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PR Newswire

Trovagene Announces Fourth Quarter and Year End 2015 Financial Results

SAN DIEGO, March 10, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today reported its financial results for the three months and year ended December 31, 2015.

“2015 was our coming out year, as the introduction of our liquid biopsy solution for cancer monitoring was met with great response by physicians,” said Antonius Schuh, Ph.D., chief executive officer of Trovagene. “In support of our commercial efforts, we are assembling a compendium of clinical data, published manuscripts, and case studies in real-world settings that demonstrate the ability of our platform to improve the management of cancer patients by determining and tracking actionable oncogene mutations. Our goals for 2016 include increasing the number of oncologists using our assays in clinical practice, solidifying favorable health insurance reimbursement, and presenting and publishing additional clinical results from larger  data sets supporting the utility of our assay platform. Liquid biopsy for cancer monitoring offers tremendous potential, and we continue to be positioned well financially to execute on our business plan, improve the care of cancer patients, and increase stockholder value.”

Fourth Quarter Financial Results

For the fourth quarter ended December 31, 2015, Trovagene reported a net loss of $7.4 million, or $0.26 per fully diluted common share, as compared to a net loss of $4.7 million, or $0.25 per fully diluted common share, for the fourth quarter ended December 31, 2014. The change in net loss is primarily due to increased operating expenses.

Year End 2015 Financial Results

For the year ended December 31, 2015, Trovagene reported a net loss of $27.5 million, or $1.21 per fully diluted common share, as compared to a net loss of $14.3 million, or $0.88 per fully diluted common share, for the year ended December 31, 2014. The increase in net loss is primarily due to increased operating expenses versus the prior year comparable period.

Cash and Cash Equivalents

Trovagene had cash and cash equivalents of approximately $67.5 million on December 31, 2015, as compared to approximately $27.3 million on December 31, 2014.

Summary of 2015 Activities

Trovagene continues to advance its Precision Cancer Monitoring® (PCM) platform for the non-invasive monitoring of clinically actionable mutations for cancer patients. The Company currently has ongoing clinical collaborations to demonstrate the ability to determine and monitor mutational status and response to therapy in lung, colon, pancreatic, and skin cancer. Trovagene remains focused on commercializing its highly sensitive and quantitative liquid biopsy service for cancer monitoring.

In 2015, the Company’s key accomplishments included the following:

Assembled commercial infrastructure and launched pilot marketing and sales program for Precision Cancer Monitoring platform

  • Four sales professionals initially in the field, generated strong interest and ordering of PCM tests by practicing oncologists
  • Trovagene Clinical Experience Program (CEP) deployed to enable trial use of technology by oncologists

Presented clinical study results at several medical and scientific conferences

  • 2015 European Cancer Congress (ECC)
    • Quantitative detection and monitoring of circulating tumor DNA (ctDNA) and driver mutations can be used to rapidly determine treatment response
  • World Lung Congress on Lung Cancer
    • Urine-based liquid biopsy platform shown to detect the impact of cancer therapy within 24 hours
  • Next Generation DX summit
    • Clinical data in lung, colorectal, and pancreatic cancer demonstrate the utility of Trovagene’s PCM platform as an important disease management tool
  • 2015 American Association for Cancer Research Annual Meeting
    • Studies highlighted clinical utilities and advantages of Trovagene’s PCM platform, including the ability to obtain significantly more ctDNA from urine samples versus plasma samples
  • Association for Value-Based Cancer Care Meeting
    • Cost-benefit analysis of Trovagene’s PCM platform demonstrated that the use of urinary liquid biopsy can significantly reduce costs when compared to tissue biopsy
  • 2015 American Society of Clinical Oncology Annual Meeting
    • Studies addressed advantages of liquid biopsy over tissue biopsy and demonstrated ability to monitor tumor dynamics in lung, pancreatic, and colon cancers

Initiated study to monitor response to immunotherapy in melanoma patients  

  • Study objective is to deliver a urinary liquid biopsy-based solution to provide faster and more accurate information for measuring response to immunotherapy

Strengthened balance sheet through two offerings of common stock

  • Raised aggregate gross proceeds of approximately $63 million

Formed Trovagene Srl, also known as the Trovagene Research Institute, a European subsidiary

