Archive for October, 2017

$GERN Fast Track Designation Granted to Imetelstat for Myelodysplastic Syndromes

Expanded Part 1 of IMerge is Open for Patient Enrollment

MENLO PARK, Calif., Oct. 31, 2017 — Geron Corporation (Nasdaq:GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are non-del(5q) and who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA). Imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech, Inc. (Janssen) on a worldwide basis. Janssen sponsored the application for Fast Track designation utilizing preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS.

The FDA’s Fast Track Program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and supported by data that demonstrate the potential to address an unmet medical need. Fast Track designation provides opportunities for frequent interactions with FDA review staff, including meetings to discuss the drug’s development plan and to ensure the collection of appropriate data needed to support approval. Through the Fast Track Program, a product candidate may be eligible for priority review, if supported by the clinical data, and for the ability to submit completed sections of a New Drug Application (NDA) on a rolling basis as data become available prior to completion of the full application.

Imetelstat Clinical Development in MDS

Imetelstat is being evaluated in an ongoing Phase 2/3 clinical trial (IMerge) in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an ESA. IMerge is designed in two parts: Part 1 is a Phase 2, open-label, single-arm design and Part 2 is designed to be a Phase 3, randomized, controlled trial.

As previously announced, 32 patients were enrolled in Part 1 of IMerge, of which a subset of 13 patients had not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and did not have a del(5q) chromosomal abnormality. As of May 2017, the 13-patient subset showed an increased durability and rate of red blood cell (RBC) transfusion independence (TI) compared to the overall trial population (≥8-week RBC-TI: 53.8% vs 34.4%). Based on these data, Part 1 is being expanded to enroll approximately 20 additional patients who are non-del(5q) and naïve to HMA and lenalidomide treatment to increase the experience and confirm the benefit-risk profile of imetelstat in this refined target patient population. Janssen has opened the expanded Part 1 for patient enrollment. For more information about IMerge, please visit https://clinicaltrials.gov/ct2/show/NCT02598661.

Results for the original 32 patients in Part 1 of IMerge, including hematologic improvement and rate of RBC-TI lasting at least 24 weeks, as well as duration of response and safety information, are expected to be presented at an upcoming major medical conference.

About Imetelstat

Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat might have disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Imetelstat has not been approved for marketing by any regulatory authority.

About the Collaboration with Janssen

On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.

About Geron

Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

Use of Forward-Looking Statements

Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) continued conduct by Janssen of IMerge and any future clinical trials of imetelstat; (ii) expanding enrollment to Part 1 of IMerge in a refined target patient population; (iii) the timing for enrollment to begin for the expanded Part 1 of IMerge; (iv) any future presentation of data from current clinical trials of imetelstat by Janssen at a major medical conference; (v) potential outcomes of any data reviews conducted by Janssen for IMerge; (vi) the safety and efficacy of imetelstat; (vii) that approximately 20 additional patients in IMerge will be sufficient for decision-making; (viii) potential receipt by Geron of additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, and royalties from sales of imetelstat; and (ix) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) whether Janssen decides to continue to conduct IMerge; (ii) whether imetelstat is safe and efficacious and will succeed in IMerge by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (iii) whether the FDA or other health authorities permit IMerge to continue to proceed under the existing protocols or any amendments thereto; (iv) Janssen’s ability to collect additional and more mature data from current clinical trials of imetelstat; (v) Geron’s dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the collaboration agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the collaboration agreement with Janssen and the clinical development or commercialization of imetelstat could be delayed or terminated; (vi) whether any future efficacy or safety results from any clinical trial of imetelstat may cause the benefit/risk profile of imetelstat to become unacceptable; and (vii) whether patent coverage of imetelstat enables Janssen to successfully commercialize imetelstat. Additional information on the above-stated risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended June 30, 2017. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

CONTACT:

Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
investor@geron.com
media@geron.com

Tuesday, October 31st, 2017 Uncategorized Comments Off on $GERN Fast Track Designation Granted to Imetelstat for Myelodysplastic Syndromes

$RESN Availability of Full-Band, Band 41 TDD Filter ISN Design In SAW

GOLETA, CA–(October 31, 2017) – Resonant Inc. (NASDAQ: RESN), a designer of filters for radio frequency, or RF, front-ends that specializes in delivering designs for difficult bands and complex requirements, today announced that a licensee has produced a state-of-the-art Full-Band, Band 41 Time Division Duplex (TDD) filter that is required for all handset vendors addressing the China market, using a Resonant Surface Acoustic Wave (SAW) design. Resonant’s licensee has also made this Band 41 filter available for sale and is currently sampling to OEMs.

The Band 41 TDD filter is a highly technical and complex design, widely regarded as one of the most difficult filters to design. Typically, in high frequency operation (the maximum passband frequency is 2.69GHz), these designs are restricted to small feature sizes, while the filter must handle high LTE powers because of TDD operation. In addition, this specialized design requires extremely large bandwidth at 194MHz, as well as the rejection of neighboring WiFi bands to prevent interference.

“Not only were we able to create this very complex Band 41 filter design in less than our stated time frame of 12-18 months for an ISN Pilot design, but we did it on a SAW platform, which we believe is the first of its kind in the market,” said George Holmes, CEO of Resonant Inc. “We expect this to be a high-volume filter, with the potential for rapid growth due to its use in Asia for LTE. Our customers require increasing complexity and rapidly evolving technology, which Resonant has delivered in the Band 41 filter design using our innovative software, intellectual property, and the capabilities of our experienced team.”

“This design is yet another example of how we are focusing on our core business and reducing execution risk as we drive towards royalty revenues,” Holmes added. “We continue to collaborate with our customers to reduce the time it takes to bring our designs to market, in an effort to accelerate our receipt of royalty revenues.”

The Company believes that the superior performance of Resonant’s Band 41 filter design offers several key advantages over competitive filters:

  • Full band operation (194MHz) – One part can accommodate all of the Band 41 carriers globally. This is a significant improvement, given that most of the commercially available filters are sub-band, while full band parts are traditionally processed in BAW and FBAR, which is much more expensive.
  • WiFi co-existence filter – This filter design results in high rejection to WiFi ( > 35dB). In addition, it allows for operation of TDD cellular and WiFi simultaneously, while also reducing interference.
  • Small footprint – With measurements of only 1.3 mm x 1.1 mm, the size of this design translates to less material and lower production costs, which can be passed on to customers.
  • HPUE capable – High Performance User Equipment (HPUE) is designed to improve the performance of TDD-LTE Band 41 networks around the world, by allowing higher power operation and therefore improved coverage. This is a current requirement of China Mobile.

Figure 1 compares the measured passband performance of Resonant’s Band 41 filter design as compared to the best publicly available Band 41 filter. Lower insertion loss (IL) represents higher performance.

The improved performance over BAW is validation of the capabilities of Resonant’s ISN platform. In particular, the accuracy with which the measured performance matches the simulation prior to fabrication (see Figure 2), allows optimization of performance without the need for multiple fabrication iterations.

About Resonant Inc.
Resonant is creating software tools and IP & licensable blocks that enable the development of innovative filter designs for the RF front-end, or RFFE, for the mobile device industry. The RFFE is the circuitry in a mobile device responsible for the radio frequency signal processing and is located between the device’s antenna and its digital baseband. Filters are a critical component of the RFFE that selects the desired radio frequency signals and rejects unwanted signals and noise. For more information, please visit www.resonant.com.

About Resonant’s ISN® Technology
Resonant can create designs for difficult bands and complex requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. The Company’s large suite of proprietary mathematical methods, software design tools and network synthesis techniques enable it to explore a much bigger set of possible solutions and quickly derive the better ones. These improved filters still use existing manufacturing methods (i.e. SAW) and can perform as well as those using higher cost methods (i.e. BAW). While most of the industry designs surface acoustic wave filters using a coupling-of-modes model, Resonant uses circuit models and physical models. Circuit models are computationally much faster, and physical models are highly accurate models based entirely on fundamental material properties and dimensions. Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is eased because its models speak the “fab language” of basic material properties and dimensions.

Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements, which include the following subjects, among others: the capabilities and expected sales volumes of Resonant’s Band 41 filter design. Forward-looking statements are made as of the date of this document and are inherently subject to risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, without limitation, the following: our limited operating history; our ability to complete designs that meet customer specifications; market demand for filters utilizing our designs; the ability of our customers (or their manufacturers) to fabricate our designs in commercial quantities; the ability of our designs to significantly lower costs compared to other designs and solutions; the risk that the intense competition and rapid technological change in our industry renders our designs less useful or obsolete; our ability to find, recruit and retain the highly skilled personnel required for our design process in sufficient numbers to support our growth; our ability to manage growth; and general market, economic and business conditions. Additional factors that could cause actual results to differ materially from those anticipated by our forward-looking statements are under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent Annual Report (Form 10-K) or Quarterly Report (Form 10-Q) filed with the Securities and Exchange Commission. Forward-looking statements are made as of the date of this release, and we expressly disclaim any obligation or undertaking to update forward-looking statements.

 

Investor Relations Contact:
Greg Falesnik
MZ North America
1-949-385-6449
Greg.Falesnik@mzgroup.us

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$MBIO Reports Preclinical Data on MB-103 in Breast Cancer

Data support clinical development of MB-103 HER2 CAR T cell therapy

NEW YORK, Oct. 31, 2017 — Mustang Bio, Inc. (“Mustang”) (NASDAQ:MBIO), a Fortress Biotech (NASDAQ:FBIO) Company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, announced that preclinical data for MB-103, its second-generation HER2 CAR T cell therapy, were published online in Clinical Cancer Research, a journal of the American Association for Cancer Research.  These data demonstrate effective targeting of breast cancer brain metastases with intraventricular delivery of HER2-BBζ CAR T cells, and support the clinical development of this therapy. Mustang’s research partner, City of Hope (“COH”), conducted the preclinical study.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “These encouraging preclinical data demonstrate the potential of our HER2 CAR T cell therapy to be an effective new treatment option for patients suffering from HER2+ breast cancer that has metastasized to the brain. This study shows the significance of CAR design in defining an optimized CAR T cell, and highlights intraventricular delivery of HER2 CAR T cells for treating multifocal brain metastases and leptomeningeal disease. Our team looks forward to the clinical advancement of this CAR T cell therapy in collaboration with our research partners at City of Hope, including a first-in-human Phase 1 study of MB-103 planned to initiate in 2018.”

Key Conclusions:

  • Humanized HER2 CAR T cells containing a 4-1BB intracellular co-stimulatory domain show reduced cytokine production with similar cytolytic activity compared with CD28
  • 4-1BB-containing HER2 CARs demonstrate improved tumor killing, with reduced T cell exhaustion and greater proliferative capacity compared to CD28-containing HER2 CARs
  • Regression of breast cancer brain metastasis following local delivery of HER2 CAR T cells
  • Regional intraventricular delivery of HER2-BBζ CAR T cells eradicates breast cancer brain metastasis
  • Regression of multifocal CNS disease following intraventricular HER2-BBζ CAR T cell delivery

About Mustang Bio
Mustang Bio, Inc., a subsidiary of Fortress Biotech, Inc., is a clinical‐stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to leverage the patient’s own immune system to eliminate cancer cells. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, funding research and development, and outlicensing or bringing the technologies to market. Mustang has partnered with the City of Hope National Medical Center (“COH”) and the Fred Hutchinson Cancer Research Center in the development of proprietary chimeric antigen receptor (CAR) engineered T cell (CAR T) therapies across many cancers. Mustang’s lead programs are in Phase 1 clinical trials at COH: MB-101 for the treatment of brain cancer and MB-102 as a therapeutic agent in acute myeloid leukemia. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission. For more information, visit www.mustangbio.com.

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensing arrangements, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contacts:
Jaclyn Jaffe
Mustang Bio, Inc.
(781) 652‐4500
ir@mustangbio.com

Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448-8098
lbagby@6degreespr.com

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$STML Pivotal Trial of SL-401 in BPDCN Meets Primary Endpoint

  • Detailed results will be presented at the ASH 2017 Annual Meeting (Dec. 9-12)
  • Based on FDA feedback, BLA filing remains on-track
  • Conference call scheduled for today, Tuesday, October 31, 2017 at 8:30AM ET

NEW YORK, Oct. 31, 2017 — Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, announced today that the pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has met its primary endpoint. Based on feedback from the U.S. Food and Drug Administration (FDA), Stemline remains on track to begin submission of its Biologics License Application (BLA) in the 4Q17-1Q18 timeframe.

