On February 18, 2016 (Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported financial results for the fiscal year ended December 31, 2015 (Press release, Heat Biologics, FEB 18, 2016, View Source [SID:1234509093]).

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"2015 proved to be a significant year for Heat as we reported positive Phase 1 data for HS-410 in bladder cancer, as well as initiated a Phase 1b trial evaluating HS-110 in lung cancer in combination with a PD-1 checkpoint inhibitor," stated Jeff Wolf, Heat’s Founder and Chief Executive Officer. "We expect to continue the momentum into 2016 with important milestones throughout the year highlighted by topline data for our Phase 2 trial evaluating HS-410 for non-muscle invasive bladder cancer (NMIBC) anticipated in the fourth quarter."

Recent Developments & Fourth Quarter 2015 Corporate Highlights

On February 10, 2016, Heat announced that the U.S. FDA lifted the partial clinical hold on its HS-410 Phase 2 clinical trial and patient enrollment was resumed after one week; clinical timelines were materially unchanged. The partial clinical hold came after Heat concluded that the cell line on which HS-410 is based had been previously misidentified and immediately notified FDA of this conclusion. The FDA placed Heat’s HS-410 Phase 2 clinical trial on partial clinical hold while they reviewed updated documentation. The partial clinical hold did not relate to concerns regarding the safety or efficacy of HS-410.

In January 2016, Heat reported three-month interim data from the unblinded, monotherapy cohort of the company’s ongoing Phase 2 trial of HS-410 for the treatment of high-risk, NMIBC. Images of the bladder taken from patients treated with HS-410 alone (e.g., no Bacillus Calmette-Guérin (BCG)) showed changes that resemble T cell-rich structures, indicating that systemic administration with HS-410 leads to a localized immune response within the bladder that cannot be attributed to standard of care. The interim data further validated HS-410’s mechanism of action. One of the treated patients had carcinoma in situ (CIS) – the patient population believed to be least responsive to BCG – and that patient experienced complete response. Heat continues to enroll the 25-patient arm and expects to report further monotherapy HS-410 data later this year.

In November 2015, Heat announced results from its Phase 1 clinical trial, evaluating the safety and immune response of HS-410 after surgery and treatment with standard of care, BCG, in patients with NMIBC. HS-410 had a positive safety profile with no serious adverse events. HS-410 elicited a broad-based (polyclonal) expansion of patient T cells and a high level of CD8+ tumor-infiltrating lymphocytes (TILs). Additionally, based on tissue samples taken from each patient, HS-410 shared 15 or more tumor antigens with those expressed on the patients’ cancer cells.

In October 2015, Heat completed enrollment of the 75 patients in the company’s blinded, randomized, placebo-controlled arms of its Phase 2 clinical trial of HS-410 for the treatment of NMIBC. In these three arms, Heat is evaluating the ability of HS-410 in combination with BCG to prevent cancer recurrence. The company plans to report topline efficacy, immune-response and safety data in the fourth quarter of 2016.

Fiscal Year 2015 Financial Highlights

Research and development expenses decreased to $2.6 million in 2015 from $2.9 million in 2014, a decrease of $0.3 million. The decrease is attributable to a reduction in pre-manufacturing costs associated with preparing clinical trial material and professional and consulting expenses, offset by increases in compensation costs, lab supplies and other fees.

Clinical and regulatory expenses increased to $14.1 million in 2015 from $5.3 million in 2014, an increase of $8.8 million. The increase is attributable to increases in clinical trial execution expenses, personnel costs and expenses related to the production of our clinical trial material.

General and administrative expenses increased to $4.4 million in 2015 from $4.0 million in 2014, an increase of $0.4 million. The increase is attributable to increased personnel and professional service fees.

Net loss for 2015 was $20.3 million compared to a net loss of $11.8 million for 2014.

Cash, cash equivalents and short-term investments totaled approximately $11.6 million at December 31, 2015 compared to $14.4 million at December 31, 2014.

On February 18, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, conditional approval status for RosettaGX Reveal, its novel microRNA classifier for the diagnosis of indeterminate thyroid Fine Needle Aspirate (FNA) smears from the New York State Department of Health (NYSDOH) under the Company’s Molecular Oncology permit (Filing, 6-K, Rosetta Genomics, FEB 18, 2016, View Source [SID:1234509216]). RosettaGX Reveal is the only molecular test in the thyroid market that has been validated in a multicenter, international, blinded study using convenient, routinely prepared cytology slides.

