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Mesa Biotech to Present at Next Generation Diagnostics Summit

SAN DIEGO, Aug. 22, 2016 /PRNewswire/ — Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed a testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it will unveil its novel point-of-care molecular diagnostic system at the eighth annual Next Generation Dx Summit to be held August 22 – 25 at the Grand Hyatt in Washington, DC. In a platform presentation on Wednesday August 24th entitled”Finally, a Point-of-Care Molecular System for the Physician’s Office” Emily Winn-Deen, Ph.D., Chief Strategy Officer, Mesa Biotech, Inc. will describe the new testing system, which will also be available for meeting attendees to preview in the company’s exhibit booth. The system, which is currently for investigational use only, will be launched for sale in Europe in the spring of 2017.

“This summit’s theme of ‘moving assays to the clinic’ is a great fit for us,” said Emily Winn-Deen, Chief Strategy Officer, Mesa Biotech, Inc. “Mesa Biotech is breaking diagnostic barriers by making highly advanced, accurate, laboratory quality molecular testing available to all levels of healthcare providers in a portable, easy-to-use, affordable POC system.”  

About Mesa Biotech Inc.

Mesa Biotech is an emerging molecular diagnostic company, bringing the superior diagnostic performance of nucleic acid amplification to the point-of-care (POC). Mesa Biotech’s diagnostic system consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to obtain actionable, laboratory-quality results at the POC in 30 minutes or less with greater sensitivity and specificity than many current infectious disease rapid immunodiagnostic tests. Mesa’s technology development has been funded to date by a series of grants and private equity investments totaling approximately $30 million. The company is preparing for Series A funding in 2016 and expects to obtain FDA approval for its first product, an influenza assay and dock, in 2017.  For more information visit http://www.mesabiotech.com.

 

SOURCE Mesa Biotech Inc.

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Biocept to Present at Next Generation Dx Summit

Presentation to focus on identifying medically actionable biomarkers in cancer patients using liquid biopsy to analyze both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA)

SAN DIEGO, Aug. 18, 2016 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing biomarkers to improve the detection and treatment of cancer, announces that Veena Singh, M.D., Senior Vice President and Senior Medical Director of Biocept, will present “Liquid Biopsy: Providing Answers that Matter” on August 25, 2016 at the Next Generation Dx Summit being held at the Grand Hyatt Hotel in Washington, D.C.  

“Liquid biopsies allow for the identification and monitoring of validated genetic markers from tumor material that is circulating in the bloodstream,” said Dr. Singh.  “Biocept’s current test menu includes assays for use in six major solid tumor types including lung, gastric, breast, colorectal, prostate and melanoma that enable oncologists to treat patients based on the genetic causes of their cancer.  Biocept’s Target Selector™ technology provides a non-invasive solution for physicians and their patients when a tissue biopsy is not feasible or has failed to identify a suspected cancer marker.”

Highlights from Dr. Singh’s presentation include the following:

  • The ability to analyze both CTCs and ctDNA with Biocept’s dual-platform technology
  • The high-sensitivity performance of Biocept’s Target Selector™ technology
  • The robust clinical and analytical data validating Biocept’s blood-based liquid biopsy platform

About the Next Generation Dx Summit

The Next Generation Dx Summit convenes more than 1,000 international diagnostic professionals for valuable networking and comprehensive programming spanning from clinical diagnostics to business strategy. Now in its eighth year, the event has grown to include novel immunotherapy biomarkers, cell-free DNA, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, commercialization and reimbursement.  For more information please visit www.nextgenerationdx.com.

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma.  The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer. The Company’s patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the diagnosis and treatment of cancer, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov

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SOURCE Biocept, Inc.

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PR Newswire

Greenland USA Acquires 42-Acre Property in South San Francisco’s Oyster Point

Property Expected to Transform City and Bolster Short and Long Term Economy; Strategic Acquisition Marks Third Investment for Greenland USA

LOS ANGELES, Aug. 18, 2016 /PRNewswire/ — Greenland USA, a leading developer of modern and transformative properties, in a joint venture with equity partner Ping An Trust, and minority equity partners Agile Group and Poly Sino Capital Limited, today announced its acquisition of The Landing at Oyster Point in the heart of South San Francisco, the world’s premier biotechnology innovation hub. The vast 42-acre waterfront property will be built into a large-scale office and research and development complex to support the expanding life sciences industry. The joint venture is expected to invest more than $1 billion into the project.

