(CORI) Announces Proposed Public Offering of Common Stock

MENLO PARK, Calif., Aug. 3, 2015  — Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, announced today that it has commenced an underwritten public offering of up to 4,000,000 shares of its common stock. Corium also expects to grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock offered in the public offering. All of the shares will be offered and sold by Corium.

Jefferies LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Needham & Company, LLC is acting as lead manager. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Corium intends to use the net proceeds from this offering for general corporate purposes, which may include funding research and development, increasing its working capital, acquisitions or investments in businesses, products or technologies that are complementary to its own and capital expenditures.

The public offering will be made pursuant to a shelf registration statement on Form S-3 that was filed by Corium with the Securities and Exchange Commission (“SEC”) on May 8, 2015 and declared effective by the SEC on May 21, 2015. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022, by telephone at 877-821-7388, or by email at Prospectus_Department@Jefferies.com, or from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37^th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6142, or by email at syndicate@leerink.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy Corium’s common stock, nor shall there be any sale of Corium’s common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations of offers to buy, or sales of the common stock will only be made pursuant to the registration statement filed with the SEC, including a prospectus and a related prospectus supplement.

About Corium

Corium International, Inc. is a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage the company’s broad experience in advanced transdermal and transmucosal delivery systems. Corium has developed and is the sole commercial manufacturer of seven prescription drug and consumer products with partners Teva Pharmaceuticals, Par Pharmaceutical and Procter & Gamble. The company has two proprietary transdermal platforms: Corplex™ for small molecules and MicroCor^®, a biodegradable microstructure technology for small molecules and biologics, including vaccines, peptides and proteins. The company’s late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics that is currently in Phase 3 trials, and additional transdermal products that are being co-developed with Teva. Corium has multiple proprietary programs in preclinical and clinical development for the treatment of osteoporosis and neurological disorders. For further information, please visit www.coriumgroup.com

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the proposed public offering, the anticipated use of proceeds of the offering and the expectations regarding size and timing of completion of the offering, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others, the risks identified in Corium’s filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, filed with the SEC on July 30, 2015, the preliminary prospectus supplement related to the proposed public offering and subsequent filings with the SEC. Any of these risks and uncertainties could materially and adversely affect Corium’s results of operations, which would, in turn, have a significant and adverse impact on Corium’s stock price. Corium cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Corium undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.

CONTACT: Investor and Media Contact:
         Karen L. Bergman
         BCC Partners
         kbergman@bccpartners.com
         (650) 575-1509

(CFMS) Customized Knee Replacement Study Results At 2015 Pan Pacific Intnl. Conference

ConforMIS’s Customized iTotal CR Knee Replacements Demonstrate Superior Functional Outcomes Compared to Off-the-Shelf Knee Replacements in Multiple Studies

BEDFORD, Mass., Aug. 3, 2015  — ConforMIS, Inc. (NASDAQ:CFMS) announced today results from six clinical studies presented at the 2015 Pan Pacific International Congress for Joint Reconstruction (ICJR). In an ongoing, blinded, US multicenter study, the investigators reported that patients with customized ConforMIS iTotal CR knee replacements were more likely to have an excellent or good objective Knee Society Score (KSS) and walked statistically significantly faster than patients with standard, off-the-shelf total knee replacements.

For this study, researchers at seven US centers performed an interim analysis of 295 consecutively enrolled total knee replacement patients using a variety of functional tests and the KSS, a validated testing instrument used to assess patient outcomes. The objective component of the KSS measures factors such as range of motion, alignment, and stability, which are important for regaining functional abilities. Patients with iTotal CR knee replacements were 1.7 times more likely to achieve an excellent or good objective KSS, whereas patients with off-the-shelf knee replacements were 2.6 times more likely to achieve a poor objective KSS.