The assay is CLIA certified, but New York requires an additional license from the NYSDOH for CLIA-certified tests to be offered to patients in the state. With this conditional approval, RosettaGX Reveal is now available in all 50 states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information that it may request within 60 business days.

"We are very pleased to have approval to market this important cancer diagnostic for the benefit of physicians and patients in the vast New York market," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "It is estimated that nearly 550,000 FNAs are performed on thyroid nodules each year in the U.S. and that approximately 740,000 are performed annually in Europe. Interpretation of FNA samples is not always straightforward, leading to an indeterminate result in up to 30% of the samples. Many patients with indeterminate results undergo surgery as a precaution despite the fact that up to 80% of these cases are benign. This exposes patients to unnecessary surgical risk and costs the healthcare system hundreds of millions of dollars. Through an analysis of our validation study data, we believe we can help prevent up to 75% of unnecessary thyroid surgeries."

"In addition to this expanded geographic access, recent managed care contracting initiatives have resulted in covered lives for RosettaGX Reveal exceeding 150 million in the U.S. These increases in geographic and health insurance access, along with the potential health economic benefits the RosettaGX Reveal assay can bring by avoiding unnecessary surgeries, should enhance adoption into a market valued at more than $350 million annually in the U.S. alone. This market is one that continues to see accelerating penetration of molecular classifiers such as RosettaGX Reveal, which we expect to continue over the next several years," added Mr. Berlin.

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On February 17, 2016 Eisai and PIQUR Therapeutics reported a landmark agreement to conduct a Phase 1/2b clinical study to investigate PQR309 in combination with Halaven (eribulin) in patients with triple-negative breast cancer (TNBC) (Press release, PIQUR Therapeutics, FEB 17, 2016, View Source [SID1234527273]).

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A significant number of HER2-negative breast cancer patients are expected to have activated PI3K, de novo or induced by prior chemotherapy administration. PQR309 is currently engaged in multiple Phase 1 and Phase 2 studies as a single agent and has shown promising activity. The combination of a PI3K/mTOR inhibitor with eribulin may prove to be an effective treatment in second line therapy for locally advanced or metastatic TNBC patients.

The Phase 1/2b study is scheduled to begin in early 2016. The initial Phase 1 dose-escalation part of the study will assess the safety and tolerability of PQR309 combined with eribulin in patients with locally advanced or metastatic HER2-negative and triple-negative breast cancer. The Phase 2b expansion part of the study will enroll patients with advanced or metastatic TNBC. The primary objective of this part of the study is to evaluate the efficacy of the PQR309 in combination with eribulin. In total, the Phase1/2b study will enroll approximately 60 patients. PIQUR will be responsible for conducting the Phase 1/2b clinical trial and the parties may extend the collaboration to include a Phase 3 clinical trial as well as additional trials in new indications of mutual interest.

"We are delighted to enter into this collaboration with PIQUR Therapeutics, which has rapidly established itself as one of the leading experts in the field of PI3K/mTOR inhibitors. Based on convincing pre-clinical data and on the promising results of PIQUR’s front runner compound PQR309 shown in Phase 1 study, we believe that combining eribulin with PQR309 may provide new treatment options for patients with TNBC," said Dr Takashi Owa, Chief Innovation Officer, Vice President Eisai Co., Ltd.

"We are very pleased to enter into this collaboration with Eisai, one of the worldwide leaders in oncology and to jointly explore new avenues to address an unmet need in breast cancer. We look forward to a fruitful partnership and to pursue the development of this combination treatment following the completion of this first study," said Hervé Girsault, Chief Business Officer of PIQUR Therapeutics.

Eribulin is the first in the halichondrin class, microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.1 Eribulin remains the only single agent chemotherapy to significantly improve overall survival in women with advanced breast cancer after anthracycline and taxane treatment. Metastatic breast cancer is a very difficult condition to treat and only 15% of women will survive beyond five years.2

This collaboration underscores Eisai’s human health care (hhc) mission, the company’s commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to oncology to address the unmet medical needs of patients and their families.

On February 17, 2016, BioInvent reported its Financial Statement for January 1 to December 31 2015 (Press release, BioInvent, FEB 17, 2016, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=A87CE808F590960A [SID:1234509076]).

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Fourth quarter 2015, October – December

Net sales for October-December 2015 amounted to SEK 10 (1.7) million.
Earnings after tax for October-December 2015: SEK -21 (-28) million.
Earnings after tax per share for October-December 2015 before and after dilution: -0.13 (-0.25) SEK.
Cash flow from current operations and investment activities for October-December 2015: SEK -11 (-25) million.

