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TUBEMOGUL: Tender And Support Agreement
The following excerpt is from the company's SEC filing.
TENDER AND SUPPORT AGREEMENT, dated as of November 10, 2016 (this ?
Agreement
?), among Adobe Systems Incorporated, a Delaware corporation (?
Parent
?), Tiger Acquisition Corporation, a Delaware corporation (?
Merger Subsidiary
?), and the Person listed as ?Stockholder? on the signature page hereto (?
WHEREAS, as a condition and inducement to Parent?s and Merger Subsidiary?s willingness to enter into an Agreement and Plan of Merger, dated as of the date hereof (the ?
Merger Agreement
?), with TubeMogul, Inc., a Delaware corporation (the ?
Compan y
?), Parent has requested Stockholder, and Stockholder has agreed, to enter into this Agreement with respect to all shares of common stock, par value $0.001 per share, of the Company that Stockholder Beneficially Owns (as defined in Section 5.10 below) at any time during the Support Period (as defined in Section 5.10 below).
NOW, THEREFORE, the parties hereto agree as follows:
ARTICLE 1
Section 1.01
. Tender of Shares
. Subject to the terms of this Agreement, unless the Merger Agreement has been validly terminated in accordance with its terms, Stockholder agrees: (i) to promptly (and, in any event, not later than ten (10) Business Days after commencement of the Offer) validly tender or cause to be validly tendered into the Offer, pursuant to and in accordance with the terms of the Offer and Rule 14d-2 under the Exchange Act, all of the outstanding shares of Company Common Stock Beneficially Owned by Stockholder that Stockholder is permitted to tender under applicable Law pursuant to and in accordance with the terms of the Offer (free and clear of any Liens or restrictions except for any applicable restrictions on transfer under the Securities Act and the rules and regulations promulgated thereunder or as created by this Agreement that would not in any event prevent Stockholder from tendering Stockholder?s shares of Company Common Stock in accordance with this Agreement or otherwise complying with Stockholder?s obligations under this Agreement); and (ii) if Stockholder acquires Beneficial Ownership of any additional outstanding shares of Company Common Stock during the Support Period, to promptly (and, in any event, not later than two (2) Business Days after Stockholder acquires Beneficial Ownership of such additional outstanding shares of Company Common Stock) validly tender or cause to be validly tendered into the Offer, pursuant to and in accordance with the terms of the Offer, all of such additional shares of Company Common Stock (free and clear of any Liens or restrictions except for any applicable restrictions on transfer under the Securities Act and the rules and regulations promulgated thereunder or as created by this Agreement that would not in any event prevent Stockholder from tendering Stockholder?s shares of Company Common Stock in accordance with this Agreement or otherwise complying with Stockholder?s obligations under this Agreement). Notwithstanding anything in this Agreement to the contrary, nothing herein shall require Stockholder to exercise any Company Stock Option or other equity award or require Stockholder to purchase any shares of Company Common Stock, and nothing herein shall prohibit Stockholder from exercising any Company Stock Option held by such Stockholder as of the date of this Agreement.
Section 1.02
. No Withdrawal
. Stockholder agrees not to withdraw, and not to cause or permit to be withdrawn, any shares of Company Common Stock from the Offer unless and until (A) the Offer expires without Merger Subsidiary having accepted for payment shares of Company Common Stock tendered in the Offer or (B) termination of this Agreement in accordance with Section 5.03 hereof.
Section 1.03
. Conditional Obligation
. Stockholder acknowledges and agrees that Merger Subsidiary?s obligation to accept for payment shares of Company Common Stock tendered into the Offer, including any shares of Company Common Stock tendered by Stockholder, is subject to the terms and conditions of the Merger Agreement and the Offer
Section 1.04.
Return of Subject Securities
If (a) the Offer is terminated or withdrawn by Merger Sub or (b) the Merger Agreement is terminated prior to the purchase of the Company Common Stock tendered by the Stockholder in the Offer, Parent and Merger Sub shall promptly return, and shall cause any depository acting on behalf of Parent and Merger Sub to return, all Company Common Stock tendered by Stockholder in the Offer to Stockholder.
ARTICLE 2
Section 2.01
. Voting Agreement
. Stockholder hereby agrees that, during the Support Period, Stockholder will not vote any outstanding shares of Company Common Stock Beneficially Owned by Stockholder in favor of, or consent to, and will vote against and not consent to, the approval of any (i) Takeover Proposal, (ii) reorganization, recapitalization, dissolution, liquidation or winding-up of the Company or any other extraordinary transaction involving the Company other than the Merger, (iii) corporate action the consummation of which would frustrate the purposes, or prevent or delay the consummation, of any of the transactions contemplated by the Merger Agreement or (iv) other matter relating to, or in connection with, any of the foregoing matters. Stockholder shall ensure that, during the Support Period, any other Person having voting power with respect to any outstanding shares of Company Common Stock Beneficially Owned by Stockholder will not vote any such shares in favor of or consent to, and will vote against, the approval of the matters described in clauses (i) through (iv) of the preceding sentence.
Section 2.02
. Irrevocable Proxy
. Stockholder hereby revokes any and all previous proxies granted with respect to the outstanding shares of Company Common Stock Beneficially Owned by Stockholder. By entering into this Agreement, Stockholder hereby grants a proxy appointing Parent as Stockholder?s attorney-in-fact and proxy, with full power of substitution, for and in Stockholder?s name, to vote, express consent or dissent, or otherwise to utilize such voting power in the manner contemplated by Section 2.01 above as Parent or its proxy or substitute shall, in Parent?s sole discretion, deem proper with respect to the outstanding shares of Company Common Stock Beneficially Owned by Stockholder. The proxy granted by Stockholder pursuant to this Article 2 is irrevocable and is granted in consideration of Parent and Merger Subsidiary entering into this Agreement and the Merger Agreement and incurring certain related fees and expenses. The proxy granted by Stockholder shall not be exercised to vote, consent or act on any matter
except as contemplated by Section 2.01 above. The proxy granted by Stockholder shall be revoked after the Support Period upon termination of this Agreement in accordance with its terms.
ARTICLE 3
EPRESENTATIONS
ARRANTIES
TOCKHOLDER
Stockholder represents and warrants to Parent that:
Section 3.01.
Authorization
. The execution, delivery and performance by Stockholder of this Agreement and the consummation by Stockholder of the transactions contemplated hereby are within the powers (corporate and otherwise) of Stockholder and, if applicable, have been duly authorized by all necessary corporate, company, partnership or other action. This Agreement constitutes a valid and binding agreement of Stockholder, enforceable against Stockholder in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, moratorium or similar law affecting creditors? rights generally and to rules of law governing specific performance, injunctive relief and other equitable remedies. If Stockholder is married and (i) the shares of Company Common Stock or Company Stock Awards set forth on
Exhibit A
hereto opposite such Stockholder?s name constitute community property under applicable Law or (ii) any shares of Company Common Stock or Company Stock Awards of which Stockholder acquires Beneficially Ownership during the Support Period could constitute community property under applicable Law, then this Agreement has been duly authorized, executed and delivered by, and constitutes the valid and binding agreement of, such Stockholder?s spouse, enforceable against such Stockholder?s spouse in accordance with its terms, subject to the effect of any applicable bankruptcy, insolvency, moratorium or similar law affecting creditors? rights generally and to rules of law governing specific performance, injunctive relief and other equitable remedies. If this Agreement is being executed in representative or fiduciary capacity, the Person signing this Agreement has full power and authority to enter into and perform this Agreement.
Section 3.02.
Non-Contravention
. The execution, delivery and performance by Stockholder of this Agreement and the consummation of the transactions contemplated hereby do not and will not (i) violate the certificate of incorporation or bylaws, operating agreement or other comparable charter or organizational documents, of Stockholder, if any, (ii) violate any applicable Law, (iii) conflict with or violate or require any consent, approval, notice or other action by any Person under, constitute a default (with or without notice of lapse of time or both) under, or give rise to any right of termination, cancellation or acceleration or to a loss of any benefit to which Stockholder is entitled under any provision of any Contract binding on Stockholder or any of Stockholder?s properties or assets, including the shares of Company Common Stock Beneficially Owned by Stockholder or (iv) result in the imposition of any Lien on any asset of Stockholder.
Section 3.03.
Ownership of Shares
. Stockholder (together with Stockholder?s spouse if Stockholder is married and the shares of Company Common Stock or Company Stock Awards set forth on
hereto opposite such Stockholder?s name constitute community property under Applicable Law) is the Beneficial Owner of the shares of Company Common Stock and Company Stock Awards set forth on
hereto opposite such Stockholder?s name, free and clear of any lien, encumbrance and any other limitation or restriction (including any restriction on the right to vote or otherwise dispose of the shares of Company Common Stock Beneficially Owned by Stockholder). None of such shares of Company Common Stock or such Company Stock Awards
is subject to any voting trust or other Contract with respect to the voting of such shares of Company Common Stock or Company Stock Awards (including shares underlying such Company Stock Awards), except as set forth in this Agreement.
Section 3.04
. Total Shares
. Except for the shares of Company Common Stock set forth on
hereto (including shares underlying Company Stock Awards set forth on
hereto), Stockholder does not Beneficially Own any (i) shares of capital stock or voting securities of the Company or (ii) options, warrants or other rights to acquire, or securities convertible into or exchangeable for (in each case, whether currently, upon lapse of time, following the satisfaction of any conditions, upon the occurrence of any event or any combination of the foregoing), any capital stock, voting securities or securities convertible into or exchangeable for capital stock or voting securities of the Company.
ARTICLE 4
OVENANTS
Stockholder hereby covenants and agrees that:
Section 4.01.
No Proxies for, Encumbrances on or Disposition of Shares
(i) During the Support Period, except pursuant to the terms of this Agreement, Stockholder shall not, without the prior written consent of Parent, directly or indirectly (except, if Stockholder is an individual, as a result of the death of Stockholder), (a) grant any proxies, or enter into any voting trust or other Contract, with respect to the voting of any shares of Company Common Stock Beneficially Owned by Stockholder, (b) sell, assign, transfer, tender, encumber or otherwise dispose of, or enter into any Contract with respect to the direct or indirect sale, assignment, transfer, tender, encumbrance or other disposition of, any such shares or (c) take any other action that would make any representation or warranty of Stockholder contained herein untrue or incorrect in any material respect or in any way restrict, limit or interfere in any material respect with the performance of Stockholder?s obligations hereunder or the transactions contemplated hereby or by the Merger Agreement, or seek to do or solicit any of the foregoing actions, or cause or permit any other Person to take any of the foregoing actions, and agrees to notify Parent and Merger Subsidiary promptly, and to provide all details reasonably requested by Parent or Merger Subsidiary, if Stockholder shall be approached or solicited, directly or indirectly, by any Person with respect to any of the foregoing. Without limiting the generality of the foregoing, during the Support Period, Stockholder shall not tender, agree to tender or cause or permit to be tendered any shares of Company Common Stock Beneficially Owned by Stockholder into or otherwise in connection with any tender or exchange offer, except pursuant to the Offer.
(ii) Notwithstanding the foregoing clause (i), Stockholder may transfer shares of Company Common Stock held by Stockholder to any member of Stockholder?s immediate family or to a trust for the benefit of Stockholder or any member of Stockholder?s immediate family; provided that a transfer referred to in this sentence shall be permitted only if, as a precondition to such transfer, the transferee agrees in a writing, reasonably satisfactory in form and substance to Parent, to be bound by all of the terms of this Agreement.
Section 4.02
. Other Offers
. Neither Stockholder (in Stockholder?s capacity as such), nor any of Stockholder?s Subsidiaries, if any, shall, nor shall Stockholder or any of Stockholder?s Subsidiaries, if any, authorize or permit any of its or their respective Representatives to, and Stockholder shall instruct, and cause each applicable Subsidiary of Stockholder to instruct, each such Representative not to, directly or indirectly, take any of the following actions: (i) solicit, initiate, or knowingly encourage the submission of, any Takeover Proposal or any inquiry, proposal, offer or indication of interest that would reasonably be expected to lead to a Takeover Proposal; (ii) participate or engage in any discussions or negotiations with, disclose any non-public information relating to the Company or any of its Subsidiaries to, afford access to the business, properties, assets, books or records of the Company or any of its Subsidiaries to or otherwise cooperate in any way with, or knowingly assist, participate in, facilitate or encourage any effort by, any third party that is seeking to make, or has made, any Takeover Proposal; or (iii) resolve, propose or agree to do any of the foregoing. Without limiting the foregoing, it is understood that any violation of the foregoing restrictions by any Subsidiary of Stockholder or Representatives of Stockholder or any of its Subsidiaries shall be deemed to be a breach of this Section 4.02 by Stockholder. Stockholder shall, and shall cause its Subsidiaries and its and their respective Representatives to cease immediately and cause to be terminated, and shall not authorize or knowingly permit any of its or their respective Representatives to continue, any and all existing activities, discussions or negotiations, if any, with any third party conducted prior to the date hereof with respect to any Takeover Proposal or Takeover Inquiry. Stockholder shall notify Parent promptly (but in no event later than one Business Day) after it obtains knowledge of the receipt by Stockholder, any of its Subsidiaries or any of its or their respective Representatives of any Takeover Proposal or Takeover Inquiry, or any request for non-public information relating to the Company or any of the Company Subsidiaries or for access to the business, properties, assets, books or records of the Company or any of the Company Subsidiaries by any third party with respect to any Takeover Proposal or Takeover Inquiry. In such notice, Stockholder shall identify the third party making, and the terms and conditions of, any such Takeover Proposal, Takeover Inquiry or request. Stockholder shall keep Parent informed, as promptly as practicable, of the status and terms of any such Takeover Proposal, Takeover Inquiry or request, including the material resolved and unresolved issues related thereto and material amendments or proposed amendments as to price and other material terms thereof.
