1stOncology™: Cancer Intelligence Service – Page 15719 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

8-K – Current report

On March 22, 2016 Eiger BioPharmaceuticals, Inc. (NASD: EIGR) reported completion of its merger with Celladon Corporation effective March 22, 2016 (Filing, 8-K, Celladon, MAR 23, 2016, View Source [SID:1234509850]). In connection with the merger, Celladon changed its name to Eiger BioPharmaceuticals, Inc. The combined company will commence trading as of the open of market March 23, 2016 on The NASDAQ Global Market under the symbol "EIGR."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Prior to the merger, Eiger received gross proceeds of $39.5 million, including the conversion of $6.0 million in aggregate principal amount under, and all interest accrued on, convertible promissory notes of Eiger, in new investment from a combination of certain current and new investors in Eiger, including HBM Healthcare Investments, Vivo Capital, InterWest Partners, RA Capital Management, Sabby Management, Sphera Global Healthcare, Perceptive Advisors and Monashee Capital Partners. Together with approximately $26.1 million in available, pre-merger cash on Celladon’s balance sheet, the combined company has approximately $59 million in cash available before the payment of transaction and other fees.

"We are very pleased to complete this merger, which marks a significant milestone for Eiger. We are transitioning from a private company to a publicly-traded company through this merger, and significantly increasing our financial resources," said David Cory, President and CEO of Eiger. "These funds are expected to support operations and enable us to advance all four Phase 2 Orphan Disease programs."

Following the previously announced financing and merger and 1-for-15 reverse stock split of its outstanding common stock in connection with the merger, the combined company has approximately 7.0 million shares of common stock outstanding.
Jefferies LLC acted as lead placement agent, Piper Jaffray acted as placement agent and Oppenheimer acted as financial advisor on the financing. Additionally, Jefferies LLC acted as lead financial advisor and Piper Jaffray acted as financial advisor on the merger.

Heat Biologics Announces Closing of Public Offering

On March 23, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported the closing of its previously announced underwritten public offering of 9,100,000 shares of its common stock and warrants to purchase up to an aggregate of 6,825,000 shares of its common stock at a combined public offering price of $0.75 per share and related warrant (Press release, Heat Biologics, MAR 23, 2016, View Source [SID:1234509847]). Each share of its common stock was sold together with a warrant to purchase 0.75 of a share of its common stock. The gross proceeds from this offering were approximately $6.8 million, before deducting the underwriting discount and estimated offering expenses payable by Heat, but excluding proceeds from the exercise of any warrants.

Heat intends to use the net proceeds from the offering to complete its Phase 2 clinical trial evaluating HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC), which remains Heat’s primary focus. The remaining net proceeds are expected to be used to advance the current eight patients enrolled in Heat’s Phase 1b clinical trial evaluating HS-110 for the treatment of non-small cell lung cancer (NSCLC) through the reporting of topline data, as well as for licensing or acquisition of assets complementary to its existing programs and for general corporate and working capital purposes.

Roth Capital Partners and Aegis Capital Corp. acted as joint book-running managers and Noble Financial Capital Markets acted as co-manager for this offering.

The shares of common stock and warrants described above were offered pursuant to a registration statement on Form S-1 that was declared effective by the U.S. Securities and Exchange Commission on March 17, 2016 and a related automatically effective registration statement on Form S-1 filed pursuant to Rule 462(b) of the Securities Act of 1933, as amended.

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

Navidea Announces Fourth Quarter and Full Year 2015 Results

On March 23, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), reported results for the fourth quarter and year ended December 31, 2015 (Press release, Navidea Biopharmaceuticals, MAR 23, 2016, View Source;p=RssLanding&cat=news&id=2150371 [SID:1234509838]). Navidea reported total revenue for 2015 of $13.2 million including Lymphoseek (technetium Tc 99m tilmanocept) injection sales revenue of $10.3 million compared to total revenue of $6.3 million for 2014, which included Lymphoseek sales revenue of $4.2 million.

