ACAD
36.99
+0.89
+2.47%
AEMD
0.97
-0.02
-2.02%
APRI
1.79
+0.01
+0.56%
ARNA
26.85
+1.29
+5.05%
ATEC
3.77
+0.06
+1.62%
CNAT
5.1
-0.22
-4.14%
CRXM
0.155
-0.005
-3.125%
CYTX
0.47
+0.012
+2.5322%
DXCM
44.99
+0.02
+0.04%
GNMK
8.11
-0.39
-4.59%
HALO
17.74
-0.12
-0.67%
ILMN
206.48
+0.25
+0.12%
INNV
0.087
-0.003
-2.8090%
INO
6.24
+0.03
+0.48%
ISCO
1.67
+0.04
+2.45%
ISIS
57.56
0.00
0.00%
LGND
142.15
+0.41
+0.29%
LPTN
2.93
-2.93
-100.00%
MBVX
0.73
+0.02
+2.8306%
MEIP
2.33
+0.01
+0.43%
MNOV
6.62
-0.03
-0.45%
MRTX
14.25
+0.55
+4.01%
MSTX
0.13
-0.01
0.00%
NBIX
60.87
-0.27
-0.44%
NUVA
53.71
+1.53
+2.93%
ONCS
1.21
+0.01
+0.83%
ONVO
1.52
+0.04
+2.70%
OREX
1.89
+0.06
+3.28%
OTIC
3.475
-0.125
-3.472%
QDEL
41.36
0.00
0.00%
RCPT
231.96
0.00
0.00%
RGLS
1.32
+0.04
+3.13%
RMD
78.42
+0.69
+0.89%
SCIE
0
0.00
-33.3333%
SPHS
2.28
-0.01
-0.44%
SRNE
2.85
-0.12
-4.20%
TROV
0.79
-0.01
-0.99%
VICL
2.53
-0.33
-11.54%
VOLC
18
0.00
0.00%
ZGNX
38.1
-0.45
-1.17%
ACAD
36.99
+0.89
+2.47%
AEMD
0.97
-0.02
-2.02%
APRI
1.79
+0.01
+0.56%
ARNA
26.85
+1.29
+5.05%
ATEC
3.77
+0.06
+1.62%
CNAT
5.1
-0.22
-4.14%
CRXM
0.155
-0.005
-3.125%
CYTX
0.47
+0.012
+2.5322%
DXCM
44.99
+0.02
+0.04%
GNMK
8.11
-0.39
-4.59%
HALO
17.74
-0.12
-0.67%
ILMN
206.48
+0.25
+0.12%
INNV
0.087
-0.003
-2.8090%
INO
6.24
+0.03
+0.48%
ISCO
1.67
+0.04
+2.45%
ISIS
57.56
0.00
0.00%
LGND
142.15
+0.41
+0.29%
LPTN
2.93
-2.93
-100.00%
MBVX
0.73
+0.02
+2.8306%
MEIP
2.33
+0.01
+0.43%
MNOV
6.62
-0.03
-0.45%
MRTX
14.25
+0.55
+4.01%
MSTX
0.13
-0.01
0.00%
NBIX
60.87
-0.27
-0.44%
NUVA
53.71
+1.53
+2.93%
ONCS
1.21
+0.01
+0.83%
ONVO
1.52
+0.04
+2.70%
OREX
1.89
+0.06
+3.28%
OTIC
3.475
-0.125
-3.472%
QDEL
41.36
0.00
0.00%
RCPT
231.96
0.00
0.00%
RGLS
1.32
+0.04
+3.13%
RMD
78.42
+0.69
+0.89%
SCIE
0
0.00
-33.3333%
SPHS
2.28
-0.01
-0.44%
SRNE
2.85
-0.12
-4.20%
TROV
0.79
-0.01
-0.99%
VICL
2.53
-0.33
-11.54%
VOLC
18
0.00
0.00%
ZGNX
38.1
-0.45
-1.17%
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Arena Pharmaceuticals Reports First Quarter 2016 Financial Results and Provides Corporate Update

May 9, 2016 – 1:05 pm

– Biopharmaceutical Industry Veteran Amit Munshi Appointed Chief Executive Officer — Conference Call and Webcast Scheduled for Today at 5:00 p.m. Eastern Time –

SAN DIEGO, May 9, 2016 /PRNewswire/ — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today reported financial results for the first quarter ended March 31, 2016, and provided a corporate update.

“We have continued to focus on the strategic priorities that we outlined last October, including advancing APD371 through Phase 1b and entering into a strategic collaboration with Boehringer Ingelheim that leverages our internally discovered compounds and validates the strength of our R&D platform,” said Harry F. Hixson, Jr., Ph.D., Arena’s interim Chief Executive Officer. “We are thrilled that Amit Munshi will join us in the next couple of days as our President and Chief Executive Officer, and we look forward to building stockholder value and positively impacting patient lives under Mr. Munshi’s leadership.”