“The San Francisco Bay Area is known globally for its leadership in innovation and we’re proud to bring Greenland’s expertise and vision for transformative properties to the area,” said Yuliang Zhang, Chairman of Greenland Group, parent company of Greenland USA. “The U.S. continues to play a critical role in our overseas expansion and we look forward to what will be a landmark property.”

Greenland USA is the majority shareholder in the joint venture, Oyster Point Development, LLC. Greenland USA’s CEO Gang Hu was named Chairman of the joint venture with Executive Vice President Taotao Song, who oversees Greenland USA’s west coast operations, named as CEO.

“Greenland USA is committed to the long-term health of the properties and communities we develop and we saw early on, with the support of the City of South San Francisco, that there was tremendous potential for growth in Oyster Point,” said Taotao Song, CEO of Oyster Point Development, LLC, and Executive Vice President at Greenland USA. “Our vision is to further cement South San Francisco’s role and reputation as the world’s leading biotech hub by creating a best-in-class campus that will stimulate and sustain its economic and social fabric.”

The to-be-renamed property at Oyster Point will comprise approximately 2,250,000 gross square feet of development, including public open space and recreational areas. The property builds on the established reputation of the South San Francisco area already known as the birthplace of biotechnology, which has attracted more than 240 biotechnology companies to the area. Development of the property will be completed in phases, with Phase I compromising approximately 500,000 square feet in the southern part of the property. Construction is expected to begin by mid-2018, following necessary infrastructure improvements by the City of South San Francisco, including streets, utilities and grading.

“The development of Oyster Point presents tremendous opportunity for the South San Francisco community and Greenland USA has approached it with the vision, expertise and energy needed to bring it to fruition,” said Mark Addiego, Mayor of South San Francisco. “By investing in Oyster Point, we will be able to further cement our position as the world’s leading center for innovation in biotechnology and other industries.”

The Landing at Oyster Point follows Greenland USA’s $1B+ investment in Los Angeles’ Metropolis and $6B+ investment in New York’s Pacific Park Brooklyn. Both projects exemplify Greenland USA’s expertise and vision for developing transformative properties in gateway cities that also support the local economy and foster the growth of the surrounding communities.

Contact:
Cecilia Fan for Greenland USA
323-202-1465
Cecilia.Fan@Edelman.com

About Greenland USA
Greenland USA is a leading developer of residential and commercial properties that transforms communities. Greenland USA leverages its extensive international track record, commitment to design innovation, quality and efficiency and its local market expertise to bring landmark properties to fruition. It is currently developing the $1B+ property Metropolis in Los Angeles and the $6B+ property Pacific Park Brooklyn in New York.

Established in 2013, Greenland USA is a subsidiary of the Greenland Group, which is publicly traded on the Shanghai Stock Exchange (SSE), and ranked 311th among the Fortune Global 500 in 2016.

 

SOURCE Greenland USA

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MabVax Therapeutics Announces Uplisting to The Nasdaq Capital Market and $8.625 million Public Offering

SAN DIEGO, Aug. 17, 2016 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company announces that the Company’s common stock will begin trading on The Nasdaq Capital Market under the stock symbol MBVX effective with the market open today.  The Company also announces the pricing of a public offering.  The offering consists of $8.625 million of common stock and Series F Preferred Stock at $4.81 per share of common stock or Series F Preferred Stock.  One Class A warrant exercisable at $5.55 per share and one Class B warrant exercisable at $6.29 per share are also being issued with each share of common stock or Series F Preferred Stock issued in the offering.  Each share of Series F Preferred Stock is initially convertible into one share of common stock, subject to adjustment for stock splits, stock dividends, recapitalizations, combinations, subdivisions or other similar events. The total expected gross proceeds of the public offering are $8.625 million before the underwriter’s discount and expenses.  The warrants are immediately exercisable and expire August 22, 2019.  Neither the warrants nor the Series F Preferred Stock will be separately listed on any securities exchange or other trading market. 

Laidlaw & Company (UK) Ltd. acted as the sole book-running manager for the offering.