2016 Goals and Objectives

  • Continue to build clinical evidence supporting the use of Trovagene’s PCM platform
    • Submit 8 or more abstracts for presentation at key medical meetings in 2016
    • Submit up to 9 clinical and scientific manuscripts for publication that demonstrate the technical advantages and clinical utility of Trovagene’s PCM platform
  • Establish advantageous reimbursement relationships with third party administrators
    • Secure agreements representing more than 100 million covered lives
    • Finalize  comprehensive health-economic study plan
  • Establish marketing and adoption parameters
    • Ensure high clinical interest and strong service levels
    • Expand sales and marketing presence in the oncology market
    • Conduct and document real-world case studies
  • Engage in strategic partnerships for clinical trial service agreements and translational research collaborations, and to expand global presence
  • Conduct  clinical studies with top academic institutions and comprehensive cancer centers

Trovagene will hold a conference call today at 5:00 p.m. Eastern Standard Time (2:00 p.m. Pacific Standard Time) to review its fourth quarter and year end 2015 financial results. A live webcast of the Company’s conference call will be available online at http://trovagene.investorroom.com/events. To access the conference call, please dial (888) 347-6081 (domestic), (412) 902-4285 (international), or (855) 669-9657 (Canada), conference ID# 10078930. To access a telephone replay of the call, dial (877) 344-7529 (domestic), (412) 317-0088 (international), or (855) 669-9658 (Canada), replay ID# 10078930. The replay will be available one hour after the conclusion of the call. The webcast and telephone replay will be archived on the Company’s website following the conference. 

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition;  our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technologies or products will be utilized by oncologists or prove to be commercially successful, that Trovagene’s PCM platform will ultimately be successful or result in better reimbursement outcomes or that Trovagene will meet any of its 2016 goals and objectives. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene’s most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission.

(Financial Information to Follow)

Contact

Investor Relations

Media Relations

David Moskowitz and Amy Caterina

Investor Relations

Jody LoMenzo

Corporate Practice Counsel

Trovagene, Inc.

Inventiv Health Public Relations

858-952-7593

212-364-0458

ir@trovagene.com

Jody.LoMenzo@inventivhealth.com

 

Trovagene, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except for per share amounts)

Three Months Ended

December 31,

Year Ended

December 31,

2015

2014

2015

2014

Revenue:

Royalty income

$

52

$

56

$

275

$

270

License fees

10

Diagnostic service revenue

3

14

Other revenue

24

24

Total Revenue

79

56

313

280

Costs and expenses:

Cost of revenue

199

15

629

15

Research and development

3,166

1,835

10,594

6,665

Selling and marketing

1,935

1,035

6,444

2,735

General and administrative

2,164

1,675

7,920

5,810

Total operating expenses

7,464

4,560

25,587

15,225

Loss from operations

(7,385)

(4,504)

(25,274)

(14,945)

Other income (expense):

   Net interest expense

(368)

(384)

(1,468)

(831)

   Gain (loss) on change in fair value of derivative instruments- warrants

379

205

(726)

1,426

   Other (income) loss, net

(7)

(3)

25

Net loss and comprehensive loss

$

(7,381)

$

(4,683)

$

(27,471)

$

(14,325)

Preferred stock dividend

(6)

(6)

(24)

(23)

Net loss and comprehensive loss attributable to common stockholders

$

(7,387)

$

(4,689)

$

(27,495)

$

(14,348)

Net loss per common share – basic

$

(0.25)

$

(0.25)

$

(1.05)

$

(0.76)

Net loss per common share – diluted

$

(0.26)

$

(0.25)

$

(1.21)

$

(0.88)

Weighted average shares outstanding – basic

29,723

18,904

26,202

18,904

Weighted average shares outstanding – diluted

30,157

19,071

26,452

19,071

 

Trovagene, Inc.

Condensed Consolidated Balance Sheets

(in thousands)

December 31,

2015

December 31,

2014

Assets

Current assets:

Cash and cash equivalents

$

67,493

$

27,294

Accounts receivable

99

57

Prepaid expense and other assets

789

369

Total current assets

68,381

27,720

Property and equipment, net

2,691

840

Other assets

374

337

Total Assets

$

71,446

$

28,897

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

1,041

$

748

Accrued expenses

1,935

1,842

Current portion of long-term debt

5,226

1,898

Total current liabilities

8,202

4,488

Long-term debt, less current portion

11,246

13,053

Derivative financial instruments

3,297

3,006

Total Liabilities

22,745

20,547

Stockholders’ equity

48,701

8,350

Total liabilities and stockholders’ equity

$

71,446

$

28,897

 

Logo – http://photos.prnewswire.com/prnh/20120620/LA28014LOGO

 

SOURCE Trovagene, Inc.