In a separate, validated functional test administered during this study, known as the Aggregated Locomotor Function (ALF) test, blinded operators assessed patients’ ability to perform various activities of daily living, including walking, standing from a chair and climbing stairs. Patients with iTotal CR knee replacements showed a statistically significantly better ALF score than patients with off-the-shelf knee replacements.  In addition to achieving an overall better ALF score, the data also showed statistical significance in one individual component of the ALF test: patients with iTotal CR knee replacements walked statistically significantly faster than patients with off-the-shelf knee replacements.

“After performing several thousand total knee replacements, I have seen firsthand that using a customized implant designed specifically for each patient could have a significant impact on restoring function and improving overall patient satisfaction and ability to perform daily activities,” said Robert Tait, MD, Chief of Staff at St. Rose Dominican Hospital Siena in Henderson, Nev., and lead investigator on this clinical study. “This new data provides additional clinical evidence demonstrating that customized knee implants can deliver measurable advantages for patients that have a direct and positive impact on patient quality of life.”

Other studies presented at ICJR evaluated the ConforMIS iTotal CR knee replacement with regard to kinematics, safety profile and patient satisfaction:

• The lead investigator in a prospective, single-arm, multicenter study of 252 patients with iTotal CR knee replacements presented results at ICJR that showed high patient reported outcome scores, high range of motion, short hospital stay and excellent safety profile.
• In two other studies, investigators used real-time x-ray imaging with mobile fluoroscopy to study the movement, or kinematics, of the knee during deep knee bend and chair rise in patients with iTotal CR knee replacements compared to patients with off-the-shelf knee replacements.  In the first study, investigators analyzed a total of 63 total knee replacements implanted by a single surgeon.  The investigators observed knee motion that was more consistent with normal knee movement in patients with iTotal CR knee replacements compared to patients with off-the-shelf knee replacements.  In addition, during a deep knee bend, patients with iTotal CR knee replacements achieved greater weight bearing flexion compared to patients with off-the-shelf knee replacements. In the second study, investigators analyzed 38 patients with total knee replacements. During a deep knee bend, 35% of patients with off-the-shelf knee replacements experienced implant lift-off in early flexion, whereas none (0%) of the patients with iTotal CR knee replacements experienced implant lift-off in early flexion. This difference was statistically significant. According to the investigators in this study, implant lift-off in early flexion is correlated with mid-flexion instability, a common source of patient dissatisfaction after knee replacement.

Additional studies presented at ICJR relating to customized ConforMIS iUni and iDuo partial knee replacements showed high patient satisfaction scores at two or more years post-surgery:

• In a prospective, single-arm, multicenter study, 118 patients with ConforMIS iUni knee replacements demonstrated improved range of motion and high functional scores at two years post-surgery, with 89% of patients stating that the movement of their knee felt natural.
• In a single-center study of 31 patients with ConforMIS iDuo customized implants, investigators found that a majority of patients rated their result as good or excellent, and 97% of patients reported that they would hypothetically undergo the same surgery again.

“Previous clinical studies have shown that about 20% of patients who receive a total knee replacement are not satisfied with the results.  By focusing on the patient and specifically each patient’s unique anatomy, we believe ConforMIS is transforming the knee replacement experience for patients,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS.  “By designing implants to match the fit and natural curves of each patient’s knee, we believe our iTotal CR, iUni and iDuo knee replacements can provide patients with improved functional outcomes and higher overall satisfaction levels.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. In addition, we believe ConforMIS implants provide economic advantages for hospitals by improving patient recovery times, reducing blood loss and reducing adverse event rates at discharge. ConforMIS owns or exclusively in-licenses approximately 470 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints. For more information, visit www.conformis.com.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS’s strategy, future operations, future financial position and expected market growth, including expectations regarding the potential impact and advantages of using customized implants and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales, expenses, gross margins and other results of operations, and the other risks and uncertainties  described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

CONTACT: Investor Contact:
         Oksana Bradley
         ir@conformis.com
         (781) 374-5598

         Media Contacts:
         Bill Berry
         Berry & Company Public Relations
         Bberry@berrypr.com
         (212) 253-8881