First Quarter and Recent Developments

Corporate Update

  • Appointed Amit D. Munshi as President, Chief Executive Officer and interim principal financial officer, effective May 11, 2016. Mr. Munshi will also join Arena’s Board of Directors following Arena’s 2016 annual stockholders’ meeting, which is scheduled for June 13, 2016.

Research and Development Update

  • Announced favorable results from a Phase 1b multiple-ascending dose clinical trial of APD371, a highly selective and potent agonist of the cannabinoid 2 (CB2) receptor with potential utility in the treatment of pain.
  • Arena and Boehringer Ingelheim International GmbH entered into a collaboration that grants Boehringer Ingelheim exclusive worldwide rights to Arena’s internally discovered, novel compounds and intellectual property related to an orphan central nervous system (CNS) receptor. The collaboration also enables joint research in the field of schizophrenia aimed at identifying additional drug candidates.

BELVIQ® (lorcaserin HCl) Update

  • IMS Health estimates that approximately 121,000 prescriptions for BELVIQ were filled in the United States in the first quarter of 2016.
  • Ildong Pharmaceutical Co., Ltd., estimates that approximately 2.1 million tablets of BELVIQ were prescribed in South Korea in the first quarter of 2016, which equates to approximately 34,700 one-month prescriptions.

First Quarter 2016 Financial Results

  • Revenues totaled $9.8 million, including $3.5 million in net product sales of BELVIQ
  • Research and development expenses totaled $18.5 million
  • General and administrative expenses totaled $6.9 million
  • Net loss was $21.5 million, or $0.09 per share
  • At March 31, 2016, cash and cash equivalents totaled $139.5 million and approximately 243.0 million shares of common stock were outstanding

Scheduled Conference Call and Webcast

Arena will host a conference call and webcast today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to provide a corporate update and report first quarter 2016 financial results. The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the “Arena Pharmaceuticals’ First Quarter 2016 Financial Results and Corporate Update Conference Call.” The conference call will be webcast live under the investor relations section of Arena’s website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About BELVIQ®(lorcaserin HCl) CIV

BELVIQ is approved by the US Food and Drug Administration to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of:

  • 30 kg/m2 or greater (obese), or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).

Limitations of Use:

  • The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been established.
  • The effect of BELVIQ on cardiovascular morbidity and mortality has not been established.

In clinical trials, the most common adverse reactions for patients without diabetes treated with BELVIQ were headache, dizziness, fatigue, nausea, dry mouth, and constipation, and, in patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.

For additional information about BELVIQ, including important safety information, click here for the full Prescribing Information or visit www.BELVIQ.com.

About Arena Pharmaceuticals

Arena embraces the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena’s focus is discovering, developing and commercializing drugs to address unmet medical needs, and BELVIQ® (lorcaserin HCl) is Arena’s first internally discovered drug approved for marketing. Arena has US operations located in San Diego, California, and operations outside of the United States, including its commercial manufacturing facility, located in Zofingen, Switzerland. For more information, visit Arena’s website at www.arenapharm.com.

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the timing and significance of Mr. Munshi’s appointment as an executive officer and director; building stockholder value and impacting lives; rights, activities and expectations with respect to the collaboration with Boehringer Ingelheim; the therapeutic indication, use, safety, efficacy, mechanism of action and potential of BELVIQ and APD371; embracing the challenge of improving health and seeking to bring innovative medicines to patients; and Arena’s focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: having adequate funds and other resources and their effective use; enrollment in the ongoing Phase 2 clinical trials of APD334 and ralinepag is competitive and challenging, and their progress, completion and results are uncertain; recruiting and retaining effective management and other key employees; risks related to commercializing drugs, including regulatory, product supply, marketing and use; the focus, efforts and decisions of collaborators; the entry into, modification or termination of collaborative arrangements, and risks related to relying on such arrangements; the timing and receipt of payments from others; the risk that Arena’s revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena’s guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and lorcaserin may not receive any additional marketing approvals; regulatory decisions in one territory may impact other regulatory decisions and Arena’s business prospects; reimbursement and pricing decisions; the timing, success and cost of Arena’s research and development; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena’s research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; intellectual property rights; and satisfactory resolution of litigation or other disagreements. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Contact: Arena Pharmaceuticals, Inc. 


Craig M. Audet, Ph.D., Senior Vice President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612


www.arenapharm.com

 

Arena Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

Three months ended

March 31,

2016

2015

(unaudited)

Revenues

Net product sales

$  3,518

$  6,618

Other Eisai collaborative revenue

3,226

2,136

Toll manufacturing

1,023

346

Other collaborative revenue

2,080

3,156

  Total revenues

9,847

12,256

Operating Costs & Expenses

Cost of product sales

2,428

3,191

Cost of toll manufacturing

1,188

402

Research & development

18,502

21,968

General & administrative

6,924

8,439

  Total operating costs & expenses

29,042

34,000

Interest & Other Income (Expense)

Interest income

88

34

Interest expense

(1,679)

(1,696)

Loss from valuation of derivative liabilities

0

(1,549)