SL-401 has been granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of BPDCN, and Orphan Drug Designation (ODD) by the FDA and EU for the treatment of patients with BPDCN and acute myeloid leukemia (AML).

Pivotal Trial
The pivotal Phase 2 trial of SL-401 is the largest multicenter prospective study ever conducted in BPDCN. The trial enrolled 45 BPDCN (32 first-line, 13 relapsed/refractory) patients at 7 sites in the U.S. The trial consisted of 3 Stages: Stage 1 (lead-in, dose escalation), Stage 2 (expansion), and Stage 3 (pivotal, confirmatory).

Stage 3: Design
Stage 3 of the Phase 2 trial was designed with input from the FDA to provide the pivotal, confirmatory evidence of efficacy of SL-401 in BPDCN. First-line-only BPDCN patients received SL-401 intravenously at 12 mcg/kg/day on days 1-5 of a 21-day cycle. The primary endpoint of Stage 3 was the rate of CR, defined per protocol as CR + CRc + CRi (CR = complete response; CRc = clinical complete response: absence of gross disease with minimal residual skin abnormality; CRi = CR with incomplete hematologic recovery) by investigator assessment. Statistical significance is achieved if the lower bound of the 95% confidence interval (CI) of the primary endpoint exceeds 10%.

Stage 3: Top-Line Results
In Stage 3 of the trial, 13 first-line BPDCN patients were enrolled. Stage 3 met its primary endpoint, with a CR rate of 54% (7/13) (95% CI: 25.1, 80.8). Overall response rate (ORR) was 77% (10/13). 46% (6/13) of patients were bridged to stem cell transplant (SCT) following remission on SL-401. 86% (6/7) of complete responders remain relapse-free at 5+ to 8+ months, ongoing.

All Stages (1, 2, and 3): Top-Line Results
Across all stages, lines, and doses in the trial (n=45 BPDCN patients; 32 first-line, 13 relapsed/refractory), the CR rate was 60% (27/45) and the ORR was 82% (37/45). In first-line patients who received SL-401 at all tested doses (n=32 patients), the CR rate was 69% (22/32) and the ORR was 88% (28/32). 41% (13/32) of first-line patients who received SL-401 at all tested doses have been bridged to SCT following remission on SL-401.

All SL-401 Trials: Top-Line Safety Results
The most common treatment-related adverse events (TRAEs) with SL-401 across BPDCN and other clinical trials (acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and multiple myeloma) (n=148 patients) were hypoalbuminemia (47%), aspartate aminotransferase increase (46%), alanine aminotransferase increase (45%), nausea (28%), and thrombocytopenia (28%). Capillary leak syndrome (CLS), a well-documented side effect, occurred in 19% of patients, of which 2% (3/148) were grade 5, as previously reported.

Andrew A. Lane, M.D., Ph.D., Director of the BPDCN Center at the Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School in Boston, and a co-investigator on the study, commented, “BPDCN is a devastating malignancy for which there are no approved therapies. Due to the increasing awareness around BPDCN and the promise of novel targeted agents such as SL-401, we have built a new BPDCN center at Dana-Farber to focus on this historically poorly understood, yet increasingly appreciated, patient population with unmet need. SL-401 has demonstrated efficacy with meaningful clinical benefit in BPDCN while maintaining a manageable safety profile, particularly notable in this predominantly older population, representing a major advance in the management of BPDCN. Also, given the presence of CD123 on additional aggressive hematologic cancers, we are also exploring SL-401 in combination with other agents in clinical trials of high risk MDS and AML.”

Ivan Bergstein, MD, CEO of Stemline, commented, “The successful completion of the largest prospective clinical trial ever conducted in BPDCN, is a major milestone for Stemline, our investigators, and most importantly, patients and their families. We would like to thank and congratulate all those involved in this groundbreaking trial. We look forward to working closely with regulatory authorities in an effort to provide SL-401 to patients as quickly as possible. In parallel, our commercial team continues to ramp-up activities setting the stage, if SL-401 is approved, for a successful launch.”

Conference Call and Webcast
Stemline Therapeutics will host a conference call and audio webcast this morning, Tuesday, October 31, 2017 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing 844-389-8660 (U.S./Canada) or 478-219-0408 (International) and referencing conference ID: 1686609. An audio webcast can also be accessed via the Investor Relations tab of the Stemline Therapeutics website at http://ir.stemline.com.

About BPDCN
Please visit www.bpdcninfo.com and the BPDCN awareness booth (#3143) at ASH 2017.

About Stemline Therapeutics
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers. Stemline is developing three clinical stage product candidates: SL-401, SL-801, and SL-701. SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123), a cell surface receptor expressed on a variety of malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive, lethal malignancy of unmet medical need, with no approved therapies. SL-401 was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with BPDCN. A pivotal Phase 2 trial with SL-401 in BPDCN has completed enrollment. An additional cohort is currently enrolling BPDCN patients to ensure continued access to SL-401. Additional Phase 1/2 trials with SL-401, including as a single agent or in combination with other agents, are ongoing in patients with other malignancies including myeloproliferative neoplasms (MPN) (focused on chronic myelomonocytic leukemia [CMML] and myelofibrosis [MF]), acute myeloid leukemia (AML), and multiple myeloma. A Phase 1 trial of SL-801, a novel oral small molecule reversible XPO1 inhibitor, is enrolling patients with advanced solid tumors. Results presented at the European Society of Medical Oncology (ESMO) Annual Congress in September 2017 included dose escalation data of SL-801 through 6 dosing cohorts without dose limiting toxicity. The ideal therapeutic dose of SL-801 has not yet been determined and dose escalation/schedule optimization continues. A Phase 2 trial of SL-701, an immunotherapeutic, has completed dosing of patients with second-line glioblastoma and patients are being followed for outcomes including survival.

Forward-Looking Statements
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, institutional review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities including the risk that the FDA or other ex-U.S. national drug authority ultimately does not agree with our data, find our data supportive of approval, or approve any of our product candidates; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Contact
Investor Relations
Stemline Therapeutics, Inc.
750 Lexington Avenue
Eleventh Floor
New York, NY 10022
Tel: 646-502-2307
Email: investorrelations@stemline.com

Tuesday, October 31st, 2017 Uncategorized Comments Off on $STML Pivotal Trial of SL-401 in BPDCN Meets Primary Endpoint

$IGC Highlighted in Report on Leaders in Medical Marijuana, Global Alzheimer’s Markets

NetworkNewsWire Editorial Coverage: By now, the potential for cannabinoids like tetrahydrocannabinol (THC) and cannabidiol (CBD) to reduce the symptoms and even help prevent the onset of diseases such as Alzheimer’s has been fairly well-documented by a wide variety of studies (http://nnw.fm/RRjS8). The global potential for cannabis-based therapies has triggered a medical marijuana arms race, as countries like Canada, Israel and many of those in Western Europe seize the initiative and more boldly go where the U.S. federal government has feared to allow private industry to tread. Rising stars in the sector, such as phytocannabinoid combination therapy developer India Globalization Capital, Inc. (NYSE MKT: IGC) (IGC Profile), are acutely aware of this immense global potential and have begun to position themselves to secure what will no doubt be hotly-contested market share. Investors interested in medicinal marijuana and/or Alzheimer’s treatments will find themselves looking at a global landscape of key players that includes Medical Marijuana, Inc. (OTC: MJNA), the first U.S. publicly traded cannabis company, as well as Canadian pharmaceutical-grade marijuana producers Aphria, Inc. (OTCQB: APHQF) (TSX: APH), MYM Nutraceuticals, Inc. (OTCQB: MYMMF) (CNSX: MYM) and Supreme Pharmaceuticals, Inc. (OTC: SPRWF) (TSXV: FIRE).

As attitudes grow increasingly favorable to the medicinal capabilities of cannabis, the companies that excel in this new field are those focused on the development of therapies that address global market concerns, such as Alzheimer’s. According to the Alzheimer’s Association, Alzheimer’s disease and other dementias will cost the U.S. roughly…

Read more »

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This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and NNW undertakes no obligation to update such statements.

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$AAAP Announces $3.9 Billion All Cash Proposed Tender Offer by $NVS

Novartis Oncology Expertise to Facilitate Ongoing Development of Theragnostic Pipeline

SAINT-GENIS-POUILLY, France, Oct. 30, 2017 – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), a leader in nuclear medicine theragnostics, today announced that it has entered into a Memorandum of Understanding with Novartis, pursuant to which Novartis proposes to make a cash tender offer to acquire all the outstanding shares of AAA, including shares represented by American Depositary Shares (the “ADSs”), for $41 per ordinary share and $82 per ADS (each representing 2 ordinary shares), in a transaction that is valued at approximately $3.9 billion. This represents a 47% premium to the 30 volume-weighted trading days prior to the unaffected share price on NASDAQ on September 27, 2017.

Under the terms of the Memorandum of Understanding, which has been approved by the AAA Board of Directors, Novartis will commence a tender offer upon completion of works council consultation and AAA’s Board of Directors recommending the tender offer to AAA shareholders. The proposed transaction is subject to customary transactional regulatory approvals.

The members of the Board of Directors and the management of AAA, including Mr. Claudio Costamagna, Chairman of the Board of Directors and Mr. Stefano Buono, Chief Executive Officer of AAA, are supportive of the proposed transaction and, in their capacity as shareholders, have all entered into irrevocable undertakings to tender their company shares into the proposed offer.

Mr. Stefano Buono, Chief Executive Officer of AAA, commented, “It is with great satisfaction that we announce this proposed transaction with Novartis, who we have long felt would be an ideal partner, not only to enhance the launch of lutetium Lu 177 dotatate* (Lutathera®) for neuroendocrine tumors (NETs), but especially to accelerate the advancement of our unique oncology theragnostic platform. We recognize the value creation this proposed transaction provides for our shareholders, who have supported our growth over the past 15 years. We believe that the combination of our expertise in radiopharmaceuticals and theragnostic strategy together with the global oncology experience and infrastructure of Novartis, provide the best prospects for our patients, physicians and employees, as well as the broader nuclear medicine community.”

AAA recently announced European approval of the marketing authorization for lutetium Lu 177 dotatate* (Lutathera®) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. A New Drug Application is currently under review by the US Food and Drug Administration. The Prescription Drug User Fee Act (PDUFA) action date is January 26, 2018.

Transaction Terms

The tender offer will be implemented in accordance with the terms and conditions of the binding memorandum of understanding between Advanced Accelerator Applications and Novartis. In addition to the offer terms, the memorandum of understanding contains representations, warranties and undertakings by Advanced Accelerator Applications and Novartis typical in similar transactions. The memorandum of understanding may be terminated by Advanced Accelerator Applications or Novartis under certain circumstances prior to the commencement or completion of the tender offer, including, for example, a material breach by either party of the terms and conditions of the memorandum of understanding prior to the commencement of the tender offer, the Board of Directors of AAA not issuing their positive recommendation following successful completion of the works council consultation, or amending its recommendation in a manner adverse to Novartis, non-receipt of customary transactional regulatory approvals and certain other circumstances. The parties have further agreed on certain expense reimbursement and termination fees payable by AAA to Novartis under certain circumstances, including, if the Board of Directors of AAA determines not to issue a positive recommendation following completion of the works council consultation or subsequently changes or withdraws its recommendation.

* USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide

Advisors

Jefferies LLC acted as exclusive financial advisor to AAA.

Davis Polk & Wardwell LLP is serving as legal counsel to AAA.

About Advanced Accelerator Applications S.A.

Advanced Accelerator Applications (NASDAQ:AAAP) is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA’s theragnostic platform is based on radiolabeling a targeting molecule with either gallium Ga 68 for diagnostic use, or lutetium Lu 177 for therapy. AAA’s first theragnostic pairing for neuroendocrine tumors includes diagnostic drugs NETSPOT® in the US and SomaKit TOC™ in Europe; and therapeutic USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®), which is approved for use in Europe and currently under review with the FDA. Additional theragnostics in development target gastrointestinal stromal tumors (GIST), and prostate and breast cancer. AAA is also an established leader in molecular nuclear diagnostic radiopharmaceuticals for PET and SPECT, mainly used in clinical oncology, cardiology and neurology. Headquartered in Saint-Genis-Pouilly, France, AAA currently has 21 production and R&D facilities, and more than 550 employees in 13 countries (France, Italy, the UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the US and Canada). AAA reported sales of €109.3 million in 2016 (+23% vs. 2015) and €69.2 million in 1H17 (+27% vs. 1H16). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com.