Full year report 2015, January – December
Net sales for January-December 2015 amounted to SEK 16 (47) million.
Earnings after tax for January-December 2015: SEK -91 (-54) million.
Earnings after tax for January- December 2015 before and after dilution: SEK -0.64 (-0.53).
Liquid funds as of 31 December 2015: SEK 40 (46) million. Cash flow from current operations and investment activities for January- December 2015: SEK -73 (-76) million.

Important events in the fourth quarter and after the reporting period
The Board of Directors of BioInvent resolved on 16th of February on a private placement of SEK 43 million to the US-based healthcare investor Omega Funds and a rights issue of SEK 191 million subject to approval by an Extraordinary General Meeting on 18 March 2016. Notice to the General Meeting is published in a separate press release.
BioInvent announced in December 2015 that the company had been selected by a major global pharmaceutical company to provide manufacturing services for one of the products in the pharmaceutical company’s development portfolio. Revenues are expected to amount to approximately SEK 25 million.
In December 2015 BioInvent announced the increased commitment to the BI-505 programme and the submission of a clinical trial application to the US Food and Drug Administration (FDA).
BioInvent announced in December 2015 that it had gained access to novel technology for making highly efficacious immune stimulatory antibodies to combat cancer. This initiative continues BioInvent’s long standing research collaborations with the University of Southampton.
In January BioInvent announced that the FDA had completed the safety review of its Investigational New Drug application for TB-403 and have concluded that the proposed pediatric clinical investigation can proceed.

Comments from the CEO
"In 2015, through collaboration with leading international research groups, charities and patient organizations, BioInvent secured most of the financial and operational resources needed to implement our three clinical programs in Phase I and II with a total of approximately 200 patients. As a result, we have ensured funding for these trials while retaining our ownership and interest in them.

I am now pleased to announce a further significant step forward in the development of BioInvent.
Based on recent progress in our project portfolio, including important scientific publications and the projected initiation of clinical trials in three of our immuno-oncology programs during 2016, BioInvent has attracted considerable interest from international and local health care-investors. From this position of strength, we now intend to create the financial leverage to fully exploit the commercial potential of our key programs.

The MSEK 234 financing round announced yesterday is anchored by a private placement of MSEK 43 to Omega Funds – a US-based healthcare investor, reputable for actively supporting its portfolio companies in creating long-term shareholder value. In parallel, we are offering our current shareholders to participate in a fully guaranteed MSEK 191 rights issue at equal terms. The investors guaranteeing the rights issue are renowned private investors, foundations and institution like investors such, such as LMK, Bengt Sjöberg, Kamprad foundation, Crafoord foundation, Peter Edwall and Laurent Leksell.

Omega Funds will be a welcome addition as shareholders, partly because they make their own team of experts available, but also as BioInvent gains the opportunity to leverage on Omega’s longstanding and strong relationships with major pharmaceutical companies, financial institutions and investors.

The capital from the equity issues is mainly intended to finance BioInvent’s costs related to clinical trials, supporting pre-clinical work aiming to optimize the value of the clinical projects and continued development of the Company’s prioritized pre-clinical projects. In addition, a strengthened financial position enables increased strategic flexibility and improved ability to negotiate with potential partners.

BioInvent has an attractive clinical portfolio in the orphan oncology area; niche categories with significant unmet medical needs. This focus combines a shorter and more cost-effective way to market, while providing an opportunity for reimbursement and rapid uptake of our products. The company’s pre-clinical research in immuno-oncology is of high quality and has gained significant interest from the pharmaceutical industry for collaboration.

All three studies planned to start in 2016, are designed as open, which offers the possibility to monitor results continuously. This increases the opportunities for transparency with the stock market and flexibility in negotiations with future partners in order to maximize shareholder value. BioInvent’s antibody BI-1206 will undergo a Phase I/II trial in patients with non-Hodgkin’s lymphoma and chronic lymphatic leukaemia. Further development will be focused on subgroups with high, unmet medical needs and short time to market. Two of BioInvent’s programs, BI-505 for multiple myeloma and TB-403 in childhood cancer are both orphan drug projects. The trials for these programs are designed to potentially form the basis for registration files, provided that the clinical endpoints are met.

The share issues provide BioInvent with a new large international shareholder, and will enable the company to reach important value inflection points in our key programs over a period of at least two years. I am confident that this major milestone in BioInvent’s development will further increase our ability to deliver significant value to our shareholders in the short and long term," says Michael Oredsson, President and CEO of BioInvent.