Other

(762)

660

  Total interest & other expense, net

(2,353)

(2,551)

Net loss

$(21,548)

$(24,295)

Net loss per share:

Basic

$    (0.09)

$    (0.10)

Diluted

$    (0.09)

$    (0.10)

Shares used in calculating net loss per share:

Basic

242,876

235,703

Diluted

242,876

235,703

 

Arena Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet Data

(In thousands)

March 31, 2016

December 31, 2015

(unaudited)

1

Assets

  Cash & cash equivalents

$ 139,533

$ 156,184

  Accounts receivable

6,166

4,934

  Inventory

9,054

9,502

  Prepaid expenses & other current assets

5,362

4,218

  Land, property & equipment, net

71,003

71,828

  Intangibles & other non-current assets

10,246

10,126

       Total assets

$ 241,364

$ 256,792

Liabilities & Stockholders’ Equity

  Accounts payable & accrued liabilities

$   25,122

$   25,493

  Total deferred revenues

110,632

109,042

  Total lease financing obligations & other long-term liabilities

68,052

68,715

  Total stockholders’ equity

37,558

53,542

       Total liabilities & stockholders’ equity

$ 241,364

$ 256,792

1

The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.

 

 

 

SOURCE Arena Pharmaceuticals, Inc.

BRCA Gene Mutations Associated with Increased Prostate Cancer Risk

May 9, 2016 – 10:00 am

SAN DIEGO, May 9, 2016 /PRNewswire-USNewswire/ — Though predominantly known for their increased associations with breast cancer risk, germline mutations in the BRCA1 and BRCA2 genes are also associated with an increased susceptibility to other diseases, including prostate cancer. New data being presented during the 111th Annual Scientific Meeting of the American Urological Association (AUA) highlights new research on the role that genetic sequencing and testing could play in prostate cancer screening and treatment. Three studies will be highlighted by study authors during a special press conference, moderated by Dr. Brian Helfand, on May 9, 2016 at 10:00 a.m. PDT.

Studies to be presented:
Higher Frequency of Germline BRCA1 and BRCA2 Mutations in African American Prostate Cancer (Abstract MP39-18): African American men with prostate cancer may be more likely to have germline mutations in the BRCA1 and BRCA2 genes than Caucasian men with prostate cancer, suggesting that genetic testing could provide important information for treatment stratification. Using archived blood DNA samples from 857 prostate cancer patients who underwent radical prostatectomy at the institution, researchers at Walter Reed National Military Medical Center (WRNMMC) analyzed previous gene sequencing data for known and novel mutations on the BRCA1 and BRCA2 genes and compared the mutations (classified as benign or likely benign, pathogenic, or “variant of unknown significance,” or VUS) with the known clinic-pathological parameters for each patient. Men with African ancestry were more likely to have pathogenic and VUS mutations (7.3 percent) than Caucasian men (2.2 percent). Patients with pathogenic or VUS mutations had an increased frequency of metastasis (9.4 percent) than those who did not have the mutations (2.4 percent), and were more likely to have a significantly shorter time to metastasis.

Should a Man with a History of Breast Cancer be Screened for Prostate Cancer? (Abstract PD09-07): Men diagnosed with male breast cancer could benefit from screening for prostate cancer, according to new data from researchers in Illinois who identified a possible association between the two conditions. In this retrospective study using data from the Surveillance, Epidemiology and End Results (SEER) program, researchers identified men 5,753 men with first primary breast cancers. At a median follow up of 4.3 years, 250 men were subsequently diagnosed with second primary prostate cancer. A greater incidence was identified in men ages 65-74 and those with American Joint Committee on cancer (AJCC) stage I breast cancer, or hormone receptor positivity, suggesting that prostate cancer screening could be indicated for men in this age range with these disease characteristics.

High Rates of Metastatic Disease in Prostate Cancer Among BRAC2 Mutation Carriers: Implications for Screening (Abstract MP09-09): A meta-analysis of reported cases of prostate cancer in men with known BRCA2 mutations demonstrated that men with BRCA mutations are more likely to have a poorer risk at presentation including a higher rate of non-localized disease and worse outcomes than those men who do not carry the mutation. Using studies from the MEDLINE database, researchers in Buffalo and Syracuse identified and reviewed 261 cases of prostate cancer in men with BRCA2 mutations. Of those men (mean age at diagnosis 61.7 years), 71 percent had a Gleason score of 7 or higher, 41 percent had stage T3/T4 disease, and 26 percent had M1 metastasis at presentation. Upon comparing these data with the general population (using SEER data), men with BRCA2 mutations had significantly higher rates of metastatic disease (17.4 percent vs. 4.4 percent) and higher rates of stage T3/T4 cancer (40.3 percent vs. 10.8 percent).

“Though the relationship between mutations on the BRCA genes and breast cancer are well established, we are only just beginning to truly understand how these genes could impact a man’s risk of prostate cancer and aggressive disease,” Dr. Helfand said. “These studies give insight into some important ways we can use this information to develop new methods of identifying and treating men with potentially lethal prostate cancer.”