Additional Information

This press release is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the outstanding ordinary shares and American Depositary Shares of AAA described in this press release has not commenced. At the time the tender offer is commenced, Novartis and an indirect wholly owned subsidiary of Novartis (“Purchaser”) will file, or will cause to be filed, a Schedule TO Tender Offer Statement with the U.S. Securities and Exchange Commission (the “SEC”) and AAA will file a Schedule 14D-9 Solicitation/Recommendation Statement with the SEC, in each case with respect to the tender offer. The Schedule TO Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Schedule 14D-9 Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials and all other documents filed by, or caused to be filed by, Novartis and Purchaser with the SEC will be available at no charge on the SEC’s website at www.sec.gov. The Schedule TO Tender Offer Statement and related materials may be obtained for free under the “Investors – Financial Data” section of Novartis website at https://www.novartis.com/investors/financial-data/sec-filings. The Schedule 14D-9 Solicitation/Recommendation Statement and such other documents may be obtained for free from the Company under the “Investor Relations” section of the Company’s website at http://investorrelations.adacap.com/.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements that appear in a number of places in this press release include the Company’s current expectation regarding future events and various matters, including the proposed transaction, expected timing of filings with the FDA and EMA, and approval dates. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the ability of the parties to complete the transaction on a timely basis or at all, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) and our other products or product candidates; our estimates regarding the market opportunity for USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®), our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the US; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigation; and general economic, political, demographic and business conditions in Europe, the US and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

AAA Corporate Communications
Rachel Levine
Director of Communications
rachel.levine@adacap.com
Tel: + 1-212-235-2395

AAA Investor Relations
Jordan Silverstein
Head of Investor Relations
jordan.silverstein@adacap.com
Tel: + 1-212-235-2394

Monday, October 30th, 2017 Uncategorized Comments Off on $AAAP Announces $3.9 Billion All Cash Proposed Tender Offer by $NVS

$MBIO Establishes CAR T Cell Therapy Manufacturing Facility in Massachusetts

Facility located in the UMass Medicine Science Park will support clinical development and commercialization of CAR T pipeline

Preparations underway for clinical production in 2018

NEW YORK, Oct. 30, 2017 — Mustang Bio, Inc. (“Mustang”) (NASDAQ:MBIO), a Fortress Biotech, Inc. (NASDAQ:FBIO) company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell (CAR T) technology, announced today that it has entered into a lease agreement with the UMass Medicine Science Park in Worcester, Massachusetts, for a manufacturing facility to support the clinical development and commercialization of the Company’s CAR T product candidates.

The facility is expected to be operational for the production of personalized CAR T therapies in 2018. Mustang anticipates initially building cell-processing capabilities to support its lead CAR T product candidates MB-101 in glioblastoma, and MB-102 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “Establishing top-notch manufacturing capabilities early on is essential to the long-term success of CAR T programs. Securing a facility in the UMass Medicine Science Park, one of the nation’s leading centers for biotechnology research and production, is significant, as it will enable us to recruit industry leaders in manufacturing. We are thrilled to announce this important milestone, which lays the foundation for the clinical development and potential commercialization of our CAR T pipeline, and may expedite manufacturing innovations to improve patient outcomes.”

About Mustang Bio
Mustang Bio, Inc., a subsidiary of Fortress Biotech, Inc., is a clinical‐stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to leverage the patient’s own immune system to eliminate cancer cells. Mustang aims to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest, funding research and development, and outlicensing or bringing the technologies to market. Mustang has partnered with the City of Hope National Medical Center (“COH”) and the Fred Hutchinson Cancer Research Center in the development of proprietary chimeric antigen receptor (CAR) engineered T cell (CAR T) therapies across many cancers. Mustang’s lead programs are in Phase 1 clinical trials at COH: MB-101 for the treatment of brain cancer and MB-102 as a therapeutic agent in acute myeloid leukemia. Mustang is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the U.S. Securities and Exchange Commission. For more information, visit www.mustangbio.com.

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensing arrangements, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our ability to complete the manufacturing facility in the time frame we have projected; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contacts:
Jaclyn Jaffe
Mustang Bio, Inc.
(781) 652‐4500
ir@mustangbio.com

Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448-8098
lbagby@6degreespr.com

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$CGIX Launches AntigenID™, Solidifying Position as Leader in Precision Immuno-Oncology

  • CGI’s AntigenID identifies neoantigens and neoantigen signatures that accelerate immuno-oncology drug identification, predict patient-specific immune therapy response, and help create personalized immuno-vaccines – the immuno-oncology therapy and drug development market is expected to grow to nearly USD $200 Billion by 2021. [1]
  • Precision immunotherapy and personalized t-cell vaccines are predicted to become nearly 33% of the IO therapy market and AntigenID™ is expected to further solidify CGI’s position in personalized cancer treatment.
  • CGI’s AntigenID helps in the precise identification of the right set of neoantigens that are potent, and will generate a robust immune response to fight and kill the tumor cells – creating this immune response, at a personalized level, is the cornerstone to personalized immune therapy.

RUTHERFORD, N.J., Oct. 30, 2017 — Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The Company”), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announced today the launch of its neoantigen discovery service offering, AntigenID, based on neoantigen identification technology utilizing unique and comprehensive sequencing combinations and sophisticated bioinformatics algorithms and computational workflows. The accurate identification of neoantigens, cancer markers that are unique to an individual’s tumor, has become an emerging area of immuno-oncology (IO) believed to be critical in the development of personalized cancer immunotherapy and predicting potential response to existing immune-oncology therapies.

“We are pleased to be able to broaden our precision medicine offerings to support personalized and targeted immune therapies,” said Panna Sharma, President and CEO of CGI. “The identification of a patient’s unique repertoire of cancer antigens holds great potential for the success of IO therapies and we have focused our efforts on building a comprehensive immuno-oncology testing portfolio and service offerings for use in clinical trials, translational research, and therapy selection. We believe adding a neoantigen discovery service was the logical next step in helping personalized therapies become a reality for cancer patients and we look forward to future collaborations that will apply the discoveries made possible with neoantigen identification platform, AntigenID.”

Recent studies show that the manipulation of neoantigens used alone or in combination with other immunotherapies could prove to be an important therapeutic tool to reduce and control cancer. There are currently over 50 clinical trials and studies involving neoantigen identification as a core component, with many distinctly geared towards developing personalized neoantigen-based cancer vaccines. According to industry analysts, these therapies and combinations will help drive a future predicted global cancer immunotherapy market of close to USD 200 Billion by 2021 (from USD 61.97 Billion in 2016). [1]

Harnessing the patient’s own immune system to eradicate malignant cancer cells is becoming the most powerful new approach to cancer therapy, and CGI’s AntigenID™ will be available to help power clinical studies and trials while also helping in early discovery to identify the most promising compounds and combinations. FDA approval of the immunotherapy-based drugs, including checkpoint inhibitors, for the treatment of multiple types of cancers, has greatly advanced research and clinical studies in the field of cancer immunotherapy. Despite the great success of checkpoint blockade therapy, many patients fail to respond to this approach and require a more personalized approach. This personalized approach can be identified by CGI’s AntigenID through a combination of massively parallel genomic, immune marker and transcriptome profiling along with state-of-the-art bioinformatics.

The present-day revolution in oncology therapy and patient management is emerging to advances in sequencing and bioinformatics that have developed a more comprehensive picture of the immune response and mechanisms to cancer. CGI’s AntigenID™ has the potential to play a pivotal role in both drug discovery and therapy development and also in the clinical setting by both predicting and monitoring the effect of personalized therapy on the patient. This sophisticated understanding of the interaction between the tumor and host immune system enhances our ability to identify relevant tumor-specific antigens, and therefore predict the host immune response both before and after exposure to immune therapies.

Rita Shaknovich, MD, Ph.D., CGI’s Chief Medical Officer and Group Medical Director, added, “Next generation sequencing enabled rapid profiling of somatic mutations and predicting which neo-epitopes can provide therapeutic benefit. It is one of the most exciting discoveries in the field of oncology in the last decade and we are eager to offer a commercial approach and platform that enables a truly personalized approach to treatment that harnesses powers of each patient’s immune system.”

AntigenIDTM offers an extremely comprehensive approach to neoantigen discovery and identification as it utilizes genomic and transcriptomic profiles of matched patient samples, involves HLA typing, as well as sophisticated bioinformatics workflow which integrates different pipelines. This unique offering expands CGI’s portfolio of immuno-oncology services and technologies, reinforcing CGI as a precision oncology leader and a partner of choice to power the development of personalized IO drugs and products for pharmaceutical and biotech companies.

[1] MarketsandMarkets. Cancer Immunotherapy Market by Type (Monoclonal Antibodies, Cancer Vaccines, Check Point Inhibitors & Immunomodulators), Application (Lung, Breast, Colorectal, Melanoma, Prostate, Head & Neck), End User (Hospital and Clinics) – Global Forecast to 2021. http://www.marketsandmarkets.com/Market-Reports/cancer-immunotherapy-market-197577894.html

ABOUT CANCER GENETICS
Cancer Genetics Inc. is a leader in enabling precision medicine in oncology from bench to bedside through the use of oncology biomarkers and molecular testing. CGI is developing a global footprint with locations in the US, India and China. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.

The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.

For more information, please visit or follow CGI at:
Internet: www.cancergenetics.com
Twitter: @Cancer_Genetics
Facebook: www.facebook.com/CancerGenetics

Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Cancer Genetics Inc.’s expectations regarding the completion, timing, pricing and size of the offering described in this press release constitute forward-looking statements.

Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2016 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.

INVESTOR CONTACT:
Panna Sharma
Cancer Genetics, Inc.
Tel: 201-528-9200
Email: panna.sharma@cgix.com

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$CRME Commercial Launch of Xydalba™ in Three New European Geographies

VANCOUVER, Oct. 30, 2017 – Cardiome Pharma Corp. (NASDAQ:CRME / TSX:COM) today announced that it has initiated the commercial launch of Xydalba™ (dalbavancin hydrochloride) in Sweden, Finland and the Republic of Ireland.  Xydalba is approved by the European Medicines Agency (EMA) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults.

“We’re making steady progress in advancing the commercial availability of Xydalba throughout our licensed territories and have now launched this important antibiotic in a total of six European countries,” said Hugues Sachot, Cardiome’s Chief Commercial Officer. “Our established commercial infrastructure throughout Europe continues to support these launches and ensures that patients suffering from infectious disease have access to this acute care treatment.”

“Xydalba offers medical professionals a flexible dosing option that will allow them to best manage therapy of this serious infection based on individual patient need,” said Dr. William Hunter, Cardiome’s President and CEO. “Our geographic footprint continues to expand, allowing us to make our portfolio of differentiated hospital products available to patients through our ex-U.S. global distribution capabilities and as we build a world-class acute care pharmaceutical company.

Xydalba was approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA. Dalbavancin is commercialized under the trade name Dalvance® in the U.S. and Xydalba in certain countries outside the U.S.  Cardiome has rights to commercialize Xydalba under an agreement with Allergan plc in France, the United Kingdom, Germany, Belgium, Nordic countries, certain other Western European countries, various Middle Eastern countries, and Canada.

About XYDALBA™

Xydalba™ for infusion is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. Xydalba is the first and only 30-minute, one-dose treatment option for acute bacterial skin and skin structure infections (ABSSSI) that delivers a full course of IV therapy. Xydalba can be administered as either one 1500 mg dose or as a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. Xydalba demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.

About ABSSSI

There were more than 4.8 million hospital admissions of adults with ABSSSI from 2005 through 2011, which included patients with cellulitis, erysipelas, wound infection, and major cutaneous abscess. In fact, hospital admissions for ABSSSI significantly increased by 17.3 percent during this timeframe. The majority of all skin and soft tissue infections in hospitalized patients are caused by streptococci and Staphylococcus aureus, and approximately 59 percent of these S. aureus infections in the U.S. are estimated to be caused by MRSA. Early and effective treatment of ABSSSI is critical to optimize patient recovery and for certain patients may also help to avoid potentially lengthy and costly hospital stays.

About Cardiome Pharma Corp.