"2015 was marked by a strong turnaround in our commercial business, more than doubling total brand sales to approximately $20 million and recognizing revenue to Navidea of more than $10 million, meeting guidance for the first time under the leadership of our new management team," said Rick Gonzalez, Navidea President and Chief Executive Officer. "Importantly, we have advanced several innovative programs in our pipeline and have begun clinical testing for new large market opportunities, leveraging our Manocept immune-cell targeting platform. These achievements were accomplished while managing our operations within very restrictive capital constraints. Looking forward to 2016, we will continue our efforts to aggressively streamline operations and manage expenses while working towards our goals of doubling sales for the second year in a row, achieving operational cash flow break-even, and advancing our development pipeline, which is essential to sustaining our long-term growth."

Financial Results

Revenues for the year ended December 31, 2015 were $13.2 million compared to $6.3 million for 2014. Navidea’s revenues for 2015 consisted of $10.3 million in sales of Lymphoseek, $1.1 million related to licensing milestones and $1.9 million from various federal grants and other revenue, compared to $4.2 million, $300,000 and $1.7 million, respectively, for 2014. The Company also recorded $1.2 million related to royalties on the gamma detection device business we sold in 2011 (which is reported net of tax as income from discontinued operations).

Operating expenses for the year ended December 31, 2015 were $30.0 million compared to $32.3 million for 2014. Research and development expenses were $12.8 million during 2015 compared to $16.8 million during 2014. The net decrease from 2014 to 2015 was primarily a result of reductions in NAV4694 and NAV5001 product development costs coupled with reduced headcount and related support costs, offset by increased Lymphoseek EU-related manufacturing and regulatory activities, support for our therapeutics initiatives, and Manocept diagnostic product development costs. Selling, general and administrative expenses were $17.3 million for 2015 compared to $15.5 million for 2014. The net increase is due to increased costs related to the establishment and operation of our internal sales team coupled with one-time costs related to the first quarter 2015 reduction in force and increased professional services, license fees related to Lymphoseek, and other support costs which were partially offset by decreased launch-related marketing costs.

Navidea’s loss from operations for the year ended December 31, 2015 was $18.6 million compared to $27.6 million for the same period in 2014. For the year ended December 31, 2015, Navidea reported a loss attributable to common stockholders of $27.6 million, or $0.18 per share, compared to a loss attributable to common stockholders of $35.7 million, or $0.24 per share, for the same period in 2014.

Fourth Quarter Financial Results: Revenues for the fourth quarter of 2015 were $4.3 million compared to $2.2 million for the same period in 2014 representing an increase of 95% period over period. Navidea’s revenues for the fourth quarter of 2015 consisted of $3.5 million in sales of Lymphoseek, $250,000 related to licensing milestones and $541,000 from various federal grants and other revenue, compared to $1.5 million, $0 and $738,000, respectively, for the same period in 2014.

Fourth quarter 2015 operating expenses were $6.4 million compared to $6.4 million for the fourth quarter of 2014. Research and development expenses were $2.6 million during the fourth quarter of 2015 compared to $2.3 million during fourth quarter of 2014. The net increase from 2014 to 2015 was primarily a result of increased Lymphoseek EU-related manufacturing and regulatory activities and therapeutics product development costs, offset by decreased NAV4694 product development costs coupled with reduced headcount and related support costs. Selling, general and administrative expenses were $3.8 million for the fourth quarter of 2015 compared to $4.1 million for the same period in 2014 for reasons consistent with the annual variances discussed above.

Navidea’s loss from operations for the fourth quarter of 2015 was $2.6 million compared to $4.5 million for the fourth quarter of 2014. For the fourth quarter of 2015, Navidea reported a loss attributable to common stockholders of $2.5 million, or $0.02 per share, compared to a loss attributable to common stockholders of $6.9 million, or $0.05 per share, for the fourth quarter of 2014.