About the American Urological Association: The 111th Annual Scientific Meeting of the American Urological Association takes place May 6-10, 2016 at the San Diego Convention Center in California. Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 21,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.

Contact:
Christine Frey, AUA
443-909-0839, cfrey@AUAnet.org

Logo – http://photos.prnewswire.com/prnh/20160210/332064LOGO

SOURCE American Urological Association

BRCA Gene Mutations Associated with Increased Prostate Cancer Risk

May 9, 2016 – 10:00 am

SAN DIEGO, May 9, 2016 /PRNewswire-USNewswire/ — Though predominantly known for their increased associations with breast cancer risk, germline mutations in the BRCA1 and BRCA2 genes are also associated with an increased susceptibility to other diseases, including prostate cancer. New data being presented during the 111th Annual Scientific Meeting of the American Urological Association (AUA) highlights new research on the role that genetic sequencing and testing could play in prostate cancer screening and treatment. Three studies will be highlighted by study authors during a special press conference, moderated by Dr. Brian Helfand, on May 9, 2016 at 10:00 a.m. PDT.

Studies to be presented:
Higher Frequency of Germline BRCA1 and BRCA2 Mutations in African American Prostate Cancer (Abstract MP39-18): African American men with prostate cancer may be more likely to have germline mutations in the BRCA1 and BRCA2 genes than Caucasian men with prostate cancer, suggesting that genetic testing could provide important information for treatment stratification. Using archived blood DNA samples from 857 prostate cancer patients who underwent radical prostatectomy at the institution, researchers at Walter Reed National Military Medical Center (WRNMMC) analyzed previous gene sequencing data for known and novel mutations on the BRCA1 and BRCA2 genes and compared the mutations (classified as benign or likely benign, pathogenic, or “variant of unknown significance,” or VUS) with the known clinic-pathological parameters for each patient. Men with African ancestry were more likely to have pathogenic and VUS mutations (7.3 percent) than Caucasian men (2.2 percent). Patients with pathogenic or VUS mutations had an increased frequency of metastasis (9.4 percent) than those who did not have the mutations (2.4 percent), and were more likely to have a significantly shorter time to metastasis.

Should a Man with a History of Breast Cancer be Screened for Prostate Cancer? (Abstract PD09-07): Men diagnosed with male breast cancer could benefit from screening for prostate cancer, according to new data from researchers in Illinois who identified a possible association between the two conditions. In this retrospective study using data from the Surveillance, Epidemiology and End Results (SEER) program, researchers identified men 5,753 men with first primary breast cancers. At a median follow up of 4.3 years, 250 men were subsequently diagnosed with second primary prostate cancer. A greater incidence was identified in men ages 65-74 and those with American Joint Committee on cancer (AJCC) stage I breast cancer, or hormone receptor positivity, suggesting that prostate cancer screening could be indicated for men in this age range with these disease characteristics.

High Rates of Metastatic Disease in Prostate Cancer Among BRAC2 Mutation Carriers: Implications for Screening (Abstract MP09-09): A meta-analysis of reported cases of prostate cancer in men with known BRCA2 mutations demonstrated that men with BRCA mutations are more likely to have a poorer risk at presentation including a higher rate of non-localized disease and worse outcomes than those men who do not carry the mutation. Using studies from the MEDLINE database, researchers in Buffalo and Syracuse identified and reviewed 261 cases of prostate cancer in men with BRCA2 mutations. Of those men (mean age at diagnosis 61.7 years), 71 percent had a Gleason score of 7 or higher, 41 percent had stage T3/T4 disease, and 26 percent had M1 metastasis at presentation. Upon comparing these data with the general population (using SEER data), men with BRCA2 mutations had significantly higher rates of metastatic disease (17.4 percent vs. 4.4 percent) and higher rates of stage T3/T4 cancer (40.3 percent vs. 10.8 percent).

“Though the relationship between mutations on the BRCA genes and breast cancer are well established, we are only just beginning to truly understand how these genes could impact a man’s risk of prostate cancer and aggressive disease,” Dr. Helfand said. “These studies give insight into some important ways we can use this information to develop new methods of identifying and treating men with potentially lethal prostate cancer.”

About the American Urological Association: The 111th Annual Scientific Meeting of the American Urological Association takes place May 6-10, 2016 at the San Diego Convention Center in California. Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 21,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.

Contact:
Christine Frey, AUA
443-909-0839, cfrey@AUAnet.org

Logo – http://photos.prnewswire.com/prnh/20160210/332064LOGO

SOURCE American Urological Association

Sorrento Therapeutics engaged advisors for exploring strategic alternatives

May 9, 2016 – 9:32 am

SAN DIEGO, May 9, 2016 /PRNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE; “Sorrento”), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, announced today that early this year it engaged financial advisors to assist the company in exploring and evaluating strategic alternatives to maximize shareholder value.