         Lynn Granito
         Berry & Company Public Relations
         Lgranito@berrypr.com
         (212) 253-8881

(CDRB) Announces Closing of ThinOps Resources LLC Acquisition

MAUI, Hawaii and NEW YORK, Aug. 3, 2015  — Code Rebel Corp. (NASDAQ: CDRB), an enterprise software development firm that licenses its proprietary software solution to enable simplified secure access and communications between PC and Mac environments on virtually any computer, tablet, or smartphone, announced today that it closed its previously announced acquisition of all of the outstanding membership interests of ThinOps Resources LLC from Thomas M. Moreno, ThinOps Resources’ sole member.  ThinOps Resources is a management and technology consulting services firm based in Houston, Texas, which had revenue of over $2 million in 2014.  As of the closing, ThinOps is a wholly-owned, independently operated subsidiary of Code Rebel.

Under the terms of the Membership Interest Purchase Agreement, Code Rebel paid to Mr. Moreno a combination of $9.25 million in cash and stock, including the issuance of 667,511 shares of its common stock at a price of approximately $12.73 per share, which was based on the volume weighted average closing price of Code Rebel’s common stock on the Nasdaq Capital Market for the ten trading days immediately preceding the closing date.  In connection with the Membership Interest Purchase Agreement, Code Rebel also entered into an employment letter agreement with Mr. Moreno to serve as ThinOps’ President for three years.

The acquisition brings a number of benefits to Code Rebel, including:

• Increased revenues;
• An increase in the capacity of its in-house sales and project support team to support Code Rebel’s expanding distribution channels; and
• Access to potential new customers and users of Code Rebel’s software.

At the closing, Code Rebel had outstanding 13,350,225 shares of common stock after reflecting the issuance.  The shares of Code Rebel common stock issued in the transaction have not been registered under the Securities Act of 1933.

About ThinOps

ThinOps Resources provides products and services to a wide variety of organizations from leading academic institutions and healthcare organizations to many Fortune 500 companies located around the country and abroad. In the consulting business, having a true understanding of the client needs only comes from experienced people that have “earned their experience.” Our service offerings focus on understanding our client’s needs and providing them a focused roadmap and supporting plan on how to bridge the gap between business theory and business reality.

About Code Rebel

Code Rebel is an enterprise software company that develops, licenses, and supports software designed for cross-platform enterprise security and productivity. The proprietary Code Rebel iRAPP software addresses the growing requirement of corporate IT departments for secure access from diverse enterprise devices. Code Rebel software was developed by its in-house engineering team to address the demand for secure interoperability between mobile, desktop, and server environments and interaction between Apple and Microsoft devices and software. Code Rebel software facilitates mobile, desktop, and server environment interoperability seamlessly across Apple and Microsoft devices and software. The company provides enterprise client support for its software to a diverse range of industries. For more information visit: http://www.coderebel.com.

Forward-Looking Statements

This press release contains information about Code Rebel’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 software 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.  Code Rebel encourages you to review other factors that may affect its future results in Code Rebel’s registration statement and in its other filings with the Securities and Exchange Commission.

Code Rebel Investor Relations Contact:

Howard Gostfrand, President
American Capital Ventures
Phone: 305.918.7000
Email: info@amcapventures.com
www.amcapventures.com

(PPSI) Acquires Pacific Power Systems Integration, Inc.

Acquisition Rounds Out Product Suite and Expands Customer Base

FORT LEE, N.J., Aug. 3, 2015  — Pioneer Power Solutions, Inc. (Nasdaq: PPSI) (“Pioneer” or the “Company”), a company engaged in the manufacture, sale and service of electrical transmission, distribution and on-site power generation equipment, today announced that its Pioneer CEP subsidiary had acquired substantially all of the assets of Pacific Power Systems Integration, Inc. (“Pacific”).

