follows: 1. The preamble to the Original Agreement, as previously amended, is hereby deleted in its entirety and replaced with the following: Sesen Bio, Inc., a Delaware corporation (the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time through Jefferies LLC, as sales agent and/or principal (the “Agent”), shares of the Company’s common stock, par value $0.001 per share (the “Common Shares”), under one or more registration statements on Form S-3 filed with the Commission, on the terms set forth in this agreement (this “Agreement”). 2. The Company represents and warrants to, and agrees with the Agent that: (a) this Amendment has been duly authorized, executed and delivered by, and is a valid and binding agreement of, the Company, enforceable in accordance with its terms, except as rights to indemnification hereunder may be limited by applicable law and except as the enforcement hereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting the rights and remedies of creditors or by general equitable principles; (b) that on the date hereof, the Company will file a prospectus supplement with respect to the Shares and that the filing of such a prospectus supplement constitutes a Triggering Event Date on which the Company is required to provide a certificate pursuant to Section 4(o) of the Original Agreement; (c) that the filing of any prospectus supplement pursuant to this Agreement subsequent to the prospectus supplement dated the date hereof shall constitute a Triggering Event Date on which the Company is required to provide a certificate pursuant to Section 4(o) of the Original Agreement; and (d) notwithstanding the last sentence of Section 3(d) of the Original Agreement, that the fees and disbursements of Agent’s counsel that shall be reimbursed by the Company pursuant to subsections 3(d)(vi) and 3(d)(vii) of the Original Agreement in connection with each Triggering Event Date resulting from the filing of the prospectus supplement dated the date hereof and any subsequent prospectus supplement shall not exceed $50,000 for each such Triggering Event Date.
2 3. This Amendment together with the Original Agreement, as previously amended, (including all schedules and exhibits attached thereto and Placement Notices issued pursuant hereto and thereto) constitutes the entire agreement and supersedes all other prior and contemporaneous agreements and undertakings, both written and oral, among the parties hereto with regard to the subject matter hereof. Neither this Amendment nor any term hereof may be amended except pursuant to a written instrument executed by the Company and the Agent. In the event that any one or more of the provisions contained herein, or the application thereof in any circumstance, is held invalid, illegal or unenforceable as written by a court of competent jurisdiction, then such provision shall be given full force and effect to the fullest possible extent that it is valid, legal and enforceable, and the remainder of the terms and provisions herein shall be construed as if such invalid, illegal or unenforceable term or provision was not contained herein, but only to the extent that giving effect to such provision and the remainder of the terms and provisions hereof shall be in accordance with the intent of the parties as reflected in this Amendment. All references in the Original Agreement to the “Agreement” shall mean the Original Agreement as amended by this Amendment; provided, however, that all references to “date of this Agreement” in the Original Agreement shall continue to refer to the date of the Original Agreement. 4. This Amendment shall be governed by and construed in accordance with the internal laws of the State of New York applicable to agreements made and to be performed in such state. Any legal suit, action or proceeding arising out of or based upon this Amendment or the transactions contemplated hereby (“Related Proceedings”) may be instituted in the federal courts of the United States of America located in the Borough of Manhattan in the City of New York or the courts of the State of New York in each case located in the Borough of Manhattan in the City of New York (collectively, the “Specified Courts”), and each party irrevocably submits to the exclusive jurisdiction (except for proceedings instituted in regard to the enforcement of a judgment of any such court (a “Related Judgment”), as to which such jurisdiction is non-exclusive) of such courts in any such suit, action or proceeding. Service of any process, summons, notice or document by mail to such party’s address set forth above shall be effective service of process for any suit, action or other proceeding brought in any such court. The parties irrevocably and unconditionally waive any objection to the laying of venue of any suit, action or other proceeding in the Specified Courts and irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such suit, action or other proceeding brought in any such court has been brought in an inconvenient forum. The provisions of this paragraph shall survive any termination of this Amendment. 5. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Delivery of an executed amendment by one party to the other may be made by facsimile transmission or electronic transmission (e.g., PDF). [Remainder of Page Intentionally Blank]
[Signature Page to Amendment No. 3 to the Sales Agreement] If the foregoing correctly sets forth the understanding between the Company and the Agent, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding amendment to the Original Agreement between the Company and the Agent. Very truly yours, JEFFERIES LLC By: /s/ Donald Lynaugh Name: Donald Lynaugh Title: Managing Director ACCEPTED as of the date first-above written: SESEN BIO, INC. By: /s/ Thomas R. Cannell, D.V.M. Name: Thomas R. Cannell, D.V.M. Title: President and Chief Executive Officer