Cardiome Pharma Corp. is a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. With a commercial presence and distribution network covering over 60 countries worldwide, Cardiome develops, acquires and commercializes brands for the in-hospital, acute care market segment. The Company’s portfolio of approved and marketed brands includes: Xydalba™ (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera®/Mabelio® (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess® (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat® (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome, and Esmocard® and Esmocard Lyo® (esmolol hydrochloride), a short-acting betablocker used to control rapid heart rate in a number of cardiovascular indications. Cardiome’s pipeline of product candidates includes Trevyent®, a drug device combination that is designed to deliver Remodulin® (treprostinil) the world’s leading treatment for pulmonary arterial hypertension.

Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM).  For more information, please visit our web site at www.cardiome.com.

Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward-looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for 2017 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing or future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities. These and other risks are described in the Form 40F and associated documents filed March 29, 2017 (see for example, “Risk Factors” in the Annual Information Form for the year ended December 31, 2016), in the Form 6-K filed August 10, 2017, and in our other filings with the Securities and Exchange Commission (“SEC”) available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com.  Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

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$STLHF Signs MoU to Expand California Project With Permitted Brine Producer

VANCOUVER, British Columbia, Oct. 30, 2017 — Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSX-V:SLL) (FRA:S5L) (OTCQX:STLHF) is pleased to announce that it has entered into a Memorandum of Understanding (“MoU”), with TETRA Technologies, Inc., a NYSE-listed company (“TETRA”) to secure access to additional operating and permitted land consisting of approximately 12,100 acres in Bristol Dry Lake, and up to 11,840 acres in the adjacent Cadiz Dry Lake, Mojave Desert, California.  As a result, the Company now has access to approximately 48,000 acres of mixed private, patented and placer claim land in the Bristol Dry Lake and Cadiz Dry Lake basins that allows for exclusive lithium brine exploration and processing.  The new MoU with TETRA allows for the exclusive right to negotiate and conduct exploration activities and to enter into a mineral lease to allow exploration and production activities for lithium extraction on property held under longstanding mining claims and permits by TETRA (transaction terms described below). In connection with the entering into of the MoU, and in support of the transaction with TETRA, the Company has made a non-refundable deposit of US$100,000.

Standard Lithium CEO, Robert Mintak said, “Since day one we have recognized the bigger opportunity with respect to expanding the resource base and strengthening project economics at Bristol Dry Lake by securing the rights for lithium development over the entire basin.  By inking an agreement with TETRA, the only other permitted operator in the area, we have now effectively achieved that.  This is a significant and strategic move for Standard, but has only been made possible by the excellent relationships we have developed with the permitted brine operators in the region.  Gaining access to the adjacent Cadiz Dry Lake operating project is an additional benefit to our relationship with TETRA.”

TETRA currently operates two passive solar evaporation plants in the Mojave Desert area of San Bernardino County, California, which produce liquid calcium chloride from underground brine reserves that are pumped to the surface.  The Bristol Dry Lake project is currently permitted for brine extraction and processing activities, has significant production infrastructure in place and is serviced by major highways, power and a dedicated rail siding and loading spur.  The Cadiz Dry Lake Property is located approximately 20 km southeast of the Bristol Dry Lake Property and brings the Company’s total project opportunity in the Mojave Desert to approximately 48,000 acres.

Dr. Andy Robinson, President and COO of Standard Lithium said, “Three initial grab samples of brine from wells at Cadiz show lithium concentrations in pumped brine ranging between 112 to 139 mg/L.  These concentrations from relatively shallow wells suggests that there is a potentially significant lithium brine deposit present in the Cadiz Dry Lake basin.  Our technical team is currently performing due-diligence on all available data for the Cadiz Dry Lake basin and will be laying out a plan for new data collection over the coming months.  Additional investigation of  TETRA’s properties in both Bristol Dry Lake and Cadiz Dry Lake will be performed concurrently with our existing resource definition program, and as such, we should be able to significantly expand our resource base as we move towards producing maiden lithium resource estimates for the Mojave projects.”

Transaction Terms – Option Agreement

Under the terms of the MoU, the parties have agree to negotiate a definitive option agreement (the “Option Agreement”) which will provide Standard Lithium with a period of six (6) years to conduct brine exploration activities (the “Option Period”) on the Bristol Dry Lake Property and/or the Cadiz Dry Lake Property.  If during the Option Period, Standard Lithium elects to conduct exploration activities on both Properties, the Company will be required to make a series of cash payments and share issuances to TETRA which will be set forth in the Option Agreement.  Any such payments or share issuances will be adjusted in the event the Option Agreement includes only one of the Properties.

Lease Agreement & Royalty

In accordance with the terms of the MoU, at any time during the Option Period, Standard Lithium has the right to exercise the Option, following which the Company and TETRA would negotiate and enter into a lease granting Standard Lithium a period of thirty (30) years of commercial production of lithium from brine produced by the Properties and subject to an annual royalty on the gross revenue derived by Standard Lithium from the sale of lithium resulting from the brine produced from the Properties.

Definitive Documentation

Standard Lithium’s right to conduct exploration activities on the Properties remains subject to the negotiation and finalization of a definitive Option Agreement.  Any share issuances contemplated by such an Option Agreement will be subject to the approval of the TSX Venture Exchange and would be subject to statutory restrictions on resale.

Quality Assurance

Raymond Spanjers, Certified Professional Geologist (SME No. 3041730), is a qualified person as defined by NI 43-101, and has supervised the preparation of the scientific and technical information that forms the basis for this news release.  Mr. Spanjers is not independent of the Company as he is an officer in his role as Vice President, Exploration and Development.

About Standard Lithium

Standard’s value creation strategy encompasses acquiring a diverse and highly prospective portfolio of large-scale domestic brine resources, led by an innovative and results-oriented management team with a strong focus on technical skills.  The Company is currently focused on the immediate exploration and development of the Bristol Dry Lake Lithium Project located in the Mojave region of San Bernardino County, California; the location has significant infrastructure in-place, with easy road and rail access, abundant electricity and water sources, and is already permitted for extensive brine extraction and processing activities.  The Company is also commencing resource evaluation on 33,000 acres of brine leases located in the Smackover Formation.

Standard Lithium is listed on the TSX Venture under the trading symbol “SLL”; quoted on the OTCQX under the symbol “STLHF”; and on the Frankfurt Stock Exchange under the symbol “S5L”. Please visit the Company’s website at www.standardlithium.com.

For further information, contact Anthony Alvaro at 604.240.4793.

On behalf of the Board,

Standard Lithium Ltd.

Robert Mintak, CEO & Director

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release may contain certain “Forward-Looking Statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. When used in this news release, the words “anticipate”, “believe”, “estimate”, “expect”, “target”, “plan”, “forecast”, “may”, “schedule” and other similar words or expressions identify forward-looking statements or information. These forward-looking statements or information may relate to future prices of commodities, accuracy of mineral or resource exploration activity, reserves or resources, regulatory or government requirements or approvals, the reliability of third party information, continued access to mineral properties or infrastructure, fluctuations in the market for lithium and its derivatives, changes in exploration costs and government regulation in Canada and the United States, and other factors or information. Such statements represent the Company’s current views with respect to future events and are necessarily based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social risks, contingencies and uncertainties. Many factors, both known and unknown, could cause results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements. The Company does not intend, and does not assume any obligation, to update these forward-looking statements or information to reflect changes in assumptions or changes in circumstances or any other events affections such statements and information other than as required by applicable laws, rules and regulations.

Neither the Company, nor TETRA Technologies makes any representations as to the value of lease rights associated with TETRA Technologies Bristol Dry Lake and or Cadiz Dry Lake mineral claims (the “Properties”), the availability of any particular resource or minerals on the Properties, or the merits of any proposed exploration work to be completed on the Properties.  TETRA Technologies expressly disclaims any responsibility for the adequacy or accuracy of disclosure made by the Company in respect of the Properties.  Readers are cautioned that a “Qualified Person” (as that term is defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects) has not done sufficient work to specify any mineral resource or reserve on the Properties.

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$AKAO Announces New Employment Inducement Grants

SOUTH SAN FRANCISCO, Calif., Oct. 27, 2017 — Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that on October 21, 2017, the compensation committee of the Company’s board of directors granted 22 new employees the option to purchase an aggregate of 78,150 shares of the Company’s common stock and 39,080 restricted stock units. Each stock option has an exercise price per share equal to $13.88, which was the closing trading price on October 20, 2017. The stock options and restricted stock units were granted pursuant to the Company’s 2014 Employment Commencement Incentive Plan, which was approved by the Company’s board of directors in December 2014 under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.

About Achaogen
Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. Achaogen is developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. The Food and Drug Administration has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. The Company’s second product candidate is C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination. Achaogen’s plazomicin program has been funded, and its C-Scape program is funded, in part with Federal funds from the Biomedical Advanced Research and Development Authority. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections and additional disease areas. All product candidates, including plazomicin, are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com.

Source: Achaogen, Inc. (NASDAQ: AKAO)

Media and Investor Contact:
David Arrington
Vice President, Investor Relations and Corporate Communications
650.440.5856
darrington@achaogen.com

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$TOCA Updated Data, Phase 1 for Toca 511/FC in Glioma

All responders now in complete response; median duration of response not reached after nearly 3 years of follow up

SAN DIEGO, Oct. 27, 2017 — Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today reported updated data demonstrating long-term durable responses, and the conversion of initial partial responses (PRs) into complete responses (CRs), from a Phase 1 study of Tocagen’s investigational product, Toca 511 & Toca FC, for the treatment of patients with recurrent high-grade glioma (HGG), a type of brain tumor. These updated Phase 1 data were selected for inclusion in the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics official press program (abstract A085) and will be presented in a scientific session at 10:50 a.m. ET today by Clark Chen, M.D., Ph.D., Lyle French Chair in Neurosurgery and head of the University of Minnesota Medical School Department of Neurosurgery.

HGGs are among the most common and aggressive primary brain cancers. Approximately 160,000 patients worldwide are expected to be diagnosed with HGG in 2017. The two most common forms of HGGs are glioblastoma and anaplastic astrocytoma. With current standard of care, recurrent HGG patients have a median survival of approximately seven to nine months.

Tocagen’s Phase 1 ascending-dose trial involved 56 patients across seven clinical sites, who, at the time of surgical resection, received Toca 511, followed by multiple courses of Toca FC. Some of the cohorts within the study combined the investigational therapy with antiangiogenic therapy (bevacizumab) or chemotherapy (lomustine). Data highlights are below.1 The full presentation can be found on Tocagen’s website.

Overall Phase 1 Trial Data Summary:

  • Toca 511 & Toca FC continued to demonstrate a favorable safety profile and were well tolerated by patients.
  • Tocagen has previously presented CR and PR data for the six patients who responded to treatment. The data presented today is updated to show that two previously announced PRs have converted into CRs, bringing the total number of CRs to six.
    • Five CRs followed treatment with Toca 511 & Toca FC, and one CR followed combination treatment with Toca 511 & Toca FC and bevacizumab.
    • Three of the CRs were glioblastoma IDH1 wildtype, one CR was anaplastic astrocytoma IDH1 wildtype and two CRs were anaplastic astrocytoma IDH1 mutant
  • Responses were observed across six different clinical sites.
  • All responders are complete responders and remain in response. Median duration of response had not been reached after a median follow-up of 35.1 months (range: 9.2 to 44.9 months).
  • An association between durable response and overall survival is suggested as all responders remain alive following study entry (range: 21.4 to 52.2 months).

Toca 5 Qualifying Patient Subgroup:

  • In a subgroup analysis of 23 patients in the Phase 1 trial who were in the high-dose cohorts and would qualify for Tocagen’s ongoing, Phase 3 Toca 5 trial:
    • Five of 23 patients had a durable complete response, bringing the durable response rate (objective responses lasting at least 24 weeks) to 21.7%.2
    • Median duration of response had not been reached after a median follow up of 35.7 months (range: 14.1 to 44.9 months).
    • Stable disease (lasting at least 8 weeks) was observed in 5 additional patients, bringing the clinical benefit rate to 43.5% (10/23 patients).
    • Median survival was 14.4 months.
    • Landmark overall survival rates at two and three years (OS24, OS36) was 34.8% and 26.1% respectively.

“Once high-grade glioma recurs, the expected survival is typically measured in months. At recurrence, physicians and caregivers are left with limited treatment options,” said Dr. Chen. “Today’s results show some high-grade glioma patients are experiencing complete responses and living multiple years after receiving Toca 511 & Toca FC. The duration of response and the number of patients with durable response or stable disease are impressive in this Phase 1 study, supporting further evaluation of Toca 511 & Toca FC as a potential treatment for recurrent high-grade glioma.”