Pacific specializes in manufacturing custom electrical power distribution and control equipment, with a specific emphasis on low voltage draw-out, metal-enclosed and metal-clad switchgear. Pacific has successfully completed more than 100 projects over the last 15 years through EPC firms and directly with customers, mostly in the oil refining, utility and mass transit sectors, including: Jacobs Engineering, British Petroleum, Conoco Phillips, Pacific Gas & Electric, LADWP, SMUD and transportation agencies such as the LA Metropolitan Transportation Authority, Bay Area Rapid Transit and the Port Authority of New York and New Jersey.

The acquisition significantly enhances Pioneer CEP’s technical qualifications with more advanced classifications of switchgear, and provides access to larger, long-cycle project opportunities, new customers and end markets where Pioneer should be able to leverage its full suite of engineered product solutions. By December 2015, Pacific’s facility is expected to be closed and its operations consolidated into Pioneer CEP’s larger facility, located five miles away in Santa Fe Springs, California.

“This acquisition effectively completes our portfolio of low and medium voltage switchgear offerings, and is expected to sustain our overall growth objectives for years to come,” commented Nathan Mazurek, Pioneer’s Chairman and Chief Executive Officer. “At the same time, it provides multiple new avenues to drive efficiency and operational growth in both our T&D Solutions and Critical Power Solutions businesses. The rippling effect of this transaction will be felt throughout Pioneer, as it enables us to capitalize on new production and internal supply chain synergies, and should generate incremental sales across the organization, given the breadth of solutions we now have to offer. Our team’s focus on operational execution, both internally and externally, will be critical. I am confident that our efforts will place us in a stronger market position from which to engage and serve our customers, and improve our financial performance in 2016 and beyond.”

Kytchener Whyte, Pacific’s founder, added, “I am thrilled to be reunited with so many of my former colleagues at Pioneer, and look forward to working closely with Pioneer CEP’s President, Geo Murickan, to help take the combined business to the next level.”

Financial terms of the transaction were not disclosed. Based on Pacific’s current order backlog, the timing of the acquisition and integration activities remaining to be completed, the Company expects the transaction to be neutral to full-year 2015 non-GAAP earnings. In 2016, the acquisition is expected to be approximately $0.05 to $0.10 accretive to non-GAAP earnings per share.

About Pioneer Power Solutions, Inc.

Pioneer Power Solutions, Inc. manufactures, sells and services a broad range of specialty electrical transmission, distribution and on-site power generation equipment for applications in the utility, industrial, commercial and backup power markets. The Company’s principal products and services include custom-engineered electrical transformers, switchgear and engine-generator sets and controls, complemented by a national field-service organization to maintain and repair power generation assets. Pioneer is headquartered in Fort Lee, New Jersey and operates from 14 additional locations in the U.S., Canada and Mexico for manufacturing, centralized distribution, engineering, sales, service and administration. To learn more about Pioneer, please visit our website at www.pioneerpowersolutions.com.

Safe Harbor Statement:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the Company’s ability to expand its business through strategic acquisitions, (ii) the Company’s ability to integrate acquisitions and related businesses, (iii) the fact that many of the Company’s competitors are better established and have significantly greater resources, and may subsidize their competitive offerings with other products and services, which may make it difficult for the Company to attract and retain customers, (iv) the Company’s dependence on Hydro-Quebec Utility Company and Siemens Industry, Inc. for a large portion of its business, and the fact that any change in the level of orders from Hydro-Quebec Utility Company or Siemens Industry, Inc. could have a significant impact on the Company’s results of operations, (v) the potential loss or departure of key personnel, including Nathan J. Mazurek, the Company’s Chairman, President and Chief Executive Officer, (vi) the fact that fluctuations between the U.S. dollar and the Canadian dollar will impact the Company’s revenues, (vii) the Company’s ability to generate internal growth, (viii) market acceptance of existing and new products, (ix) the Company’s dependence on a distributor agreement with Generac Power Systems through which it derives a significant portion of its revenues, (x) operating margin risk due to competitive pricing and operating efficiencies, supply chain risk, material, labor or overhead cost increases, interest rate risk and commodity risk, (xi) restrictive loan covenants or the Company’s ability to repay or refinance debt under its credit facilities that could limit the Company’s future financing options and liquidity position and may limit the Company’s ability to grow its business, (xii) general economic and market conditions in the electrical equipment, power generation, commercial construction, industrial production, oil and gas, marine and infrastructure industries, (xiii) the impact of geopolitical activity on the economy, changes in government regulations such as income taxes, climate control initiatives, the timing or strength of an economic recovery in the Company’s markets and the Company’s ability to access capital markets, (xiv) the fact that unanticipated increases in raw material prices or disruptions in supply could increase production costs and adversely affect the Company’s profitability, (xv) the fact that the Company’s Chairman controls a majority of the Company’s combined voting power, and may have, or may develop in the future, interests that may diverge from yours, (xvi) material weaknesses in the Company’s internal control over financial reporting that could have an adverse effect on the Company’s business and common stock price, and (xvii) the fact that future sales of large blocks of the Company’s common stock may adversely impact the Company’s stock price. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual and Quarterly Reports on Form 10-K and Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