Section 4.03
. Communications.
Stockholder hereby (i) consents to and authorizes the publication and disclosure by Parent, Merger Subsidiary and the Company (including in the Schedule TO, the Schedule 14D-9 or any other publicly filed documents relating to the Merger, the Offer or any other transaction contemplated by the Merger Agreement) of: (a) Stockholder?s identity; (b) Stockholder?s Beneficial Ownership of shares of Company Common Stock or Company Stock Awards (including the number of such shares or Company Stock Awards Beneficially Owned by Stockholder); and (c) the nature of Stockholder?s commitments, arrangements and understandings under this Agreement, and any other information that Parent, Merger Subsidiary or the Company determines to be necessary in any SEC disclosure document in connection with the Offer, the Merger or any of the other Transactions and (ii) agrees as promptly as practicable to notify Parent, Merger Subsidiary and the Company of any required corrections with respect to any written information supplied by Stockholder specifically for use in any such disclosure document.
Section 4.04
. Additional Shares
. In the event that Stockholder acquires Beneficial Ownership of, or the power to dispose of or vote or direct the disposition or voting of, any additional shares or other interests in or with respect to the Company, such shares or other interests shall, without further action of the parties, be subject to the provisions of this Agreement, and the number of shares of Company Common Stock Beneficially Owned by Stockholder set forth on
hereto will be deemed amended accordingly. Stockholder shall promptly notify Parent, Merger Subsidiary and the Company of any such event.
Section 4.05.
Waiver of Appraisal and Dissenters? Rights and Actions
. Stockholder hereby (i) waives and agrees not to exercise any rights (including under Section 262 of the General Corporation Law of the State of Delaware) to demand appraisal of any shares of Company Common Stock Beneficially Owned by Stockholder or rights to dissent from the Merger which may arise with respect to the Merger and (ii) agrees not to commence or participate in, and to take all actions necessary to opt out of any class in any class action with respect to, any claim, derivative or other Legal Proceeding, against Parent, Merger Subsidiary, the Company or any of their respective successors relating to the negotiation, execution or delivery of this Agreement or the Merger Agreement or the making or consummation of the Offer or consummation of the Merger, including any Legal Proceeding (x) challenging the validity of, or seeking to enjoin the operation of, any provision of this Agreement or (y) alleging a breach of any fiduciary duty of the Board of Directors of the Company in connection with the Merger Agreement or the Transactions.
ARTICLE 5
ISCELLANEOUS
Section 5.01
. Other Definitional and Interpretative Provisions.
Unless specified otherwise, in this Agreement the obligations of any party hereto consisting of more than one Person are joint and several. The words ?hereof,? ?herein? and ?hereunder? and words of like import used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. The captions herein are included for convenience of reference only and shall be ignored in the construction or interpretation hereof. References to Articles and Sections are to Articles and Sections of this Agreement unless otherwise specified. Any singular term in this Agreement shall be deemed to include the plural, and any plural term the singular. Whenever the words ?include?, ?includes? or ?including? are used in this Agreement, they shall be deemed to be followed by the words ?without limitation?, whether or not they are in fact followed by those words or words of like import. The word ?or? has the inclusive meaning represented by the phrase ?and/or.? ?Writing,? ?written? and comparable terms refer to printing, typing and other means of reproducing words (including electronic media) in a visible form. References to any Contract (including the Merger Agreement) are to that Contract as amended, modified or supplemented from time to time in accordance with the terms hereof and thereof. References to any Person include the successors and permitted assigns of that Person. References from or through any date mean, unless otherwise specified, from and including or through and including, respectively.
Section 5.02
. Further Assurances
. Parent and Stockholder (in its capacity as such) will each execute and deliver, or cause to be executed and delivered, all further documents and instruments as the other may reasonably request and use reasonable best efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary and all things the other party may reasonably deem proper or advisable under applicable Law, to consummate and make effective the transactions contemplated by this Agreement. Without limiting the generality of the foregoing, Stockholder shall, to the extent requested by Parent, promptly: (i) cause each other Person having voting power with respect to any shares of Company Common Stock Beneficially Owned by Stockholder to execute and deliver to Parent a proxy with respect to such shares, which shall be identical to the proxy in Section 2.02 above; and (ii) cause the certificates representing outstanding shares of Company Common Stock Beneficially Owned by Stockholder to be surrendered so that the transfer agent for such shares may affix thereto an appropriate legend referring to this Agreement.
. Amendments; Termination
. Any provision of this Agreement may be amended if, but only if, such amendment is in writing and is signed by each party to this Agreement. This Agreement, and the obligations of Stockholder hereunder, shall terminate upon the termination of the Support Period;
however
, that no termination of this Agreement shall relieve any party hereto from any liability for any breach of any provision of this Agreement prior to such termination.
Section 5.04
. Expenses
. All costs and expenses incurred in connection with this Agreement shall be paid by the party incurring such cost or expense.
Section 5.05.
Successors and Assigns; Third-Party Beneficiary
. The provisions of this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns; provided, however, that Stockholder may not assign, delegate or otherwise transfer any of Stockholder?s rights or obligations under this Agreement without the prior written consent of Parent. Any assignment, delegation or transfer in violation of the foregoing shall be null and void. The Company is an express third-party beneficiary of this Agreement and, subject to the foregoing, shall have the express right to enforce this Agreement without the consent or any other action of Parent.
Section 5.06
. Governing Law
. This Agreement shall be governed by and construed in accordance with and governed by the laws of the State of Delaware, without regard to the conflicts of law rules of such State that would result in the application of any law other than the law of the State of Delaware.
Section 5.07
. Counterparts; Effectiveness
. This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. Signatures to this Agreement transmitted by facsimile transmission, by electronic mail in PDF form, or by any other electronic means designed to preserve the original graphic and pictorial appearance of a document, will be deemed to have the same effect as physical delivery of the paper document bearing the original signatures. This Agreement shall become effective when each party hereto shall have received counterparts hereof signed by all of the other parties hereto and the Merger Agreement has become effective. Until and unless each party has received a counterpart hereof signed by the other party hereto and the
Merger Agreement has become effective, this Agreement shall have no effect and no party shall have any right or obligation hereunder (whether by virtue of any other oral or written agreement or other communication).
Section 5.08
. Severability
. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction or other Governmental Authority to be invalid, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions of this Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any party hereto. Upon such a determination, the parties hereto shall negotiate in good faith to modify this Agreement so as to effect the original intent of the parties hereto as closely as possible in an acceptable manner in order that the transactions contemplated hereby be consummated as originally contemplated to the fullest extent possible.
Section 5.09
. Specific Performance
. The parties hereto agree that irreparable damage to Parent or Merger Subsidiary would occur, damages would be incalculable and would be an insufficient remedy and no other adequate remedy would exist at law or in equity, in each case in the event that any provision of this Agreement were not performed by Stockholder in accordance with the terms hereof, and that each of Parent and Merger Subsidiary shall be entitled to an injunction or injunctions to prevent breaches of this Agreement or to enforce specifically Stockholder?s performance of the terms and provisions hereof, in addition to any other remedy to which Parent or Merger Subsidiary may be entitled at law or in equity. Stockholder hereby waives any defenses based on the adequacy of any other remedy, whether at law or in equity, that might be asserted as a bar to the remedy of specific performance of any of the terms or provisions hereof or injunctive relief in any action brought therefor by Parent or Merger Subsidiary. Stockholder further agrees that neither Parent nor any other Person shall be required to obtain, furnish or post any bond or similar instrument in connection with or as a condition to obtaining any remedy referred to in this Section 5.09, and Stockholder irrevocably waives any right Stockholder may have to require the obtaining, furnishing or posting of any such bond or similar instrument.
Section 5.10.
Defined Terms
. For the purposes of this Agreement:
(i) Capitalized terms used but not defined herein shall have the respective meanings set forth in the Merger Agreement.
(ii) Stockholder shall be deemed to ?
? or to have acquired ?
Beneficial Ownership
? of a security if Stockholder (a) is the record owner of such security, or (b) is the ?beneficial owner? (within the meaning of Rule 13d-3 under the Exchange Act) of such security.
(iii) ?
? shall mean the period from the date of this Agreement through the earlier of (a) the date upon which the Merger Agreement is validly terminated, or (b) the Effective Time.
Section 5.11.
Action in Stockholder?s Capacity Only
. Stockholder, if a director or officer of the Company, does not make any agreement or understanding herein as a director or officer of
the Company. Stockholder signs this Agreement solely in Stockholder?s capacity as a Beneficial Owner of the shares of Company Common Stock and Company Stock Awards Beneficially Owned by Stockholder, and nothing herein shall limit or affect any actions taken in Stockholder?s capacity as an officer or director of the Company, including complying with or exercising such Stockholder?s fiduciary duties as a member of the Board of Directors of the Company.
Section 5.12.
Notices
. All notices and other communications hereunder shall be in writing and shall be deemed to have been duly given (a) upon receipt, if delivered personally, (b) two Business Days after being sent by certified mail (return receipt requested) or sent by overnight courier, (c) if sent by email transmission on a day other than a Business Day or after 6:00 p.m. recipient?s local time, and receipt is confirmed, the Business Day following the date of transmission, or (d) if sent by facsimile email transmission before 6:00 p.m. recipient?s local time on a Business Day, and receipt is confirmed, on the date of transmission;
in each case the notice or other communication is sent to the physical address or email address set forth beneath the name of such party below (or to such other physical address or email address as such party shall have specified in a written notice given to the other parties hereto):
if to Parent or Merger Subsidiary, to:
Adobe Systems Incorporated
345 Park Avenue
San Jose, CA 95110-2704
Attention: Justin Judd
Email: pjudd@adobe.com
with a copy (which shall not constitute notice) to:
Weil, Gotshal & Manges LLP
201 Redwood Shores Parkway
Redwood Shores, CA 94065
Attention: Jane Ross
Facsimile No: (650) 802-3100
Email: jane.ross@weil.com
if to Stockholder, to: the address for notice set forth on the signature page hereto
with a copy to:
TubeMogul, Inc.
1250 53
Street, Suite 2
Emeryville, CA 94608
Attention: Brett Wilson
Facsimile No.: (510) 653-0461
Email: brett@tubemogul.com
DLA Piper LLP (US)
2000 University Avenue
East Palo Alto, CA 94303
Attention: Peter Astiz and Brandee Fernandez
Facsimile No.: (650) 687-1159
Email: peter.astiz@dlapiper.com and brandee.fernandez@dlapiper.com
Section 5.13.
Submission to Jurisdiction
. Each party to this Agreement hereby (i) irrevocably and unconditionally consents to the submission to the exclusive personal jurisdiction of the Court of Chancery of the State of Delaware, New Castle County, or, if that court does not have jurisdiction, a Federal court sitting in the State of Delaware in any action or proceeding arising out of or relating to this Agreement or any the transactions contemplated hereby, (ii) agrees that all claims in respect of such action or proceeding shall be heard and determined in any such court, (iii) agrees that it shall not attempt to deny or defeat such personal jurisdiction by motion or other request for leave from any such court, and (iv) agrees that it shall not bring any action relating to this Agreement or any of the transactions contemplated hereby in any other court. Each of the parties hereto waives any defense of inconvenient forum to the maintenance of any action or proceeding so brought and waives any bond, surety or other security that might be required of any other Person with respect thereto. Each of the parties hereto agrees that a final judgment in any such Legal Proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by applicable Law.
Section 5.14.
Period Waiver of Jury Trial
. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY.
Section 5.15.
Rules of Construction
. The parties hereto agree that they have been represented by counsel during the negotiation and execution of this Agreement and, therefore, waive the application of any law, regulation, holding or rule of construction providing that ambiguities in an agreement or other document will be construed against the party drafting such agreement or document.
Section 5.16.