Sorrento engaged Guggenheim Securities and PJT Partners to review a number of strategic alternatives.

“As part of the ongoing evaluation of our portfolio of assets we decided to engage industry leading firms to advise us on potential alternatives and strategies,” stated Dr. Henry Ji, President and CEO. “Although there are no assurances that the process we commenced will result in a transaction, we believe the expertise of both Guggenheim Securities and PJT Partners will provide us with the best ability to fully evaluate options to enhance shareholder value,” added Dr. Ji.

Sorrento does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the evaluation will result in any strategic alternative being announced or consummated.  Sorrento does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

About Sorrento Therapeutics, Inc. 

Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for cancer, inflammation and autoimmune diseases. Sorrento’s lead products are multiple late-stage biosimilar and biobetter antibodies, as well as clinical CAR-T therapies targeting solid tumors.

Forward-Looking Statements

This press release contain forward-looking statements related to Sorrento Therapeutics, Inc., and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the announcement or consummation of any strategic alternatives and any related transactions; Sorrento’s proposed joint venture with Yuhan; Sorrento’s and its subsidiaries’ prospects; Sorrento’s expectations for its technologies and collaborations; Sorrento’s and its subsidiaries’ advances made in developing antibody drug conjugates (ADCs), human monoclonal antibodies using its proprietary G-MAB fully human antibody technology and any of their other respective technologies, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2015, as amended, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

All other trademarks and trade names are the property of their respective owners.

© 2016 Sorrento Therapeutics, Inc.  All Rights Reserved.

Logo – http://photos.prnewswire.com/prnh/20150105/167173LOGO

 

SOURCE Sorrento Therapeutics, Inc.

Sorrento Therapeutics engaged advisors for exploring strategic alternatives

May 9, 2016 – 9:32 am

SAN DIEGO, May 9, 2016 /PRNewswire/ — Sorrento Therapeutics, Inc. (NASDAQ: SRNE; “Sorrento”), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, announced today that early this year it engaged financial advisors to assist the company in exploring and evaluating strategic alternatives to maximize shareholder value.

Sorrento engaged Guggenheim Securities and PJT Partners to review a number of strategic alternatives.

“As part of the ongoing evaluation of our portfolio of assets we decided to engage industry leading firms to advise us on potential alternatives and strategies,” stated Dr. Henry Ji, President and CEO. “Although there are no assurances that the process we commenced will result in a transaction, we believe the expertise of both Guggenheim Securities and PJT Partners will provide us with the best ability to fully evaluate options to enhance shareholder value,” added Dr. Ji.

Sorrento does not have a defined timeline for the exploration of strategic alternatives and is not confirming that the evaluation will result in any strategic alternative being announced or consummated.  Sorrento does not intend to discuss or disclose further developments during this process unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate.

About Sorrento Therapeutics, Inc. 

Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for cancer, inflammation and autoimmune diseases. Sorrento’s lead products are multiple late-stage biosimilar and biobetter antibodies, as well as clinical CAR-T therapies targeting solid tumors.

Forward-Looking Statements

This press release contain forward-looking statements related to Sorrento Therapeutics, Inc., and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the announcement or consummation of any strategic alternatives and any related transactions; Sorrento’s proposed joint venture with Yuhan; Sorrento’s and its subsidiaries’ prospects; Sorrento’s expectations for its technologies and collaborations; Sorrento’s and its subsidiaries’ advances made in developing antibody drug conjugates (ADCs), human monoclonal antibodies using its proprietary G-MAB fully human antibody technology and any of their other respective technologies, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2015, as amended, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

All other trademarks and trade names are the property of their respective owners.

© 2016 Sorrento Therapeutics, Inc.  All Rights Reserved.

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SOURCE Sorrento Therapeutics, Inc.

GenomeDx’s Decipher Platform Identifies Gene Expression Associated with Resistance to Chemotherapy Treatment in Bladder Cancer

May 9, 2016 – 5:00 am

Study Presented at American Urologic Association 2016 Annual Meeting

SAN DIEGO, May 9, 2016 /PRNewswire/ — GenomeDx Biosciences today announced that its Decipher® platform was used to evaluate molecular subtypes associated with resistance to platinum-based neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC), supporting the potential use of a genomic signature to guide patient therapy. The study was presented at the American Urological Association (AUA) 2016 Annual Meeting by GenomeDx collaborators from the Vancouver Prostate Center. Roland Seiler, M.D., a urologic oncology fellow at the University of British Columbia, led a podium presentation titled, “Neoadjuvant Chemotherapy in Bladder Cancer: p53-ness is Associated with Chemo-Resistance and Unfavorable Outcome,” which can be found on the AUA 2016 website.

In the multi-center study, tissue obtained before NAC was analyzed from 203 patients, and matching post-NAC radical cystectomy tissue was available in 70 patients. The Decipher platform evaluated how patients fitting into three molecular subtypes, proposed previously by researchers at MD Anderson, responded to NAC. Individuals with tumors falling into the p53-like molecular subtype displayed the worst prognosis with NAC therapy. Findings have the potential to be used in the development of prognostic signatures to guide treatment of prostate cancer.