Added Asha Das, M.D., senior vice president and chief medical officer of Tocagen, “Patients and physicians urgently await new treatments for high-grade glioma, one of the deadliest cancers. We are encouraged by the maturing durable response results of our earlier trial, and remain committed to advancing Toca 511 & Toca FC through the ongoing Phase 3 Toca 5 trial to bring a potentially transformative product to patients as quickly as possible.”

About the Toca 5 Trial

Toca 5 is a Phase 3, pivotal, randomized, double-blind study of Toca 511 & Toca FC in patients with recurrent high-grade glioma, a type of brain tumor. The study is being conducted at 167 sites globally and is expected to enroll 380 patients. Patients will be randomized following surgical resection 1:1 to receive either the Toca 511 & Toca FC regimen or chemotherapy. The primary endpoint of the trial is overall survival (OS). The primary endpoint assumes a median OS of 9.8 months for the control arm versus 14.3 months for the Toca 511 & Toca FC arm. A total of 257 events will provide the study with 85% power to detect a hazard ratio of 0.685. Interim analyses are planned at 50% and 75% of events. More information can be found at www.tocagen.com/toca5 or by searching clinicaltrials.gov using the clinical trial identifier NCT02414165.

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a cancer-selective immunotherapy comprised of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC, that are designed to be used together. Toca 511 is an injectable retroviral replicating vector (RRV) that encodes a prodrug activator enzyme, cytosine deaminase (CD). CD is derived from yeast, and humans do not naturally have this gene. Its selective delivery to cancer cells means that the infected cancer cells selectively carry the CD gene and produce CD. Toca FC is an investigational orally administered prodrug, 5-fluorocytosine (5-FC) that is inactive as an anti-cancer drug. In animal models, Tocagen has shown that 5-FC is converted into the anticancer drug, 5-FU, at high concentrations in Toca 511-infected cancer cells that are producing CD. Together, the Toca 511 & Toca FC combination directly kills cancer cells and immune-suppressive myeloid cells resulting in activation of the immune system against the cancer.

About Tocagen

Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. Tocagen is developing its lead investigational product candidate, Toca 511 & Toca FC, initially for the treatment of recurrent highgrade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of HGG.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our business plans and objectives, expectations regarding the timing and success of our clinical trials and planned clinical trials. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities and planned clinical trials; our ability to execute on our strategy; regulatory developments in the United States and foreign countries; and our estimates regarding expenses, future revenue and capital requirements. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Tocagen’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Tocagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

1Data cutoff date was Aug. 15, 2017.

2Responses were assessed using Macdonald Criteria including MRI assessment by independent radiology review and clinical data.

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$TYHT Agreement to Market Authorized Products of Daiso on JD.com

BEIJING, October 27, 2017 – Shineco, Inc. (“Shineco” or the “Company”; NASDAQ: TYHT), a producer and distributor of Chinese herbal medicines, organic agricultural products, specialized textiles, and other health and well-being focused plant-based products in China, today announced that the Company, through its subsidiary Tianjin Tajit E-Commerce Ltd., has obtained contractual rights to distribute branded products of Daiso Industries Co., Ltd.(“Daiso”), a large franchise of 100-yen shops founded in Japan, via JD.com (“JD”), the largest e-commerce company and largest retailer in China.

Pursuant to the contractual arrangement, Shineco is authorized to distribute Daiso’s branded products and utilize its brand names in connection therewith in China through Tianjin Tajit E-Commerce Ltd. The cooperation between Shineco and JD includes many business initiatives, covering a broad spectrum of online retail. It allows the Company to access JD’s significant online customer base to advance Shineco’s business pursuit in China. JD will leverage Shineco’s business expertise, and Shineco will serve as JD’s authorized vendor for providing its customers with access to a wide range of products of Daiso.

JD and Shineco is expected to join forces on promoting innovation of online retail business model, which is expected to improve Shineco’s brand awareness and might result in enhanced marketing and continued growth.

Mr. Yuying Zhang, Chairman and Chief Executive Officer of Shineco, stated, “We are excited about teaming up with China’s e-commerce giant JD and Japan’s retail giant Daiso, and the potential market that new relationship can bring to our business. JD’s vast online retail channel will enable us to distribute Daiso’s products in a more efficient and economical manner to meet the growing consumer demand in China, which further drives the Company’s fast expansion in e-commerce, enhances the influence of the Company and builds up the brand awareness of Shineco.”

Mr. Zhang continued, “As the market globalization and digital transformation continues to challenge traditional business concept, we need to develop the business faster and in a more flexible way. Distributing Daiso branded products via JD would be an exciting leap in this transformation and allows us to move forward with an even greater focus on innovation and development to meet changing customer needs in China. Given the fact that Daiso can now benefit over 20 million Chinese families, this part of our business is expected to achieve an annual growth rate of 20% subject to contract renewal. We look forward to offering customers a tremendous number of Daiso’s quality products not previously widely available across China through JD.”

About Shineco, Inc.

Incorporated in August 1997 and headquartered in Beijing, China, Shineco, Inc. (“Shineco” or the “Company”) is a Delaware holding company that uses its subsidiaries’ and variable interest entities’ vertically- and horizontally-integrated production, distribution and sales channels to provide health and well-being focused plant-based products in China. Utilizing modern engineering technologies and biotechnologies, Shineco produces, among other products, Chinese herbal medicines, organic agricultural produce and specialized textiles. For more information about the Company, please visit  www.tianyiluobuma.com.

About Daiso Industries Co., Ltd.

Founded in December 1977 and headquartered in  Higashihiroshima, Hiroshima Prefecture, Japan, Daiso Industries Co., Ltd.(“Daiso”) operates home center chains throughout the world. Daiso develops and sells dining, kitchen, living, food, household, and home decorating products, as well as accessories, stationery, toys, and hardware. Daiso has a range of over 100,000 products, of which over 40 percent are imported goods, many of them from China. Daiso has locations in 25 countries and regions worldwide. Daiso uses such locations as previous pachinko parlours for its retail outlets. Daiso invest on shelving and fixtures to help the stores compete with more high-end retailers. Daiso has 2,800 stores in Japan, 1,150 in South Korea, and 700 stores overseas in Australia, Bahrain, Brazil, Cambodia, Canada, China, Hong Kong, Indonesia, Kuwait, Macau, Malaysia, Mexico, Myanmar, New Zealand, Oman, Philippines, Qatar, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, United States of America, and Vietnam.  For more information about the Company, please visit www.daiso-sangyo.co.jp

About JD.com, Inc.

JD.com, Inc. is China’s leading online direct sales company and the country’s largest Internet company by revenue. The Company strives to offer consumers the best online shopping experience. Through its content-rich and user-friendly website jd.com and mobile applications, JD.com offers a wide selection of authentic products at competitive prices and delivers products in a speedy and reliable manner. The Company believes it has the largest fulfillment infrastructure of any ecommerce company in China. As of March 31, 2016, JD.com operated 7 fulfillment centers and 209 warehouses, and in total 5,987 delivery stations and pickup stations in 2,493 counties and districts across China, staffed by its own employees. JD.com is a member of the NASDAQ100. For more information about the Company, please visit www.jd.com

Forward-Looking Statements

This press release contains information about Shineco’s view of its future expectations, plans and prospects that constitute forward-looking statements. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets into its portfolio of products and services, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the requirements of its clients, and its ability to protect its intellectual property. Shineco encourages you to review other factors that may affect its future results in Shineco’s registration statement and in its other filings with the Securities and Exchange Commission.

For more information, please contact:

Tina Xiao
Ascent Investor Relations LLC
Phone: +1-917-609-0333
Email: tina.xiao@ascent-ir.com

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$STLHF NetworkNewsWire Publication on Future of Lithium, Demand for Li-ion Batteries

NEW YORK, NY–(Oct 27, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring Standard Lithium Ltd. (TSX VENTURE: SLL) (FRANKFURT: S5L) (OTCQX: STLHF), a client of NNW that is building one of the largest portfolios of high quality, domestic U.S. lithium brine assets.

The publication, titled, “Investors Increasingly Confident in Lithium as Industry Gains Momentum,” highlights some key players preparing for the ‘lithium revolution’ brought on by the increasing popularity of battery-powered homes and electric vehicles.

To view the full publication, visit: https://www.networknewswire.com/investors-increasingly-confident-lithium-industry-gains-momentum/

“Demand for lithium is projected to mushroom over 300% within eight years. Growth projections are largely based on increased consumer uses and the global proliferation of electric vehicles. However, the estimates may be vastly understated and could skyrocket much further. A recent Wall Street Journal article uncovered what may be an even greater demand driver. Multiple states and municipalities, in conjunction with utilities, are revamping their electric grids and utilizing high-density Li-ion energy storage solutions to power homes and make the grid more efficient (http://nnw.fm/M1LJu).

“Acquired through a strategic mineral lease agreement with National Chloride Corporation of America, the Bristol Dry Lake area has long been surface-mined to produce chloride for industrial applications. Consequently, the area has exceptional mining infrastructure already in place, mitigating the primary challenges of cost effective lithium mining and production — location, access and infrastructure. Standard Lithium’s location has easy road and rail access and abundant electricity and water sources, and it is already permitted for extensive brine extraction and processing activities. Electric power and water are on the property with a major paved road on the western edge and a rail siding nearby. The mineral lease agreement with National Chloride allows Standard Lithium immediate access to conduct exploration brine sampling and extraction, evaporation and processing activities, enabling a fast-tracked project development schedule.”

About Standard Lithium
Standard’s value creation strategy encompasses acquiring a diverse and highly prospective portfolio of large-scale domestic brine resources, led by an innovative and results-oriented management team with a strong focus on technical skills. The company is currently focused on the immediate exploration and development of the Bristol Dry Lake Lithium Project located in the Mojave region of San Bernardino County, California; the location has significant infrastructure in-place, with easy road and rail access, abundant electricity and water sources, and is already permitted for extensive brine extraction and processing activities. The company is also commencing resource evaluation on its 33,000 acres of lithium brine leases located in the Smackover Formation.

For more information, visit the company’s website at www.StandardLithium.com.

About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information please visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

Forward-Looking Statements
This 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 forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

NNW Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

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$CIIX & Wall Street Multimedia Launch New Daily Video Broadcast “Bitcoin Multimillionaire”

October 26, 2017

  • Wall Street Multimedia telecasts reach 125 million households in China, targeting the Chinese-speaking global market, raising CIIX’s profile in cryptocurrency worldwide
  • CIIX expands consulting services, focuses on advertising, subscription revenues, and sales of hemp oil (CBD) related products
  • CIIX reported 76% YOY operating sales growth in FY2017, projected by Consilium Global Research to reach $14.8 million by FY2020

ChineseInvestors.com, Inc. (OTCQB: CIIX) has launched its daily video telecast on cryptocurrencies from the NYSE, “Bitcoin Multimillionaire,” by teaming with specialist broadcaster to the Chinese-speaking global community, Wall Street Multimedia, Inc. (WSM) (http://nnw.fm/NElH4).

CIIX’s goal is to become the primary Chinese publicly traded company that offers real time information on its website. In addition to its “Bitcoin Multimillionaire” broadcasts, it offers consulting services, subscriptions and retails hemp oil-based cannabidiol (CBD) products under the “OptHemp” brand and plans to market a line of hemp-infused skin care products through its wholly-owned subsidiary, CBD Biotechnology Co. Ltd.

In a 10Q filing (http://nnw.fm/OH4y5), CIIX said it was working with WSM to reach the Chinese-speaking community throughout the world to offer more information and news about cryptocurrency. “In an effort to expand its media products, as the first year of fiscal year 2018 came to a close, the company announced that it would be working with Wall Street Multimedia, an independent news agency located in the NYSE, to produce a daily cryptocurrency video newscast in Chinese, providing timely information and exclusive analysis regarding all aspects of the emerging digital currency world, including specific cryptocurrencies, such as Bitcoin and Ethereum, industry trends, price movement, blockchain technology, sector-related stocks and ETF’s, etc.”

Consilium Global Research has projected that CIIX will reach revenues of $14.8 million by FY2020, representing a nearly 100% compound annual growth rate (CAGR) from FY2016-FY2020 (http://nnw.fm/BAtB6). To boost its revenues, the company is expanding its consulting services, targeting advertising and subscriptions, as well as sales of its hemp-oil CBD products.