We have granted the underwriters an option for a period of up to 45 days from the date of the Company’s prospectus to purchase up to an aggregate of 169,179 additional shares of our common stock (with additional Class A Warrants and Class B Warrants) solely to cover overallotments.

On August 16, 2016 the Company effected a 1 for 7.4 reverse split of its common stock which will be effective with the open of trading on The Nasdaq Capital Market on August 17, 2016, as reflected above and in the final prospectus in connection with the offering.  

A registration statement relating to these securities was previously filed on Form S-1 (333-211421) with the Securities and Exchange Commission (the “SEC”), and was declared effective by the SEC on August 16, 2016. A final prospectus relating to the offering may be obtained on the SEC’s website located at www.sec.gov, and electronic copies of the final prospectus may also be obtained from Laidlaw & Company (UK) Ltd., Attention: Syndicate Department, 546 Fifth Avenue, New York, NY 10036, by telephone at (212) 953-4900 or by email at syndicate@laidlawltd.com.

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

Purpose of the Reverse Stock Split and Public Offering

The reverse stock split and public offering enables the Company to satisfy the minimum stockholder’s equity and stock price requirements of The Nasdaq Capital Market for uplisting and provides capital to continue the Company’s clinical development plans.    

As a result of the reverse stock split, the Company’s issued and outstanding shares of common stock before the offering will decrease to approximately 4,235,339 post-split shares.  As a result of the reverse stock split, the total number of shares of common stock held by each stockholder will be converted automatically into the number of whole shares of common stock equal to the number of shares of common stock held by such stockholder immediately prior to the reverse stock split, divided by 7.4.  No fractional shares will be issued, and no cash or other consideration will be paid. Instead, any stockholder who otherwise would have received a fractional share as a result of the reverse stock split will receive one whole share of the post-split common stock.

Stockholders who hold their shares in electronic form at their brokerage firms need not take any action, as the shares held in brokerage accounts will be automatically adjusted to reflect the reverse stock split. Stockholders holding paper certificates may (but are not required to) send the certificates to the Company’s transfer agent. The transfer agent will issue a new share certificate reflecting the terms of the reverse stock split to each requesting stockholder who submits its paper certificate.

About MabVax:

MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer.  MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines.  MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center, or MSK.  In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers.  The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.   MabVax’s two lead antibody clinical programs, currently in Phase I clinical trials, utilize HuMab-5B1 as a naked antibody (MVT-5873) and as an immuno-PET imaging agent (MVT-2163).  MabVax also has the exclusive license to the therapeutic vaccines from MSK.   Additional information is available at www.mabvax.com.

Forward Looking Statements:

This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to the Company’s clinical trials and product development pipeline.  We have no assurance that all of the product development pipeline will be fully developed by the Company.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties.  Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2015, as amended and supplemented from time to time and the Company’s Quarterly Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov.  The parties do not undertake any obligation to update forward-looking statements contained in this press release.

 

SOURCE MabVax Therapeutics Holdings, Inc.

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Audentes Therapeutics Announces First Patient Enrolled in the INCEPTUS Clinical Assessment Study of XLMTM

Study intended to serve as longitudinal baseline and within-patient control for ASPIRO, the planned Phase 1/2 study of AT132 for the treatment of XLMTM

SAN FRANCISCO, Aug. 17, 2016 /PRNewswire/ — Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today reported that the first patient has been enrolled in INCEPTUS, a prospective study designed to characterize the disease presentation in children living with X-Linked Myotubular Myopathy (XLMTM). The study is evaluating subjects prior to potential enrollment in ASPIRO, the planned Phase 1/2 clinical study intended to evaluate the safety and preliminary efficacy of AT132, the Audentes product candidate for treatment of XLMTM.

“The initiation of enrollment for INCEPTUS is an important first step in the clinical development of AT132 for the treatment of XLMTM and a notable milestone for Audentes,” stated Dr. Suyash Prasad, Audentes Senior Vice President and Chief Medical Officer. “The burden of the disease of XLMTM to children and families is considerable, and we are grateful to those who have agreed to participate in the study,” concluded Dr. Prasad.