. No failure on the part of any party to exercise any power, right, privilege or remedy under this Agreement, and no delay on the part of any party in exercising any power, right, privilege or remedy under this Agreement, shall operate as a waiver of such power, right, privilege or remedy; and no single or partial exercise of any such power, right, privilege or remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy. A party hereto shall not be deemed to have waived any claim arising out of this Agreement, or any power, right, privilege or remedy under this Agreement, unless the waiver of such claim, power, right, privilege or remedy is expressly set forth in a written instrument duly executed and delivered on behalf of such party; and any such waiver shall not be applicable or have any effect except in the specific instance in which it is given.
Section 5.17.
No Ownership Interest.
All rights, ownership and economic benefits of and relating to the shares of Company Common Stock and Company Stock Awards Beneficially Owned by Stockholder at a given time shall remain vested in and belong to Stockholder as of such time, and Parent shall have no authority to exercise any power or authority to direct Stockholder in the voting of any of the shares of Company Common Stock Beneficially Owned by Stockholder, except as otherwise specifically provided herein, or in the performance of Stockholder?s duties or responsibilities as a stockholder of the Company.
Section 5.18
. Entire Agreement
. This Agreement constitutes the entire agreement among the parties hereto with respect to the subject matter hereof and supersedes all other prior agreements and understandings, both written and oral, among the parties hereto with respect to the subject matter hereof.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the day and year first above written.
ADOBE SYSTEMS INCORPORATED
Title:
TIGER ACQUISITION CORPORATION
Signature Page to Tender and Support Agreement
STOCKHOLDER:
SPOUSE OF STOCKHOLDER:
Exhibit A
Shares Beneficially Owned
Shares Owned
of Record
Shares subject to
Options
other Company
The above information was disclosed in a filing to the SEC. To see the filing, click here.
___________________________________________________
TUBE
Adobe to Acquire TubeMogul
By Business Wire, November 10, 2016, 08:05:00 AM EDT
TubeMogul Acquisition Brings Leading Video Advertising Platform to Adobe Marketing Cloud
SAN JOSE, Calif.--(BUSINESS WIRE)-- Adobe (Nasdaq:ADBE) today announced it has entered into a definitive agreement to acquire TubeMogul (Nasdaq:TUBE) for approximately $540 million net of debt and cash. Under the terms of the agreement, Adobe will commence a cash tender offer to acquire all of the outstanding common stock of TubeMogul for $14 per share. TubeMogul is a leader in video advertising, with a single platform that enables brands and agencies to plan and buy video advertising across desktops, mobile, streaming devices and TVs. Adobe Marketing Cloud is the world's most comprehensive and integrated solution for delivering exceptional digital experiences. Adobe's acquisition of TubeMogul will create the first end-to-end independent advertising and data management solution that spans TV and digital formats, simplifying what has been a complex and fragmented process for the world's biggest brands.
Video consumption is exploding across all devices and video advertising is the fastest growing advertising category. Adobe is the leader in video content creation and delivery with its Premiere Pro CC and Primetime solutions. Adobe's acquisition of TubeMogul will enable brands to capitalize on the meteoric shift to online video.
The acquisition of TubeMogul further strengthens Adobe's leadership in digital marketing and advertising technology. Building upon its expertise in search, display and social advertising planning and delivery with Adobe Media Optimizer, the addition of TubeMogul will enable Adobe's customers to maximize their video advertising investments across desktop, mobile, streaming devices and TV. TubeMogul's video advertising platform, combined with Adobe Marketing Cloud, will give customers access to first-party data and measurement capabilities from Adobe Audience Manager (Adobe's data management platform) and Adobe Analytics respectively.
"Whether it's episodic TV, indie films or Hollywood blockbusters, video consumption is exploding across every device and brands are following those eyeballs," said Brad Rencher
, executive vice president and general manager, digital marketing, Adobe. "With the acquisition of TubeMogul, Adobe will give customers a ‘one-stop shop' for video advertising, providing even more strategic value for our Adobe Marketing Cloud customers."
TubeMogul is a video demand-side platform (DSP) leader according to Forrester Research in its Q4 2015 Forrester Wave™ Video Advertising Demand Side Platform report. Adobe and TubeMogul share a long list of joint customers that will benefit from the integration of TubeMogul into Marketing Cloud solutions. Joint customers include Allstate, Johnson & Johnson, Kraft, Liberty Mutual, L'Oréal, Nickelodeon and Southwest Airlines.
"Adobe and TubeMogul share a similar culture and vision for the future of advertising," said Brett Wilson
, CEO and co-founder, TubeMogul. "The combination of Adobe Marketing Cloud with TubeMogul's software creates a uniquely comprehensive platform that will help marketers always know what's working -- and act on it. We're thrilled to call Adobe home and believe this will be a great move for our clients, team and shareholders."
The transaction, which is expected to close during the first quarter of Adobe's 2017 fiscal year, is subject to customary closing conditions. The potential financial impact to Adobe of this transaction is not reflected in financial targets previously provided by Adobe. Until the transaction closes, each company will continue to operate independently. Assuming the completion of the transaction, Adobe believes the acquisition of TubeMogul will be neutral to Adobe's non-GAAP earnings in fiscal year 2017. Due to the absence at this time of certain acquisition-related cost estimates and purchase price accounting, Adobe is currently unable to provide an estimated impact on future GAAP earnings.
TubeMogul CEO Brett Wilson
will continue to lead the TubeMogul team as part of Adobe's Digital Marketing business.
Forward-Looking Statements Disclosure
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks and uncertainties related to Adobe's ability to integrate TubeMogul's technology into Adobe Marketing Cloud. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including statements regarding: the ability of Adobe to extend its leadership in digital marketing and other anticipated benefits of the transaction to Adobe and to the combined companies; the effectiveness of TubeMogul technology; potential benefits of the transaction to Adobe and TubeMogul customers, the ability of Adobe and TubeMogul to close the announced transaction; the possibility that the closing of the transaction may be delayed; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. These risks, uncertainties and other factors, and the general risks associated with Adobe's and TubeMogul's business, could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. All forward-looking statements are based on information currently available to Adobe and are qualified in their entirety by this cautionary statement. For a discussion of these and other risks and uncertainties, individuals should refer to Adobe's and TubeMogul's SEC filings. Adobe does not assume any obligation to update any such forward-looking statements or other statements included in this press release.
Adobe assumes no obligation to, and does not currently intend to, update these forward-looking statements.
Securities Law Disclosures
In connection with the proposed acquisition, Adobe will commence a tender offer for the outstanding shares of TubeMogul. The tender offer has not yet commenced. This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of TubeMogul, nor is it a substitute for the tender offer materials that Adobe and its acquisition subsidiary will file with the SEC upon commencement of the tender offer. At the time the tender is commenced, Adobe and its acquisition subsidiary will file tender offer materials on Schedule TO, and TubeMogul will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. The tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other tender offer documents) and the Solicitation/Recommendation Statement will contain important information. Holders of shares of TubeMogul are urged to read these documents when they become available because they will contain important information that holders of TubeMogul securities should consider before making any decision regarding tendering their securities. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of TubeMogul at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC's web site at www.sec.gov.
About TubeMogul
TubeMogul (Nasdaq:TUBE) is a leader in software for brand advertising. By reducing complexity, improving transparency and leveraging real-time data, our platform enables advertisers to gain greater control of their global advertising spend and achieve their brand advertising objectives. TubeMogul was incorporated in 2007 and is based in Emeryville, California with operations in Kyiv, London, New York, Paris, Sao Paulo, Shanghai, Singapore, Sydney, Tokyo, Toronto and offices across the United States.
About Adobe
Adobe is changing the world through digital experiences. For more information, visit www.adobe.com.
2016 Adobe Systems Incorporated. All rights reserved. Adobe and the Adobe logo are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. All other trademarks are the property of their respective owners. TubeMogul and the TubeMogul logo are trademarks or registered trademarks of TubeMogul, Inc. in the United States and other countries.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161110005746/en/
Source: Adobe
Read more: http://www.nasdaq.com/press-release/adobe-to-acquire-tubemogul-20161110-00539#ixzz4Pbw7w1zp
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TUBE
TubeMogul +3.3% on revenue beat, strong guidance
Nov. 9, 2016 8:10 PM ET|About: TubeMogul (TUBE)|By: Jason Aycock, SA News Editor
TubeMogul (TUBE -0.3%) wrapped the after-hours trading session up 3.3% after posting Q3 revenues that beat expectations and raising full-year guidance above consensus.
Revenues grew 21% to $56.1M, and total spend rose 34% to $138.3M. The company posted wider losses, however (operating loss of $11.1M vs. a year-ago operating loss of $3M, and GAAP net loss of $12.4M vs. the prior year's loss of $3.8M).
Revenue breakout: Platform direct, $20.9M (up 16.9%); Platform Services, $35.2M (up 23%).
The company boosts its 2016 guidance for revenue (GAAP basis) of $220M-$222M (above consensus for $219.6M), total spend of $562M-$564M, gross profit of $151M-$153M and EBITDA of $4M-$6M (well above expectations for $1M).
For Q4, it's forecasting revenue of $66M-$68M (in line with expectations) and EBITDA of $6M-$8M (vs. expected $5.7M), as well as total spend of $172M-$174M and gross profit of $45M-$47M.
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http://seekingalpha.com/news/3223131-tubemogul-plus-3_3-percent-revenue-beat-strong-guidance
TUBE
Bristol-Myers' Opdivo successful in late-stage gastric cancer study
Nov. 10, 2016 7:52 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
A Phase 3 clinical trial, ONO-4538-12, assessing Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for the treatment of patients with unresectable advanced or recurrent gastric cancer resistant to standard therapy met its primary endpoint of overall survival (OS). The company says this is the first immuno-oncology agent to show such a benefit in these patients.
Bristol-Myers and development partner Ono Pharmaceutical Co. Ltd. are working with investigators on the future presentation of the results.
Opdivo is currently approved for the treatment of non-small cell lung cancer, melanoma, kidney cancer and classical Hodgkin lymphoma. It is BMY's fastest growing product and is poised to overtake top-selling Eliquis in the near future. Over the past four quarters, Opdivo's sales were $2.929B compared to $2.997B for Eliquis.
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http://seekingalpha.com/news/3223294-bristol-myers-opdivo-successful-late-stage-gastric-cancer-study
BMY
Aeterna Zentaris' (AEZS) CEO David Dodd on Q3 2016 Results - Earnings Call Transcript
Nov. 9, 2016 12:44 PM ET|2 comments | About: AEterna Zentaris, Inc. (AEZS)
Q3 2016 Earnings Summary
Q3 2016 Earnings Conference Call
November 09, 2016 08:30 AM ET
Executives
Philip Theodore - Senior Vice President & General Counsel
David Dodd - President and Chief Executive Officer
Genevieve Lemaire - Vice President of Finance and Chief Accounting Officer
Jude Dinges - Senior Vice President and Chief Commercial Officer
Analysts
Jason Kolbert - Maxim Group.
Swayampakula Ramakanth - H.C. Wainwright & Co., LLC
Operator
Greetings and welcome to the Aeterna Zentaris Third Quarter 2016 Financial Results and Operating Results. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Phil Theodore, for Aeterna Zentaris. Thank you, Mr. Theodore. You may now begin.
Philip Theodore
Good morning and welcome, everyone. I’m Philip Theodore, Senior Vice President & General Counsel of Aeterna Zentaris. I’m the leader of today’s call.
With me are David Dodd, President and CEO; Genevieve Lemaire, Vice President of Finance and Chief Accounting Officer; Jude Dinges, Chief Commercial Officer.
During this call, we will be making forward-looking statements regarding future events and the performance of Aeterna Zentaris that involve risks and uncertainties that could cause actual events and results to differ materially. These risks are described in further detail in the Company’s press releases and reports filed with the U.S. and Canadian securities regulatory authorities.
These forward-looking statements represent the Company’s judgment as of today, Wednesday, November 9, 2016 and the company disclaims any intent or obligation to update these forward-looking statements unless we are required to do so by applicable law or by a securities regulatory authority. However, we may choose to update, and if we do so, we will disseminate the updates to the investing public.
It is now my pleasure to introduce the President, and CEO of Aeterna Zentaris, Mr. David Dodd.
David Dodd
Good morning and thank you for joining us. We entered the third quarter with $21.1 million of unrestrictive cash and cash equivalents which is indicative of an average monthly use of cash and operations of $2.3 million during the nine-month period ended September 30th. We still expect the use of average of between $2.5 million and $2.7 million of cash for operations per month in 2016.
After the end of Q3, we concluded a successful financing transaction which substantially improved our financial condition on the eve of the completion of our two pivotal Phase III trials. We raised $7.56 million of gross proceeds from the sale of common share, pre-funded warrants and warrants that are registered direct offering on November 1. Also between September 14 and October 14, we raised approximately $2.3 million in gross proceeds from the sale of common shares pursuant to our ATM program.