For more information, visit the company’s website at www.ChineseInvestors.com

More from NetworkNewsWire

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information please visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

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$ALKS Unveils Investigational Product for Treatment of Schizophrenia

Initiation With Aripiprazole Lauroxil NanoCrystal® Dispersion Designed to Replace Need for Concomitant Three Weeks of Oral Aripiprazole With First ARISTADA Dose —

New Drug Application Has Been Submitted to U.S. Food and Drug Administration —

Alkermes plc (NASDAQ: ALKS) today unveiled Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), a novel, investigational product designed for initiation onto ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ALNCD leverages the company’s proprietary NanoCrystal technology and is designed to provide extended-release aripiprazole lauroxil in a formulation using a smaller particle size compared to ARISTADA, thereby enabling faster dissolution and leading to more rapid achievement of therapeutic levels of aripiprazole. Alkermes has submitted a New Drug Application (NDA) for ALNCD to the U.S. Food and Drug Administration (FDA). If approved, administration of ALNCD in conjunction with a single oral dose of 30 mg aripiprazole will replace the need for three weeks of concomitant oral aripiprazole with the first dose of ARISTADA. The ALNCD investigational product is designed for initiation onto any dose or duration of ARISTADA (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks, and 1064 mg once every two months).

“Patients with schizophrenia are particularly vulnerable to non-adherence and relapse when transitioning from inpatient care to outpatient settings.1 The ability to initiate long-acting treatment with ARISTADA on Day 1 without the need to continue oral supplementation during this critical transition period may be a useful and welcomed option for the clinical community,” said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “ARISTADA is designed to offer flexibility to meet the real-world needs of patients in both inpatient and outpatient settings. The development of Aripiprazole Lauroxil NanoCrystal Dispersion for initiation onto any of ARISTADA’s three approved dosing durations reflects our ongoing commitment to provide healthcare providers with a range of options to help tailor treatment to the individual needs of their patients.”

“If approved, Aripiprazole Lauroxil NanoCrystal Dispersion would expand ARISTADA’s product offerings to include an initiation alternative to the three weeks of concomitant oral aripiprazole supplementation with the first dose of ARISTADA. Alkermes is focused on providing patient-centered solutions and building the ARISTADA product family to help patients and their healthcare providers achieve their treatment goals,” said Richard Pops, Chief Executive Officer of Alkermes. “We have submitted a NDA for ALNCD to the FDA, and look forward to working closely with the Agency with the goal of expeditiously bringing this important potential new initiation product to patients and healthcare professionals.”

About Schizophrenia
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.

About ARISTADA®
ARISTADA is an injectable atypical antipsychotic approved in four doses and three dosing durations for the treatment of schizophrenia (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks, and 1064 mg once every two months). Once in the body, ARISTADA converts to aripiprazole. Oral aripiprazole should be administered for 21 consecutive days in conjunction with the first injection of ARISTADA. Alkermes has submitted a New Drug Application (NDA) for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), an investigational product designed for initiation onto ARISTADA, to the U.S. Food and Drug Administration (FDA). If approved, administration of ALNCD in conjunction with a single oral dose of 30 mg aripiprazole will replace the need for three weeks of concomitant oral aripiprazole with the first dose of ARISTADA.

INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use

INDICATION

ARISTADA is indicated for the treatment of schizophrenia.

IMPORTANT SAFETY INFORMATION
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. ARISTADA is not approved for the treatment of patients with dementia-related psychosis.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Reactions, Including Stroke: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, have been reported in placebo-controlled trials of elderly patients with dementia-related psychosis treated with risperidone, aripiprazole, and olanzapine. ARISTADA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as NMS may occur with administration of antipsychotic drugs, including ARISTADA. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with the need to minimize TD. Discontinue ARISTADA if clinically appropriate. TD may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with oral aripiprazole. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Other compulsive urges less frequently reported include sexual urges, shopping, binge eating and other impulsive or compulsive behaviors which may result in harm for the patient and others if not recognized. Closely monitor patients and consider dose reduction or stopping ARISTADA if a patient develops such urges.

Orthostatic Hypotension: Aripiprazole may cause orthostatic hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope.

Falls: Antipsychotics including ARISTADA may cause somnolence, postural hypotension or motor and sensory instability which may lead to falls and subsequent injury. Upon initiating treatment and recurrently, complete fall risk assessments as appropriate.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have been reported. Patients with a history of clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC) and history of drug-induced leukopenia/neutropenia should have frequent complete blood count (CBC) during the first few months of receiving ARISTADA. Consider discontinuation of ARISTADA at the first sign of a clinically significant decline in WBC count in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue ARISTADA in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC until recovery.

Seizures: ARISTADA should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain ARISTADA does not affect them adversely.

Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use; use caution in patients at risk for aspiration pneumonia.

Concomitant Medication: Decreasing the ARISTADA dosage is recommended in patients taking strong CYP3A4 inhibitors and/or strong CYP2D6 inhibitors for longer than 2 weeks. Increasing the ARISTADA dosage from 441 mg to 662 mg is recommended in patients taking CYP3A4 inducers for longer than 2 weeks. No ARISTADA dosage changes are recommended for patients taking CYP450 modulators for less than 2 weeks.

Most Commonly Observed Adverse Reaction: The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441 mg and 882 mg monthly) was akathisia.

Injection-Site Reactions: Injection-site reactions were reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were injection-site pain and associated with the first injection and decreased with each subsequent injection. Other injection-site reactions (induration, swelling, and redness) occurred at less than 1%.

Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses.

Pregnancy/Nursing: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider of a known or suspected pregnancy. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA during pregnancy. Aripiprazole is present in human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for ARISTADA and any potential adverse effects on the infant from ARISTADA or from the underlying maternal condition.

Please see FULL PRESCRIBING INFORMATION, including Boxed Warning, for ARISTADA.

About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: approval by the FDA of the NDA for ALNCD; and the potential therapeutic and commercial value of ALNCD and ARISTADA for the treatment of schizophrenia. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the NDA for ALNCD will be accepted and approved by the FDA; if approved, whether ALNCD will be commercialized successfully; whether ARISTADA or ALNCD could be shown ineffective or unsafe; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2016 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2017 and June 30, 2017 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

ARISTADA® and NanoCrystal® are registered trademarks of Alkermes Pharma Ireland Limited.

1Markowitz, M., et al. (2013). “Antipsychotic adherence patterns and health care utilization and costs among patients discharged after a schizophrenia-related hospitalization.” BMC Psychiatry 13(1): 246.
2National Institutes of Health. Schizophrenia. Accessed Oct. 25, 2017 from https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=67.

 

Alkermes Contacts:
For Investors:
Eva Stroynowski, +1 781-609-6823
or
Sandy Coombs, +1 781-609-6377
or
For Media:
Lindsey Smith, +1 781-609-6231

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$ACHV Exclusive Manufacturing Agreement with Sopharma for Supply of Cytisine

BOTHELL, Wash. and VANCOUVER, British Columbia, Oct. 26, 2017 — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, today announced it has entered into an exclusive supply agreement with Sopharma AD (BSE: 3JR, WSE: SPH) for the manufacture of cytisine active pharmaceutical ingredient (API) and finished tablets.

Under the terms of the agreement, Sopharma agrees to produce cGMP-grade cytisine for Achieve’s use in the development and commercialization of cytisine. Sopharma has over 20 years of experience producing cytisine through its commercialization efforts in Central and Eastern Europe. In addition, Achieve will have full access to the cytisine supply chain and Sopharma will manufacture sufficient cytisine to meet specified forecasted demand of cytisine in the Achieve territories. The exclusive license agreement provides supply of cytisine to Achieve for up to 20 years.

“This agreement with Sopharma reinforces our commitment and ability to bring cytisine forward as a new treatment option to help the millions of smokers who are battling nicotine and tobacco addiction,” said Rick Stewart, Chairman and CEO of Achieve. “We look forward to our continued partnership with Sopharma as we work together to address this global public health epidemic that claims the lives of more than six million people annually worldwide.”

Achieve recently announced completion of enrollment in a clinical study evaluating the effect of food on the bioavailability of 3mg cytisine and commencement of a multi-dose, PK/PD clinical study. Data from both trials will be used to further inform the Phase 3 clinical program, which is expected to begin enrollment in the United States in mid-2018.

About Cytisine
Achieve’s focus is to address the global smoking health epidemic through the development and commercialization of cytisine. Tobacco use is currently the leading cause of preventable death and is responsible for nearly six million deaths annually worldwide1. It is estimated that 28.6% of all cancer deaths in the U.S. are attributable to cigarette smoking2.

Cytisine is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for over 20 years. It is estimated that over 20 million people have used cytisine to help combat nicotine addiction, including over 2,000 patients in investigator-conducted, Phase 3 clinical trials in Europe and New Zealand.

Two prior, large-scale Phase 3 clinical studies of cytisine, with favorable outcomes, have been successfully completed in over 2,000 patients. The TASC trial was a 740 patient, double-blind, placebo controlled trial conceived by Professor Robert West at University College London and funded by the U.K. National Prevention Research Initiative. The CASCAID trial was a 1,310 patient, single-blind, non-inferiority trial comparing cytisine to nicotine replacement therapy (NRT). The CASCAID trial was conceived by Dr. Natalie Walker, National Institute for Health Innovation, University of Auckland and funded by the Health Research Council of New Zealand. Both trials were published in the New England Journal of Medicine. Learn more at www.achievelifesciences.com

About Sopharma AD
Sopharma is a Bulgarian based EU pharmaceutical producer with over 80 years tradition in the field. The company is a strong regional player and a responsible partner to the Bulgarian government in the health care sector supporting the entire healthcare system and the hospital sector in particular. The product portfolio expands to over 200 products in all main therapeutic areas known in more than 40 markets on 5 continents. Sopharma has over 30 subsidiaries in the production, distribution and retail sectors in more than 10 countries. In H1 2017 the Group reached almost 250 million EUR sales revenues with EBITDA growth of 37.3% and net profit growth of 14.2% compared to H1 2016. The Group continues to grow and establish itself as a preferred partner in the region. Learn more at www.sopharmagroup.com

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing of clinical development of cytisine, the market size for cytisine and the potential benefits of cytisine. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisine may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisine; the risk that cytisine will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including the final Proxy Statement/Prospectus/Information Statement filed pursuant to Rule 424(b)(3) in connection with Achieve’s recent merger, and Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Achieve Contact
Jason Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4

 

1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2011, Geneva: World Health Organization, 2011.
2Annals of Epidemiology , Volume 25 , Issue 3 , 179 – 182.e1
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$NEOS to be Acquired by $PDLI for $10.25 per Share in Cash

Proposal provides immediate and certain value to Neos shareholders – Proposal represents a 40% premium to Neos’ October 25 closing price and provides shareholders a substantial premium – Supports PDL’s specialty pharmaceutical acquisition strategy

INCLINE VILLAGE, Nev., Oct. 26, 2017 — PDL BioPharma, Inc. (“PDL” or “the Company”) (NASDAQ: PDLI) today announced that it has submitted a proposal to acquire Neos Therapeutics, Inc. (“Neos”) (NASDAQ: NEOS) for $10.25 per share in cash. This all-cash transaction represents a premium of 40% to the closing price of Neos shares on October 25, 2017 and a premium of 41% to Neos’ share price prior to PDL’s initial proposal on June 23, 2017. The PDL proposal is not subject to any financing conditions.

The acquisition of Neos is consistent with PDL’s stated strategy for growth and is a logical next step in the execution of its strategic plan. In particular, the Company believes that this acquisition would create an attractive pediatric platform and foundation for future growth.

Based on its due diligence, PDL’s Board of Directors strongly believes that PDL’s backing and substantial financial resources would greatly augment the performance of the Neos product portfolio and allow more patients to benefit from Neos’ products. PDL has high regard for Neos’ organization and sales force and believes that the addition of PDL’s greater resources will add substantial value to currently marketed treatments over a shorter period of time as well as accelerate the development of additional products.

PDL first approached the Neos Board of Directors in early June of 2017 in an effort to privately negotiate a mutually beneficial transaction. On June 23, 2017, PDL formally proposed to acquire Neos for $10.25 per share, a proposal the Neos Board promptly rejected. PDL notes that three days after Neos’ Board rejected PDL’s proposal, Neos announced a significantly dilutive financing at a substantially lower price, selling shares at a net price of $6.25 per share.

