On March 6, 2019 INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported that it will release its fourth quarter and full year 2018 financial results on Thursday, Mar. 7, after the U.S. financial markets close (Press release, Insys Therapeutics, MAR 6, 2019, View Source [SID1234534075]).

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Following the release, Saeed Motahari, president and chief executive officer, and Andy Long, chief financial officer, will host a conference at 5:00 p.m. Eastern Time to discuss the results.

Interested parties can listen to the call live as it occurs via the company’s website, View Source, on the Investors section’s Presentations & Events page; or by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.) and using the Conference ID 9498523. A webcasted replay of the call will be available on the site a few hours after the event.

On March 6, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that it will present at the Cowen and Company 39th Annual Health Care Conference on Wednesday, March 13, 2019, at 8:40 a.m. Eastern Time (Press release, Odonate Therapeutics, MAR 6, 2019, View Source [SID1234534036]).

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On March 6, 2019 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet medical needs, reported its financial and operational results for the fourth quarter and year ended December 31, 2018 (Press release, Idera Pharmaceuticals, MAR 6, 2019, View Source [SID1234534076]).

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"2018 ended with incredibly positive momentum for tilsotolimod which carried into 2019 and continues today," stated Vincent Milano, Idera’s chief executive officer. "Despite the challenges we faced in the first half of 2018, we emerged as a tightly focused organization with a clear understanding of our mission to bring tilsotolimod to the market in our initial indication of anti-PD-1 refractory metastatic melanoma. We also are exploring tilsotolimod as an investigational therapy for patients with other tumor types that have not been well-served by available immunotherapies to date," continued Milano. "The ILLUMINATE development program is making excellent progress across the board and I am incredibly proud of our team for their continued dedication and execution."

"As it pertains to Idera overall, we will continue business development efforts to identify and pursue assets and opportunities with the purpose of further growing our company for long-term success and value creation for our loyal shareholders. However, I cannot be any clearer that the advancement and future success of tilsotolimod is our highest priority, passion and focus."

ILLUMINATE (tilsotolimod) Clinical Development Update

ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:

• Overall Response Rate (ORR) and Overall Survival (OS) as primary endpoints;

• Trial initiated in the first quarter of 2018;

• Sites planned in 12 countries: 78 sites activated;

• Planned enrollment of approximately 300 patients; and

• Completion of enrollment expected during the fourth quarter of 2019.

ILLUMINATE 206 – Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).

• Received notice from the U.S. Food and Drug Administration that the company can proceed to implement the ILLUMINATE-206 clinical trial under a new Investigational New Drug (IND) application; and

• Both trial cohorts of SCCHN and MSS-CRC expected to initiate in the second quarter of 2019.

ILLUMINATE 204 – Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:

• Completed enrollment with 52 patients in Phase 2 expansion at 8 mg (RP2D) dose with ipilimumab;

• Completed target enrollment of at least 40 patients in the primary enrollment population constituting patients who are naïve to prior ipilimumab treatment in the metastatic setting;

• Presented an interim data update in December 2018 which showed:

32.4% ORR of the first 34 patients evaluable for efficacy including 9% (N=3) achieve Complete Response (CR); 24% (N=8) achieving Partial Response (PR); and 76.5% (N=26) achieving disease control (CR, PR or Stable Disease [SD]); and
• Data from ILLUMINATE-204 expected in the fourth quarter of 2019.

ILLUMINATE 101 – Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:

• Completed enrollment in all dose cohorts of the trial; and

• Abstract accepted for presentation of translational data from this trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting, being held March 29 – April 3, 2019 in Atlanta, GA.

Corporate Updates:
The company today is announcing the planned retirement of Senior Vice President and Chief Medical Officer Joanna Horobin, M.B. Ch.B, given the consolidation of Idera’s business operations and team in Pennsylvania. The retirement will be effective July 31, 2019. Dr. Horobin joined Idera in November 2015 and notably has led the advancement of the tilsotolimod ILLUMINATE program, advancing the program from pre-clinical into exploratory early phase clinical and translational evaluation through to the ongoing ILLUMINATE 301 phase 3 trial in anti-PD-1 refractory metastatic melanoma and most recently expanding into a study in patients SCCHN and MSS-CRC.