[…]

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PR Newswire

Pfenex Reports Fourth Quarter and Full Year 2015 Results and Provides Business Update

SAN DIEGO, March 10, 2016 /PRNewswire/ — Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, including high value and difficult to manufacture proteins, today reported financial results for the fourth quarter and full year ended December 31, 2015 and provided a business update.

“2015 was a very productive and eventful year for Pfenex,” stated Bertrand C. Liang, chief executive officer of Pfenex.  “We signed the collaboration agreement for PF582, our biosimilar candidate to Lucentis, with Hospira, now a subsidiary of Pfizer (together, Pfizer) in February 2015, we led our successful secondary offering in April 2015 and we signed a significant contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS) for the advanced development of our anthrax vaccine in August 2015.  2015 was also a year marked by the continued successful progress of our portfolio of biosimilar and vaccine candidates and by the strengthening of Pfenex through key additions to our company and to our board of directors.  2016 should be an exciting year for Pfenex as we look to continue our successful pipeline advancement and provide updates on our key milestones throughout the year.”

Business Updates and 2015 Highlights

  • Pfenex initiated a Phase 1 trial of PF530, a biosimilar candidate to Betaseron, in the first quarter of 2015 and enrolled 12 healthy subjects.  Based on the analysis of the trial PK and PD parameters, no statistical differences between PF530 compared to the reference compound were observed.  The pivotal PK/PD study and immunogenicity trial are expected to initiate in 2H2016.
  • PF708, our peptide candidate that we are developing as a therapeutic equivalent to Forteo, initiated a bioequivalence study in 2015 and we expect to provide a data read-out from that study in 2H2016.   
  • The pivotal clinical comparator trial for PF582, our biosimilar candidate to Lucentis, is expected to initiate in 2016. We entered into a collaboration with Pfizer in February 2015.  The collaboration included an upfront payment of $51 million and milestone payments valued at up to $291 million as well as tiered double digit royalties on net sales of PF582. Pfizer is responsible for the clinical comparative trial and we will share costs of the trial 50/50 up to a cap for Pfenex of $20 million, with $10 million of that amount offset as a credit against the royalties payable to us.
  • Pfenex initiated the Phase 1 trial for its recombinant anthrax vaccine in 2015 and expects an interim data read-out in 2H2016.  In August, Pfenex announced it had signed a five year, cost plus fixed fee contract valued at up to $143.5 million with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the advanced development of our mutant recombinant protective antigen anthrax vaccine which offers the potential for a dramatic improvement in the rapid production of large amounts of high value stable recombinant anthrax vaccine for the U.S. Government.
  • During 2015 we further strengthened our board of directors.  In September 2015, we announced that Dennis M. Fenton, Ph.D., was appointed to the company’s board of directors, deepening the manufacturing and product development expertise of the biosimilar company. Dr. Fenton has over three decades of experience in the biotechnology industry. Additionally, in April 2015 we announced that John Taylor was elected to the company’s board of directors.  Mr. Taylor brings more than 20 years of regulatory experience working with the U.S. Food and Drug Administration (FDA).
  • In April 2015, Pfenex announced the closing of our follow on offering. The net proceeds to Pfenex from this offering were approximately $38.0 million, after deducting underwriting discounts and commissions but before deducting estimated offering expenses.

Financial Highlights for the Fourth Quarter

Total Revenue increased by $1.2 million, or 62%, to $3.3 million for the quarter ended December 31, 2015 compared to $2.0 million in same period in 2014. The increase in revenue was due to the stage of development of our Px563L product candidate under our government contracts and by an increase in license revenue from our collaboration with Pfizer, partially offset by a decline in protein production services. We expect revenue related to our protein production services to decline in the near-term as we shift our resources to developing our product pipeline.

Cost of revenue increased by approximately $0.5 million, or 44%, to $1.7 million in the three month period ended December 31, 2015 compared to $1.2 million in same period in 2014. The increase in cost of revenue was due primarily to the stage of development of our Px563L product candidate under our government contracts. Given the nature of the novel vaccine development process, these costs will fluctuate depending on stage of development.