On February 16, 2016 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its interim report and financial results for the half-year ended 31 December 2015 (Press release, Starpharma, FEB 17, 2016, View Source [SID:1234509077]).

Financial Summary
Reported loss of $10.0M (Dec 2014: $8.5M)
Revenue of $3.7M (Dec 2014: $0.7M)
R&D tax incentives of $1.8M reported in the half-year (Dec 2014: $1.6M)
Cash position at 31 December 2015 of $54.7M (June 2015: $30.8M)
Cash inflows of $7.2M from partners and grants, includes US$2.0M from AstraZeneca and $3.4M R&D tax incentive refund
Proceeds from completion of $32.0M equity placement
Operational Highlights
Signing of a multiproduct drug delivery license with AstraZeneca with potential milestones payments of up to US$126M, plus royalties;
AstraZeneca selected second DEP candidate under the drug delivery license;
EU marketing approval granted for VivaGel BV treatment and the rapid relief of BV including symptoms;
Signing of Memorandum of Understanding to manufacture and sell the VivaGel condom in the Chinese Government sector;
Targeted DEP outperforms leading treatments in ovarian cancer model; and
Additional US patent granted for VivaGel BV with 7 year extension of term.

Starpharma concluded the half-year in a strong financial position with a cash balance of $54.7 million following the $32 million equity placement in the period, with a further $1.9 million received after the period from the closing of a share purchase plan. Cash receipts in the half-year totalled $7.2 million with $3.8 million received from partners, including AstraZeneca, and a further $3.4 million from R&D tax incentives.

The signing of the AstraZeneca DEP drug delivery licence agreement was a major highlight in the period triggering the receipt of the first US$2 million milestone under the multiproduct deal. Under the license, AstraZeneca has selected an oncology compound as the initial DEP candidate which provides for potential development, launch and sales milestones payable to Starpharma of up to US$126 million, plus royalties on net sales. In November AstraZeneca also nominated a second candidate for development, with potential milestones of up to US$93 million, plus royalties.

The net loss after tax for the half-year of $10.0 million reflects investment across the Company’s VivaGel, drug delivery and agrochemical portfolios, including the conduct of two clinical programs in parallel – the VivaGel Phase 3 clinical trials for the prevention of recurrent bacterial vaginosis and the Phase 1 DEPTM docetaxel trial.

The double-blinded, placebo controlled Phase 3 trials of VivaGel for prevention of recurrent bacterial vaginosis are actively enrolling participants across sites in the US, Canada, Mexico, Europe and Asia. Each trial will enrol around 600 women, with more than 75% of total participants enrolled to-date.

The Phase 1 clinical trial of DEP docetaxel in cancer patients, at four Australian sites continues to show very encouraging clinical data with more than 75% of patients having been recruited and administered multiple cycles of treatment. DEP docetaxel has been dosed at levels at and above the most commonly used dose for Taxotere (75mg/m2), with no bone marrow toxicities (including neutropenia) or hair loss reported. Patients treated with DEP docetaxel have also not required anti-nausea or cortisone pre-treatment.

Commenting on the Company’s achievements and outlook, Starpharma CEO Dr Jackie Fairley said:

"During the half year, we achieved several important milestones across our VivaGel, drug delivery and agrochemicals programs, and Starpharma is very well placed financially to build upon these developments in 2016. Within the VivaGel portfolio, the granting of EU marketing approval of VivaGel BV treatment for the rapid relief of bacterial vaginosis and its symptoms, and the signing of a Memorandum of Understanding for the VivaGel condom in the Chinese government sector were important regulatory and commercialisation achievements in the half-year. These achievements, combined with ongoing commercial and regulatory progress and the rollout of the VivaGel condom with existing partners in additional geographies, strengthens VivaGel’s commercial product opportunities.

"In addition to the signing of the AstraZeneca deal and the progress in the DEPTM docetaxel clinical programs, substantial progress has also been made in drug delivery, in both internal and partnered programs. Starpharma has built on its DEP pipeline of potential internal clinical candidates, with compelling pre-clinical results achieved in both DEP carbazitaxel and its novel Targeted DEPTM program, where complete tumour regression and 100% survival was achieved in an ovarian cancer model, significantly outperforming Roche’s currently marketed antibody-drug conjugate, Kadcyla."

"Finally, Starpharma’s agrochemical partnerships have been extended and expanded in scope with existing and new agrochemical companies for the development of Priostar dendrimer-improved crop protection formulations for the European, Asian and North American markets."

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