Therefore, we have the funds necessary to complete our pivotal Phase III trials to report top-line results from both and to file a new drug application for Macrilen during the first half of 2017. If the results of that trial weren't doing so.
While we will need to raise additional funds before we are able to bring a product to market we expect that reporting favorable top-line results from one or both of our clinical trials will permit us to do on favorable terms.
Also after quarter end, we concluded our fourth license agreement for Zoptrex with a specialized therapeutics agent for the territories of Australia and New Zealand. We received an upfront payment and will receive additional milestone and royalty payments if have positive top-line results and as commercialization of the product proceeds.
Specialized Therapeutics is a successful specialty oncology competitor in that region and we are delighted to have their confidence of Zoptrex and to have them as our commercial licensee. Recruitment of patients for our confirmatory clinical trial of Macrilen was concluded after quarter end.
We are confident in our ability to complete the trial and report top-line results in early 2017. We are also on track to file an NDA for Macrilen during the first half of 2017 if the results of the trial support.
Since the regulatory review period for the Macrilen confirmatory study is six months, we could begin commercializing the product late in 2017. As noted in our press release we expect to release top-line results for both our Phase III clinical trials of Zoptrex and Macrilen in the first quarter of next year.
If approved Macrilen will be the only FDA approved drug for assessing adult growth hormone deficiency. We expect that endocrinologists will rapidly abandon the insulin college test in favor of the much simpler and much safer use of Macrilen for the assessment.
We believe that Macrilen represents a $30 million to $50 million market opportunity in U.S. alone and then approximately 40,000 confirmatory tests for adult growth hormone deficiency or AGHD will be conducted each year after the introduction of Macrilen.
We believe that there is an opportunity to significantly expand that market, if we are able to convince medical practitioners who follow existing Endocrine Society guidelines for the evaluation for brain injury patients for AGHD. We are continuing to study this market and are working with a leading pricing consultant to assist us with our access and reimbursement strategy.
Zoptrex if approved will be the only FDA approved treatment for advanced, recurrent or metastatic endometrial cancer. We believe this represents a $300 million to $500 million annual market opportunity in the US and that there is significant additional upside for other indications including ovarian and prostate cancer, both of which have already been the subject of Phase II trials.
For comparison like the [indiscernible] doxorubicin currently generates approximately $500 million in annual revenues in the U.S. it is nearly a coded form of doxorubicin lacks the targeting mechanism of Zoptrex and appears to represent a slide improve on over standard doxorubicin.
As a result, upon FDA approval we will hope to displace most of the [indiscernible] doxorubicin used within our indication fairly quickly. These two Phase III clinical trials represent potentially significant near-term value drive. Few companies can look forward to the completion of two Phase III clinical trials at about the same time.
If one or both of our trials were successful, we would expect to see the creation of significant value for our shareholders. Confirmatory Phase III trials protocol Macrilen and the straightforward, which is why we will be able to complete in just about one year.
We recruited approximately 150 patients in several groups, consisting of those with high medium and low risk of having AGHD and a group of healthy volunteers. Approximately 25% of the patients were recruited in the U.S. overall, there were approximately 25% of the total patient within each of the four groups.
Each patient was randomized to receive either the insulin tolerance test or Macrilen. The results of the test were recorded and after brief washout period, the participant was evaluated using the other treatment or procedure. A small number of participants were asked to undergo continued evaluation with Macrilen to satisfy the EMA's request for generation of data or reproducibility of the test.
You will recall that our confirmatory Phase III trials design to satisfy the EMA’s requirements as well as the FDA’s. We expect to be able to report top-line results in early 2017, because the trial is so straightforward. Primary end-point s of the study or the percentage of negative and positive agreement between the insulin tolerance test and Macrilen.
Our NDA preparations is in very good shape as we will be updating many of the modules from the previous [indiscernible] and expect to be able to submit the NDA during the first half of next year and because we have a six month review period to begin commercializing Macrilen before the end of 2017.
And let's take a few minutes to review the background related to the medical need for and value opportunity potential for the Macrilen. Growth hormone is the hormone created by the pituitary gland that plays a critical role in health throughout life. Most of us are familiar with the role growth hormone plays in the development stature and body maturation in early child growth and development.
However, in adults, growth hormone is a potent regulator of various elements of our ongoing health. Critical to maintain the appropriate balance of metabolism, cell growth, cell reproduction and cellular regeneration. In other words, growth hormone is a critical regulator on our ongoing health and wellbeing throughout life.
Deficiency of growth hormone has consequences in adults just has it does in children. Typical presentations within adult growth hormone deficiency include the diminishing body mass, or bone density as well as numerous physical and physiological symptoms.
There are numerous causes of AHGD as compared to growth hormone deficiency in children. While in adults, it is more complicated to initially identified patients who might be suffering from AGHD. Regardless the primary method of confirming growth hormone deficiency in both children and adults is the same, provocative testing.
Primarily using the insulin tolerance test referred to as ITT. This has been the gold standard over the past 30 to 40 years. The ITT is the standard of provocative testing for growth hormone deficiency in fact throughout the world.
Treatment for growth hormone deficiency or GHD in either children or adults is straightforward. It consists of the administration of recombinant growth hormone. Beginning at the time of confirmed diagnosis until the endocrinologist determines that such treatment is no longer necessary.
In children this is typically when they complete their growth, usually around ages 18 or 19. In adults, it continues from the point of confirmed diagnosis throughout the remainder of their live. In adults, growth hormones therapy provides a host of meaningful benefits resulting in improvement and quality of life for most patients. Macrilen potentially represents a significant improvement in the way endocrinologist will evaluate AGHD.
It will be dispensed in a form of the powder in a sachet, which will be dissolved in water. The endocrinologist will determine the amount of solution which the fasting patient will drink based on the patient’s body weight.
The Macrilen that the patients drinks will enter the blood stream where it will travel to the pituitary gland. In the pituitary gland, it will bind to the ghrelin receptor and calls the pituitary gland if it is healthy to secrete growth hormone.
After a brief waiting period, a nurse or physician’s assistant will draw a blood sample from the patients. Then the patient will be discharged and would be able to drive himself or herself home or to work and to complete his or her daily routine.
The growth hormone level will be measured in the blood drawn after administration on Macrilen using a standard test that can be performed by any clio lab and will be compared versus a predefined cut-offs value.
If the patient’s pituitary gland is healthy, the growth hormone level in the post administration blood sample will be above the cut-off level. If it is not the endocrinologist knows that the patient’s pituitary gland is not healthy and thus the patient is suffering from AGHD.
Now let’s some compare this with the current gold standard for evaluating AGHD. The illustration on top of the slide depicts the administration of the insulin tolerance test or ITT. It beings with the blood draw from a [Indiscernible] patients and it gets complicated to somewhat scary.
The patient is placed in a medical setting and receives an insulin injection to induce a hypoglycemic state. Following the insulin injection the patient must be continuously monitored by a physician, because the results of induced hypoglycemic can be detrimental to one’s health.
In fact, the procedure requires such close physician monitoring that some hospitals and clinics refuse to allow it to be performed in their facilities. Moreover, the procedures is contraindicated in specific patient groups such as patients with cardiovascular disease or patients with seizure disorder.
Following the insulin injection, blood is drawn from the patients several times so that the physician can monitor the patient's blood glucose levels. But also to measure of growth hormone plasma concentrations, when the desired to agree the hypoglycemia is produced including hypoglycemic symptoms, a final blood draw is taken and the patient is allowed to recover.
The patient must be observed during the recovery and depending on symptoms severity may require to receive a glucose drinking solution or even a glucose infusion. Moreover, the patient is not able to drive or to return to work. The blood samples are sent to the Clio lab where they undergo the same testing used following the evaluation with Macrilen.
We believe that the insulin tolerance test is sufficiently complicated, dangerous and expensive. The endocrinologist are discouraged for evaluating patients for AGHD and medications. We also believe that many patients who should be tested for AGHD avoid such if the intended test is the ITT.
In fact we believe that is likely why most traumatic brain injury patients are not evaluated according to the existing Endocrine Society guidelines. Changing this paradigm with the approval and availability of Macrilen represents a significant commercial opportunity for us if the product is approved and a significant improvement in the marrow testing for adult growth hormone deficiency. So we believe that there is a compelling commercial case for Macrilen. Let me also remind you that the ITT is not an FDA approved procedure.
What really sets Aeterna Zentaris apart is that we have another compound Zoptrex to which in our opinion the commercial case is even more compelling. Now let me explain why. As you know, overall survival is the primary end point of our pivotal Phase III study of Zoptrex. We are seeking to demonstrate through our Zoptrex study that patients who receive Zoptrex survive longer than patients who receive doxorubicin.
The conclusion of a study with an overall survival end-point is reached when a predetermined number of patients in the trial die. Only then is it reasonable to compare the survival of the patients who received the investigational drug with the survival of the participants who did not.
Success of our study depends on patients who are randomizing Zoptrex attaining a statistically meaningful difference in median overall survival as compared to those randomized on doxorubicin.
The women who enrolled in our study were afflicted with locally advanced, recurrent or metastatic endometrial cancer that progressed after they receive one care chemotherapy regiment with platinum and [indiscernible] either as adjuvant or first line treatment.
We designed our study around this type of patients, because we believe that their treatment represented the greatest medical need. Our goal is to increase the overall survival beyond what could be expected with doxorubicin alone while reducing the potential drastic side effects typically associated with doxorubicin such as cardio toxicity.
We completed enrollment in the study at the end of the second quarter of 2015 and dosing was completed in February of 2016. The period of overall survival is now longer than we assumed when we designed the trial. As a result, it is taking longer than we expected to complete the trial.
Although we don't know the breakout between those on Zoptrex versus those on doxorubicin, we are encouraged that these patients are continuing to survive and we look forward to the completion and results reporting of this clinical program.
Our current expectation is that we will report top-line results during the first quarter of 2017 and then we'll be able to file a new drug application for Zoptrex during the second half of 2017 based upon supportive results.
As a result of the increased interest in the non-U.S. rights to Zoptrex we created an electronic data room and are admitting parties who are potentially interested in licensing the product. There has been quite a bit of interest, at this time we will entertain offers for smaller territories, but intend to postpone discussions with parties interested in the larger territories and so after we receive top-line results.
If top-line results are positive, we believe the rights to Zoptrex in large territories such as the EU will be very valuable. The interest in Zoptrex is indeed gratifying. We have not disclosed the amount of upfront payments we received from our last three licensees, because of the wish to maintain the confidentiality of the commercial terms of their transactions with us. Of course, we must respect their wishes.
These transactions are important to us for two reasons. Firstly, indicate that other companies share our optimism about the potential of Zoptrex. Second, if Zoptrex is approved in the territories of our licensees we can expect to receive both milestone and royalty payments from our licensees as they commercialize the product in their respective territories.
Now I'll turn the call over to Genevieve Lemaire our Vice President, Finance and Chief Accounting Officer who will provide more information about our third quarter financial results.
Genevieve Lemaire
Thank you David and good morning everyone. Most what I will be covering is presented in more detail in our interim consolidated financial statements and MD&A for the third quarter which were filled yesterday.
From an operating expense standpoint, our main operating activity during the third quarter included ongoing efforts associated with our clinical development initiatives guest. As well as to a lesser extent with our commercial operation and general and administrative activity.
Total operating expenses amounted approximately $8 million for the quarter ended September 30, 2016. Representing a 4% increased if we compared to the same period in 2015. Which mainly explained by R&D costs.
Our total R&D cost in the quarter were approximately $4.5 million as compared to $4.1 million in the third quarter of 2015. The increase in R&D expenses about the 400,000 and mainly attributable to the new [indiscernible] clinical trial for Macrilen, which started during the second half of 2015.
The first patient was enrolled in the fourth quarter of 2015 and we announced completion of patient recruitment in the fourth quarter of 2016. We continue to realize the benefit of lower employee compensation and benefits costs and lower other costs. A substantial portion of which is due to the realization of cost savings in connection with our efforts to streamline our R&D activities and to increase our commercial operations flexibility by reducing our R&D staff.
Our pivotal Phase III trial of Zoptrex and complimentary Phase III pivotal trial Macrilen continues to be the primary driver of our third-party R&D expenses. Excluding the foreign exchange rate fluctuation, we now expect that we will incur overall R&D cost of between $17 million and $19 million for the year ended December 31, 2016.
The increase as compared to [Indiscernible] guidance for 2016 as mainly explained by the infinitive additional adjustments that will be made to a contract with Argaman which are mainly due to increased timeline.
Looking now to our G&A expenses. The recent quarter ended September 30, 2016, G&A expenses totaled approximately $1.6 million as compared to G&A expenses of $1.9 million during the same period in 2015. The 300,000 quarter-over-quarter reduction in G&A cost was attributable to the realization of cost savings in connection with our corporate restructuring, which was announce in the fourth quarter of 2015.