Research and development expenses increased by approximately $4.7 million, or 355%, to $6.1 million in the three month period ended December 31, 2015 compared to $1.3 million in same period in 2014. The increase in research and development expenses was due primarily to the increase in development activity on our product candidates PF708, PF530 and PF529 and the hiring of additional personnel dedicated to our research and development efforts. We expect research and development costs will increase going forward as we independently advance PF530 as a wholly-owned product candidate, as well as continuing to advance our wholly-owned pipeline including PF708, our therapeutic equivalent candidate to Forteo, and PF529, our biosimilar candidate to Neulasta. Additionally, we expect research and development expenses to increase as we advance our other lead candidates and pipeline product candidates. For example, under our agreement with Pfizer, we will share the confirmatory clinical study costs for PF582 with our share capped at $20 million, $10 million of which will be setoff as a credit against royalties payable to us unless the collaboration agreement is terminated prior to such setoff.

Selling, general and administrative expenses increased by $0.7 million, or 23%, to $3.7 million in the three month period ended December 31, 2015 compared to $3.0 million in the same period in 2014. The increase in selling, general and administrative expenses was due to an increase in activities associated with operating as a publicly-traded company. We expect general and administrative costs to increase for activities associated with company operations. These increases will likely include the hiring of additional personnel. In addition, we intend to continue to incur increased internal and external business development costs to support our various product development efforts, which can vary from period to period.

Cash and cash equivalents as of December 31, 2015 was $106.2 million.

Cautionary Note Regarding Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Pfenex’s future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or expressions that concern Pfenex’s expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, statements regarding the future potential of Pfenex’s product candidates, including future plans to develop, manufacture and commercialize its product candidates and the potential to receive future milestone and royalty payments under its collaboration agreements; Pfenex’s expectations regarding the timing of the release of additional data and results for its product candidates, and the timing of the initiation of additional studies for its product candidates; and Pfenex’s future projections related to increases in expenses and reductions in protein production revenue. Pfenex’s expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of the uncertainties inherent in the clinical drug development process, including, without limitation, Pfenex’s ability to successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates or may require Pfenex to conduct additional clinical trials or modify ongoing clinical trials; challenges related to commencement, patient enrollment, completion, and analysis of clinical trials; difficulties in achieving and demonstrating biosimilarity in formulations; Pfenex’s ability to manage operating expenses; Pfenex’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives; Pfenex’s dependence on third parties for development, manufacture, marketing, sales and distribution of products; unexpected expenditures; and difficulties in obtaining and maintaining intellectual property protection for its product candidates. Information on these and additional risks, uncertainties, and other information affecting Pfenex’s business and operating results is contained in Pfenex’s Annual Report on Form 10-K for the year ended December 31, 2014 and in Pfenex’s subsequent reports on Form 10-Q and Form 8-K, filed with the Securities and Exchange Commission. Additional information will also be set forth in Pfenex’s Annual Report on Form 10-K for the period ended December 31, 2015 to be filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.

Pfenex investors and others should note that we announce material information to the public about the Company through a variety of means, including our website (http://www.pfenex.com/), our investor relations website (http://pfenex.investorroom.com/), press releases, SEC filings, public conference calls, corporate Twitter account (https://twitter.com/pfenex), Facebook page (https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/), and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with our disclosure obligations under Regulation FD. We encourage our investors and others to monitor and review the information we make public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time. For a link to our most recent corporate presentation, visit our investor relations website (http://pfenex.investorroom.com/).

About Pfenex Inc.

Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. The company’s lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology® platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines,therapeutic equivalents to reference listed drug products, and next generation biologics.

 

PFENEX INC.

Condensed Consolidated Statements of Operations

Three Months Ended
December 31,

(unaudited)

Twelve months ended
December 31,

(audited)

(in thousands, except per share data)

2015

2014

2015

2014

Revenue

$      3,261

$      2,019

$       9,583

$    10,644

Cost of revenue

1,729

1,202

4,640

7,233

Gross profit

1,532

817

4,943

3,411

Operating expense

Selling, general and administrative

3,743

3,037

14,598

9,003

Research and development

6,085

1,336

18,183

4,125

Total operating expense

9,828

4,373

32,781

13,128

Loss from operations

(8,296)

(3,556)

(27,838)

(9,717)

Other income (expense), net

36

(19)

74

(77)

Net loss before income taxes

(8,260)

(3,575)

(27,764)

(9,794)

Income tax benefit (expense)

(411)

1

(452)

Net loss

$     (8,671)

$     (3,574)

$    (28,216)

$     (9,794)

Net loss per common share basic and diluted

$       (0.37)

$       (0.18)

$        (1.26)

$       (1.04 )

Weighted-average common shares used to compute basic and diluted net loss per share

23,295

20,388

22,376

9,441

 

PFENEX INC.