CONTACT:
Brett Maas, Managing Partner
Hayden IR
(646) 536-7331
brett@haydenir.com

(LXRX) Positive Top-Line Results For Pivotal Phase 3 Telotristat Etiprate Cancer Study

Telotristat Etiprate has FDA Fast-Track, Orphan Drug Status Conference call and webcast on August 3, 2015 at 8:00 a.m. Eastern Time

THE WOODLANDS, Texas, Aug. 3, 2015 — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the pivotal TELESTAR Phase 3 clinical trial met its primary endpoint, showing the benefit of oral telotristat etiprate in treating cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care. Telotristat etiprate was discovered using Lexicon’s gene science, based on Nobel Prize-winning technology, and is the company’s first discovery to complete a pivotal Phase 3 clinical trial. If approved, telotristat etiprate would be the first oral treatment successfully developed for carcinoid syndrome and the first addition to the standard of care in more than 16 years[1].

Top-line results from the Phase 3 study show that patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), meeting the study’s primary endpoint.

“We are extremely pleased with these top-line results,” said Lexicon President and Chief Executive Officer Lonnel Coats. “Carcinoid syndrome is severely debilitating, preventing many patients from leading active and predictable lives, and unfortunately, a majority of patients will not be adequately controlled over time with the current standard of care. We are committed to working closely with the FDA to file our first new drug application (NDA) and to bring this innovative new treatment to patients whose lives are already impacted by the challenges of cancer.”

“The TELESTAR results are promising, and the community of patients and caregivers who live and deal with carcinoid syndrome are excited about the prospect of a new treatment becoming available,” said principal investigator Matthew H. Kulke, M.D., Director, Program in Neuroendocrine and Carcinoid Tumors and Senior Physician, Dana Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School.

Lexicon received Fast Track designation and Orphan Drug status for telotristat etiprate from the U.S. Food and Drug Administration (FDA) in 2008 and 2012, respectively. The company plans to announce complete results from the Phase 3 TELESTAR study at an upcoming scientific conference.

About Carcinoid Syndrome

Carcinoid syndrome is a rare disease affecting thousands of patients with neuroendocrine tumors that originate in the gastrointestinal tract and metastasize or spread to the liver or other organs. Overproduction of serotonin within these metastatic neuroendocrine tumor (mNET) cells is a driver of carcinoid syndrome, which is characterized by debilitating diarrhea, facial flushing, abdominal pain, heart valve damage and other serious consequences.  The severe and unpredictable diarrhea associated with carcinoid syndrome has a profound impact on cancer patients’ lives, often preventing them from participating in daily activities.

The current standard of care for carcinoid syndrome is somatostatin analog depot injection (SSA), first approved in 1998. SSA therapy fails to maintain adequate control of carcinoid syndrome for most patients, with many becoming not adequately controlled within the first two years after the therapy is initiated.  Patients with carcinoid syndrome can live for many years with metastatic cancer, requiring the need for long-term treatment options to effectively manage their disease[2].