Our 2016, [indiscernible] G&A cost was now a range between $7 million and $8 million which exclude any online instructing program as included in transaction cost related to the warranty due in connection with the November 2016 operating, which was announce in September 30, 2016.
From a commercial operation standpoint. We continue to [indiscernible]. Selling expenses during the third quarter of 2016 were approximately $1.8 million and we are essentially unchanged compared to the selling expenses during the same period in 2016. We are still comfortable with our estimate at total selling cost in 2016 we were in a range between $7 million and $8 million.
We reported net finance income of approximately $1.6 million in the third quarter of 2016 as compared to net finance cost of approximately $7.9 million during the third quarter of 2015. The variance is mainly attributable to the in fair value of our warrant liability, which resulted from the periodic mark-to-market valuation of our outstanding warrants.
The mark-to-market warrant valuation during the quarter was mainly impacted by the exploration of the remaining [Indiscernible] warrants. And that intend the closing price of our common share on the NASDAQ was more stable in 2016 are some greater to the same period in 2015.
From a cash flow standpoint, we used approximately $5.7 million of cash in operation in the third quarter of 2016, as compared to approximately $7.2 million in the same period in 2015. We used less cash in the third quarter of 2016 than in the prior year quarter, primarily due to the increase in trade accounts payable as compared to June 30, 2016, as well as the upfront cash payments received in consideration for the license issued to [Indiscernible].
During the nine month period ended September 30th, our average monthly cash flow used in operation was approximately $2.3 million. We intend to now expect that our average monthly cash flow used in operation will range between $2.5 million and $2.7 million in 2016. We ended the quarter with unrestricted cash and cash equivalents of approximately $21.1 million.
And now, I’ll turn back the call over to David, who will entertain questions.
David Dodd
Thank you, Genevieve. My colleagues and I will now answer your questions. I’m therefore turning the call to the operator for instructions on the question-and-answer period.
Question-and-Answer Session
Operator
Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first is coming from the line of Jason Kolbert with Maxim. Please proceed with your question.
Jason Kolbert
Congratulations, very exciting a lot of progress on the quarter. Can we talk just a little about exactly where you are in terms of the Zoptrex trail? Help me understand kind of the process of going through closing the data set, doing this statistical and now offset and then we are reporting the data and I wonder if you can give me a little bit tighter granularity in terms of when exactly we might see the data and a similar set of questions for Macrilen.
David Dodd
Sure, Jason. This is David. Thank you, good question. So as of couple of days ago we have 371 events of deaths minimum of 384 to lock the database. Now as we have mentioned in recent calls and on this call also the rate of deaths has slowdown considerably we believe there is likelihood that we will reach the minimum number possibly this month. And the process that we will go through is once we achieve a number of around 375 we will inform all sights that the next patient visit - they schedule the last patient visit for each patient log. And then as we reset minimum, we will then lock the database.
Now since there are 125 sites and over 500 patients in this trial and about a 130 remaining, we are 129 now remaining and all when we get a report that there are 371 deaths as you might imagine there probably at that point more than that I don’t know what the number is, maybe we're at 375 already, because the process is if someone in the family needs to report the death to the clinical office which then reports it to the CRO et cetera, et cetera.
And it's usually not the first thing someone wants to do when a loved one has passed away. And so there is a timing factor in there, but the process we will go through will be the following. As soon as we reach a point that we then inform and all sites notify the patients to be scheduled for their last visit and all. We will then go lock the database down, every site needs to be visited before we have the CRO all the case report forms check, all the quality assurance has to be done leading to then the quality sign out from the appropriateness of the database to then being addressed statistically. In total, it is estimated that it takes about eight weeks from the point in which we lock the database at the patient level to when we have top-line results.
If we are correct on this then we would be looking at the early part of next year that we would be receiving and the process of receiving a top-line result is that the CRO whatever [indiscernible] present them, everything is reviewed, it's a very formal process as you might imagine and its signed off. And then at that point we will issue a press release and possibly hold a conference call.
Right now we're anticipating that to occur promptly - excuse me on Zoptrex that would be in early to mid February, I apologize I was thinking Macrilen. So that would be in early to mid February as everything we see going on right now.
With Macrilen, we have now ended the recruitment, we may this week complete all enrollments of the patients and all and then we will go through the process, same type of process. On a smaller scale there are about 29 sites, we previously thought there were 30 in all, but there were actually 29 full productive useful sites. So we have 29 sites, quicker process to go through, our anticipation is in the very early part of January we will be able to announce and report the top-line results for Macrilen.
Jason Kolbert
David that's really helpful and it does help me appreciate the timing. When you look at the internal resources in your ability to kind of process two trials at the same time. I just wonder if that’s a little bit of a constraint and at the same time, help me understand when your BD [indiscernible] should we be expecting a lot of activity, because I would think at this point that of the BD state pharma opportunities around both products right now would be starting to ease off. So the stress factors on management have to be really high right now.
David Dodd
And the excitement, so we actually have five clinical programs that cover these two products, because we have the reproducibility study, we have the QT study, so those are three for Macrilen. We have the clinical trial program for Zoptrex, the PK study also, et cetera. So our team has been managing five clinical programs that relate to these two products now.
We have engaged external resources to assist in the dossier preparation, in some instances they have already begun on their portion of it, fortunately for Macrilen much of the elements of the dossier were already done a few years ago. So there is not a lot of work, obviously the clinical work is the full clinical design. Now that is lieu in all.
So in that way we will be focused in doing that. We are doing most of that on ourselves but with some external system. We have some very good external systems in several of the sections that going to an NDA for Zoptrex. That process is already become for those elements of the NDA for which they can already be addressed. Obviously the rate limiting one is the final clinical types, but there is a lot of other corporation can be done and our team is managing that well.
We are seeing increased activity behind both products interest. We setup data rooms for both products, we have companies that are in those data rooms reviewing for products including for the locations that we have already announced, but also for Canada, for Latin America, for Japan, for Europe in those territories.
But Eastern Europe we have companies that are actively reviewing in some cases we've already receive proposals, which we are holding off, because it relate to larger territories and we preferred to wait to see top-line results. Where there territories that are not as major territories. We believe it’s worthwhile and beneficial to go ahead and conclude the agreement as we've done three times now and make the announcements and all and so the marketplace understands the interest that we're seeing in that.
Otherwise, in terms of business development activities, as you might imagine, our primary focus as this stage is very heavily on these tow products and during everything possible. Not just prepared the dossiers but prepared for commercialization.
Assuming Macrilen is successful, we will be launching that products approximately a year from that. And there is a lot that has to be done between now and then organizationally, operationally making decision which will be done internally versus externally. This is our primary focus.
Yes we were prepared for in 2014, we had set everything out, we would be able to roll out the launch of our product in January 2015. You revisit it, you look at it, you reassess, but we're spending a lot of time in preparation in that area right now. And then, managing the relationships that we have from our business developer where there continues to be increase interest in these two products.
Jason Kolbert
David, thank you very much. Congratulations on all the progress. They are pretty, very, very exciting time going forward.
David Dodd
Thank you.
Operator
[Operator Instructions]. Our next question is from the line of Swayampakula Ramakanth with H.C. Wainwright. Please go ahead with your question.
Swayampakula Ramakanth
Thanks. Good morning David. Congratulations on the quarter and then [indiscernible] at this point. My first question is on Zoptrex, can you remind us what your understanding is with the FDA and the EMA since the study that you are doing. If per data is it's very positive [indiscernible].
David Dodd
So we are working under a special protocol assessment with the FDA and with the median overall survival is a primary input. We do not have a defined increment between Zoptrex and doxorubicin that it is the minimal that has to be achieved for approval. Based upon the information in the data that was review and presented in the Phase II trial where it showed - with the qualifiers of the Phase II of not having a competitor in there and being a relatively small trial of 42 patients.
We did demonstrate however 14.9 months of meeting overall survival and that's was significantly more than what had previously been seen and published about for doxorubicin. The maximum has been nine before 9.2 month. Although it wasn’t specifically stated, the element of zero cardio toxicity being observed in our Phase II program appears to have been an element of real interest, because the possibility of having a product with this type of safety profile would be a major change relative to the [Indiscernible] of chemotherapeutic agents, especially doxorubicin.
And so obviously events important element we've always focused on. We hope to demonstrate a material difference and side effects specifically perhaps cardio toxicity. We are expecting zero in a trail of the size and all, but we would not be surprised to see that there was a meaningful difference that would allow them the clinician, the oncologist to either use greater cycles rather than the current or protocol regiment which max is at six cycles. So in our own trial the FDA has allowed nine cycles of our products, they limit no more than six for doxorubicin.
So that's a basis of what we are working on. If the results support what we believe are sufficient for a [Indiscernible] priority review we will request such, but we are anticipating for all of our planning reasons a one year review. So we submitted and in the second half then we would expect to be commercializing and about a year from that. Does that help to shed some light on it?
Swayampakula Ramakanth
Yes, that's fantastic. It's very good. Again on the Zoptrex in terms of the [Indiscernible] and I do understand you cannot talk all about the financial details, but in general, what are the terms that you are looking for that makes you comfortable so that you can walk up to the table and think about signing a [Indiscernible] companies.
David Dodd
You mean for the larger territories?
Swayampakula Ramakanth
Yes.
David Dodd
There are a couple of ways we look at that and that's another reason why we think it's more important to have top-line results. Clearly if we have supportive results and we are talking about major territories such as EU. So then we would see a more substantial upfront and we don’t want to define it, because we don’t know what companies might be thinking of their in the data room and all, but you see up fronts when there are licenses established in oncology of successful Phase III products and all.
So we think we are out of the somewhere in the competitive range there. However, we also are very interested and willing to consider a cross licensing where someone would receive the rights to Zoptrex for their interested geography and we would receive the reciprocal rights of a product that they might have that would be complementary say to oncology for the U.S. And that is a way that we believe will help us to more strongly build our portfolio and move forward.
There will be still be elements of royalties to each other and of course it is creative, as we would be working together with that partner. We have engaged in such discussions, we do have such types of concepts in discussion. But in one sense we find that perhaps more to our liking, because at this stage and juncture of the company if we can build a stronger portfolio behind our oncology products, we think that will have much greater long-term value than receiving an upfront cash payment. When we've seen pretty fast cash generation with the commercialization of these two products.
So what we would do with the cash is probably go out to find a product that we would either have to hunt for or that we would receive the rights in earlier stage and then have to engage in development. So we're very interested in that reciprocal rights concepts and all and where it makes sense because of the other party that's expressed an interest in Zoptrex we are having those types of discussions now.
With Macrilen frankly, what we have found is very little interest until next summer. And then, because of the state of where we are, probably in that type of thing, we started receiving meaningful inquiries and discussions as we then were able to validate that in addition to the U.S. and Europe the ITT is pretty much the standard of provocative testing in Japan, in other parts of the Asia-Pacific region, in South America.
And so companies who are in the endocrine space or in the metabolism and endocrinology space in those territories we have begun to engage in discussions in the data room they have entered. And that really has occurred just more recently, starting this summer and when we went to the international bio meeting, we were frankly surprised at the level of interest we were receiving on Macrilen. No proposals to-date, but certainly the activity was a surprise and has been encouraging.
Swayampakula Ramakanth
Great, actually your talk about soft licensing brings me to the next question, but this is regarding the resources that you have on the [indiscernible] to get a commercial structure growing in the U.S. and also you know what kind of additional resources would you need to get started on the free market activities or do they want to wait till you get all this data before you start thinking about.
Jude Dinges
Sure. RK it’s an excellent question, we have just concluded a meeting with our board yesterday, in which the primary focus was how do we transition from the company we have today to an operating company that has all the capabilities and resources necessary to commercialize our first product a year from now. And so we had successful and encouraging discussion on that.
The good news is that we don't require 25 additional people; we require a fraction of that because our model will be in main areas we will outsource. We don’t plan to build an internal pharmacovigilance department. We certainly need to have someone who can facilitate and manage that external relationship that we will have.
We will work externally with people related to accessory imbursement 3PL; we will have people internally small, very small staff to ensure that our compliance programs are inflation operating well. We will utilize a few additional staff and I emphasize a few additional staff internally, but we have mapped out all the processes all the element we need and all of that has focused into new budget for 2017 that we will be reviewing in just few weeks with the board and we have gone through with off.
And so our additional staffing is minimal from the standpoint of what we need to add, they will be on our payroll and we believe by the outsource and we will be a leverage to expertise to have much better support that we otherwise would have. Relative to the Macrilen in terms of a sales force, we pretty much have the number we would need right now.
Now depending on how you look at and how your profile the adult endocrinologist out there in the areas where they are - one might from with around 27 reps, that one needs and we have on our on our rose today 23. So that's a small increase and as you might have imagine when you talking to difference between 23 to 27 whether not you actually have to do 27 may be just a relook at it and you may end up determining that you may need thirdly now.
