SAN FRANCISCO and BASKING RIDGE, N.J., Jan. 14, 2015 /PRNewswire/ -- Regado Biosciences, Inc. (RGDO) and Tobira Therapeutics, Inc. today announced that they have entered into a definitive agreement under which privately-held Tobira will merge with a wholly-owned subsidiary of Regado in an all-stock transaction. The merger will create a company focused on the development of novel treatments for liver and inflammatory diseases. Tobira's lead product, immunomodulator and anti-fibrotic agent cenicriviroc (CVC), received Fast Track Designation and is currently in a Phase 2b trial in non-alcoholic steatohepatitis (NASH). Upon closing of the transaction, Regado will be renamed Tobira Therapeutics, Inc., and will be under the leadership of Tobira's chief executive officer, Laurent Fischer, M.D.
A Tobira investor syndicate has committed to invest up to $22 million in the combined company. This financing is expected to fully fund the CVC development program through the completion of the Phase 2b program. The financing is expected to close before or concurrently with the completion of the merger with Leerink Partners and Oppenheimer & Co. expected to act as financial advisors. All of Tobira's preferred stock investors, including Domain Associates, Novo Ventures, Frazier Healthcare, Montreux Equity Partners and Canaan Partners, have committed to participate in the financing. Total cash balance of the combined company following the closing of the merger and the financing is expected to be approximately $60 million.
"Following an extensive and thorough review of strategic alternatives, we believe the proposed merger with Tobira provides the opportunity for substantial returns for Regado shareholders," said Michael A. Metzger, Regado's president and chief executive officer. "We expect Tobira to be the next breakout company in NASH based on the best-in-class profile and potential of their lead drug CVC. The merged company will derive a significant advantage from the extensive clinical, commercial and transactional expertise of the combined board and management teams. We are optimistic that the strength of the leadership team, coupled with the cash Regado will contribute to the merger, will enable CVC to reach significant value inflections in the near term."
Laurent Fischer, M.D., chairman and chief executive officer of Tobira, said, "The merger and concurrent financing will allow the company to fully fund Tobira's ongoing Phase 2b CENTAUR study of CVC in patients with NASH and liver fibrosis. We expect to have top line data from the study in the second quarter of 2016. In addition, the strong closing balance sheet allows us to expand our NASH program with additional studies of CVC in non-alcoholic fatty liver disease and combination settings that will help position CVC as a cornerstone therapy for this troubling complication of the ongoing obesity epidemic."
CVC is a first-in-class immunomodulator and the only compound in development for NASH that targets inflammation and fibrosis. CVC has been evaluated in approximately 580 subjects across clinical programs. CVC is being evaluated in patients with NASH for its potential to reduce liver inflammation and slow down or reverse progression of liver fibrosis or progression to cirrhosis.
The CENTAUR study is a randomized, double-blind Phase 2b study of a single 150 mg tablet of CVC given once daily versus placebo in patients with NASH and liver fibrosis. CENTAUR is an international study with planned treatment centers across North America, Europe, Hong Kong and Australia. The study will enroll approximately 250 patients and will evaluate the non-alcoholic fatty liver disease (NAFLD) activity score (NAS) and resolution of NASH without worsening of liver fibrosis after one and two years of treatment as compared to placebo. These endpoints are aligned with findings and recommendations from an American Association for the Study of Liver Diseases (AASLD) – FDA joint workshop that identified potentially acceptable surrogate endpoints for clinical studies of agents for NASH and liver fibrosis, a disease for which no treatments are approved.
Details of the Proposed Transaction
On a pro forma basis and based upon the number of shares of Regado common stock to be issued in the merger, current Regado shareholders will own approximately 32% of the combined company and current Tobira shareholders will own approximately 68% of the combined company (determined before accounting for the financing transaction discussed above). The actual allocation will be subject to adjustment based on Regado's net cash balance. The transaction has been approved by the board of directors of both companies. The merger is expected to close in the second quarter of 2015, subject to the approval of the stockholders of each company as well as other customary conditions.
MTS Health Partners, L.P., and Cowen and Company, LLC, served as financial advisors, and Cooley LLP served as legal counsel to Regado and Gunderson Dettmer LLP served as legal counsel to Tobira with respect to the transaction.
Management and Organization
Following the merger, the company will be led by Dr. Fischer as chief executive officer. The board of directors of the combined company will be comprised of nine representatives, three of whom will be designated by Regado and the remaining six of whom will be designated by Tobira. Dennis Podlesak, current chairman of Regado's board, will be chairman of the board of the combined company. The corporate headquarters will be located in South San Francisco, California.
Interested participants and investors may access the conference call by dialing (888) 347-1165for domestic callers or (412) 902-4276 for international callers. The conference call will be webcast live under the investor relations section of the Regado website at www.regadobio.comand will be archived there for 60 days following the call.
About Cenicriviroc & NASH
Cenicriviroc (CVC) is an oral, once daily, first-in-class dual CCR2/CCR5 antagonist with implications in fibrosis and HIV-1. Both the CCR2 and CCR5 pathways play a key role in the cycle of inflammation and fibrosis and CVC has been shown in clinical trials to bind to both CCR2 and CCR5 targets. CVC's safety and tolerability profile has been evaluated in approximately 580 subjects who have been dosed in Phase 1 and Phase 2 trials, including 115 HIV-1 infected subjects on treatment for up to 48 weeks. NASH is a disease that affects three to five percent of the U.S. population and can lead to liver cirrhosis and liver cancer. Currently there are no approved treatments for NASH. Tobira believes CVC has the potential to play a differentiated role in the management of this chronic disease and expects the eventual management of NASH will include multi-targeted combination treatment approaches, much the same as HIV-1 is treated today.