“We estimate that almost 34,000 bladder cancer patients every year are eligible for bladder removal to treat their disease,” said Doug Dolginow, M.D., chief executive officer of GenomeDx. “We believe our genomic test for bladder cancer, being developed in collaboration with the urologic oncology community through Decipher GRID®, will facilitate better decision-making at different stages of the disease. This includes determining whether a patient with advanced disease should undergo chemotherapy first or be prioritized to immediate surgery, thereby avoiding toxic and costly chemotherapy regimens that are unlikely to provide any additional benefit over surgery alone.”

The American Cancer Society estimates that nearly 77,000 patients will be diagnosed with bladder cancer in 2016 in the United States alone. It is the fourth most commonly diagnosed cancer in men and the twelfth in women and is projected in 2016 to account for over 16,000 deaths in the United States.  Platinum-based chemotherapy treatment before or after surgery is the standard of care for patients with high grade and muscle-invasive bladder cancer. Suboptimal response rates to chemotherapy and the associated burden of treatment underscore the need to develop new tools to help identify patients who will benefit most from treatment and spare those who will not benefit from the toxicity of chemotherapy.

About Decipher® Prostate Cancer Classifier Tests
Our Decipher prostate cancer classifier tests are currently comprised of Decipher Biopsy and Decipher Post-Op. These commercially available genomic tests provide an assessment of tumor aggressiveness based on the patient’s unique genomic profile. Decipher Biopsy is indicated for men after biopsy diagnosis and Decipher Post-Op is indicated for men after prostate removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups to better determine which patients will likely benefit from additional treatment and which will not, thereby enabling improved decision-making and helping low-risk patients avoid unnecessary treatments that have serious adverse side effects and result in unnecessary costs to the healthcare system. Studies of thousands of patients from leading cancer centers, published in multiple peer-reviewed journals, demonstrate that the Decipher tests can more accurately predict disease aggressiveness than traditional clinical measures, such as PSA and Gleason score. Decipher Post-Op is covered by Medicare and by a number of private payors and preferred provider organizations representing, together with Medicare, about 70% of the approximately 66 million adult men in the United States age 40 or older who are at increased risk of being diagnosed with prostate cancer.

Learn more at www.DecipherTest.com

About Decipher GRID®
Our Decipher Genomics Resource Information Database (Decipher GRID) is a genomic expression database that provides a foundation for open and interactive research collaboration and knowledge creation. Decipher GRID is a rapidly growing database that contains genomic profiles of thousands of patient tumors, and constitutes what we believe to be the world’s largest shared, clinically-annotated genomic expression database in urologic cancer as well as one of the world’s largest global RNA expression databases utilizing cloud-based analytics. We believe Decipher GRID gives rise to new opportunities for information technology-enabled genomic solutions and enables us to more rapidly discover, develop, commercialize and drive the adoption of our existing and new genomic tests. Through Decipher GRID, GenomeDx is building a suite of genomic tests in urologic cancer that we believe will allow us to achieve our goals of reducing costs to the healthcare system and improving patient lives, from screening through late-stage therapy.    

Learn more at www.DecipherGRID.com

About GenomeDx Biosciences
GenomeDx Biosciences uses the power of collaborative genomics to transform the management and treatment of cancer patients. GenomeDx has built Decipher GRID, a large genomics database in urologic cancer that provides a foundation for open and interactive research collaboration and knowledge creation. Using Decipher GRID to analyze vast amounts of genomic data, GenomeDx develops and commercializes proprietary clinical tests that are intended to provide more accurate and useful diagnostic information than both traditional diagnostic tools and existing genomic tests. GenomeDx’s Decipher Biopsy and Decipher Post-Op are commercially available prostate cancer genomic tests that provide an assessment of tumor aggressiveness based on a patient’s unique genomic profile. GenomeDx is headquartered in Vancouver, British Columbia and has offices in San Diego, California.

Learn more at www.GenomeDx.com

Media Contact:
Ian Stone
Canale Communications
619-849-5388
ian@canalecomm.com

 

SOURCE GenomeDx Biosciences

Avelas Biosciences Announces Positive Interim Phase 1b Results and Advances to Dose Expansion Stage

May 9, 2016 – 4:30 am

Initiates Stanford Cancer Center as Third Clinical Trial Site alongside UCSD Moores Cancer Center and UCSF Helen Diller Cancer Center

SAN DIEGO, May 9, 2016 /PRNewswire/ — Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced positive interim results from a Phase 1b trial of its AVB-620 surgical marker in women with primary, non-recurrent breast cancer undergoing surgery.

Fifteen patients were enrolled at UCSD Moores Cancer Center in the initial dose escalation part of the Phase 1b trial, the purpose of which was to evaluate safety and pharmacokinetics and to determine the dose for additional imaging analysis in the next stage of the study. Interim analysis showed no toxicity issues, differentiated fluorescence between cancerous and non-cancerous tissue and identified a preferred dose to take forward into the expansion phase of the trial.