Following Neos’ dilutive financing at $6.25 per share, PDL maintained its $10.25 proposal to the Board, an increase in the total transaction size given the dilution of the financing. As a result of the Board’s recent rejection of PDL’s latest proposal—and in light of the Board’s refusal to negotiate in good faith toward a transaction in the best interests of Neos shareholders—PDL’s Board and management are now making its proposal to the Neos Board public so that Neos shareholders can decide what is in their best interest.

The Neos Board has had approximately four months since PDL’s first proposal, therefore PDL expects the Neos Board to have sufficient information to make its public response to this proposal quickly. The PDL proposal will remain outstanding for a period of fourteen (14) days. The proposal does not create any binding obligation on Neos, PDL or any of their respective affiliates. With appropriate engagement from Neos’ management, PDL is ready to finalize diligence and conclude the transaction within a short time.

PDL currently owns common stock of Neos amounting to less than 5% of Neos’ outstanding shares. If Neos is unable to complete this transaction, PDL reserves the right to sell any and all of these shares at any time.

The full text of PDL’s letter to Neos’ Board of Directors follows:

October 26, 2017

The Board of Directors
NEOS Therapeutics, Inc.
2940 N. Hwy 360
Suite 400
Grand Prairie, TX 75050

Dear Directors:

Today we are reconfirming our proposal to purchase all of the outstanding common shares of Neos Therapeutics, Inc. (“Neos”) for a cash purchase price of $10.25 per share (assuming a year end cash balance of $45 million). We continue to believe our proposal represents substantial value to your shareholders, which is an approximately 40% premium to the closing price of $7.30 on October 25, 2017.

Considering the importance of the proposed transaction to shareholders of both companies, we issued a press release and made public a copy of this letter. We believe Neos shareholders should not be denied the opportunity to consider our all-cash proposal of $10.25 per share.

Sincerely,

John P. McLaughlin
PDL BioPharma, Inc.
Chief Executive Officer

About PDL BioPharma, Inc.

PDL seeks to provide a significant return for its shareholders by acquiring and managing a portfolio of companies, products, royalty agreements and debt facilities in the biotech, pharmaceutical and medical device industries. In 2012, PDL began providing alternative sources of capital through royalty monetizations and debt facilities, and in 2016, began acquiring commercial-stage products and launching specialized companies dedicated to the commercialization of these products. To date, PDL has consummated 17 such transactions, of which nine are active and outstanding. PDL has one debt transaction outstanding, representing deployed and committed capital of $20.0 million: CareView; one hybrid royalty/debt transaction outstanding, representing deployed and committed capital of $44.0 million: Wellstat Diagnostics; and five royalty transactions outstanding, representing deployed and committed capital of $396.1 million and $397.1 million, respectively: KYBELLA®, AcelRx, University of Michigan, Viscogliosi Brothers and Depomed. PDL’s equity and loan investments in Noden represent deployed and committed capital of $179.0 million and $202.0 million, respectively, and its converted equity and loan investment in LENSAR represents deployed capital of $40 million.

NOTE: PDL, PDL BioPharma, the PDL logo and the PDL BioPharma logo are trademarks or registered trademarks of, and are proprietary, to PDL BioPharma, Inc. which reserves all rights therein.

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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company’s assets or business, are disclosed in the risk factors contained in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission, filed with the Securities and Exchange Commission on March 1, 2017. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward-looking statement except as required by law.

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$STLHF NetworkNewsWire Publication on Lithium’s Role in Shift in the Automotive Industry

NEW YORK, NY–(Oct 26, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring Standard Lithium Ltd. (TSX VENTURE: SLL) (FRANKFURT: S5L) (OTCQX: STLHF), a client of NNW that is building one of the largest portfolios of high quality, domestic U.S. lithium brine assets.

The publication, titled, “How Lithium is Driving the Global Push to End Gas-Powered Vehicles,” discusses a widespread push for electric vehicles and several companies preparing to supply the subsequent demand for lithium.

To view the full publication, visit: https://www.networknewswire.com/lithium-driving-global-push-end-gas-powered-vehicles/

“Germany, with the fourth-largest auto manufacturing industry in the world, plans a total ban on all internal combustion engines by 2030, while the UK has set its deadline for 2040. The Netherlands is mulling similar plans, and France wants all petrol and diesel cars off its roads by 2040. In addition to air pollution, oil spills are also a great global concern, posing ravishing and long-lasting economic and environmental consequences (http://nnw.fm/kwHt0).

“Naturally, more electric vehicles on the road means more lithium-powered batteries, and, consequently, demand for the metal is climbing. Standard Lithium Ltd. (TSX VENTURE: SLL) (FRANKFURT: S5L) (OTCQX: STLHF) is gearing up to play its part in boosting supplies. The Canada-based junior exploration company is intent on acquiring more domestic lithium-rich properties, looking to unlock value from overlooked U.S. lithium assets by applying new technologies and processes. Its first project in San Bernardino County, California, at the Bristol Dry Lake has already started to show signs of promise. Test results from a new geophysical survey of the 25,000-acre Bristol Lake site indicate that high concentrations of lithium-bearing brines are present throughout the company’s mineral lease agreement claims.”

About Standard Lithium

Standard’s value creation strategy encompasses acquiring a diverse and highly prospective portfolio of large-scale domestic brine resources, led by an innovative and results-oriented management team with a strong focus on technical skills. The company is currently focused on the immediate exploration and development of the Bristol Dry Lake Lithium Project located in the Mojave region of San Bernardino County, California; the location has significant infrastructure in-place, with easy road and rail access, abundant electricity and water sources, and is already permitted for extensive brine extraction and processing activities. The company is also commencing resource evaluation on its 33,000 acres of lithium brine leases located in the Smackover Formation.

For more information, visit the company’s website at http://nnw.fm/standardlithium

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information please visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

Forward-Looking Statements

This 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 forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

NNW Contact:

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

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$PBIO NetworkNewsWire Releases Exclusive Audio Interview with Pressure BioSciences

NEW YORK, NY–(Oct 26, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions for business, today announces the online availability of its interview with Pressure BioSciences Inc. (OTCQB: PBIO), a leader in the development and sale of innovative solutions for the worldwide life sciences industry.

The interview can be heard at http://NNW.fm/PBIO-Interview-October-2017

Kicking off the interview, NNW’s Stuart Smith introduces Richard T. Schumacher, founder and CEO of Pressure BioSciences, who describes the unique technologies at play with the company’s award-winning, high pressure table-top instruments.

“We supply instruments and consumables to life science laboratories all over the world,” says Schumacher. “These are the laboratories that are aggressively looking for the next billion-dollar drug, the next cure, the next preventive strategy, the next vaccine.”

Instruments designed and manufactured by Pressure BioSciences are constructed to handle extremely high pressure points, up to 100,000 pounds per square inch of hydrostatic pressure. Schumacher points out that everything in nature has its own pressure point, which means under the right pressure and temperature conditions every biological cell sample — whether it is from a virus, bacterium, normal or cancerous cell, animal or plant — can be placed under pressure to be broken open to release its biomolecules (e.g., DNA, RNA, proteins, lipids) for analysis. The company’s patented high pressure cycling technology (PCT) provides researchers with the ability to exquisitely control the critical sample preparation process. PBI believes that there are as many as 500,000 researchers worldwide who need to break cells in their studies, and that many are using old, archaic methods to do so.

Pressure BioSciences recently received patents for its Ultra Shear Technology (UST), a process that has the potential to play a significant role in a number of commercially important areas through its ability to create high-quality, stable nanoemulsions. Schumacher says this technology could provide a breakthrough when it comes to making cannabidiol (CBD) oil water soluble.

“We believe we can take CBD rich oil, put it through our system, break the oil down to very small droplets, and thus make it essentially water soluble, which means the bioavailability of CBD would dramatically increase,” he says, noting the problem of making CBD oils water soluble has plagued the cannabis industry from the beginning.

Pressure BioSciences, which completed 2016 with $2 million in sales with only one salesperson on board, has recently added five more people to the sales staff — and the team is diligently working to continue the company’s progress in the industry. Its newest table-top, high-pressure instrument is a finalist in the 2017 R&D 100 Awards, which are often referred to as the “Oscars of Innovation”. Furthermore, key opinion leaders around the globe are beginning to recognize the Barocycler 2320EXT instrument as a “must have” for laboratory research because of the many advantages the instrument has over its competitors, including a new USB output port where data generated by the instrument can be downloaded, making it a useful tool for FDA-required testing in biopharma quality control, a brand new application.

About Pressure BioSciences, Inc.

Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or “PCT”) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug development and design, bio-therapeutics characterization, soil & plant biology, forensics, and counter-bioterror applications. Major new focal market opportunities are emerging in the use of our patented, scalable, high-efficiency Ultra Shear Technology (“UST”) to create stable nanoemulsions of otherwise immiscible fluids (such as oils and water), and to prepare higher quality, homogenized, extended shelf-life or room temperature stable, low-acid liquid foods that cannot be effectively prepared using existing technologies.

For more information, visit https://www.pressurebiosciences.com/

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

Forward-Looking Statements

This 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 forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

Thursday, October 26th, 2017 Uncategorized Comments Off on $PBIO NetworkNewsWire Releases Exclusive Audio Interview with Pressure BioSciences

$SNSS Announces Pricing of $20 Million Offering of Securities

SOUTH SAN FRANCISCO, Calif., Oct. 25, 2017  — Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the pricing of underwritten public offerings of (i) 7,500,000 shares of its common stock and accompanying warrants to purchase 3,750,000 shares of its common stock and (ii) 2,500 shares of its non-voting Series D Convertible Preferred Stock (“Series D Stock”) and accompanying warrants to purchase 1,250,000 shares of its common stock.  The public offering price of each share of common stock and accompanying warrant to purchase 0.5 shares of common stock is $2.00 and the public offering price of each share of Series D Stock, convertible into 1,000 shares of common stock, and accompanying warrant to purchase 500 shares of common stock is $2,000. The exercise price of the warrants is $3.00 per whole share of common stock. The warrants may be exercised at any time until and including October 27, 2018.

Sunesis expects to receive combined gross proceeds of approximately $20 million from these offerings, before deducting the underwriting discount and other estimated offering expenses. If exercised in full, the warrants could result in additional net financing proceeds to Sunesis of up to $15 million. These offerings are expected to close on or about October 27, 2017, subject to customary closing conditions.

Each share of non-voting Series D Stock is convertible into 1,000 shares of Sunesis common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.98% of the total number of shares of Sunesis common stock then outstanding. Sunesis anticipates using the net proceeds from the proposed offerings to fund the continued development of SNS-062, additional kinase inhibitor programs and for working capital and other general corporate purposes.

Cowen and Wells Fargo Securities are acting as joint book-running managers. Oppenheimer & Co. Inc. is acting as Lead Manager in these offerings.

Each of these offerings is being made by Sunesis pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the “SEC”), which the SEC declared effective on June 10, 2014. For each of these offerings, a preliminary prospectus supplement has been filed with the SEC and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of each final prospectus supplement and the accompanying prospectus relating to each offering, when available, may be obtained from Cowen and Company, LLC (c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: 631-274-2806, Fax: 631-254-7140) or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by email at cmclientsupport@wellsfargo.com, or by telephone at (800) 326-5897.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Sunesis Pharmaceuticals

Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the future treatment of solid and hematologic cancers. Sunesis has built an experienced cancer drug development organization committed to improving the lives of people with cancer. The company is focused on advancing its novel kinase-inhibitor pipeline, with an emphasis on establishing proof of concept that its oral non-covalent BTK-inhibitor, SNS-062, treats ibrutinib-resistant chronic lymphocytic leukemia.

SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.

This press release contains forward-looking statements, including statements related to the anticipated gross proceeds from the proposed offerings, use of such proceeds, and expectations regarding the completion and timing of Sunesis’ proposed offerings. Words such as “may,” “expect,” “intends,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis’ current expectations. Forward-looking statements involve risks and uncertainties. Sunesis’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offerings. These and other risk factors are discussed under “Risk Factors” in Sunesis’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and in the preliminary prospectus supplements related to the proposed offerings filed with the SEC on October 24, 2017. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Sunesis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor and Media Inquiries:
Maeve Conneighton
Argot Partners
212-600-1902

Dan Swisher
Sunesis Pharmaceuticals Inc.
650-266-3715

Wednesday, October 25th, 2017 Uncategorized Comments Off on $SNSS Announces Pricing of $20 Million Offering of Securities

$SRRA Appoints Dr. Andrew Allen to its Board of Directors

– Dr. Allen, key contributor in the advancement of PARP inhibitors, to support Sierra in developing next-generation DDR therapeutics –

VANCOUVER, Oct. 25, 2017 – Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, today announced the appointment of Dr. Andrew Allen to its Board of Directors, effective October 23, 2017.

