On August 6, 2015 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, reported financial results and business highlights for the second quarter ended June 30, 2015 (Press release, BIND Therapeutics, AUG 6, 2015, View Source [SID:1234507054]).

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"In the second quarter we made significant progress with our clinical programs and continued executing on our vision to develop new categories of Accurins that have a significant impact in multiple therapeutic areas," said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. "We believe BIND-014, which is on track for an initial phase 2 data readout from the iNSITE 1 trial later this year, has the potential to have a meaningful impact on patients with multiple solid tumors types. We have also initiated programs that leverage the broad potential of our platform to develop Accurins that target new cell types and compartments with highly efficacious payloads and limited exposure to healthy tissue. We believe our innovative approach to develop new categories of Accurins can fundamentally change how diseases are treated."

During the quarter, BIND advanced its product development pipeline with continued strong enrollment of the KRAS mutant and squamous histology cohorts in the iNSITE 1 non-small cell lung cancer trial with BIND-014. The Company also initiated site activation in the iNSITE 2 trial in patients with four orphan tumor histologies: cholangiocarcinoma, advanced cervical cancer, advanced bladder cancer, and advanced squamous cancer of the head and neck. First patient dosing in the iNSITE 2 trial is anticipated in the third quarter of 2015.

Additionally, BIND’s collaborator AstraZeneca filed an investigational new drug application (IND) and received clearance to begin a phase 1 trial with AZD-2811, a novel Aurora B kinase inhibitor that will be the second Accurin to enter the clinic. BIND and AstraZeneca expect the patient enrollment in this trial to begin in the fourth quarter of 2015. Under the terms of its agreement with AstraZeneca, BIND will earn a $4 million milestone payment upon first dosing a patient in a phase 1 clinical trial with AZD-2811.

"We are making great progress with our BIND-014 clinical program and enrollment for both cohorts of iNSITE 1 is proceeding as planned and fully meeting our expectations," said Hagop Youssoufian, M.Sc., M.D., chief medical officer at BIND. "We are also excited to enroll the first patient in the iNSITE 2 trial with BIND-014, an important milestone considering the signals of clinical efficacy we saw in our phase 1 trial in patients with cholagio, cervical and head and neck cancers. BIND-014 has the potential to become an effective new therapy that both improves the treatment experience and offers greater efficacy for patients with multiple tumor types who currently have limited options."

BIND previously announced efforts to develop new categories of Accurins that can be applied to multiple therapeutic areas. During the second quarter of 2015, the Company initiated early formulation work to engineer new Accurin product concepts containing anti-infectives and oligonucleotides. These programs leverage the ability of the Accurin platform to target promising payloads to diseased cells and tissues types that have been challenging to treat with conventional therapies.

BIND also entered into a research collaboration with Macrophage Therapeutics to combine their Manocept platform, which targets the CD206 receptor on disease-associated macrophages, with BIND’s Accurin platform. Activated macrophages play an important role in the tumor microenvironment and other diseases and the goal of the collaboration is to target Accurins to CD206 disease-associated macrophages in the tumor microenvironment.

"Our collaboration with Navidea’s Macrophage Therapeutics is a result of our efforts to develop Accurins that incorporate novel APIs and ligands that target important pathways in additional therapeutic areas," continued Hirsch. "This collaboration could result in Accurins that are able to selectively bind to CD206 positive disease-associated macrophages, which help create an immunosuppressive tumor environment for many types of cancers. In addition to a potentially innovative approach in oncology, this collaboration could result in Accurins that provide new treatments across a broad array of diseases that trigger the activation of disease-associated macrophages, including infectious disease, autoimmune and CNS diseases."

Anticipated upcoming milestones include:

Initial data readouts in the fourth quarter of 2015 from the iNSITE1 trial in KRAS mutant and squamous histology non-small cell lung cancer, which we expect to provide the evidence needed to determine the most appropriate regulatory path to market.
Dose first patient in the iNSITE 2 clinical trial in multiple solid tumors in the third quarter of 2015.
Report overall survival data from the completed phase 2 non-small cell lung cancer study with BIND-014 in the broader patient population following occurrence of all survival events.