“I’m delighted to announce that our Phase 1b trial is proceeding as planned,” said Carmine N. Stengone, president and chief executive officer of Avelas Biosciences. “We are seeing a clearly differentiated signal from cancerous versus non-cancerous tissue with no safety concerns and a selected dosage, based on fluorescence performance, with which we can proceed. Given these results, we look forward to presenting data from the completed study later this year.”

“Fluorescent surgical markers like AVB-620 have the potential to transform cancer surgery by finally enabling surgeons to see cancer and make real-time decisions to improve surgical treatment,” said Anne Wallace, M.D., Director of the Comprehensive Breast Health Center at Moores Cancer Center at UC San Diego Health. “Long term, this technology could lead to decreased surgical time and a reduction in the number of re-operations, both of which could result in better outcomes for patients and substantial cost savings.”

Avelas is now advancing the dose-expansion stage of the Phase 1b trial, for which several patients have already been enrolled, where the focus remains on safety, pharmacokinetics, and the timing of imaging after AVB-620 administration. The company expects to announce data from its completed Phase 1b trial later this year, by which time a total of 27 patients is expected to have been enrolled. Coincident with advancing to the dose-expansion stage, a third clinical site for the trial has been initiated, the Stanford Cancer Center Palo Alto, with Irene Wapnir, M.D., Professor of Surgery at the Stanford University Medical Center, serving as the site’s principal investigator.

About AVB-620

AVB-620 is an intravenously administered in vivo fluorescent protease-activatable peptide that detects, labels, and visualizes cancer. The initial indication is intraoperative identification of primary tumor extent and metastatic lymph nodes in breast cancer patients. AVB-620 displayed outstanding preclinical data with sensitivity of >95% in preclinical breast cancer models and 100% in ex vivo analysis of human breast cancer tissue. AVB-620 is currently being evaluated in a phase 1b clinical study in breast cancer patients.

About Avelas Biosciences

Avelas Biosciences is a San Diego-based biotechnology company focused on developing technologies that advance a new standard-of-care for cancer surgery and therapeutic intervention. The company’s lead candidate, AVB-620, is in a Phase 1b trial planned for enrollment of 27 breast cancer patients, assessing safety, pharmacokinetics and fluorescence properties using tissue image analysis. Avelas was founded by Avalon Ventures on technology from Nobel laureate Roger Y. Tsien, Ph.D. For additional information, please visit www.avelasbio.com.

 

SOURCE Avelas Bioscienes, Inc.

Ansun BioPharma Named Buzz of BIO Winner for the 2016 BIO International Convention

May 9, 2016 – 3:00 am

SAN DIEGO, May 9, 2016 /PRNewswire/ — On Thursday, the Biotechnology Innovation Organization (famously known as BIO) announced the Buzz of BIO winners for the 2016 BIO Convention to be held in San Francisco, California June 6-9, 2016.  Ansun BioPharma won the award in the category of Pipelines of Promise, and EpiBiome won the award in the category of Technologies of Tomorrow.  Ansun will be making a presentation at the convention where it will provide an update on the status of its phase 2 program to treat parainfluenza in immunocompromised patients as well as its pipeline of projects in influenza, RSV and other respiratory viruses.  “We are honored to be part of an organization like BIO that strives to bring innovative therapies like Ansun’s experimental biologics, Paradase™ and Fludase™, to the public to treat dangerous viral infections and other diseases that have so far been untreatable,” stated Dr. Ron Moss, CEO of Ansun.  “We are thrilled to receive the Pipelines of Promise award this year, and we look forward to participating and collaborating with the innovative companies and people who come to BIO each year,” added Mark Attebury, Ansun’s Vice President of Finance.

http://convention.bio.org/BuzzOfBIO/winners.aspx?utm_source=Highroads&utm_medium=email&utm_campaign=Buzz-of-BIO-Winners&utm_content=All&utm_term=Campaign-image

About Ansun BioPharma

Ansun BioPharma is a San Diego based clinical stage biopharmaceutical company focused on the development of unique host-directed anti-viral biologic therapies for respiratory viruses.  Ansun BioPharma has two products in late stage clinical development. FluDase™ is a first-in-class broad-spectrum investigational therapeutic agent to treat all forms of influenza, including pandemic variants and drug-resistant variants that cannot be treated by any currently approved flu therapies, including H1N1, H5N1 and H7N9. ParaDase™ is an investigational drug which is designed to target the receptor for parainfluenza viruses and is being evaluated in a Phase 2 trial for the treatment of severe parainfluenza infection in immunocompromised patients. ParaDase™ also has received Fast Track Designation by the U.S. FDA.

For more information, please visit www.ansunbiopharma.com or www.clinicaltrials.gov using the identifier NCT01644877.