“With the proven success of PARP inhibitors in treating cancer, significant attention has been focused on identifying and advancing the next-generation of targeted therapeutics that leverage the DNA damage response,” said Dr. Allen. “I’ve been highly encouraged by the sophisticated approach Sierra is taking to developing SRA737, leveraging the rich biology of Chk1 synthetic lethality to incorporate prospective genomic profiling strategies to enhance patient selection in their trials and potentially improve their prospects for positive outcomes. I look forward to working closely with this outstanding team.”

“Andrew Allen’s experience and exemplary track record of success in oncology drug development are highly aligned with the vision at Sierra Oncology to build a commercial company delivering impactful therapeutics for patients with cancer,” added Mr. Donald Parfet, Chairman of the Board of Directors of Sierra Oncology. “Our ongoing ability to attract renowned thought leaders in the DDR field like Dr. Allen reflects the quality of our assets and the growing momentum of our clinical programs.”

Dr. Andrew Allen is a co-founder of Gritstone Oncology and serves as its President, Chief Executive Officer and a member of its Board of Directors. He was a Co-Founder of Clovis Oncology (NASDAQ: CLVS) where he served as Executive Vice President of Clinical and Preclinical Development and Chief Medical Officer, leading the in-licensing and global development of RubracaTM, a PARP inhibitor approved for treatment of ovarian cancer. Prior to that, he was Chief Medical Officer at Pharmion Corporation, which was sold to Celgene Corporation for $2.9 billion following the global development of Vidaza™ for the treatment of myelodysplastic syndromes and Thalomid™ for the front-line treatment of multiple myeloma in Europe. Previously, Dr. Allen served in clinical development leadership roles at Chiron Corporation and Abbott Laboratories, and worked at McKinsey & Company, where he advised life science companies on strategic issues. He currently serves on the Board of Directors of the epigenetic cancer therapy company, Epizyme (NASDAQ: EPZM), and Cell Design Labs, a privately held CAR-T company. Dr. Allen received a medical degree from Oxford University and a Ph.D. in immunology from Imperial College London.

The company also reported it has increased the size of the Board from seven directors to eight.

About Sierra Oncology
Sierra Oncology is a clinical stage drug development company advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer. Our lead drug candidate, SRA737, is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of important cell cycle checkpoints and central mediator of the DDR network. SRA737 is currently being investigated in two Phase 1 clinical trials in patients with advanced cancer: a monotherapy study evaluating SRA737 in patients with tumors identified to have genetic aberrations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality, and a study evaluating the combination of SRA737 potentiated by low-dose gemcitabine. Sierra is also preparing for potential clinical studies of SRA737 in combination with other agents where there is a strong biological rationale for synergy with Chk1 inhibition, such as immune oncology therapeutics, and other DDR inhibitors including PARP inhibitors.

Sierra Oncology is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7) undergoing preclinical development. Cdc7 is a key regulator of DNA replication and is involved in the DDR network, making it a compelling emerging target for the potential treatment of a broad range of tumor types. For more information, please visit www.sierraoncology.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Sierra Oncology’s market and industry position, expectations from current data, anticipated clinical development and potential benefits of Sierra Oncology’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that Sierra Oncology may be unable to successfully develop and commercialize product candidates, SRA737 and SRA141 are at early stages of development and may not demonstrate safety and efficacy or otherwise produce positive results, Sierra Oncology may experience delays in the preclinical and anticipated clinical development of SRA737 or SRA141, Sierra Oncology may be unable to acquire additional assets to build a pipeline of additional product candidates, Sierra Oncology’s third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, Sierra Oncology’s cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, Sierra Oncology may be unable to obtain and enforce intellectual property protection for its technologies and product candidates and the other factors described under the heading “Risk Factors” set forth in Sierra Oncology’s filings with the Securities and Exchange Commission from time to time. Sierra Oncology undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Wednesday, October 25th, 2017 Uncategorized Comments Off on $SRRA Appoints Dr. Andrew Allen to its Board of Directors

$QTNT Announces $40 Million Private Placement, Warrants to Raise Additional $49 Million

JERSEY, Channel Islands, Oct. 25, 2017 — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today announced that it has entered into agreements to issue to certain subscribers: (i) 7,864,683 ordinary shares at $4.64 per share (the “Ordinary Shares”); (ii) 550,000 pre-funded warrants at $4.755 per underlying pre-funded warrant exercisable for up to 550,000 ordinary shares at $0.01 per ordinary share (the “Pre-funded Warrants”); and (iii) 8,414,683 warrants at $0.125 per underlying warrant share exercisable for up to 8,414,683 ordinary shares at $5.80 per ordinary share (the “Warrants”). The aggregate gross proceeds of the private placement are expected to be approximately $40 million. An additional $49 million is expected to be received prior to July 31, 2018 assuming full exercise of the Warrants.  Quotient intends to use the net proceeds from the financing to fund the ongoing development and commercial scale up and, if approved, commercialization of MosaiQ™ and for working capital and other general corporate purposes. Subject to the satisfaction of customary closing conditions, the private placement is expected to close on or about October 26, 2017.

The Ordinary Shares, Pre-funded Warrants and Warrants issued in the private placement, and the ordinary shares issuable upon exercise of the Pre-funded Warrants and the Warrants, have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements. The Ordinary Shares, Pre-funded Warrants and Warrants were offered only to a limited number of accredited investors. Quotient has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the Ordinary Shares and the Warrants issued in the private placement and the ordinary shares issuable upon exercise of the Pre-funded Warrants and the Warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Quotient Limited

Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQ™ technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The company’s operations are based in Edinburgh, Scotland; Eysins, Switzerland and Newtown, Pennsylvania.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the closing of the private placement, the intended use of proceeds from the private placement, the registration of the shares sold in the private placement, the exercise of the warrants and pre-funded warrants, and the registration of the shares issuable upon exercise of warrants and pre-funded warrants. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially, including: Quotient’s ability to complete the private placement; the application of the net proceeds from the private placement; and other risks set forth in Quotient’s most recent Annual Report on Form 10-K, as well as other documents that Quotient files with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements because of new information, future events or circumstances or other factors.

The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

CONTACT: Christopher Lindop, Chief Financial Officer – christopher.lindop@quotientbd.com; +41 22-545-5226

Wednesday, October 25th, 2017 Uncategorized Comments Off on $QTNT Announces $40 Million Private Placement, Warrants to Raise Additional $49 Million

$MGNX & $INCY Global Collaboration, Licensing Agreement for Anti-PD-1, MGA012

WILMINGTON, Del. & ROCKVILLE, Md.

  • Incyte gains exclusive, worldwide development and commercialization rights to MGA012 in all indications
  • MacroGenics to receive an upfront cash payment of $150 million plus potential milestone payments and royalties, and retains right to develop its pipeline assets in combination with MGA012

Incyte Corporation (NASDAQ:INCY) and MacroGenics, Inc. (NASDAQ:MGNX) announced today that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while MacroGenics retains the right to develop its pipeline assets in combination with MGA012.

“Anti-PD-1 therapy is becoming a mainstay of cancer treatment across multiple tumor types, and we believe the addition of MGA012 to our clinical pipeline is important to fulfilling our long-term development strategy in immuno-oncology. This collaboration with MacroGenics will allow us to rapidly explore the potential clinical benefit of developing MGA012 as a monotherapy and also combining anti-PD-1 therapy with several of our existing portfolio assets,” said Steven Stein, M.D., Chief Medical Officer of Incyte.

“We believe Incyte is the ideal partner for MGA012, given its immuno-oncology portfolio and dedication to researching and developing innovative and transformative cancer therapies and we hope that the combined resources of both companies will be able to significantly expand and accelerate the current development efforts for this promising molecule,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. “Furthermore, we look forward to exploring the combination of MGA012 with multiple molecules in our own portfolio, including DART molecules for redirected T-cell killing, antibodies with enhanced effector function and ADCs, potentially to provide improved patient benefit.”

Enrollment in the dose escalation portion of the Phase 1 study of MGA012 has been completed and the molecule is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the study. Data from the dose escalation portion of the Phase 1 study have been accepted for poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting in November 2017.

Terms of the Collaboration

Upon closing, Incyte will pay MacroGenics an upfront payment of $150 million. Incyte will receive worldwide rights to develop and commercialize MGA012 in all indications.

Per the terms of the collaboration, MacroGenics will also be eligible to receive up to $420 million in potential development and regulatory milestones, and up to $330 million in potential commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte.

Under the terms of the collaboration, Incyte will lead global development of MGA012. MacroGenics retains the right to develop its pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and MacroGenics commercializing its asset(s), if any such potential combinations are approved.

In addition, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012. MacroGenics intends to utilize its commercial-scale GMP facility, which is expected to be fully operational in 2018.

The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.

About Incyte Corporation

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

About MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases. MacroGenics generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed MacroGenics to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see MacroGenics’ website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether the planned transaction will close within the expected timeframe or ever; whether MGA012 will successfully advance through clinical studies or will ever be approved for use in humans anywhere or will be commercialized anywhere successfully or at all; whether MGA012 will be effective in the treatment of cancer or other indications; and whether and when any of the milestone payments or royalties under this collaboration will ever be paid by Incyte. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: obtaining approval for this planned collaboration; research and development efforts related to the collaboration programs; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; other market or economic factors; unanticipated delays; each company’s ability to compete against parties with greater financial or other resources; greater than expected expenses; and such other risks detailed from time to time in each company’s reports filed with the Securities and Exchange Commission, including the Form 10-Q for the quarter ended June 30, 2017 filed by each company. Each party disclaims any intent or obligation to update these forward-looking statements.

MacroGenics’ Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for MacroGenics, including statements about MacroGenics’ strategy, future operations, clinical development of MacroGenics’ therapeutic candidates, milestone or opt-in payments from MacroGenics’ collaborators, MacroGenics’ anticipated milestones and future expectations and plans and prospects for MacroGenics and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of MacroGenics’ product candidates and other risks described in MacroGenics’ filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent MacroGenics’ views only as of the date hereof. MacroGenics anticipates that subsequent events and developments will cause MacroGenics’ views to change. However, while MacroGenics may elect to update these forward-looking statements at some point in the future, MacroGenics specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing MacroGenics’ views as of any date subsequent to the date hereof.

 

Incyte Contacts:
Investors
Michael Booth, DPhil, +1 302-498-5914
mbooth@incyte.com
or
Media
Catalina Loveman, +1 302-498-6171
cloveman@incyte.com
or
MacroGenics Contacts:
Investors
Jim Karrels, +1 301-251-5172
info@macrogenics.com
or
Media
Karen Sharma, +1 781-235-3060
ksharma@macbiocom.com

Wednesday, October 25th, 2017 Uncategorized Comments Off on $MGNX & $INCY Global Collaboration, Licensing Agreement for Anti-PD-1, MGA012

$IGC to Distribute its Formulations in Germany in Early 2018

BETHESDA, Md., Oct. 25, 2017 — India Globalization Capital, Inc. (NYSE MKT:IGC) announced that it has entered into a Memorandum of Understanding (MOU) with MediCann Handels GmbH, a company based in Hamburg Germany, for the import and distribution of IGC’s cannabinoid based therapies including IGC-AD1 (Hyalolex) to pharmacies in Germany.

MediCann plans to distribute to pharmacies, apothecaries and other licensed retail outlets that are legally allowed to sell cannabinoid-based products. Under the current MOU, MediCann will provide the capital required for the transportation, import, storage, sales and marketing of products intended for the German market. The agreement is subject to standard closing conditions such as due diligence relating to satisfactory licensing and product procurement.

“There are many benefits to developing a strong presence in the German pharmacy market including, a favorable regulatory environment and reimbursement from health insurance providers. The agreement with MediCann is the first step in the commercialization process of our therapies, as we work out the logistics of how to efficiently deliver our products to Germany,” states Ram Mukunda, CEO. “We are glad to add the products of IGC to our portfolio. With these products we will have a unique selling point in the German market,” states Carsten Siegemund, CEO of MediCann.

About IGC
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats. IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.

For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/

Forward-looking Statements
Please see forward looking statements as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.

Contact:
Claudia Grimaldi
301-983-0998

Wednesday, October 25th, 2017 Uncategorized Comments Off on $IGC to Distribute its Formulations in Germany in Early 2018