"Over the last year and a half, we have made dramatic progress streamlining operations and cutting expenses. Based on our current projections and plans, we expect total operating expenses for 2016 to be roughly 25% lower than 2015 levels, while moving Lymphoseek forward commercially and continuing the development of our Manocept platform," said Brent Larson, Chief Financial Officer. "These measures, coupled with growing revenue, continue to bring us closer to our goal of cash flow break-even in the second half of 2016, which will further support the long term sustainability of the business. In addition, the recently reaffirmed Platinum line of credit will also provide flexibility in the near-term to ensure we have ample capital to support interim needs, but we expect the draws will not exceed $5 million during 2016, leaving us over $20 million of available credit in reserve."

2016 Financial Guidance

Navidea expects Total Revenues for 2016 to range from $23 million to $25 million including Lymphoseek product sales revenue, license revenue, grant and other revenue.

Navidea expects its 2016 total operating expenses, excluding costs related to its Macrophage Therapeutics subsidiary, to be in the range of $21.5 million to $23.5 million.
Milestones & Highlights

Select milestones and highlights that the Company achieved in 2015 and year to date in 2016 include:

Achieved 2015 Lymphoseek revenue guidance with $10.3 million in sales to NAVB, more than doubling year-over-year revenue;

Reduced total operating expenses and, in combination with record total revenues of $13.2 million, reduced the overall corporate cash burn by 35% over the prior year;

Recorded income from discontinued operations related to royalty payments from the Neoprobe/Devicor GDS business of $1.2 million;

Received notice of award for $3.8 million in non-dilutive NIH grants to advance Lymphoseek pipeline expansion programs through Phase 1/2;

Advanced our immunodiagnostics development pipeline, initially into rheumatoid arthritis, addressing a far greater number of patients than our current Lymphoseek label;

Reported investigator initiated clinical study results demonstrating that Lymphoseek reduces sentinel lymph node biopsy imaging time, facilitates patient throughput and workflow efficiencies and enhanced patient experience;

Presented promising data demonstrating that a Manocept-doxorubicin immunotherapeutic conjugate induced apoptosis in Kaposi’s Sarcoma and tumor associated macrophages;

Initiated patient enrollment in Lymphoseek expansion trials for pediatric cancer and cervical cancer;

Published 4 articles in noteworthy medical journals and presented data on Lymphoseek and Manocept compounds at 13 scientific and medical meetings; and,

Strengthened the Board of Directors by appointing two new shareholder-nominated candidates, Dr. Mark Greene and Dr. Anthony Fiorino.

Advaxis Hosts Research Reception to Review Late-Breaking AACR Abstract

On March 23, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that the company will host a Research Reception at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Advaxis, MAR 23, 2016, View Source [SID:1234509834]). The Research Reception, for which registration is required, will be held at 6:30 PM CT on April 18, 2016 at the Sheraton New Orleans Hotel in New Orleans, Louisiana.

The Advaxis Research Reception will feature two presentations:

Lm Immunotherapy: Impact within the Tumor Microenvironment
A review of the late-breaking poster presentation (Abstract #LB-095) on the immunogenicity of Advaxis’ lead immunotherapy candidate, axalimogene filolisbac, as preoperative treatment prior to robotic-assisted surgery in patients with HPV-associated head and neck cancer.
Rosemarie Krupar, MD, Baylor College of Medicine

Immunogenicity of ADXS-HER2 in Canine Osteosarcoma
Nicola Mason, PhD, BVetMed, Assistant Professor of Medicine, University of Pennsylvania

Effects of Advaxis’ Lm Immunotherapy on the STING Pathway
Robert Petit, PhD, Chief Scientific Officer, Advaxis

Cancer Neoepitope Immunotherapy: An Update on ADXS-NEO
Robert Petit, PhD, Chief Scientific Officer, Advaxis

Attendees will also have the opportunity to view the late breaking Phase 2 poster featured at AACR (Free AACR Whitepaper) and ask questions of the lead author. Space is limited and registration, which is required, can be completed online at: www.regonline.com/advaxisreception2016.

