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Sophiris Bio Reports Fourth Quarter and Full Year 2015 Financial Results and Key Business Highlights

On March 23, 2016 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, reported financial results for the three months and year ended December 31, 2015 (Press release, Sophiris Bio, MAR 23, 2016, View Source [SID:1234509857]).

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"Compelling data have been announced from both topsalysin programs over the past few months. Topsalysin demonstrated promising therapeutic activity in four of the initial seven patients with localized prostate cancer – including one with a complete tumor ablation. This encouraging data follows the announcement in November of 2015 that topsalysin met the primary endpoint in a Phase 3 study in BPH," stated Randall Woods, president and CEO of Sophiris Bio. "We believe that these robust and consistent BPH results will help us secure the capital needed to advance the BPH program into the final clinical study required for marketing approval, in a non-dilutive manner such as through a development and/or commercial partner."

Liquidity:

At December 31, 2015, we had cash, cash equivalents and securities available-for-sale of $8.4 million and net working capital of $5.6 million. We expect that our cash, cash equivalents and securities available-for-sale as of December 31, 2015 will be sufficient to fund our operations through September 2016 assuming that we do not initiate any additional clinical development of topsalysin beyond our on-going Phase 2a proof of concept study in localized prostate cancer. We will need to obtain additional capital to fund a second Phase 3 clinical trial of topsalysin for the treatment of the symptoms of BPH and for any future clinical development of topsalysin for the treatment of localized prostate cancer beyond our ongoing Phase 2a proof of concept clinical trial and to fund our ongoing operations. As of December 31, 2015, the outstanding principal balance of our term loan was $5.3 million on which we make principal and interest payments monthly.

Business Highlights:

Topsalysin BPH Program:

On November 10, 2015, the Company announced final positive results from its Phase 3 "PLUS-1" study of topsalysin (PRX302) as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH, enlarged prostate)
Topsalysin met the primary endpoint of the study, demonstrating a statistically significant improvement in International Prostate Symptom Score (IPSS) total score from baseline over 12 months compared to the vehicle-only control group, (p = 0.043).
The clinical relevance of the overall improvement in IPSS was assessed by an additional efficacy endpoint, the patient self-assessment of the impact of treatment on their quality of life. Patients reported a sustained improvement in their quality of life from Weeks 18 through 52, which was statistically significantly superior to patients treated with vehicle for every post-baseline visit beginning at week 18 (reaching p = 0.004).
Topsalysin continues to have an attractive safety profile, with no evidence of any treatment related sexual or cardiovascular side effects.
Topsalysin Localized Prostate Cancer Program:

As of December 31, 2015, a total of 18 patients with clinically significant, localized low to intermediate risk prostate cancer (prostate cancer that has not yet metastasized) had been enrolled in the ongoing Phase 2a proof of concept study.
On January 28, 2016, the Company announced that a review of the 6-month biopsy data from the first seven patients to complete the study showed that four patients experienced a response to treatment: One patient experienced complete ablation of the tumor where no evidence of the treated tumor remained on a targeted biopsy at 6 months; three patients experienced either a reduction in the maximum cancer core length or a reduction in Gleason pattern; three patients had no response to treatment.
The Company held a conference call to review clinical data with principal investigators from the BPH program and the prostate cancer program, which can be accessed at View Source
The Company expects to have final data on all patients by the end of second quarter of 2016.
Woods added, "Practicing urologists view topsalysin as a compelling alternative for their BPH patients who have discontinued their oral medications and are unwilling to take the leap to the more invasive surgical procedures. Given the convenience of this four minute administration of topsalysin in the urologist’s office, 12 months of benefit and a benign safety profile, we believe topsalysin has the potential to obtain a significant position within the BPH treatment paradigm."

Financial Results:

For the fourth quarter ended December 31, 2015

The Company reported a net loss of $2.5 million ($0.15 per share) for the three months ended December 31, 2015 compared to a net loss of $5.3 million ($0.31 per share) for the three months ended December 31, 2014.

Research and development expenses

Research and development expenses were $1.7 million for the three months ended December 31, 2015 compared to $4.1 million for the three months ended December 31, 2014. The decrease in research and development costs is attributable to decreases in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin, costs associated with the manufacturing activities for topsalysin and personnel related costs. These decreases are partially offset by an increase in costs associated with the Phase 2a proof of concept clinical trial for localized low to intermediate risk prostate cancer which enrolled its first patient in the second quarter of 2015.

General and administrative expenses

General and administrative expenses were $0.7 million for the three months ended December 31, 2015 compared to $1.0 million for the three months ended December 31, 2014. The decrease is primarily due to a decrease in non-cash stock-based compensation expense, consulting, and personnel related costs.

For the year ended December 31, 2015

The Company reported a net loss of $14.2 million ($0.84 per share) for the year ended December 31, 2015 compared to a net loss of $30.7 million ($1.85 per share) for the year ended December 31, 2014.

Research and development expenses

Research and development expenses were $9.9 million for the year ended December 31, 2015 compared to $24.7 million for the year ended December 31, 2014. The decrease in research and development costs is attributable to decreases in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial of topsalysin, costs associated with the manufacturing activities for topsalysin and personnel related costs. These decreases are partially offset by an increase in costs associated with the Phase 2a proof of concept clinical trial for localized low to intermediate risk prostate cancer.

General and administrative expenses

General and administrative expenses were $3.6 million for the year ended December 31, 2015 compared to $5.3 million for the year ended December 31, 2014. The decrease is primarily due to a decrease in non-cash stock based compensation expense and, to a lesser extent, decreases in legal, travel, professional, consulting, and personnel related costs.

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."

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.