Exhibit 5. 1 Hogan Lovells US LLP is a limited liability partnership registered in the District of Columbia. “Hogan Lovells” is an international legal practice that includes Hogan Lovells US LLP and Hogan Lovells International LLP, with offices in: Alicante Amsterdam Baltimore Beijing Birmingham Boston Brussels Colorado Springs Denver Dubai Dusseldorf Frankfurt Hamburg Hanoi Ho Chi Minh City Hong Kong Houston Johannesburg London Los Angeles Luxembourg Madrid Mexico City Miami Milan Minneapolis Monterrey Moscow Munich New York Northern Virginia Paris Perth Philadelphia Rome San Francisco São Paulo Shanghai Silicon Valley Singapore Sydney Tokyo Warsaw Washington, D.C. Associated Offices: Budapest Jakarta Riyadh Shanghai FTZ Ulaanbaatar Zagreb. Business Service Centers: Johannesburg Louisville. Legal Services Center: Berlin. For more information see www.hoganlovells.com Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 T +1 267 675 4600 F +1 267 675 4601 www.hoganlovells.com June 1, 2021 Board of Directors Sesen Bio, Inc. 245 First Street, Suite 1800 Cambridge, MA 02142 Ladies and Gentlemen: We are acting as counsel to Sesen Bio, Inc., a Delaware corporation (the “Company”), in connection with the issuance and sale of up to $100,000,000 of shares of common stock, par value $0.001 per share, of the Company (the “Shares”), from time to time and at various prices in an “at the market offering” pursuant to the terms of the Open Market Sale AgreementSM, dated November 29, 2019, as amended by Amendment No. 1 to the Open Market Sale AgreementSM, dated October 30, 2020, Amendment No. 2 to the Open Market Sale AgreementSM, dated February 17, 2021 and Amendment No. 3 to the Open Market Sale AgreementSM, dated June 1, 2021 (the “Agreement”), between the Company and Jefferies LLC, as placement agent (the “Agent”). The offering of the Shares by the Company is being made pursuant to its registration statement on Form S-3, as amended (File No. 333-255943) (the “Registration Statement”), filed with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the “Act”), the accompanying prospectus dated May 14, 2021 (the “Base Prospectus”) that forms a part thereof and the Prospectus Supplement dated June 1, 2021 (the “Prospectus Supplement” and together with the Base Prospectus, the “Prospectus”). This opinion letter is furnished to you at your request to enable you to fulfill the requirements of Item 601(b)(5) of Regulation S-K, 17 C.F.R. § 229.601(b)(5), in connection with the Registration Statement. For purposes of this opinion letter, we have examined copies of such agreements, instruments and documents as we have deemed an appropriate basis on which to render the opinions hereinafter expressed. In our examination of the aforesaid documents, we have assumed the genuineness of all signatures, the legal capacity of all natural persons, the accuracy and completeness of all documents submitted to us, the authenticity of all original documents, and the conformity to authentic original documents of all documents submitted to us as copies (including pdfs). As to all matters of fact, we have relied on the representations and statements of fact made in the documents so reviewed, and we have not independently established the facts so relied on. This opinion letter is given, and all statements herein are made, in the context of the foregoing. This opinion letter is based as to matters of law solely on the Delaware General Corporation Law, as amended. We express no opinion herein as to any other statutes, rules or regulations. Based upon, subject to and limited by the foregoing, we are of the opinion that following (i) execution and delivery by the Company of the Agreement, (ii) issuance of the Shares pursuant to the terms of
Sesen Bio, Inc. - 2 - June 1, 2021 the Agreement, and (iii) receipt by the Company of the consideration for the Shares specified in the resolutions of the Board of Directors and the Pricing Committee of the Board of Directors, the Shares will be validly issued, fully paid, and nonassessable. This opinion letter has been prepared for use in connection with the filing by the Company of a Current Report on Form 8-K on the date hereof relating to the offer and sale of the Shares, which Form 8-K will be incorporated by reference into the Registration Statement and Prospectus, and speaks as of the date hereof. We assume no obligation to advise you of any changes in the foregoing subsequent to the delivery of this letter. We hereby consent to the filing of this opinion letter as Exhibit 5.1 to the Company’s Current Report on Form 8-K filed on the date hereof and to the reference to this firm under the caption “Legal Matters” in the Prospectus constituting a part of the Registration Statement. In giving this consent, we do not thereby admit that we are an “expert” within the meaning of the Act. Very truly yours, /s/ HOGAN LOVELLS US LLP HOGAN LOVELLS US LLP
Sesen Bio Strengthens Senior Leadership Team Company hires four experienced leaders across commercial, medical and human resources functions as it works towards launch readiness Company remains on track for potential approval of Vicineum™ in the US in August 2021 CAMBRIDGE, Mass., June 1, 2021 – Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the expansion of its senior leadership team with the appointment of experienced industry leaders to several key roles: • Patricia Drake to Chief Commercial Officer • Steve Barbera to Vice President, Market Access • Julie Hoff to Vice President, Human Resources • Dewey McLin to Vice President, Medical Affairs “I am thrilled to have Patricia, Steve, Julie and Dewey join us to help accelerate our capabilities across these key functions,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “As we prepare for a potential world-class launch of Vicineum, I strongly believe that these leaders will not only bring diverse and invaluable expertise to our team but will also drive the Company to continue executing our mission to save and improve the lives of patients with cancer.” Patricia Drake is a seasoned biopharma executive with over 30 years of experience. Prior to joining Sesen Bio, Ms. Drake spent her career at Merck & Co., Inc in various leadership roles. During her tenure, Ms. Drake progressed through numerous commercial roles of increasing responsibility in marketing, sales, strategy and operations, most recently as Managing Director and CEO of Merck, Sharp & Dohme (MSD) Finland. Prior to this, Ms. Drake led the Global Human Health Strategy realization and orchestrated sales force deployments as Vice President of Sales in Canada. She enjoyed commercial success in Latin America managing Merck’s Diversified Brands, including Bacillus Calmette–Guérin (BCG) in 2011 and 2012. Ms. Drake is well-known as an inspiring and inclusive leader who is dedicated to the development of her teams and solely focused on organizational success for the benefit of patients. Ms. Drake received her bachelor’s degree from Wichita State University and is a graduate of the Harvard Business School Executive Leadership Program. Steve Barbera is an accomplished cross-functional leader in the healthcare industry, with over 20 years of experience in the development and implementation of complex market access strategies including health policy, pricing and reimbursement, contracts and coding. Prior to joining Sesen Bio, Mr. Barbera served as the Vice President of Market Access at UroGen Pharma and played a critical role in the launch of the company’s first commercial product, Jelmyto®. Prior to UroGen, Mr. Barbera held various leadership roles at Dendreon Pharmaceuticals, Allergan, and Medimmune, among others. Mr. Barbera holds a Bachelor of Science in nursing from Villanova University, and proudly served in the United States Marine Corps.