Consolidated Balance Sheets

December 31,

2015

2014

(in thousands)

Assets

Current assets

Cash and cash equivalents

$     106,162

$       45,722

Restricted cash

3,959

Accounts and unbilled receivables, net

2,683

1,584

Inventories

24

23

Income tax receivable

508

402

Deferred income taxes

3,281

Other current assets

1,694

1,753

Total current assets

115,030

52,765

Restricted cash

3,955

Deferred income taxes

1,955

Property and equipment, net

3,179

2,310

Other long term assets

121

53

Intangible assets, net

5,832

6,363

Goodwill

5,577

5,577

Total assets

$     131,694

$       71,023

Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity

Current liabilities

Accounts payable

$             886

$          1,129

Accrued liabilities

5,997

2,633

Current portion of deferred revenue

3,870

201

Line of credit obligation

3,813

3,813

Income tax payable

1,676

Total current liabilities

16,242

7,776

Deferred revenue, less current portion

44,225

Deferred tax liability

3,281

Other long-term liabilities

46

92

Total liabilities

60,513

11,149

Commitments and contingencies

Stockholders’ equity

Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued and outstanding

Common stock, par value $0.001, 200,000,000 shares authorized at December 31, 2015 and 2014, respectively, 23,316,413 and 20,405,066 shares issued and outstanding at December 31, 2015 and 2014, respectively

24

21

Additional paid-in capital

212,661

173,141

Accumulated deficit

(141,504)

(113,288)

Total stockholders’ equity

71,181

59,874

Total liabilities and stockholders’ equity

$     131,694

$       71,023

 

 

SOURCE Pfenex Inc.

[…]

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PR Newswire

Imprimis Pharmaceuticals Announces Proposed Public Offering of Common Stock

SAN DIEGO, March 10, 2016 /PRNewswire/ — Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), (“Imprimis” or the “company”), a pharmaceutical company focused on the development and commercialization of proprietary compounded drug formulations, announced today a proposed underwritten public offering of its common stock, subject to market and other conditions. In connection with the offering, the company intends to grant the underwriters the option, exercisable for 45 days, to purchase additional shares equal to up to 15% of the aggregate number of shares sold in the offering to cover over-allotments. 

National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ:NHLD), is acting as the sole book-running manager for the offering.   

A registration statement on Form S-3 relating to these securities was filed with the U.S. Securities and Exchange Commission (“SEC”) and was declared effective on September 29, 2014. The securities may be offered only by means of a prospectus. Copies of the prospectus and a preliminary prospectus supplement relating to the offering have been filed with the SEC and may be obtained by request to the offices of National Securities Corporation, Attn: Kim Addarich, Senior Vice President, 410 Park Avenue, 14th Floor, New York, NY 10022, Email: Kaddarich@nhldcorp.com

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

ABOUT IMPRIMIS PHARMACEUTICALS

Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a national leader in the development, production and dispensing of novel compounded pharmaceuticals. The company’s two business programs, Imprimis Cares™ and Custom Compounding Choice™, focus on patient outcomes and affordability by offering high quality customizable compounded drugs in all 50 states.  Headquartered in San Diego, California, Imprimis owns and operates four dispensing facilities located in California, Texas, New Jersey and Pennsylvania. For more information about Imprimis, please visit the corporate website at www.ImprimisPharma.com.