INCEPTUS is an international study of boys with XLMTM, ages three years or younger, designed to characterize their individual disease presentation, with a specific focus on respiratory measurements and assessment of muscle strength and function. Patients enrolled in INCEPTUS will be evaluated over a three to twelve-month period prior to their potential participation in ASPIRO. INCEPTUS is designed to serve as a longitudinal baseline and within-patient control for subjects who enroll in the ASPIRO study, while also facilitating the operational aspects of ASPIRO once initiated.  

Audentes plans to file investigational new drug applications for AT132 with North American and European regulatory authorities in the first quarter of 2017. The company expects preliminary data from the ASPIRO study in the fourth quarter of 2017.

For additional information on INCEPTUS, please visit www.clinicaltrials.gov.

About X-Linked Myotubular Myopathy (XLMTM)

X-Linked Myotubular Myopathy (XLMTM) is a rare, inherited disorder characterized by severe muscle weakness, respiratory impairment and early mortality. There is no approved treatment for the condition. It is caused by mutations in the MTM1 gene, which encodes a protein called myotubularin. Myotubularin plays an important role in the development, maintenance and function of skeletal muscle cells. XLMTM affects approximately 1 in 50,000 newborn males worldwide. Audentes is developing AT132 for the treatment of XLMTM in collaboration with Genethon (www.genethon.fr). AT132 is a novel product based on AAV gene therapy technology.

About Audentes Therapeutics, Inc.

Audentes Therapeutics (Nasdaq: BOLD) is a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases.  We have four products in development, AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM), AT342 for the treatment of Crigler-Najjar Syndrome, AT982 for the treatment of Pompe disease, and AT307 for the treatment of the CASQ2 subtype of Catecholaminergic Polymorphic Ventricular Tachycardia (CASQ2-CPVT).  We are a focused, experienced and passionate team committed to forging strong, global relationships with the patient, research and medical communities.

For more information regarding Audentes, please visit www.audentestx.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 company’s anticipated clinical development and regulatory activities and the timing of clinical results. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercial its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other  risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Audentes Contacts:

Investor Contact:
Thomas Soloway, CFO
415.818.1040
ir@audentestx.com

Media Contact:
Jeffrey Gruis
415.818.1015
media@audentestx.com

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SOURCE Audentes Therapeutics, Inc.

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PR Newswire

Ambrx’s Innovative Antibody Drug Conjugate (ADC) US IND Active

SAN DIEGO, Aug. 17, 2016 /PRNewswire/ — Ambrx announced today that their ARX788 US IND is now active. ARX788 is Ambrx’s most advanced internally developed site-specific ADC targeting Her2. Ambrx ARX788 may hold the potential for a broader patient population than the currently available Her2-targeting therapies. Ambrx will open US sites for the first-in-human (FIH) study which is currently recruiting patients at several sites in Australia and New Zealand. The primary end point is safety and tolerability. The pharmacokinetics and antitumor activity of ARX788 will also be evaluated.

“The opening of the US IND for ARX788 represents an important milestone for Ambrx to advance the development of this innovative ADC drug in the world market, such as the US, in addition to China and other regions,” said Alex Qiao, Chief Executive Officer of Ambrx. “This will help us accelerate the development timeline for ARX788 which will provide clinical validation of our proprietary EuCODE technology for the improvement of cancer patient lives.”

About Ambrx
Ambrx®, Inc. is a clinical stage biopharmaceutical company with a mission to deliver breakthrough protein therapeutics using an expanded genetic code. Unlike conventional conjugation techniques that create a mixture of suboptimal molecules, Ambrx technology combines site specific conjugation with proprietary linkers, payloads and pharmacokinetic extenders to create a single molecular species that is optimized for safety, efficacy and biophysical properties. We call this process Protein Medicinal Chemistry.

The company is developing ARX788 – a site-specific antibody drug conjugate for breast cancer and gastric cancer. In addition to its ADC collaborations with Astellas, Bristol-Myers Squibb and Zhejiang Medicine Co. Ltd, Ambrx has collaborations to discover and develop products incorporating Ambrx technology with Bristol-Myers Squibb, Eli Lilly and Hisun. Ambrx is developing a robust portfolio of product candidates that are optimized for efficacy and safety in oncology.

At Ambrx, we are dedicated to assembling and developing an exceptional team and a novel technology to create the next generation of protein-based medicines. For additional information, visit www.ambrx.com.

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SOURCE Ambrx, Inc.

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