About TELESTAR

The double-blind Phase 3 study known as TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) enrolled 135 patients with carcinoid syndrome which was not adequately controlled on SSA therapy, the current standard of care. The three-arm study evaluated two doses of oral telotristat etiprate – 250 mg and 500 mg, each taken three times daily – against placebo over a 12-week period and measured the reduction from baseline in the average number of daily bowel movements. Patients in both the treatment and placebo arms continued their SSA therapy throughout the study.

Top-line results from TELESTAR show that patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), meeting the study’s primary endpoint.

In a key secondary measure, a substantially greater proportion of patients on telotristat etiprate achieved a durable response (44 percent and 42 percent in the 250 mg and 500 mg arms, respectively), defined as at least a 30 percent reduction in daily bowel movements over at least half the days of the study period, as compared to 20 percent response on placebo (p<0.040).

Patients who received 250 mg of telotristat etiprate experienced a 29 percent reduction in the average number of daily bowel movements during the final week (week 12) of the study period compared to baseline, and those in the 500 mg arm experienced a 35 percent reduction, while the placebo group showed a 17 percent reduction. These results are consistent with those seen in the 12-week Phase 2 study of telotristat etiprate.

The proportion of patients with treatment-emergent adverse events (AEs), serious AEs and discontinuation due to AEs were generally similar in all three treatment arms. The tolerability profile of the telotristat etiprate 250 mg dose appeared similar to placebo and somewhat better than the 500 mg dose with respect to gastrointestinal discomfort and mood. The overall incidence and nature of AEs in TELESTAR was consistent with those reported in previous studies. Further in depth analysis of safety and tolerability data will be conducted.

The 12-week study period is being followed by a 36-week open-label extension where all patients receive telotristat etiprate 500 mg three times daily.

About Telotristat Etiprate

Discovered using Lexicon’s unique approach to gene science, telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), an enzyme that triggers the excess serotonin production within mNET cells that leads to carcinoid syndrome. While existing treatments for carcinoid syndrome work to reduce the release of serotonin outside tumor cells, telotristat etiprate works at the source to reduce serotonin production within the tumor cells. By specifically inhibiting serotonin production, telotristat etiprate seeks to control this important driver of carcinoid syndrome and, in turn, provide patients with more control over their disease.

Lexicon retains rights to market telotristat etiprate in the U.S. and Japan, and is building the in-house commercial infrastructure to serve the U.S. market. The company has a license and collaboration agreement with Ipsen to commercialize telotristat etiprate in Europe and other countries outside the U.S. and Japan.

Lexicon Conference Call

Lexicon management will hold a conference call and webcast to discuss the TELESTAR Phase 3 top-line results at 8:00 a.m. Eastern Time on August 3, 2015.  The dial-in number for the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international).  The conference ID for all callers is 37172080.  Investors can access a live webcast of the call at www.lexpharma.com.  An archived version of the webcast will be available on the website through September 2, 2015.

About Lexicon

Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. For additional information please visit www.lexpharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of telotristat etiprate (LX1032), including characterizations of the results of and projected timing of clinical trials and the potential therapeutic and commercial potential of telotristat etiprate.  In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information.  All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to meet its capital requirements, successfully conduct clinical development of telotristat etiprate and preclinical and clinical development of its other potential drug candidates, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements.  Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission.  Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

[1] Octreotide acetate for injectable suspension was approved by FDA for the treatment of carcinoid syndrome in 1998.

[2] Shebani KO, Souba WW, Finkelstein DM, et al. (1999). Prognosis and Survival in Patients With Gastrointestinal Tract Carcinoid Tumors. Annals of Surgery. 1999;229(6):815.