SAFE HARBOR

This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered forward looking statements, including statements regarding, among other things, the completion, timing, size and terms of the proposed public offering. Forward looking statements are based on management’s current views, expectations and assumptions and therefore are not guaranties of future performance and are subject to risks and uncertainties that may cause actual results to differ materially and adversely from those predicted by the forward looking statements.  Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, market and other general economic conditions; the company’s ability to satisfy the conditions required to complete the offering; and the company’s perception of future availability of equity or debt financing needed to fund the growth of its business. As a result of these risks and uncertainties, undue reliance should not be placed on forward looking statements. The limited information contained in this press release is not adequate for making an informed investment judgment about the company, and you are encouraged to read Imprimis’ filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and its subsequent Quarterly Reports on Form 10-Q, which more fully describe the company and its business and the risks and uncertainties that may impact future performance. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. Forward looking statements speak only as of the date they are made and except as required by law, Imprimis undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Investor Contact
Bonnie Ortega
bortega@imprimispharma.com
858.704.4587

Logo – http://photos.prnewswire.com/prnh/20150108/167712LOGO

 

SOURCE Imprimis Pharmaceuticals, Inc.; National Holdings, Inc.

[…]

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More Than Meets the Eye

You probably recognize her as the quirky Lily Adams character in AT&T commercials, but there is far more to UC San Diego alumna Milana Vayntrub than what you see on screen. Though dubbed “Advertising’s New ‘It Girl’” by Adweek, the story behind 28-year-old Vayntrub is one of ambition and audacity coming straight from her days at UC San Diego.

[…]

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AnaptysBio Announces First-In-Human Dosing Of Anti-IL-33 Antibody

SAN DIEGO, March 10, 2016 /PRNewswire/ — AnaptysBio, Inc., a biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology, today announced first-in-human dosing of its proprietary anti-IL-33 antibody (ANB020) in a Phase I clinical trial.  The double-blind, placebo-controlled single and multiple ascending dose trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ANB020 in healthy volunteers. 

Interleukin-33, or IL-33, is a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, including atopic dermatitis, food allergies and asthma.  IL-33 acts on white blood cell types that subsequently release atopic disease-mediating cytokines such as IL-5, IL-13 and IL-4. Since ANB020 potently inhibits IL-33 function, and acts upstream broadly across the key cell types involved in atopy, AnaptysBio believes its mechanism has potential advantages in human therapy over agents that block only a subset of the cytokines responsible for atopic diseases. The role of IL-33 signaling in asthma has been genetically validated through human studies published in the medical literature.  

Subsequent to the completion of this Phase I study, AnaptysBio plans to continue clinical development of ANB020 in patients with atopic dermatitis, peanut allergy and asthma. 

“We are pleased to advance ANB020 into the clinic and look forward to demonstrating proof-of-concept in patient studies that we plan to initiate later this year,” said Hamza Suria, President & CEO of AnaptysBio.  “IL-33 signaling plays an important role in atopic diseases and we believe ANB020 is the most advanced antibody targeting the IL-33 cytokine.  ANB020 was advanced from initial concept to the clinic by AnaptysBio, and stands as a testament to our antibody discovery and development capabilities.”

About AnaptysBio

AnaptysBio is an antibody development company focused on novel programs in inflammation and immuno-oncology.  In addition to ANB020, the Company’s proprietary pipeline includes ANB019, an anti-IL-36 receptor antibody initially being developed for the treatment of generalized pustular psoriasis.  AnaptysBio’s SHM-XEL platform has pioneered the use of in vitro somatic hypermutation for antibody discovery, which is designed to replicate key features of the human immune system and overcome limitations of prior antibody technologies. AnaptysBio has previously announced partnerships with several biopharmaceutical companies, including Celgene and TESARO.   

Contacts:

Julie Rathbun 
julie@rathbuncomm.com 
206-769-9219

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SOURCE AnaptysBio, Inc.

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MabVax Therapeutics to Present at the ROTH Conference

SAN DIEGO, March 10, 2016 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, announces that President and Chief Executive Officer David Hansen is scheduled to present a corporate overview at the 28th Annual ROTH Conference on Wednesday, March 16, 2016, at 11:00 a.m. Pacific time (2:00 p.m. Eastern time).  The conference is being held at The Ritz Carlton Laguna Niguel hotel in Dana Point, Calif.

About MabVax:
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing antibody-based products and vaccines 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 has an exclusive license to these therapeutic vaccines from Memorial Sloan Kettering Cancer Center (MSKCC).  In December 2015 MabVax received authorization from the U.S. Food and Drug Administration (FDA) to proceed with initiation of a Phase I clinical trial with HuMab-5B1 as a therapeutic treatment for pancreatic cancer and patient enrollment in the Phase I clinical trial is expected to begin at multiple investigational sites in the first quarter of 2016.  In February 2016, MabVax announced that the FDA had provided authorization to proceed with 89Zr-HuMab-5B1, utilizing the company’s fully human antibody product as a new generation PET scan cancer imaging agent in patients with pancreatic cancer.  We expect patient enrollment for the new generation PET scan cancer imaging agent to begin in early 2016.  MabVax also has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof-of-concept Phase II multicenter clinical trials.  Additional information is available at www.mabvax.com.