When we look at in the future about a year later, assuming Zoptrex comes forward, that will not be a separate sales force we've satisfied our sales that given the timing, giving the nature of Macrilen. We were have plenty of times to establish it as the core product for assessing adult growth hormone deficiency.
And then may be a marginal increase to be able to reach out to some of the medical oncologist that we know we can cover. We have the number to cover the gynecological oncologist. But when we look at that, we have time to look at that and how we address the field selling and commercial development of Zoptrex as it comes forward.
But we have been focused, I would say in the asses our number one activity going forward now is towards the implementation of the process map. We have laid out to be ready to not only just sell the product, be able to ship the product, be able to manage and forecast and understand what we need from inventory interact with our three parts of supply chain element. Interact with the 3PL process, all of that we have to spend quite a bit of time on and as you might imagine, we had done - we had prepared for all in 2014, but we certainly have revisited and gone in great detail now and we will begin to roll it out as we go into 2017.
Swayampakula Ramakanth
Thank you, thank you for that elaborate answer. Congratulation again on the quarter and then [indiscernible] to the end of the year. Good luck about it.
David Dodd
Thank you for your interest.
Operator
[Operator Instructions] Thank you. There are no additional questions at this time. I will turn the floor back to management for concluding remarks.
David Dodd
Thank you. And thank everyone for your continued and supportive interest in the transformation of Aeterna Zentaris. Truly it is transformational, because between now and the next couple of weeks to few months, we are going to be reporting on some very exciting results.
Hopefully they will be positive, they will be supportive and based upon that we will then proceed towards a very significant valuable transformation of this company into being a commercial entity. Working towards our goal of being a profitable company by the end of 2018 based upon having both Macrilen and Zoptrex out in the marketplace.
So again, thank you for your continued interest and support. We look forward to keeping you updated. Have a great day.
Operator
This concludes today’s conference. Thank you for your participation. You may now disconnect your lines at this time.
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AEZS
Idera Pharmaceuticals to Provide Multiple Presentations on Intratumoral IMO-2125 at the 2016 Society for Immunotherapy of Cancer
Date : 11/09/2016 @ 7:30AM
Source : GlobeNewswire Inc.
Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced that new data from the Phase 1/2 clinical trial for intratumoral IMO-2125, a TLR9 agonist, being evaluated for the treatment of late-stage metastatic melanoma, will be presented at the 2016 Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, MD, November 9-13, 2016.
Oral Presentations
Date: Wednesday, November 9, 2016, Presentation Time: 11:15 AM E.T.
Session Title: Clinical New Agents in Development
Presentation Title: IMO-2125, An Investigational Intratumoral Toll-Like Receptor 9 Agonist, Modulates the Tumor Microenvironment to Enhance Anti-Tumor Activity
Presenter: Mark J. Cornfeld, M.D. M.P.H., Vice President, Oncology Medical Lead, Idera Pharmaceuticals
Location: Gaylord National Hotel & Convention Center, Cherry Blossom Ballroom
Date: Friday, November 11, 2016, Presentation Time: 3:15 PM E.T.
Session Title: State of the Art Immunotherapies: Challenges and Opportunities
Presentation Title: Reactivating the anti-tumor immune response by targeting innate and adaptive immunity in a phase I/II study of intratumoral IMO-2125 in combination with systemic ipilimumab in patients with anti-PD-1 refractory metastatic melanoma
Presenter: Presenter: Cara Haymaker, Ph.D., Instructor, The University of Texas MD Anderson Cancer Center
Location: Gaylord National Hotel & Convention Center, Maryland Ballroom
Poster Presentation
Date: Saturday, November 12, 2016: Presentation Time: 11:45 AM E.T. – 1:00 PM E.T.
Session Title: Immunotherapy
Poster Number: 216
Presentation Title: Reactivating the anti-tumor immune response by targeting innate and adaptive immunity in a phase I/II study of intratumoral IMO-2125 in combination with systemic ipilimumab in patients with anti-PD-1 refractory metastatic melanoma
Presenter: Cara Haymaker, Ph.D., Instructor, The University of Texas MD Anderson Cancer Center
Location: Gaylord National Hotel & Convention Center, Prince George’s Exhibition Hall AB
A copy of the slides from Dr. Cornfeld’s presentation will be made available on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/ on Wednesday, November 9 at 11:15 AM E.T. Copies of Dr. Haymaker’s presentation and related poster will be also be made available on Idera’s corporate website on Friday, November 11 at 3:15 PM E.T., in accordance with the embargo policies set forth by SITC.
“As we noted in late September, we are extremely excited by the initial clinical outcomes we have generated with intratumoral IMO-2125, in combination with ipilimumab,” stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer. “The translational data from this trial is adding to our understanding of how IMO-2125 positively modulates the tumor microenvironment and enabling previously cold tumors an opportunity for regression and ultimately successful outcomes for patients. The translational research from this trial is critical to further this understanding as well as to help guide the direction of IMO-2125’s development.”
These early results are from the phase 1 portion of study IMO-2125-204 (NCT02644967) in which cohorts of patients with metastatic melanoma unresponsive to PD-1 inhibitor therapy are being administered escalating doses of IMO-2125 ranging from 4 mg/kg through 32 mg/kg. IMO-2125 is injected intra-tumorally into a designated tumor lesion together with a standard dosing regimen of ipilimumab. The trial has recently been amended to also study the combination of IMO-2125 and pembrolizumab given intravenously. Following determination of the recommended phase 2 doses (RP2D) additional patients will be treated in an expansion phase 2 portion of the study. The primary objective of the phase 1 portion of the trial is to characterize the safety and determine a RP2D of IMO-2125 when administered intra-tumorally in combination with ipilimumab or pembrolizumab. The primary objective of the phase 2 portion is to assess the clinical activity of IMO-2125 in each combination at the respective RP2Ds. Assessment will be based on the immune-related response criteria (irRC) and additionally the traditional RECIST criteria. Serial biopsies are being taken of selected injected and non-injected tumor lesions to assess immune changes and correlate with clinical response assessments. The trial will enroll approximately 60 patients. The study is being conducted at The University of Texas MD Anderson Cancer Center and is being led by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson as part of a strategic research alliance announced by Idera and MD Anderson in 2015.
About Toll-like Receptors and Idera's Immuno-Oncology Research Program
Toll-like receptors (TLRs) play a central role in the innate immune system, the body's first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intra-tumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs), and thereby potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically.
Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created using the company's proprietary chemistry-based discovery platform. IMO-2125 has been shown in various scientific presentations and publications to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile. In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C. Idera has conducted further preclinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data being presented at several medical conferences during the past twelve months. The posters from these presentations can be found at http://www.iderapharma.com/our-approach/key-publications.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as by through the lymphatic system (metastatic disease). Melanoma accounts for only one percent of skin cancer cases, but causes a large majority of skin cancer deaths. The American Cancer Society estimates that in 2016, there will be 76,380 new cases of melanoma in the U.S., and about 10,130 will die of this disease.
About Idera Pharmaceuticals
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel nucleic acid-based therapies for the treatment of certain cancers and rare diseases. Idera’s proprietary technology involves designing synthetic oligonucleotide-based drug candidates to modulate the activity of specific TLRs. In addition to its TLR programs, Idera has used its proprietary knowledge to create a third generation antisense technology platform which inhibits the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether interim results from a clinical trial, such as preliminary results reported in this release, will be predictive of the final results of the trial, whether results obtained in preclinical studies and clinical trials such as the preclinical data described in this release will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; and such other important factors as are set forth under the caption "Risk Factors" in the Company's Annual Report and on Form 10-Q for the period ended September 30, 2016. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
Office: 617-679-5515
Mobile: 484-639-7235
rdoody@iderapharma.com
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IDRA
Was not too smart. Longs did well.
ACAD
FWIW, sold shares just now at $22.80 for a loss. No insight, just conservative and am announcing leaving a stock, for now, as I typically do.
Good luck should be a volatile move following the Q results.
ACAD
ACADIA Pharmaceuticals Initiates Phase III Trial of Pimavanserin for Adjunctive Treatment in Patients with Schizophrenia
SAN DIEGO--(BUSINESS WIRE)--
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in central nervous system disorders, today announced the initiation of ENHANCE-1, a Phase III study to evaluate pimavanserin for adjunctive treatment of schizophrenia in patients with an inadequate response to current antipsychotic therapy. Current antipsychotics approved for schizophrenia primarily target the dopaminergic pathway. As a selective serotonin inverse agonist (SSIA), pimavanserin is a new class of antipsychotic medication with a distinct mechanism of action targeting serotonergic 5-HT2A receptors while avoiding activity at dopamine and other receptors commonly targeted by other antipsychotics.
"About 30 percent of patients with schizophrenia do not achieve an adequate response to a single antipsychotic medication, and as a result more than one in four schizophrenia patients are treated with two or more antipsychotics," said Serge Stankovic
, M.D., M.S.P.H., ACADIA's Executive Vice President, Head of Research and Development. "We believe pimavanserin, through its highly selective mechanism of action, could provide an important new option for adjunctive treatment of schizophrenia and improve clinical outcomes by both augmenting the efficacy of currently used antipsychotics and lessening the undesirable side effects associated with polypharmacy."
About ENHANCE-1
ENHANCE-1 is a Phase III, six-week, randomized, double-blind, placebo-controlled, multi-center, outpatient study designed to examine the efficacy and safety of adjunctive use of pimavanserin in patients with schizophrenia who have not achieved an adequate response to their current antipsychotic treatment. Approximately 380 patients will be randomized to receive pimavanserin, or placebo, orally, once daily, in addition to their ongoing antipsychotic in a flexible dosing regimen. The starting daily dose of 20 mg of pimavanserin at baseline may be adjusted to 34 mg or 10 mg during the first three weeks of treatment. The primary endpoint of the study is the change from baseline to week six on the Positive and Negative Syndrome Scale (PANSS) total score. Following participation in ENHANCE-1, patients will be eligible to enroll in a 52-week open-label extension study.
About Schizophrenia
According to the National Mental Health Institute, approximately one percent of the U.S. population develops schizophrenia during their lifetime. Schizophrenia is a chronic, debilitating mental illness characterized by disturbances in thinking, emotional reaction, and behavior. These disturbances may include positive symptoms, such as hallucinations and delusions, and a range of negative symptoms, including loss of interest, emotional withdrawal and cognitive disturbances. Current drugs used to treat schizophrenia have substantial limitations, including severe side effects and a lack of efficacy on the full range of symptoms of the disease.
According to the American Psychiatric Association, about 30 percent of patients with schizophrenia have inadequate response to antipsychotic medications, meaning that they exhibit improvement, but continue to have residual hallucinations or delusions. As a result, about 25 to 50 percent of schizophrenia patients are treated with two or more antipsychotics. This polypharmacy has led to increased dose-related side effects and complicated dosing regimens that can further contribute to poor treatment compliance and subsequent relapse in these patients.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in schizophrenia. Pimavanserin is being evaluated in an extensive clinical development program by ACADIA across multiple indications. Pimavanserin (34 mg) was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for the adjunctive treatment of patients with schizophrenia.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the progress and timing of ACADIA's drug discovery and development programs, the expected design and scope of ACADIA's clinical trials, and the benefits to be derived from NUPLAZID (pimavanserin) and ACADIA's product candidates, including whether pimavanserin could provide an important new option for adjunctive treatment of schizophrenia or improve clinical outcomes by augmenting the efficacy of currently used antipsychotics and/or lessening the undesirable side effects associated with polypharmacy. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, approval and commercialization, and in collaborations with others, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2015 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Important Safety Information and Indication for NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
Adverse Reactions:Themost common adverse reactions(≥2% for NUPLAZID and greater than placebo) wereperipheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
Drug Interactions:Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.
For additional Important Safety Information, including boxed warning, please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161103005542/en/
Source: ACADIA Pharmaceuticals Inc.
Read more: http://www.nasdaq.com/press-release/acadia-pharmaceuticals-initiates-phase-iii-trial-of-pimavanserin-for-adjunctive-treatment-in-20161103-00259#ixzz4Ox3L2UwH
____________________________________________
ACAD
ACADIA Pharmaceuticals Initiates Phase II Study of Pimavanserin in Alzheimer’s Disease Agitation
By Business Wire, October 31, 2016, 09:00:00 AM EDT
SAN DIEGO--(BUSINESS WIRE)--
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in central nervous system disorders, today announced the initiation of SERENE, a Phase II study with pimavanserin for the treatment of agitation in patients with Alzheimer's disease (AD Agitation). There is currently no drug approved by the FDA for the treatment of AD Agitation. Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors, with a distinct mechanism of action compared to other currently available medicines used off-label to treat AD Agitation.