(GAI) Announces Receipt of a Preliminary Non-Binding “Going Private” Offer

Global-Tech Advanced Innovations Inc. (NASDAQ: GAI) today announced that its Board of Directors (the “Board”) has received an unsolicited preliminary non-binding proposal letter, dated August 1, 2015, from Mr. John C.K. Sham, President and Chief Executive Officer of the Company, and certain of his controlled or affiliated entities (collectively, the “Acquirer”), proposing a potential offer to acquire all of the outstanding common shares of the Company (the “Offer”) not already beneficially owned or controlled by the Acquirer for $8.75 in cash per share (“Shares”).

According to the proposal letter, the Acquirer plans to form an acquisition company for the purpose of implementing the Offer, and the Offer is intended to be financed with a combination of cash and debt. The proposal letter states that the Acquirer is confident of its ability to timely secure adequate financing to consummate the Offer subject to the terms and conditions set out therein. A copy of the proposal letter is attached hereto as Exhibit A.

The Company’s Board of Directors intends to form a special committee comprised of and selected by independent directors (the “Special Committee”) to consider the proposal and any resulting Offer. The Special Committee is authorized to retain advisors, including an independent financial advisor and legal counsel, to assist it in evaluating any such proposal or Offer.

The Board cautions the Company’s shareholders and others considering trading in its securities since the Board has just received the unsolicited preliminary non-binding proposal letter from the Acquirer and no decisions have been made with respect to the Company’s response to the proposal. There can be no assurance that any definitive offer will be made, or that if an offer is received, that such an offer or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law.

Global-Tech Advanced Innovations Inc. is a holding company, owning subsidiaries that manufacture and market electronic components and other related products, such as complementary metal oxide semiconductor (CMOS) camera modules (CCMs). The primary focus of its subsidiaries is to develop and market high-quality products for the communications industry in China and export such products to markets in other countries throughout the world.

Except for historical information, certain statements contained herein are forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “should,” “estimates,” or variations of such words and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are subject to risks and uncertainties, including but not limited to, the impact of competitive products and pricing, demand for new and existing products in our core business, the financial condition of the Company’s customers, product demand and market acceptance especially of our new products, the success of new product development especially in the area of cellular phone components and solutions, compact camera modules and other pending projects, reliance on material customers, suppliers and key strategic alliances, the terms and conditions of customer contracts and purchase orders, availability and cost of raw materials, the timely and proper execution of certain business plans, including the plan to diversify and transform a portion of manufacturing capacity to higher-value, technology-oriented products, currency fluctuations, including the revaluation of the Chinese Renminbi, the imposition by China’s trading partners of economic sanctions and/or protective tariffs on Chinese manufactured goods, uncertainties associated with investments, the regulatory environment, fluctuations in operating results, the impact of changing global, political and economic conditions and other risks detailed from time to time in the Company’s filings with the U.S. Securities and Exchange Commission including its most recent Report on Form 20-F. The Company does not undertake to update its forward-looking information, or any other information contained or referenced in this press release to reflect future events or circumstances.

Exhibit A

August 1, 2015

The Board of Directors
Global-Tech Advanced Innovations Inc.
12/F., Kin Teck Industrial Building
26 Wong Chuk Hang Road
Aberdeen, Hong Kong

Dear Directors:

John C.K. Sham, President and Chief Executive Officer of Global-Tech Advanced Innovations Inc. (the “Company”), and certain of his controlled or affiliated entities (collectively, the “Acquirer”) are pleased to submit this preliminary non-binding proposal to acquire all outstanding common shares (the “Shares”) of the Company not beneficially owned or controlled by the Acquirer in a going-private transaction (the “Acquisition”). Our proposed purchase price for each Share of the Company is $8.75 in cash.

We believe that our proposal provides an attractive opportunity for the Company’s shareholders. Our proposed purchase price represents a premium of approximately 192% to the closing trading price of the Company’s Shares on July 31, 2015 and a premium of approximately 169% and 153% to the average closing trading price during the last 30 and 60 trading days, respectively.

1. Acquirer. The Acquirer, for the purpose of the Acquisition, plans to form an acquisition company for the purpose of implementing the Acquisition.

2. Purchase Price. The consideration payable for each Share of the Company will be $8.75 in cash per Share (other than those Shares held or controlled by the Acquirer that may be rolled over in connection with the Acquisition).