Julie Hoff is a seasoned leader, with 20 years of experience in various Human Resources positions across many industries. Prior to joining Sesen Bio, Ms. Hoff served as Director of Human Resources at Core & Main where she led various initiatives across talent management, M&A, and employee engagement and retention. Prior to her role at Core & Main, Ms. Hoff spent 15 years at Express Scripts most recently serving as Vice President, Human Resources Business Partner, where she leveraged a hands-on approach to lead teams through periods of rapid growth while implementing new programs and establishing scalable infrastructure. Over the course of her career, she has established, developed, and led several key areas of human resource functions including communications and strategy, talent engagement and management, compliance, and mergers and acquisitions. Ms. Hoff holds a Bachelor of Arts in sociology from Southern Illinois University and a Master of Business Administration from the University of Missouri, Saint Louis. Dewey McLin brings 15 years of Medical Affairs experience in establishing new organizations during corporate transitions from the research and development stage to commercialization. Prior to joining Sesen Bio, Dr. McLin was Sr. Director of Medical Affairs and a Product Development Team lead at Greenwich Biosciences, where he played an important role in the complex, successful commercialization of the first cannabis-based product approved by the FDA to treat rare forms of epilepsy. During his career, Dr. McLin has supported the launch of six products at start-up and mid-size pharmaceutical companies, where he has identified innovative, data-driven opportunities to engage patients, prescribers, and payers. Dr. McLin received his bachelor’s degree from Indiana University and his Doctorate in Biological Sciences from the University of California, Irvine. The Company intends to grant non-statutory stock options to Ms. Drake, Mr. Barbera, Ms. Hoff and Dr. McLin and four additional new employees between June 1, 2021 and June 14, 2021 pursuant to which an aggregate of up to 1,995,000 shares of Sesen Bio common stock will be purchasable upon vesting. Each stock option will vest over a four-year period, with one quarter of the underlying shares vesting on the first anniversary of the date of grant, and an additional 6.25% of the underlying shares vesting at the end of each successive three-month period following the one-year anniversary of the date of grant, subject in each case to the employee’s continued service with Sesen Bio and have a ten-year term. These non-statutory stock options will have exercise prices equal to the closing price per share of Sesen Bio’s common stock on The Nasdaq Global Market on the date of grant. The stock options will be granted outside of the Company’s 2014 Stock Incentive Plan and will be granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4). About Vicineum™ Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal
bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti- tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab. About Sesen Bio Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer. The Company’s lead program, Vicineum™, also known as oportuzumab monatox, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG- unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Sesen Bio retains worldwide rights to Vicineum with the exception of Greater China and the Middle East and North Africa (MENA), for which the Company has partnered with Qilu Pharmaceutical and Hikma Pharmaceuticals, respectively, for commercialization. Vicineum is a locally administered targeted fusion protein composed of an anti-EpCAM antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A for the treatment of BCG-unresponsive NMIBC. For more information, please visit the Company’s website at www.sesenbio.com. COVID-19 Pandemic Potential Impact Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on the Company. The Company has not yet experienced any disruptions to our operations as a result of COVID-19, however, we are not able to quantify or predict with certainty the overall scope of potential impacts to our business, including, but not limited to, our ability to raise capital and, if approved, commercialize Vicineum. Sesen Bio remains committed to the health and safety of patients, caregivers and employees. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward- looking statements as a result of various important factors, including: the timing for the FDA’s decision on the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC based on the FDA granting the BLA Priority Review and the target PDUFA date of August 18, 2021, the impact of COVID-19 on the Company, including its ability to raise capital, and, if approved, its ability to commercialize Vicineum for the treatment of BCG-unresponsive NMIBC, and other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the
Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. Contact: Erin Clark, Vice President, Corporate Strategy & Investor Relations email@example.com