"AD Agitation is a common condition and a major cause of distress for Alzheimer's patients, their families and caregivers," said Serge Stankovic
, M.D., M.S.P.H., ACADIA's Executive Vice President, Head of Research and Development. "It also is associated with more rapid decline and earlier institutionalization of patients with AD Agitation. With no FDA-approved therapy for AD Agitation, there is a large, unmet need for a new treatment option for patients."
About the SERENE Study
SERENE is a Phase II, randomized, double-blind, placebo-controlled, multi-center outpatient study designed to examine the efficacy and safety of pimavanserin in approximately 430 patients with Alzheimer's disease who have agitation and/or aggression symptoms. Patients will be randomized to receive once daily oral doses of 34 mg pimavanserin, 20 mg pimavanserin or placebo for 12 weeks. The primary endpoint in the study is a reduction in total score on the Cohen-Mansfield Agitation Inventory (CMAI). Following participation in SERENE, patients will be eligible to enroll in an open-label safety extension study.
About Alzheimer's Disease Agitation (AD Agitation)
According to the Alzheimer's Association, around 5.4 million people in the United States are living with Alzheimer's disease and approximately half are diagnosed with the disease. Studies suggest that 40 to 50 percent of patients diagnosed with Alzheimer's disease in the United States exhibit agitation. AD Agitation is characterized by verbal aggression, physical aggression, and excessive motor activities. These behavioral symptoms have been associated with more rapid cognitive decline, greater caregiver burden, and earlier institutionalization.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in AD Agitation. Pimavanserin is being evaluated in an extensive clinical development program by ACADIA across multiple indications. Pimavanserin (34 mg) was approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID™. NUPLAZID is not approved for the treatment of AD Agitation.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the progress and timing of ACADIA's drug discovery and development programs, the expected design and scope of ACADIA's clinical trials, and the benefits to be derived from NUPLAZID™ (pimavanserin) and ACADIA's product candidates, including the potential effectiveness of pimavanserin in AD Agitation patients. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, approval and commercialization, and in collaborations with others, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2015 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Important Safety Information and Indication for NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
Adverse Reactions:Themost common adverse reactions(≥2% for NUPLAZID and greater than placebo) wereperipheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
Drug Interactions:Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.
For additional Important Safety Information, including boxed warning, please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161031005429/en/
Source: ACADIA Pharmaceuticals Inc.
Read more: http://www.nasdaq.com/press-release/acadia-pharmaceuticals-initiates-phase-ii-study-of-pimavanserin-in-alzheimers-disease-agitation-20161031-00622#ixzz4OfV3oFcI
_________________________________
ACAD
Now believing there is a Hillary effect. Announcement of the re-start of FBI probe immediately dropped the Dow and shot up the LABU, together with IDRA. Leveling off for now.
IDRA
Idera Pharmaceuticals beats by $0.02, beats on revenue
Oct. 28, 2016 7:40 AM ET|About: Idera Pharmaceuticals, Inc. (IDRA)|By: Mamta Mayani, SA News Editor
Idera Pharmaceuticals (NASDAQ:IDRA): Q3 EPS of -$0.10 beats by $0.02.
Revenue of $0.32M (+1500.0% Y/Y) beats by $0.2M.
IDRA
Idera Pharmaceuticals Reports Third Quarter 2016 Financial Results
CAMBRIDGE, Mass. and EXTON, Pa., Oct. 28, 2016 (GLOBE NEWSWIRE) --
Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, today reported its financial and operational results for the third quarter ended September 30, 2016.
Since June 30, 2016, the Company:
Announced positive clinical data from the initial cohorts of the phase 1 dose escalation portion of the Company's ongoing Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab in patients with PD-1 refractory metastatic melanoma;
Presented pre-clinical data updates on both novel mechanism of action and selective targeting of single point mutations with 3rd Generation Antisense (3GA) at the Cold Springs Harbor Laboratory Conference on Regulatory & Non-Coding RNAs conference and the Annual Meeting of the Oligonucleotide Therapeutic Society, respectively;
Received acceptance of an abstract entitled "Reactivating the Anti-tumor Immune Response by Targeting Innate and Adaptive Immunity in a Phase I/II Study of intratumoral IMO-2125 in Combination with Systemic Ipilimumab in Patients with Anti-PD-1 Refractory Metastatic Melanoma" for an oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2016;
Received acceptance of an oral presentation entitled "IMO-2125, An Investigational intratumoral Toll-Like Receptor 9 Agonist, Modulates the Tumor Microenvironment to Enhance Anti-Tumor Immunity" at SITC Annual Meeting;
Generated estimated net proceeds of $48.9M, after deducting underwriters' discounts and commissions and estimated offering expenses, from a public offering of common stock, including from the partial exercise by the underwriters of their option to purchase additional shares in the offering, which option exercise is expected to close today. The Company believes that, based on its current operating plan, its existing cash, cash equivalents and investments, including the net proceeds from the offering, will enable it to fund its operations into the first quarter of 2018 and continue acceleration and development of key research and clinical development programs; and
Announced increased prioritization of IMO-2125 with plans to initiate two additional multi-center clinical trials in 2017 both as monotherapy and in combination with check-point inhibitors in multiple tumor types.
"The third quarter of 2016 was a very productive period for our team at Idera and positions us well to close out the year very strong and carry that momentum into a catalyst rich 2017," stated Vincent Milano
, Idera's Chief Executive Officer "As I noted in late September, we are incredibly energized by the IMO-2125 data we announced in such an early phase of the development and are now mobilized to advance this program rapidly, to potentially alter the lives of other patients who have exhausted all other good options."
Continued Milano, "I am also proud of the conduct of our team to complete all the work that was necessary to inform and enable our recent decision to suspend work on the B-cell program, which, while difficult, allows us to redirect additional resources to accelerate the development of IMO-2125. We remain excited for the prospects of dermatomyositis with IMO-8400 and we are looking forward to being in a position to go into greater detail in January on our plans to begin the clinical phases of development with the 3GA platform."
Research and Development Program Updates
IMO-2125 and IMO-8400 are the Company's lead clinical development drug candidates. IMO-2125 is an oligonucleotide-based agonist of Toll-like receptor (TLR) 9. IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and 9. The Company also announced, in late 2015, the first two potential development targets from its proprietary 3GA technology platform: NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4). The Company continues to evaluate these and other potential targets. The Company plans to take the first 3GA candidate into human proof of concept studies in 2017.
Toll-like Receptor (TLR) Agonism
Immuno-Oncology Program
Idera's development program in immuno-oncology is based on the rationale that intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate dendritic cells and modulate the tumor microenvironment to potentiate the anti-tumor activity of checkpoint inhibitors and other immunotherapies. This rationale is supported by pre-clinical data in multiple tumor types. These pre-clinical studies led Idera into a strategic alliance with the University of Texas MD Anderson Cancer Center to evaluate the combination of intratumoral IMO-2125 with checkpoint inhibitors.
In late 2015, Idera announced the initiation of a Phase 1/2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab, a CTLA4 antibody, which is being conducted at the University of Texas MD Anderson Cancer Center. This trial is being conducted in patients with relapsed or refractory metastatic melanoma who have failed prior PD-1 therapy. In September 2016, the Company announced positive preliminary clinical data from the initial dosing cohorts in the ipilimumab arm of the dose escalation portion of the trial. The trial has recently been amended to also include the evaluation of the combination of intratumoral IMO-2125 with pembrolizumab, an anti-PD1 antibody, with enrollment in this arm now underway. The Company plans to expand the trial to additional clinical trial sites to conduct the phase 2 portion of the trial.
The results announced are summarized as follows:
Safety
10 patients in 3 dosing cohorts (4mg, 8mg and 16mg) were dosed and assessable for safety, as of the September 19, 2016 cutoff date;
IMO-2125 in combination with ipilimumab was being generally well tolerated at all 3 dose levels;
Immune related adverse events have been observed in 3 subjects: 2 responding patients have experienced hypophysitis and 1 patient has discontinued the study due to a recurrence of immune related hepatitis previously observed on pre-study therapy with ipilimumab;
No dose limiting toxicities (DLTs) were identified and the study is currently enrolling at the highest (32mg) dosing cohort in combination with ipilimumab.
Clinical activity
6 patients treated in the first two dosing cohorts (4mg and 8mg) were assessable for initial clinical activity, as of the September 19, 2016 cutoff date;
3 of the 4 patients with cutaneous melanoma were investigator-assessed responders with one Complete Response (CR) and 2 Partial Responses (PR).
Translational observations
Translational data seen through the first two dosing cohorts (4mg and 8mg) were promising relative to the induction of immune responses and consistent with the underlying hypothesis of the mechanism of action;
Detailed information on the translational findings from biopsies taken in the first two dosing cohorts and the relationship of these to clinical response is the subject of an accepted oral presentation on November 11, 2016 at the 2016 Society for Immunotherapy of Cancer (SITC) Annual Meeting by Cara Haymaker
, Ph.D., University of Texas, MD Anderson Cancer Center.
The Company also announced plans to take another data cut at the end of 2016 and request an End of Phase 1 (EOP) meeting with the U.S. Food and Drug Administration to discuss next steps and the path to a regulatory filing. The Company also anticipates requesting a meeting with the European Medicines Agency (EMA) for scientific advice.
Idera also plans to initiate trials to explore IMO-2125 as a monotherapy in multiple tumor types as well as a Phase 2 basket study of IMO-2125 in combination with check point inhibitors in additional tumor types beyond melanoma. Both of these studies are planned to initiate in 2017.
Toll-like Receptor (TLR) Antagonism
Dermatomyositis Clinical Development Program
In late 2015, Idera announced the initiation of a Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis, a rare auto-immune condition, which negatively affects skin and may result in debilitating muscle weakness. TLRs have been reported to play a role in the pathogenesis of the disease. This randomized, double-blind, placebo controlled Phase 2 trial is expected to enroll 36 patients will be conducted at approximately 22 clinical sites worldwide. The Company plans to complete enrollment of this trial by the end of 2017 and have clinical data available in early 2018.
B-cell Lymphoma Clinical Development Program
In September 2016, Idera announced that the company had suspended the clinical development of IMO-8400 for B-cell lymphomas, including studies in Waldenstroms Macroglobulinemia (WM) and Diffuse Large B-Cell Lymphoma (DLBCL), and planned to explore strategic options in these indications. This decision was based upon the prioritization of the clinical development plans for IMO-2125 and the Company's assessment that the level of clinical activity seen in the WM trial does not support monotherapy, the very slow enrollment rate in DLBCL and the Company's commercial assessment of IMO-8400. IMO-8400 was generally well tolerated at all dose levels evaluated in the studies.
Third Generation Antisense Platform (3GA)
Idera's proprietary third-generation antisense (3GA) platform technology is focused on silencing the mRNA associated with disease causing genes. Idera has designed 3GA oligonucleotides to overcome specific challenges associated with earlier generation antisense technologies and RNAi technologies.
In late 2015, Idera announced the identification of NLRP3 (NOD-like receptor family, pyrin domain containing protein 3) and DUX4 (Double Homeobox 4) as initial gene targets to advance into IND-enabling activities, which will occur throughout 2016. Potential disease indications related to these targets include, but are not limited to, interstitial cystitis, lupus nephritis, uveitis and facioscapulohumeral muscular dystrophy (FSHD). Over the first three quarters of 2016, Idera has generated additional 3GA compounds for a series of additional gene targets, which join NLRP3 and DUX4 as potential gene targets for the first clinical development program. The Company is currently conducting clinical, regulatory and commercial analysis activities and conducting IND-enabling studies. The Company plans to enter the clinic in 2017 for the first clinical development program. These additional compounds will enable the Company to continue to expand its potential future pipeline opportunities for both internal development as well as partnerships in areas outside of Idera's focus.
In August 2016, Idera presented new pre-clinical data demonstrating the novel mechanism of action of the 3GA platform at the Cold Springs Harbor Laboratory Conference on Regulatory & Non-Coding RNAs. Subsequently, Idera presented in September 2016, new pre-clinical data demonstrating how the 3GA platforms unique mechanism of action supports selective targeting of single point mutations as well as a pre-clinical data presentation of 3GA targeting of NLRP3 for the treatment of inflammatory disorders. These presentations were made at the 12th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS).
In late 2015, Idera entered into a collaboration and license agreement with GSK to research, develop and commercialize compounds from its 3GA technology for the treatment of undisclosed, selected renal targets. As per the terms of the agreement, Idera received an upfront payment of $2.5 million and is eligible to receive up to approximately $100 million in milestone payments, including the $2.5 million payment, in addition to royalties.
Financial Results
Third Quarter 2016 Results
Net loss for the three months ended September 30, 2016 was $12.9 million, or $(0.10) per basic and diluted share, compared to a net loss of $11.4 million, or $(0.10) per basic and diluted share, for the same period in 2015. Revenue totaled $0.3 million and $0.9 million during the three and nine months ended September 30, 2016, respectively. There was nominal revenue recognized during the corresponding 2015 periods. For the nine month period ended September 30, 2016, the Company's net loss was $39.2 million, or $(0.32) per basic and diluted share, compared to a net loss of $36.6 million, or $(0.32) per diluted share, for the same period in 2015.