Dr. Horobin will assist Idera in the search to fill the role of Chief Medical Officer and will remain with the company in an advisory capacity following her July 31 retirement.

"I’m incredibly appreciative to Joanna for the critical role she has played as we transitioned Idera to a focused clinical development organization with a clear eye towards ultimate commercialization of products for patients suffering from life-threatening rare diseases," offered Milano. "We all wish Joanna the utmost happiness as she transitions to the next phase of her life following a tremendously productive and rewarding 35-year career developing critical medicines that have made a positive impact on countless patients’ lives."

"I am tremendously proud of the progress we’ve made at Idera over the past several years. We have shown clinical proof-of-concept of tilsotolimod to prime the immune system to better respond to checkpoint inhibition which may enable tilsotolimod to benefit more patients," stated Dr. Horobin. "It’s been a great honor to work with so many talented individuals during my time at Idera and I look forward to continuing to assist in an advisory capacity as the opportunities for tilsotolimod expand."

Additionally, since September 30, 2018, the following corporate updates were announced:

• The company entered into an at the market offering (ATM) agreement with JMP Securities LLC under which the company may elect to sell shares of its common stock having an aggregate offering price of up to $50 million;

• The company entered into a common stock purchase agreement and registration rights agreement with Lincoln Park Capital (LPC) Fund, LLC, under which the company has the right to sell an aggregate of up to $35 million of its common stock at the company’s discretion; and

• Carol A. Schafer was appointed to Idera’s Board of Directors on December 18, 2018, filling the seat of Mr. William Reardon, who will be resigning from the Board effective March 10, 2019.

Upcoming Investor Conference:
The company will participate in the 2019 Barclays Global Healthcare Conference on Tuesday, March 12, 2019 at 11:15 a.m. Eastern Time at the Loews Miami Beach Hotel in Florida.

Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

Financial Results
Fourth Quarter Results
Net loss applicable to common stockholders for the three months ended December 31, 2018 was $12.2 million, or $0.45 per basic and diluted share, compared to net loss applicable to common stockholders of $14.9 million, or $0.66 per basic and diluted share, for the same period in 2017. Revenue in the fourth quarter of 2018 was nominal. Research and development expenses for the three months ended December 31, 2018 totaled $8.9 million compared to $10.4 million for the same period in 2017. General and administrative expense for the three months ended December 31, 2018 totaled $3.6 million compared to $3.7 million for the same period in 2017.

Full Year Results
Net loss applicable to common stockholders for the year ended December 31, 2018 was $59.9 million or $2.25 per basic and diluted share, compared to net loss applicable to common stockholders of $66.0 million, or $3.35 per basic and diluted share, for the same period in 2017. Revenue for the year ended December 31, 2018 was $0.7 million compared to revenue of $0.9 million for the same period in 2017. Research and development expenses for the year ended December 31, 2018 totaled $41.8 million compared to $50.7 million for the same period in 2017. General and administrative expenses for the year ended December 31, 2018 totaled $15.4 million compared to $15.6 million for the same period in 2017. Merger-related costs, net for the year ended December 31, 2018 totaled $1.2 million compared to $1.1 million for the same period in 2017. Restructuring costs for the year ended December 31, 2018 totaled $3.1 million and related to our decision in July 2018 to wind-down our discovery operations. No such costs were incurred in 2017.

As of December 31, 2018, our cash and cash equivalents totaled $71.4 million compared to $112.6 million as of December 31, 2017. We currently anticipate that, based on our current operating plan, our existing cash, cash equivalents and investments will fund our operations into the first quarter of 2020.