Investor Contact:

Jody Cain
Senior Vice President
LHA
310-691-7100
jcain@LHAI.com

 

SOURCE MabVax Therapeutics Holdings, Inc.

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Progenetics to Distribute Biocept’s Liquid Biopsy Assays in Israel

SAN DIEGO, March 10, 2016 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer, announces that Progenetics LTD will market and distribute Biocept’s complete portfolio of Target Selector™ liquid biopsy assays in Israel.  Terms of the transaction were not disclosed.

“We are delighted to partner with Progenetics to bring our liquid biopsy assays and services to patients diagnosed with cancer in Israel.  Our molecular assays use a simple blood draw to provide physicians with valuable information in therapeutic decision-making and in therapeutic course-corrections over time,” said Raaj Trivedi, Biocept’s Vice President of Commercial Operations. “Importantly, this agreement serves to expand Biocept’s reach outside of the U.S., which is a component of our growth strategy.  We see our agreement with Progenetics as a model for additional agreements with distributors in select global markets.”

“We are excited by the revolution in personalized medicine and we intend to be at its forefront,” said Yoav Manaster, Ph.D., Market Director at Progenetics. “We believe that molecular tumor profiling will become an indispensable diagnostic tool in the standard protocol of oncological treatment. Our partnership with Biocept will enable us to provide Israeli physicians access to highly sensitive molecular diagnostic information using blood as a sample type for identifying predictive biomarkers.”

About Progenetics LTD

Progenetics is an innovative company in the relatively new field of molecular tumor profiling in Israel. Founded as a result of strong consumer demand for advanced cancer testing, the company is expanding fast, and is well-positioned to become a market leader in the emerging field of personalized medicine for the treatment of cancer.  For more information please visit: www.progenetics.co.il

About Biocept

Biocept, Inc. is a commercial-stage molecular diagnostics company that utilizes a proprietary technology platform and a standard blood sample to provide physicians with important prognostic and predictive information to enhance individual treatment of patients with cancer. Biocept’s patented technology platform captures and analyzes circulating tumor DNA, both in CTCs and in plasma (ctDNA). Biocept currently offers assays for gastric cancer, breast cancer, lung cancer, colorectal cancer, prostate cancer and melanoma, and plans to introduce CLIA-validated assays other solid tumors in the near term. For additional information, please visit www.biocept.com.

Forward-Looking Statements

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 detection and treatment of cancer, our ability to expand into international markets, our impact on diagnostic strategies, our ability to enhance individual cancer treatments and plans to introduce CLIA-validated assays for prostate cancer and other solid tumors in the near term, 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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OncoSec to Present at 28th Annual ROTH Conference

SAN DIEGO, March 10, 2016  /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that CEO and President Punit Dhillon will present a corporate overview at the 28th Annual ROTH Conference on Wednesday, March 16, 2016. The presentation is scheduled to begin at 8:00 AM PT at The Ritz Carlton, Orange County.

The 28th Annual ROTH Conference is one of the largest of its kind in the US with over 500 participating companies and over 3,000 attendees. The conference will feature presentations from hundreds of small and mid-cap public and private companies in a variety of sectors including: healthcare, technology, business services, and industrial growth. Over the course of the three-day event, there will be several panel discussions, one-on-one meetings, and 10 concurrent tracks of company presentations. For more information, please visit: http://www.roth.com/.

About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies for the treatment of cancer. The Company’s investigational technology, ImmunoPulse™, is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as interleukin-12 (IL-12). In Phase I and II clinical trials, OncoSec’s lead program, ImmunoPulse™ IL-12, demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. ImmunoPulse™ IL-12 is currently in Phase II development for several indications, including metastatic melanoma and triple-negative breast cancer. In addition to ImmunoPulse™ IL-12, the Company is also seeking to identify and develop new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.  

Contact:
Mary Marolla
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com

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SOURCE OncoSec Medical Incorporated

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