About Regado Biosciences
Regado Biosciences, Inc. is a development stage biotechnology company that was engaged in the development of therapies using actively controlled aptamer technology, which is designed to give physicians the ability to control the therapeutic effect in real time. In August, 2014, the Company announced the termination of its Phase 3 REGULATE-PCI study due to safety concerns with its lead drug Revolixys. The Company subsequently announced the planned reorganization of its business and the pursuit of strategic alternatives led by its financial advisors MTS Health Partners and Cowen and Company, LLC. No further development activities are ongoing nor have any been planned for the Regado pipeline. The final results of the REGULATE-PCI study will be presented at one or more upcoming medical meetings in the first half of 2015. More information can be found at www.regadobio.com.
About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV. The company's lead product, cenicriviroc (CVC), is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of non-alcoholic steatohepatitis (NASH) and HIV. Tobira is actively enrolling patients in a Phase 2b clinical trial called CENTAUR to evaluate CVC in patients with NASH and liver fibrosis. Tobira also plans to advance CVC in a fixed-dose combination for HIV type 1 infection through Phase 3 development and commercialization in collaboration with a strategic partner or with non-dilutive financing. Learn more at www.tobiratherapeutics.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this communication regarding the proposed merger and other contemplated transactions (including statements relating to satisfaction of the conditions to and consummation of the proposed merger, the expected ownership of the combined company, the alternatives to the proposed merger, and plans with respect to financing for the combined company) constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for Regado and Tobira and of the combined company include, but are not limited to: inability to complete the proposed merger and other contemplated transactions in connection with the merger; liquidity and trading market for shares prior to and following the consummation of the proposed merger and proposed financing; costs and potential litigation associated with the proposed merger; failure or delay in obtaining required approvals by the SEC or any other governmental or quasi-governmental entity necessary to consummate the proposed merger, including our ability to file an effective proxy statement in connection with the proposed merger and other contemplated transactions in connection with the merger, which may also result in unexpected additional transaction expenses and operating cash expenditures on the parties; an inability or delay in obtaining required regulatory approvals for product candidates, which may result in unexpected cost expenditures; the price of the proposed financing transaction in connection with the proposed merger and contemplated transactions in connection with the merger being materially lower than the trading price of Regado's common stock at the time of such financing; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; failure to realize any value of certain product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for the combined company's products may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; loss of or diminished demand from one or more key customers or distributors; unexpected cost increases and pricing pressures; continuing or deepening economic recession and its negative impact on customers, vendors or suppliers; failure to obtain the necessary stockholder approvals or to satisfy other conditions to the closing of the proposed merger and the other contemplated transactions; a superior proposal being submitted to either party; uncertainties of cash flows and inability to meet working capital needs; cost reductions that may not result in anticipated level of cost savings or cost reductions prior to or after the consummation of the proposed merger; and risks associated with the possible failure to realize certain benefits of the proposed merger, including future financial, tax, accounting treatment, and operating results. Many of these factors that will determine actual results are beyond Regado's, Tobira's, or the combined company's ability to control or predict.
Other risks and uncertainties are more fully described in periodic filings with the Securities and Exchange Commission (the "SEC"), including the factors described in the section entitled "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 filed with the SEC, and in other filings that Regado makes and will make with the SEC in connection with the proposed transactions, including the proxy statement described below under "Important Information and Where to Find It." Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. Unless otherwise required by applicable securities laws, we do not intend, nor do we undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.
Important Information and Where to Find It
Regado and Tobira and certain of their directors and executive officers may become participants in solicitation of proxies from Regado stockholders in connection with the proposed transactions. Additional Information regarding persons who may, under the rules of the SEC, be deemed to be participants in the solicitation of the Regado stockholders in connection with the proposed merger, and who have interests, whether as security holders, directors or employees of Regado or Tobira or otherwise, which may be different from those of Regado stockholders generally, will be provided in the proxy statement and other materials to be filed with the SEC.
Each of Regado's board of directors, Dennis Podlesak, Jeff Clark, Drew Fromkin, Anton Gopka, Pierre Legault, Michael Mendelsohn, P. Sherrill Neff, Jesse Treu and Michael Metzger; Regado's executive officers, Michael Metzger (President and Chief Executive Officer) and Don Elsey (Senior Vice President, Finance and Chief Financial and Compliance Officer); Tobira's board of directors, Eckard Weber, Laurent Fischer, Carol Brosgart, Patrick Heron, Craig Gibbs, Jeffrey Cooper, Dr. Graeme Moyle and Gwen Melincoff; and Tobira's executive officers, Laurent Fischer (Chief Executive Officer), Christopher Peetz (Chief Financial Officer and Secretary), Eric Lefebvre (Chief Medical Officer), Helen Jenkins (Chief Operating Officer), and Martine Kraus (Vice President, Regulatory Affairs); may be deemed "participants" in the solicitation of proxies from the Regado stockholders in connection with the proposed transactions.
Information regarding the special interests of these directors and executive officers in the merger will be included in the proxy statement referred to above. Additional information regarding Regado's directors' and executive officers' respective interests in Regado by security holdings or otherwise is set forth in Regado's proxy statement relating to the 2015 annual meeting of stockholders filed with the SEC on May 5, 2014.
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. A definitive proxy statement and a proxy card will be filed with the SEC and will be mailed to Regado's stockholders seeking any required stockholder approvals in connection with the proposed transactions. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT REGADO MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by Regado with the SEC in connection with the proposed transactions at the SEC's website (http://www.sec.gov), at Regado's website or by writing to the Secretary, Regado, Inc. at 106 Allen Road, Basking Ridge, NJ 07920.
Chief Financial Officer
Chief Financial Officer
Regado Biosciences, Inc.