On March 5, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada,reported through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Immune Design (NASDAQ: IMDZ) (Press release, Merck & Co, MAR 5, 2019, View Source [SID1234533965]).On Feb. 21, 2019, Merck reported its intent to acquire Immune Design .

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Upon the successful closing of the tender offer, stockholders of Immune Design will receive $5.85 in cash for each share of Immune Design common stock validly tendered and not validly withdrawn in the offer, without interest and less any required withholding taxes. Following the purchase of shares in the tender offer, Immune Design will become a wholly-owned subsidiary of Merck.

Merck will file today with the U.S. Securities and Exchange Commission (SEC) a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Immune Design will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Immune Design board of directors that their stockholders accept the tender offer and tender their shares.

The tender offer will expire at 12:00 am EDT on April 2, 2019, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares which, together with shares then owned by Merck (if any), represents a majority of the outstanding shares, and the expiration or the termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is expected to close early in the second quarter of 2019.

Additional Information about the Tender Offer

This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Immune Design ("IMDZ") or any other securities. A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed by Merck Sharp & Dohme Corp. ("Merck") and Cascade Merger Sub Inc., a wholly-owned subsidiary of Merck ("Buyer"), with the Securities and Exchange Commission (the "SEC"), and a solicitation/recommendation statement on Schedule 14D-9 will be filed by Immune Design with the SEC. The offer to purchase shares of Immune Design common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the 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.

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 the Information Agent for the Offer, which will be named in the tender offer statement. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 423-1000. In addition, Merck and Immune Design file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Merck or Immune Design at the SEC public reference room at 100 F Street, N.E., Washington, D.C., 20549. For further information on the SEC public reference room, please call 1-800-SEC-0330. Merck’s and Immune Design’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

On March 5, 2019 Ziopharm Oncology, Inc. (Nasdaq:ZIOP) reported its financial results for the fourth quarter and year ended December 31, 2018, and provided an update on the Company’s recent activities (Press release, Ziopharm, MAR 5, 2019, View Source [SID1234533982]).

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"We are executing on our strategy to focus on solid tumors with our Sleeping Beauty TCR-T program and our Controlled IL-12 platform and advancing a solution that addresses the cost and complexity of CAR-T therapies," said Laurence Cooper, M.D., Ph.D., CEO of Ziopharm. "Under our collaboration at the National Cancer Institute (NCI), we expect to begin treating patients with solid tumors mid-year with the first non-viral, neoantigen-specific TCR-T cell therapy designed to attack the very mutations that cause cancer. In addition, we are advancing – in both the United States and greater China – our non-viral CAR-T therapy to solve the issues standing in the way of commercial success for approved CD19-specific CAR-T therapies. And, with maturing data showing a positive effect on overall survival for patients with recurrent glioblastoma, there is growing excitement for our Controlled IL-12 platform among treating physicians."

David Mauney, M.D., President of Ziopharm, added, "We have significant momentum following our transformational fourth quarter 2018 when we established a new license agreement that provides us with clinical development autonomy. We secured two new business development deals and strengthened our balance sheet by eliminating $157 million in preferred stock and raising $50 million in a private placement. Thus, we are now well positioned to achieve multiple milestones and to be in the clinic in 2019 with each of our pillar programs: TCR-T, CAR-T and Controlled IL-12."

Program Updates

Sleeping Beauty TCR-T Therapies

The Company is using its Sleeping Beauty platform to develop a personalized T-cell therapy targeting solid tumors with T-cell receptors or TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is expected to initiate a Phase 1 clinical trial to treat patients who may have one of a variety of solid tumors using the Sleeping Beauty platform to genetically modify T-cells to target patient-specific neoantigens.

Phase 1 trial for TCR-T cell therapy expected to begin in mid-2019: This trial is on track to begin treating patients in mid-2019 under the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI.

CRADA extended: Ziopharm announces that the Company and the NCI agreed to extend the CRADA governing this program to evaluate genetically modified T cells targeting solid tumors, which was established in January 2017. This agreement has been extended through January 2022.