Research and development expenses for the three months ended September 30, 2016 totaled $9.4 million compared to $7.5 million for the same period in 2015. For the nine month period ended September 30, 2016, research and development expenses totaled $28.8 million compared to $25.1 million for the same period in 2015.
General and administrative expense for the three months ended September 30, 2016 totaled $3.9 million compared to $4.0 million for the same period in 2015. For the nine month period ended September 30, 2016, general and administrative expenses totaled $11.6 million compared to $11.7 million for the same period in 2015.
As of September 30, 2016, Idera's cash, cash equivalents and investments totaled $53.4 million compared to $87.2 million as of December 31, 2015.
In October 2016, the Company completed a public offering of its common stock, generating estimated net proceeds of $48.9M, after deducting underwriters' discounts and commissions and estimated offering expenses, including from the partial exercise by the underwriters of their option to purchase additional shares in the offering, which option exercise is expected to close today. The Company believes that, based on its current operating plan, its existing cash, cash equivalents and investments, including the net proceeds from the offering, will enable it to fund its operations into the first quarter of 2018 and continue acceleration and development of key research and clinical development programs.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel nucleic acid-based therapies for the treatment of certain cancers and rare diseases. Idera's proprietary technology involves using a TLR-targeting technology, to design synthetic oligonucleotide-based drug candidates to act by modulating the activity of specific TLRs. In addition to its TLR programs, Idera has created a third generation antisense technology platform using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether the Company's cash resources will be sufficient to fund the Company's continuing operations and the further development of the Company's programs for the period anticipated; whether interim results from a clinical trial, such as the preliminary results reported in this release, will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials such as the results described in this release will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera's technology will advance into or through the clinical trial process when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company's collaborations will be successful; and such other important factors as are set forth under the caption "Risk factors" in the Company's prospectus supplement filed on October 7, 2016. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Idera Pharmaceuticals, Inc.
Condensed Statements of Operations - Unaudited
(In thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2016 2015 2016 2015
Alliance Revenue $ 323 $ 20 $ 918 $ 59
Operating Expenses
Research & Development 9,393 7,454 28,817 25,134
General & Administrative 3,907 4,030 11,601 11,688
Total Operating Expenses 13,300 11,484 40,418 36,822
Loss from Operations (12,977 ) (11,464 ) (39,500 ) (36,763 )
Other Income (Expense), Net 74 99 289 198
Net Loss $ (12,903 ) $ (11,365 ) $ (39,211 ) $ (36,565 )
Basic and diluted net loss per common share applicable to common stockholders $ (0.10 ) $ (0.10 ) $ (0.32 ) $ (0.32 )
Shares used in computing basic and diluted net loss per common share applicable to common stockholders 121,389 118,248 121,332 113,821
Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
(In thousands)
At September 30, At December 31,
2016 2015
(Unaudited)
Cash, Cash Equivalents & Investments $ 53,418 $ 87,157
Other Assets 5,060 5,119
Total Assets $ 58,478 $ 92,276
Total Liabilities $ 8,606 $ 8,694
Total Stockholders' Equity 49,872 83,582
Total Liabilities & Stockholders' Equity $ 58,478 $ 92,276
IDERA PHARMACEUTICALS Contact:
Robert A. Doody, Jr.
VP, Investor Relations & Communications
Phone (617) 679-5515
RDOODY@IDERAPHARMA.COM
Source: Idera Pharmaceuticals, Inc.
Read more: http://www.nasdaq.com/press-release/idera-pharmaceuticals-reports-third-quarter-2016-financial-results-20161028-00255#ixzz4ONcjJ9Yd
FWIW, the chart has turned from positive on Tues to very bearish. I see not one good indicator. Not even oversold as it was last week.
They did the offering at the wrong time and I bought at the wrong time. Added yesterday and will add more. Needs some news to uncouple from the LABU or XBI which it is following down. See some suggestions that the recnt poll strength of Clinton is part of the reason for the downturn so could be a bad patch ahead. However, have also read that she wouldn't be as bad on pharm as some suggest. Who knows? Your thoughts?
IDRA
Offering.
AEZS
No idea. This is Canadian halt. Still trading is US.
AEZS
IROC trade halt!!
AEZS
They have a new Fact Sheet dated, October 2016, which has been updated in the iBox. Phase 3 trial is slated to be completed by the end of 2016. Completed versus data released are not the same.
Check out their website which has been greatly improved:
http://aezsinc.com/
AEZS
$BIIB effect -- helping the sector and especially ACAD with BO rumors?
ACAD
New day, same story. Sell off at open. Hopefully follows the plot and battles back up at the EOD.
IDRA
I don't have an opinion. Just posted the news as a moderator -- have no shares.
This is not major news so probably will depend on the overall sector. It would be interesting to see if they remain on track. I thought they would be further along on the recruitment for the Phase 3 clinical trial of Macrilen, but could be wrong. Will check later.
AEZS
Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen™
Date : 10/26/2016 @ 8:00AM
Expects to File NDA in H1 of 2017, if Warranted by Trial Results
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced it has successfully completed patient recruitment for the confirmatory Phase 3 clinical trial of Macrilen™ (macimorelin) as a growth hormone stimulation test for the evaluation of growth hormone deficiency in adults (“AGHD”). The Company also confirmed that it expects to file a New Drug Application for Macrilen™ with the United States Food and Drug Administration (the “FDA”) during the first half of 2017, if the results of the trial warrant doing so. Macrilen™ is the Company’s proposed tradename for macimorelin. The proposed tradename is subject to approval by the FDA.
Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “We are committed to the development of Macrilen™ because of the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD. Patients who are suspected of having AGHD are now very often evaluated by means of the insulin tolerance test (“ITT”). While the ITT is the historical gold-standard for the evaluation of AGHD, the procedure is inconvenient for patients and physicians and contraindicated in certain patients, such as patients with coronary heart disease or seizure disorder, because it requires the patient to experience hypoglycemia to obtain a result. In addition, it is not an FDA-approved procedure. Furthermore, administration of the ITT is expensive because the patient must be constantly monitored by a physician for the 2- to 4-hour duration of the test and the test must be administered in a setting where emergency equipment is available and where the patient may be quickly hospitalized, if necessary. With the completion of recruitment for our confirmatory Phase 3 clinical trial of Macrilen™ for the evaluation of AGHD, we are another step closer to being able to provide this important product to clinicians and patients.”
The Company believes that, in the US alone, approximately 40,000 confirmatory tests for AGHD will be conducted each year after the introduction of Macrilen™, if it is approved by the FDA, which represents the target market for Macrilen™ at the time of its anticipated commercialization. Furthermore, the Company believes that Macrilen™, if it is approved, is likely to be rapidly adopted by physicians as the preferred means of evaluating AGHD for the following reasons:
it is safer than the ITT because it does not require the patient to become hypoglycemic and thus avoids the symptoms and potential complications of hypoglycemia;
Macrilen™ is administered orally, while the ITT requires an intravenous infusion of insulin;
the evaluation of AGHD using Macrilen™ is significantly less time consuming and labor intensive than the ITT and, therefore, it is less expensive to conduct; and
the evaluation can be conducted in the physician’s office rather than in a hospital setting.
As a result, the Company believes that Macrilen™, if it is approved, may be used for 40% to 50% of AGHD evaluations in the U.S. during the first year after its introduction and that the percentage could grow to as high as 85% within the first three years of commercialization.
About the Study
The confirmatory Phase 3 clinical study of Macrilen™, entitled Confirmatory validation of oral macimorelin as a growth hormone (GH) stimulation test (ST) for the diagnosis of adult growth hormone deficiency (AGHD) in comparison with the insulin tolerance test (ITT), was designed as a two-way crossover study with the ITT as the benchmark comparator and involves some 30 sites in the United States and Europe. The study population consists of more than 110 subjects (at least 55 ITT-positive and 55 ITT-negative) with a medical history documenting risk factors for AGHD, and includes a spectrum of subjects from those with a low risk of having AGHD to those with a high risk of having the condition. The primary objective is validation of a single oral dose of macimorelin for the diagnosis of AGHD, using the ITT as a comparator. Based on meetings with the FDA as well as the European Medicines Agency (“EMA”) and subsequent written scientific advice, the Company believes that the study meets the FDA’s and the EMA’s study-design expectations allowing US and European approval, if successful. For more details on the trial, please consult this link:
https://www.clinicaltrials.gov/ct2/show/NCT02558829?term=macimorelin&rank=1.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this patented compound and has significant patent protection left. The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027. The Company proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.
About AGHD
AGHD affects approximately 75,000 adults across the US, Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the rejection or non-acceptance of any new drug application by one or more regulatory authorities and, more generally, uncertainties related to the regulatory process, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the degree of market acceptance once our products are approved for commercialization, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except if required to do so.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161026005227/en/
Aeterna Zentaris Inc.
Philip A. Theodore
Senior Vice President
ir@aezsinc.com
843-900-3223
AEZS
That is in part why I'm here (and in ACAD). Not the main reason, but gives some comfort when the pps is down. They don't always win but have a great record. Should do well when the sector reverses. You in either?
IDRA
4 of the last 5 days IDRA goes down at the opening and 4/4 last days went up at EOD. Hopefully will make it 5/5 ending higher at the EOD.
IDRA
I've see tweets and blogs suggesting both high call vol and high put vol so I don't know. I've not seen anything about one individual buying puts on a daily basis. I don't pay much attention to these, but you can judge for yourself:
https://finance.yahoo.com/quote/ACAD/options?p=ACAD
ACAD
Nice to know. I see the pm bid is $1.97 -- at least for now. When you say superior gain do you mean a 1 day pop or a multi-day run? Can't tell from the charts, although looking at the past 3 years it appears that roughly 80% of the time it has been higher than currently.
You are very experienced with the company. It is best to stay long continuously or do you sell on the gains and re-enter later?
IDRA
Very strong finish. MMs picked up a few $1.97 and $1.98 seconds after close. Bid remains @ $1.97.
IDRA
Doing very well today considering the biotech sector is down (LABU is -2.54%). See no news or promo tweets.
IDRA
Suppose will continue to follow the sector down (LABU down ~ 1.0% today). The volume already at the 50 daily average but guess it is just folks re-positioning.
See no more or very few twitter mentions of BO.
Hope it never goes to sub $20's, but we'll see.
ACAD
Some much for the dream. Needs a lot of push to overcome the biotech sector -- LABU is down -2.74%.
ACAD
Pretty good volume, 260K, and ACAD is now above $26.00 and has been as high as $26.80. Someone chasing.
260,322 $ 26.80
(19:00:05 PM) $ 24.9694
(16:11:44 PM)
Read more: http://www.nasdaq.com/symbol/acad/after-hours#ixzz4NlURWBGY
A second reason for the upturn today may have been the SA blog from earlier in the day:
http://seekingalpha.com/article/4013487-acadia-pharmaceuticals-seems-just-gotten-one-step-closer-europe
Some interesting comments to the blog and also a lot of Tweets for a Friday nite.
ACAD
You are correct. So the rumored price is $42. Sure didn't make sense at $24, the incorrect figure. The strong close sure looks like folks believing in the $42 figure which as has been noted probably should be closer to $60 according to a frequently mentioned target price. Hope we are good come Monday!!
Another interesting thesis:
@sharkbiotech perhaps $acad gets $40 bid which is not taking new data into acct, $biib tries to steal it cheap before +data May be $65 after
ACAD
I'd agree. Hear the BakerBros want $60 as you indicate. Just another rumor today but hoping there is no closing sell-off.
Sure got the volume going -- now about 2 1/2 times normal and holding steady.
ACAD
I think it was corrected from $42 to $24. They seemed to do it immediately. However, I see a lot of tweets using the $42 figure rather than the corrected one (some of those doing this I recognize as long ACAD).
Here is the twitter feed for them:
https://twitter.com/DAMSConsulting
ACAD
FWIW, here seems to be the rumor source:
"DAMS Consulting ?@DAMSConsulting 3h3 hours ago
$ACAD sorry price was $24
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DAMS Consulting ?@DAMSConsulting 3h3 hours ago
$ACAD $23 rumor $BIIB will make a $42 cash bid for company going around street now"
As that was 31/2 hours ago sure hope the pps remains up, especially after the corrected price of "$24".
ACAD
Exactly, I see a lot of posts doubting the rumor given it is OPEX day.
Hope the momentum holds for a sustained chart reversal.
ACAD
From what I see the high volume today (so far 50% above 50 DMA) has crossed it over from oversold based on RSI, CCI and Wm%R(14).
Baker Bros not always right, but wouldn't bet against them.
ACAD