SRI Biosciences – Stanford Drug Discovery and Development Program to Explore New Molecular Target for Treatment of Triple Negative Breast Cancer

On March 23, 2016 SRI International reported a new collaborative project between scientists at SRI International and physician-researchers from Stanford Cancer Institute which will support the development of novel drugs for treatment of triple-negative breast cancer (Press release, SRI International, MAR 23, 2016, View Source [SID:1234509917]).

Close to 20 percent of breast cancers are triple-negative, a type of tumor that lacks the three most common receptors that fuel most breast cancer growth. These tumors are unresponsive to hormone therapy or drugs targeting these receptors.

The research collaboration will explore the use of a preclinical drug known as sudemycin D6 that targets a "molecular machine" called the spliceosome. The spliceosome is critical to the basic biological transformation of DNA to RNA to proteins. It "edits" raw RNA transcribed from DNA, cutting and piecing together stretches of code to form the instructions for creating various functional proteins, much as a film editor crafts a finished movie from raw footage. If this biological editor complex is defective, proteins that ultimately result from its actions can be dysfunctional and lead to various forms of cancer, including triple-negative breast cancer.

The research team will be led by Thomas R. Webb, Ph.D., director of Medicinal Chemistry at SRI Biosciences, a division of SRI International, and George Sledge, M.D., professor and chief of the Division of Oncology at Stanford University Medical Center.

"As both a medicinal chemist and cancer survivor, I know that new treatments are desperately needed for cancer," said Webb. "It is my greatest hope that we can combine the unique strengths of SRI Biosciences and the Stanford Cancer Institute to make long-lasting impact in the treatment of triple-negative breast cancer, where unfortunately there are currently few effective therapeutic options. The strategy may also work for a range of other cancers, including lymphoma, melanoma, and certain brain and colon cancers."

"Stanford and SRI both have unique strengths, and together we can create something wonderful for patients with cancer: new treatments that are more effective and less toxic," said Dr. Sledge.

Webb’s research group designed sudemycin D6 to neutralize the SF3B1 protein of the spliceosome with enhanced activity and duration of action as well as less toxicity than previous spliceosome targeting agents. The team has also developed a marker tumor cell line that fluorescently glows when treated with sudemycin D6. This advance enables real-time monitoring of the drug’s activity, which will support translation to the clinical setting.

The SRI Biosciences and Stanford Cancer Institute collaboration is the first step in determining whether sudemycin D6 may be effective against triple-negative breast cancer. As part of the research, tumor samples from anonymous patients will be analyzed at the molecular level and examined in mouse models.

Nathan Collins Ph.D., vice president of Pharmaceutical and Chemical Technologies in SRI Biosciences and Sanjay Malhotra Ph.D., FRSC, associate professor of radiation oncology at Stanford are co-directors of the SRI Biosciences – Stanford Drug Discovery and Development Program that was announced in January 2016 to combine the translational capabilities of both organizations focused on creating a pipeline of innovative cancer drugs for unmet needs in oncology.

According to Malhotra, "The Webb-Sledge collaboration is an excellent example of how translation of a lab discovery into clinic can be expedited though the Stanford-SRI Drug Discovery and Development program. This is a new program, and we hope our wider research community will benefit from our joint efforts."

"Building on our collaborative program we are delighted to be working with the Stanford Cancer Institute to develop therapies for serious unmet needs in the treatment of cancer," added Collins.

About the Research Team

The SRI Biosciences – Stanford Cancer Institute research team also includes: Stefanie S. Jeffrey, M.D., professor at Stanford University Medical Center; Kimberly Alison, M.D., associate professor at Stanford University Medical Center; Lidia Sambucetti, Ph.D., senior program director in SRI’s Discovery Technologies Lab; and Yihui Shi, M.D., Ph.D., research scientist in SRI’s Discovery Technologies Lab.