Sleeping Beauty CAR-T Therapies

Ziopharm is advancing the Sleeping Beauty platform towards the very rapid manufacturing of genetically modified CAR+ T cells, co-expressing membrane-bound interleukin-15, or mbIL15, with a safety switch, within two days after genetically modifying T cells from the patient. This work is being done in collaboration with the University of Texas MD Anderson Cancer Center in the United States and will be done in Greater China through a joint venture, Eden BioCell.

Third-generation Phase 1 trial for very rapid manufacturing of Sleeping Beauty CD19-specific CAR-T with mbIL15 expected to begin 2H2019: The Company affirms guidance on beginning this trial and treating patients at MD Anderson Cancer Center in the second half of this year. Ziopharm announced in June 2018 that the FDA placed this investigator-led IND on clinical hold and requested additional information relating to chemistry, manufacturing and controls, specifically requesting that the product meet a minimum threshold for T-cell viability. The Company, in partnership with MD Anderson Cancer Center, has made progress toward achieving this threshold in manufacturing through improved engineering and cell processing.

Eden BioCell to advance third-generation Sleeping Beauty CAR-T for Greater China: In December 2018, Ziopharm in conjunction with TriArm Therapeutics announced Eden BioCell will be launched to develop and commercialize Sleeping Beauty-generated CD19-specific CAR-T therapies in the People’s Republic of China (including Macau and Hong Kong), Taiwan and Korea. The teams have begun meeting to prepare for technology transfer and launch the new company. Ziopharm and TriArm each will own 50 percent of the

joint venture. Eden BioCell will be funded with up to $35 million from TriArm, a privately-owned cell therapy company that was formed by Panacea Venture Healthcare, a fund co-founded and managed by James Huang, Managing Partner of Kleiner Perkins Caufield & Byers China. Ziopharm and TriArm expect to close on this joint venture in the first half of 2019. Ziopharm’s CEO Laurence Cooper, and Panacea Venture Healthcare co-founder James Huang will serve on Eden BioCell’s Board of Directors with each party sharing decision-making authority. Ziopharm looks forward to providing an update on clinical development plans for Eden BioCell later in the year.

Controlled IL-12

Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, as a drug to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit cancer-fighting T cells into tumors. In the setting for the treatment of recurrent glioblastoma (rGBM), Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex as a monotherapy and in combination with immune checkpoint inhibitors.

Enrollment completed in Phase 1 monotherapy expansion substudy: Ziopharm announced that it rapidly completed enrollment and treated a total of 36 patients in less than six months in a substudy to expand a Phase 1 trial evaluating its Controlled IL-12 platform as a monotherapy for the treatment of rGBM. The trial was over enrolled by eleven patients more than the target goal of 25, which the Company attributes to enthusiasm stemming from encouraging survival and tumor biopsy data. Preliminary data from this substudy is expected to be presented in 2019.

Third cohort has begun in combination substudy with OPDIVO (nivolumab): Ziopharm reported that it has completed two dosing cohorts in its Phase 1 substudy of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO (nivolumab), an immune checkpoint inhibitor targeting programmed death-1 (PD-1). The Company has begun the third cohort for this study to evaluate the safety and tolerability of this combination regimen, establish optimal dosing of veledimex and nivolumab, and measure overall patient survival. The Company expects to complete enrollment in the third cohort in the second quarter this year and looks forward to presenting preliminary data from this trial in 2019.

Phase 2 combination trial with Regeneron’s Libtayo (cemiplimab-rwlc) expected to open 2Q2019: The Company, in collaboration with Regeneron Pharmaceuticals, expects to open a Phase 2 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo (cemiplimab-rwlc) for treating patients with rGBM. The Company expects to enroll approximately 30 patients in this trial.

Phase 1 for pediatric tumors ongoing: Ziopharm is enrolling pediatric patients in its Phase 1 trial of Ad-RTS-hIL-12 with veledimex for the treatment of brain tumors at multiple U.S. sites.