Report final results from the phase 2 prostate cancer study with BIND-014 following occurrence of 75 percent of the survival events.

Dose first patient in phase 1 clinical trial with AZD-2811 (with collaborator AstraZeneca) in the fourth quarter of 2015.
Potential selection of Accurin candidate in BIND’s collaboration with Pfizer in September 2015.
Report the results of our proof-of-concept work with Macrophage Therapeutics before December 31, 2015.
Continue advancing BIND-510 through important preclinical studies to position it for an IND filing in 2016.

Second Quarter 2015 Financial Results

Revenue for the second quarter of 2015 increased three percent to $2.5 million compared to the second quarter of 2014. Revenue primarily represents BIND’s reimbursable research and development expenses and collaboration up-front license fees and milestones for which revenue recognition was initially deferred and is being recognized over the performance period from BIND’s collaborations with AstraZeneca and Pfizer.

The increase in revenue from the 2014 period to the 2015 period was primarily due to total revenue recognized under the Pfizer collaboration reflecting completion of the majority of BIND’s activities before Pfizer’s first option decision in September 2015, as well as higher revenue under the AstraZeneca collaboration for increased manufacturing activities in support of the IND filing and the first-in-human clinical trials. AstraZeneca anticipates enrolling the first patient in a AZD-2811 phase 1 clinical trial in the fourth quarter of 2015, which will trigger BIND earning a $4 million milestone under its collaboration agreement with AstraZeneca. Revenue during the second quarter of 2014 included recognition of the remaining up-front license fee from the Amgen collaboration as a result of its completion.

Research and development expenses totaled $8.3 million for the second quarter of 2015, compared to $6.9 million for the second quarter of 2014. The increase was primarily driven by headcount growth to support the advancement of BIND’s internal pipeline and collaborations, as well as higher expenses as the Company scales up its clinical material manufacturing capability under our AstraZeneca collaboration.

General and administrative expenses totaled $4.4 million for the second quarter of 2015, compared to $3.8 million for the second quarter of 2014. The increase was primarily driven by general and administrative headcount growth related to compensation, including stock-based expenses.

Net loss for the second quarter of 2015 was $10.5 million, compared to a net loss of $8.4 million for the second quarter of 2014.

Cash, cash equivalents and short-term investments were approximately $53 million as of June 30, 2015. The Company expects that its cash, cash equivalents and short-term investments as of June 30, 2015 will fund operating expense and capital expenditure requirements into the third quarter of 2016. This expectation is based on the Company’s current operating plans and research and development funding that it expects to receive under its existing collaborations, but excludes any potential milestone payments.

On August 6, 2015 Agios Pharmaceuticals (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported business highlights and financial results for the second quarter ended June 30, 2015 (Press release, Agios Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076543 [SID:1234507053]).

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"In the first half of 2015, we continued to drive rapid and meaningful progress across our development programs, as well as selecting our fourth molecule for development, AG-881, and advancing it into two Phase 1 studies," said David Schenkein, M.D., chief executive officer of Agios. "Additionally, we recently initiated DRIVE PK, a Phase 2 study of AG-348 in PK deficiency patients, and are on track to initiate two global, registration-enabling Phase 3 studies of AG-221 and AG-120 in patients with acute myeloid leukemia in the next six to 12 months. These efforts bring us closer to our goal of being a late-stage biopharmaceutical company capable of changing the treatment paradigm for people with cancer and rare genetic disorders."

KEY UPCOMING MILESTONES

Agios anticipates the following milestones from its IDH clinical development programs in collaboration with Celgene:

AG-221: a first-in-class, oral, selective, potent inhibitor of the mutated IDH2 protein

Initiate a global Phase 3 registration-enabling study in relapsed/refractory acute myeloid leukemia (AML) patients who harbor an IDH2 mutation by the end of 2015.

Initiate combination trials to evaluate AG-221 as a potential frontline treatment for patients with AML who harbor an IDH2 mutation by the end of 2015.

AG-120: a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein

Begin combination trials to evaluate AG-120 as a potential frontline treatment for AML patients who harbor an IDH1 mutation by the end of 2015.