 

SOURCE Ansun BioPharma

NxThera Announces Presentation Of Sexual Function Data At The 2016 Annual Meeting Of The American Urological Association

May 8, 2016 – 2:05 pm

Rez m II Clinical Trial Data Reporting the Safety and Effectiveness of Treating BPH with RF Convective Water Vapor Therapy Demonstrates Preservation of Sexual Function

MAPLE GROVE, Minn., May 8, 2016 /PRNewswire/ — NxThera, Inc. announced today that the sexual function preservation data from the Company’s pivotal IDE trial, which previously established the safety and effectiveness of the Rezūm system to treat benign prostatic hyperplasia (BPH), was presented at the 2016 American Urological Association (AUA) annual meeting in San Diego today.  The abstract, entitled, “Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia with Convective Water Vapor Energy Ablation: Preserved Erectile and Ejaculatory Function,” reported an effective non-pharmaceutical treatment option for men with BPH secondary to lower urinary tract syndrome (LUTS).  The Rezūm II IDE pivotal study was a prospective, multicenter, randomized (2:1) controlled trial that enrolled 197 subjects across 15 clinical sites in the U.S. A manuscript reporting the sexual function data from the Rezūm II study has been e-published in the Journal of Sexual Medicine.

“The progressive and increasingly bothersome symptoms of BPH afflict more than 75% of men in this country over the age of 65, and LUTS is strongly correlated with compromised sexual function,” said Kevin T. McVary, M.D., Professor and Chair, Division of Urology, Southern Illinois University School of Medicine in Springfield, IL.  “As urologists, we need BPH treatment options for our patients who decline, are resistant to, or are dissatisfied with medical management therapies, or who are unwilling or unable to undergo a surgical procedure.  This data demonstrates the Rezūm system not only provides an effective first-line treatment option for men suffering from BPH, but does so while preserving sexual function and improving their quality of life.”  

“The previously reported data from our Rezūm trials have demonstrated safe, rapid, and sustained improvement in LUTS and urinary flow over a 24-month period, and now this additional data from the Rezūm II trial demonstrates preservation of both erectile and ejaculatory functions,” said J. Robert Paulson, President and CEO of NxThera.  “We are thrilled to provide urologists and their patients with a transformational new BPH treatment option.”

About NxThera
NxThera pioneered its patented Convective Water Vapor Energy (WAVE®) technology platform to treat a variety of endourological conditions in the Rezūm System to treat BPH.  The FDA-cleared Rezūm System uses radiofrequency power to create thermal energy in the form of sterile water vapor, or steam, to convectively deliver targeted, precise treatments to ablate prostate tissue in a simple transurethral procedure with minimal discomfort, and demonstrated improvements in LUTS symptoms, urine flow, quality-of-life, and preserved sexual function.  The Company is conducting advanced development and clinical research to potentially expand application of its Convective WAVE technology to include the targeted treatment of cancerous prostate tissue and kidney tumors.  Founded in 2008, NxThera is located in Maple Grove, Minnesota.

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SOURCE NxThera, Inc.

Sophiris Bio Inc. to Raise Approximately $5 Million Through At-the-Market Offering

May 6, 2016 – 2:30 pm

SAN DIEGO and VANCOUVER, British Columbia, May 6, 2016 /PRNewswire/ — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, today announced that it is raising approximately $5 million at a price of $1.40 per share. Additionally, for each share of common stock purchased, the investor will receive a warrant to purchase one-half of a share of common stock of the Company at a price of $1.40 per full share for a period of five years from closing.

Roth Capital Partners served as sole placement agent. After the placement agent fees and estimated offering expenses payable by the company, the company expects to receive net proceeds of approximately $4.6 million. The offering is expected to close on May 11, 2016, subject to customary closing conditions.

The Company intends to use the net proceeds from the offering for general corporate purposes and to service its outstanding debt owing under a secured promissory note. 

The shares described above are being offered by Sophiris pursuant to a registration statement previously filed with and subsequently declared effective by the Securities and Exchange Commission. A prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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. Copies of the preliminary prospectus supplement and accompanying base prospectus relating to this offering may be obtained from Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

About Sophiris

Sophiris Bio Inc. is a biopharmaceutical company developing topsalysin, a clinical-stage, targeted therapy for the treatment of urological diseases. Topsalysin is in Phase 3 clinical development for the treatment of the symptoms of benign prostatic hyperplasia (BPH) and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Topsalysin is also currently in Phase 2 clinical development for the treatment of localized low to intermediate risk prostate cancer. For more information, please visit www.sophirisbio.com.

Safe Harbor / Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the proposed public offering and the intended use of proceeds from the offering. 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. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including market conditions, risks associated with the cash requirements of our business and other risks detailed from time to time in our filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.

Company Contact:

Peter Slover

Chief Financial Officer

(858) 777-1760

Corporate Communications and Investor Relations:

Jason Spark

Michael Moore

Canale Communications

NATIONAL Equicom

Corporate Communications and IR

Investor Relations

(619) 849-6005

(858) 886-7813

jason@canalecomm.com 

mmoore@national.ca

 

 

 

 

SOURCE Sophiris Bio Inc.