Corporate Update

In addition to the clinical collaboration with Regeneron and the execution of an agreement to launch Eden BioCell during the fourth quarter of last year, Ziopharm on October 9, 2018, announced that it entered into a new licensing agreement that replaced all existing agreements with Intrexon Corp. and its subsidiary Precigen, Inc. Under the new license agreement, Ziopharm has full developmental control and exclusivity utilizing Sleeping Beauty for TCRs for the treatment of cancer. The CRADA with the NCI related to Sleeping Beauty-generated T cells expressing TCRs to target neoantigens within solid tumors was transferred to Ziopharm and the Company will maintain this program. Ziopharm will build on its Controlled IL-12 platform with exclusive access to Precigen’s RheoSwitch Therapeutic System gene switch with adenovirus for the treatment of cancer. Using the Sleeping Beauty system, Ziopharm will continue to exclusively advance its CD19-specific chimeric antigen receptor (CAR) program leveraging membrane-bound interleukin 15, while retaining rights to a second, unnamed CAR target. Ziopharm has sole oversight for the relationship with MD Anderson Cancer Center, the Company’s initial development partner for the Sleeping Beauty platform.

As part of the new licensing agreement, Ziopharm successfully negotiated the complete elimination of preferred stock that had been issued to Intrexon that was valued at approximately $157 million at that time.

In December, David Mauney, M.D., was promoted to President. Dr. Mauney had joined the Company in September 2017 as Executive Vice President and Chief Business Officer.

Fourth-Quarter 2018 Financial Results

Net income (loss) applicable to the common shareholders for the fourth quarter of 2018 was $194.5 million, or $1.29 per share, basic and diluted, compared to a net loss of $18.3 million, or $(0.13) per share, basic and diluted, for the fourth quarter of 2017. The increased income attributable to common shareholders resulted primarily from the forfeiture and return of all of the Company’s Series 1 preferred stock held by Intrexon Corporation and the relinquishment of Ziopharm’s obligations under the Ares Trading Agreement.

Research and development expenses were $8.2 million for the fourth quarter of 2018, compared to $11.2 million for the fourth quarter of 2017. The decrease in research and development expenses for the three months ended Dec. 31, 2018 is primarily due to decreased preclinical activity related to our cell and gene therapy programs.

General and administrative expenses were $4.6 million for the fourth quarter of 2018, compared to $3.9 million for the fourth quarter of 2017. The increase in general and administrative expenses for the three months ended Dec. 31, 2018 is primarily due to contracted outside service costs.

Full Year 2018 Financial Results

Net income (loss) applicable to the common shareholders for the year ended December 31, 2018 was $137.2 million, or $0.96 per share, basic and diluted, compared to a net loss applicable to the common shareholders of $73.3 million, or $(0.53) per share, basic and diluted, for the year ended December 31, 2017. The increased income attributable to common shareholders resulted primarily from the forfeiture and return of all of the Company’s Series 1 preferred stock held by Intrexon Corporation and the relinquishment of Ziopharm’s obligations under the Ares Trading Agreement.

Research and development expenses were $34.1 million for the year ended December 31, 2018, compared to $45.1 million for the year ended December 31, 2017. The decrease in research and development expenses for the year ended December 31, 2018, is primarily due to decreased preclinical activity related to our cell and gene therapy programs.

General and administrative expenses were $19.9 million for the year ended December 31, 2018, compared to $14.8 million for the Year ended December 31, 2017. The increase in general and administrative expenses for the year ended December 31, 2018, is primarily due to contracted outside service costs.

The Company ended the year with unrestricted cash resources of approximately $61.7 million.

In addition, a prepayment of approximately $27.8 million remains for programs to be conducted by the Company at MD Anderson Cancer Center under the current Research and Development Agreement.

The Company believes its current resources will be sufficient to fund its currently planned operations into the second quarter of 2020.

The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 3091306. To access the slides and live webcast or the subsequent archived recording, visit the "Investors & Media" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.