Alnylam to Webcast Conference Call Discussing Fourth Quarter and Full Year 2017 Financial Results

On February 1, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that it will report financial results for the fourth quarter and year ending December 31, 2017 on Thursday, February 8, 2018, before the U.S. financial markets open (Press release, Alnylam, FEB 1, 2018, http://investors.alnylam.com/news-releases/news-release-details/alnylam-webcast-conference-call-discussing-fourth-quarter-and-9 [SID1234523699]).

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Management will provide an update on the Company and discuss fourth quarter and year-end 2017 results as well as expectations for the future via conference call on Thursday, February 8, 2018 at 8:30 am ET. To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 9496435. A replay of the call will be available beginning at 11:30 am ET on the day of the call. To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international) and refer to conference ID 9496435.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.alnylam.com. An archived webcast will be available on the Alnylam website approximately two hours after the event.

Actinium Pharmaceuticals Announces Acceptance of Abstract for AACR Annual Meeting Highlighting Superior In Vivo Survival Data for Actinium Labelled Daratumumab Versus Unlabeled Daratumumab, A Blockbuster Product

On Feb 1, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported that its abstract has been accepted for a poster presentation at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 14-18, 2018 in Chicago, Illinois (Press release, Actinium Pharmaceuticals, FEB 1, 2018, View Source [SID1234523695]). The abstract showcases the potential of Actinium’s AWE Technology Platform, specifically, the ability of actinium-225 to enhance the in vivo efficacy of daratumumab, a CD38 targeting therapy that is marketed by Johnson & Johnson as Darzalex.

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Per the abstract submission highlighted below, the Ac-225 labelled daratumumab at an equimolar concentration demonstrated superior antitumor activity to naked daratumumab in a highly predictive DAUDI model and provided a survival benefit. Additional details will be available at the time of the Annual Meeting. The Company had earlier presented initial in vitro data at ASH (Free ASH Whitepaper) which studied the effect of Actinium-225 labeled daratumumab on DAUDI, 28BM and 28PE cell lines at the 48, 72 and 96 hour time points as well as U226, a cell line that does not express CD38. The results showed that when daratumumab is labeled with Actinium-225, cell death was increased as much as ten-fold, approaching one-hundred percent cell death in certain cell lines and at certain time points, and in all three cell lines tested the Actinium-225 labeled daratumumab had higher cell death compared to naked daratumumab. In addition, immunogenicity was preserved with most or all of daratumumab’s CD38 targeting ability maintained, high rates of radioisotope labeling of the antibody from 82-85% was demonstrated, as was high rates of stability from 73-87% at various temperatures forty-eight hours post labeling.

Details on the poster are as follows:

Title: Conjugation of daratumumab with 225actinium greatly increases its antitumor activity against multiple myeloma tumors
Abstract Number: 760
Session Category: Experimental and Molecular Therapeutics

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, "We are excited to build upon the already exciting data from our AWE Program and are looking forward to presenting new data from our continued efforts. The data we will present will exemplify Actinium’s expanding R&D capabilities and the potential of our AWE technology platform, which are now being spearheaded by our new Chief Scientific Officer, Dr. Dale Ludwig. This is the first AACR (Free AACR Whitepaper) that Actinium has presented data at and we look forward to a growing and impactful presence as we are committed to continuing to leverage our AWE technology and extending our capabilities both on behalf of our internal efforts but also for partners"

About Our Actinium Warhead Enabling Technology Platform

The Actinium Warhead Enabling (AWE) Technology Platform enables a highly potent and selective form of targeted therapy that combines the powerful alpha-emitting radioisotope actinium-225 with targeting agents, which are designed to seek out cancer cells in the body that express particular markers. Actinium-225 emits significant alpha radiation making it a potent treatment modality against targeted cancer cells while limiting damage to healthy tissues as its radiation travels extremely short distances in the body. When labeled to targeting agents, actinium-225 can be delivered directly to cancer cells where the high linear energy transfer resulting from the emission of alpha particles results in irreparable DNA double stranded breaks and ultimately cancer cell death. Despite this superior cell killing power, actinium-225 when delivered in a targeted manner is sparing of the surrounding environment in the body due to the short path length of its alpha-particle radiation and can result in a superior safety profile. Actinium Pharmaceuticals owns or has licensed the rights to several issued and pending patents that pertain to its AWE Technology Platform including technology to manufacture Actinium-225 in a cyclotron. In addition, the Company obtains actinium-225 from various sources such as the U.S. Department of Energy at Oak Ridge National Laboratories and has developed considerable know-how, expertise and validated processes related to production of Actinium Radio-Conjugates (ARC’s), management of the supply chain and dealing with various regulatory bodies. The AWE Technology Platform can be utilized to potentially improve the cell-killing power of targeting agents such as antibodies, peptides, Fab fragments, nanobodies etc. via labeling with Actinium-225. In addition to increased efficacy, these Actinium-225 enhanced targeting agents can offer optimized dosing or administration and in the case of approved targeting agents provide an opportunity to extend intellectual property protection by the creation of biobetters or improved versions of the approved agent. The Company’s Actinium Warhead Enabling (AWE) Program can be accessed by biopharmaceutical companies that are interested in creating biobetters through the utilization of the AWE Platform Technology. To learn more about the AWE Technology Platform or the AWE Program please contact Keisha Thomas, Ph.D., Corporate Development at [email protected].