3. Funding. Acquirer intends to finance the Acquisition with a combination of cash and debt and is confident of its ability to timely secure adequate financing to consummate the Acquisition subject to the terms and conditions set out therein.

4. Due Diligence. We believe that we will be in a position to complete customary due diligence for the Acquisition in a timely manner and in parallel with discussions on the definitive agreements. We respectfully ask the board of directors of the Company (the “Board”) to accommodate such due diligence request and approve the provision of confidential information relating to the Company and its business to potential sources of debt financing subject to a customary form of confidentiality agreement.

5. Definitive Agreements. We are prepared to promptly negotiate and finalize definitive agreements (the “Definitive Agreements”) providing for the Acquisition and related transactions. This proposal is subject to execution of the Definitive Agreements. These documents will provide for representations, warranties, covenants and conditions, which are typical, customary and appropriate for transactions of this type.

6. Process. We believe that the Acquisition will provide superior value to the Company’s shareholders. We recognize that the Board will evaluate the Acquisition independently before it can make its determination to endorse it. Given the involvement of Mr. Sham in the Acquisition, we expect that the independent, disinterested members of the Board will proceed to consider the proposed Acquisition. In considering our offer, the Board should be aware that the Acquirer is interested only in acquiring the outstanding Shares that it does not already beneficially own or control, and that the Acquirer does not intend to sell any of its stake (owned or controlled) in the Company to any third party.

7. Confidentiality. The Acquirer will, as required by law, promptly file any document required with the U.S. Securities and Exchange Commission to disclose this proposal. However, we are sure you will agree that it is in all of our interests to ensure that we proceed in a strictly confidential manner, unless otherwise required by law, until we have executed Definitive Agreements or terminated our discussions.

8. No Binding Commitment. This letter constitutes only a preliminary indication of our interest, and does not constitute any binding commitment with respect to the Acquisition. A binding commitment will result only from the execution of Definitive Agreements, and then will be on terms and conditions as provided in such documentation.

In closing, we would like to express our commitment to working together to bring this Acquisition to a successful and timely conclusion. Should you have any questions regarding this proposal, please do not hesitate to contact us. We look forward to hearing from you.

Sincerely yours,

/s/ John C.K. Sham

International Stem Cell Corp. (ISCO)

International Stem Cell Corp. (ISCO) specializes in the therapeutic applications of human stem cells and the development and commercialization of cell-based biomedical products. The company was the first to develop and perfect a new class of human stem cells called parthenogenetic stem cells, created from unfertilized human eggs. ISCO has a strong patent portfolio offering clean intellectual property and freedom to operate. The company’s stem cells present superior immune matching capabilities and can be used in millions of people regardless of sex or racial background, with minimal expectation of immune rejection after transplantation.

The company’s human stem cells have been shown to be as pluripotent as embryonic stem cells, however their creation does not involve the destruction of a viable human embryo, which effectively sidesteps the controversy and ethical dilemmas associated with the use of human embryonic stem cells. In contrast to induced pluripotent stem cells, ISCO’s stem cells do not involve manipulation of cells’ genome thereby avoiding potential safety and regulatory obstacles in clinical applications.

The company’s scientists are currently focused on using its stem cells to treat severe unmet medical needs of the central nervous system (Parkinson’s disease), the liver and the eye, where cell therapy has been clinically proven but is limited due to the unavailability of safe human cells. Once the technology has been clinically validated there are an essentially unlimited number of potential applications. Because of their immune-matching ability a relatively small number of these stem cell lines could offer the potential of producing the first true stem cell bank as a means of serving populations of different immune types across the globe.

In addition to its therapeutic focus, ISCO also provides a growing revenue stream through two wholly owned subsidiaries. Lifeline Cell Technology specializes in producing primary human cells and growth media for biological research, and Lifeline Skin Care, the company manufactures and markets advanced anti-aging skincare products utilizing the company’s expertise in stem cell biology.