Integra LifeSciences to Host Fourth Quarter 2017 Earnings Results Conference Call on February 27, 2018

On February 1, 2018 Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, reported that it will release fourth quarter and full year 2017 financial results on Tuesday, February 27, 2018, prior to market open (Press release, IsoTis, FEB 1, 2018, View Source [SID1234523685]). In conjunction with the earnings release, Integra will host a conference call at 8:30 a.m. ET.

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Peter J. Arduini, president and chief executive officer, and Glenn G. Coleman, chief financial officer and corporate vice-president of International, will review fourth quarter and full year 2017 results during the call.

The live call is accessible by dialing (323) 794-2093 and using the passcode 7668138. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com.

A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available through March 3, 2018 by dialing (719) 457-0820 and using the passcode 7668138.

ONC201 Trial Begins at NYU for Children with H3 K27M Mutant Glioma

On January 31, 2018 Oncoceutics, Inc. reported that the first patient has been treated in a clinical trial of ONC201 for pediatric patients with brain tumors that contain a specific mutation called the histone H3 K27M mutation (Press release, Oncoceutics, JAN 31, 2018, View Source [SID1234558373]). The trial, which will treat patients with recurrent high-grade gliomas, including glioblastoma and diffuse intrinsic pontine glioma (DIPG), is led by Sharon Gardner, MD, a pediatric neuro-oncologist at NYU Langone Health’s Stephen D. Hassenfeld Children’s Center for Cancer & Blood Disorders. The study will enroll approximately 45 pediatric patients using ONC201 as a single agent or in combination with radiotherapy for patients with recurrent or newly diagnosed disease, respectively.

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The H3 K27M mutation has been identified as an important prognostic indicator in aggressive midline gliomas that involve specific parts of the brain, including the thalamus, pons, or spinal cord. In 2016, the World Health Organization categorized any midline brain tumor that contains the H3 K27M mutation as the highest grade (IV) because the mutation confers such a poor prognosis. Beyond palliative radiation, no medical therapy has been shown to provide clinical benefit for patients with this mutation in their tumor. Pediatric patients are particularly impacted by this mutation, especially those with DIPG where 70-80% of the patients have the mutation.

As previously announced, the company’s focus on H3 K27M mutual gliomas arose from success with a patient in the first group of its phase II trial for recurrent glioblastoma conducted at Harvard. This patient, a 22-year old woman, had the H3 K27M mutation and has experienced a 96% reduction in tumor size. She remains on therapy today (after 22 months) and has returned to her normal activities. Based on the strong result for this patient, Oncoceutics enrolled additional brain tumor patients with the H3 K27M mutation, and some of these patients have also done well, including a patient whose tumors have completely disappeared. In addition to enrolling more adult patients with the H3 K27M mutation at Harvard (where the trial was limited to adults), we have enrolled a handful of children with brain tumors that have the mutation under compassionate use protocols, special permission from the FDA to enroll patients on a case-by-case when there is no approved clinical trial accessible to the patient. We have also seen signs of efficacy in these children. In total, 14 patients with brain tumors that have the H3 K27M mutation have been treated with single agent ONC201 (7 in formal clinical studies and 7 in compassionate use studies), and five of these patients have demonstrated clinical and/or radiographic benefit from ONC201 therapy. These data will be reported in upcoming scientific conferences and publications. In addition, corroborating preclinical efficacy and mechanistic studies from the lab of Andrew Chi, MD, also at NYU Langone Health, have shown that H3 K27M gliomas cells are extremely sensitive to ONC201.

"The previously reported responses to ONC201 in patients with H3 K27M gliomas, combined with the preclinical results from Dr. Chi’s lab here at NYU, make me excited to offer ONC201 to our patients with this molecularly-defined disease," said Dr. Gardner. "To date, no drugs have proven effective in these tumors, and this patient population is in need of novel therapeutic options.

"We are excited to expand our existing clinical program targeted at patients with the H3 K27M mutation to the pediatric populations," said Lee Schalop, MD, Chief Operating Officer at Oncoceutics. "Based on the results we have seen in patients with the H3 K27M tumor mutation who have received ONC201, as well as the preclinical data generated by Dr. Chi, we believe that ONC201 offers a unique opportunity to eliminate these devastating tumors."

Cascadian Therapeutics reported merger with Seattle Genetics

On January 31, 2018, Cascadian Therapeutics, Inc., a Delaware corporation (the " Company "), reported that it has issued a press release announcing the entry into an Agreement and Plan of Merger (the " Merger Agreement "), by and among the Company, Seattle Genetics, Inc., a Delaware corporation (" Parent "), and Valley Acquisition Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Parent (" Purchaser "), pursuant to which Purchaser will commence a tender offer (the " Offer ") to purchase all of the issued and outstanding shares (the " Shares ") of common stock, par value $0.0001 per share, of the Company at a price of $10.00 per Share in cash, net to the seller, without interest and subject to any required withholding of taxes (Press release, Cascadian Therapeutics, JAN 31, 2018, View Source [SID1234523652]). If successful, the Offer will be followed by the merger of the Company with and into the Purchaser pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with the Company being the surviving corporation (the " Merger "), and becoming a wholly-owned subsidiary of Parent.

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This Schedule 14D-9 filing consists of the following documents related to the proposed Offer and Merger:

(i) Company email to employees

(ii) Company employee presentation

(iii) Letter to HER2CLIMB clinical investigators

(iv) Letter to partners and vendors

(v) Letter to vendors and suppliers

(vi) Email to temporary workers and contractors
The information set forth under Items 1.01, 8.01 and 9.01 of the Current Report on Form 8-K filed by the Company on January 31, 2018 (including Exhibit 2.1 and Exhibit 99.1 attached thereto) is incorporated herein by reference.

Additional Information and Where to Find It

The tender offer described in this communication (the "Offer") has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Cascadian Therapeutics or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (the "SEC") and Cascadian Therapeutics will file a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the Offer with the SEC. The offer to purchase shares of Cascadian Therapeutics common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed with such Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The tender offer statement will be filed with the SEC by Valley Acquisition Sub, Inc. and Seattle Genetics, Inc., and the solicitation/recommendation statement will be filed with the SEC by Cascadian Therapeutics. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to Innisfree M&A Incorporated toll-free at (888) 750-5834.

Cautionary Statement Regarding Forward-Looking Statements

This communication may contain, in addition to historical information, certain forward-looking statements, including, without limitation, statements regarding the pending acquisition of Cascadian Therapeutics, Inc. by Seattle Genetics, Inc. and its affiliates, including Valley Acquisition Sub, Inc. (the Offer, the merger and other related transactions are collectively referred to as the "Transactions"). Often, but not always, forward-looking statements can be identified by the use of words such as "believes," "anticipates," "plans," "expects," "expected," "will," "intends," "potential," "project," "possible," "scheduled," "estimates," "intends," "continue," "ongoing," "goal" and similar expressions or variations of such words and phrases or statements that certain actions, events, conditions, circumstances or results "may," "could," "would," "might" or "will" be taken, occur or be achieved. Forward-looking statements involve risks and uncertainties related to Cascadian Therapeutics’ business and the general economic environment, many of which are beyond Cascadian Therapeutics’ control. Such uncertainties and risks include, without limitation: uncertainties as to the timing of the Offer and merger; uncertainties as to how many of the Cascadian Therapeutics’ stockholders will tender their stock in the Offer; the possibility that various closing conditions for the Transactions may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Transactions; the occurrence of any event, change or

other circumstance that could give rise to the termination of the Merger Agreement; the effects of the Transactions (or the announcement thereof) on relationships with employees, customers, other business partners or governmental entities; transaction costs; the risk that the Transactions will divert management’s attention from Cascadian Therapeutics’ ongoing business operations; and other risks and uncertainties detailed from time to time in documents filed by the Company with the securities regulators in the United States on EDGAR and in Canada on SEDAR, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9 to be filed by the Company. These risks, uncertainties and other factors could cause Cascadian Therapeutics’ actual results to differ materially from those projected in forward-looking statements. Although Cascadian Therapeutics believes that the forward-looking statements contained in this communication are reasonable as of the date hereof, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Cascadian Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, conditions, circumstances or otherwise, except as required by applicable law.