Initiate a global registration-enabling Phase 3 study in AML patients who harbor an IDH1 mutation in the first half of 2016.
Present data on the ongoing Phase 1 study of AG-120 in IDH1 mutant-positive advanced solid tumors at a medical meeting in the fourth quarter of 2015.

RECENT DEVELOPMENT UPDATES IN CANCER METABOLISM

Agios has provided the following updates on its clinical development programs in collaboration with Celgene:

AG-221

New data from the dose-escalation phase and expansion cohorts from the ongoing Phase 1 study evaluating single agent AG-221 were presented in June at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper). Read the full AG-221 data here.
As of July, Agios completed the dose-escalation portion of the Phase 1 study of AG-221 in IDH2 mutant-positive hematologic malignances. The expansion cohorts are on track, including the fifth expansion cohort of 125 patients with IDH2 mutant-positive AML who are in second or later relapse, refractory to second-line induction or re-induction treatment, or have relapsed after allogeneic transplantation.

Dose escalation continues in the Phase 1/2 trial in patients with advanced solid tumors and angioimmunoblastic T-cell lymphoma (AITL) who carry an IDH2 mutation.

AG-120

New data from the dose-escalation phase of the ongoing Phase 1 study evaluating single agent AG-120 in advanced hematologic malignancies were presented in June at EHA (Free EHA Whitepaper). Read the full AG-120 data here.

Also announced in June, the U.S. Food and Drug Administration (FDA) granted Agios orphan drug designation for AG-120 for the treatment of patients with IDH1 mutant-positive AML.

In May, Agios announced that the FDA granted Fast Track designation to AG-120 for the treatment of patients with IDH1 mutant-positive AML.

As of July, Agios completed the dose-escalation portion of the Phase 1 study of AG-120 in IDH1 mutant-positive hematologic malignances. The three expansion cohorts to evaluate AG-120 in 175 patients with IDH1-mutated advanced hematologic malignancies, including one cohort with 125 patients with relapsed and/or refractory AML, are on track.
AG-881: a brain-penetrant, first-in-class, oral, potent pan-inhibitor of the mutated IDH1 and IDH2 proteins

In June, Agios announced that the first patient was dosed in a Phase 1, open-label, dose-escalation and expansion study of single agent AG-881 in patients with IDH mutant-positive advanced solid tumors, including gliomas.
In August, the first patient was dosed in a second dose-escalating and expansion trial for patients with IDH mutant-positive advanced hematologic malignancies, whose cancer has progressed on a prior IDH inhibitor therapy.

RECENT DEVELOPMENT UPDATES IN RARE GENETIC METABOLIC DISORDERS

AG-348: a novel, first-in-class, oral activator of pyruvate kinase-R (PKR) for the treatment of pyruvate kinase (PK) deficiency

In June, final data from the Phase 1 multiple-ascending dose (MAD) study in healthy volunteers were presented at EHA (Free EHA Whitepaper), establishing clear proof-of-mechanism for AG-348. Read the full AG-348 data, as well as data from Boston Children’s natural history study, here.

Also in June, Agios initiated DRIVE PK, a global Phase 2, open-label safety and efficacy trial in adult, transfusion-independent patients with PK deficiency. The first patient was dosed in July.

CORPORATE UPDATE

Agios plans to host and webcast an investor event in October 2015 in an effort to provide background and education on the novel programs it is targeting and the diseases the company aims to treat. Additional details will be provided in the coming weeks.

SECOND QUARTER 2015 FINANCIAL RESULTS

Cash, cash equivalents and marketable securities as of June 30, 2015 were $434.0 million, compared to $467.4 million as of December 31, 2014. The decrease was driven by cash expenditures for operating activities of approximately $64.9 million, which was offset by cash received from Celgene of approximately $43.3 million during the six months ended June 30, 2015 related to our collaboration agreements.

Collaboration revenue was $13.2 million for the second quarter of 2015, compared to $8.4 million for the comparable period in 2014. The increase reflects revenues recognized under the company’s collaboration agreements with Celgene, including $8.8 million related to the delivery of the U.S. and ex-U.S. licenses for AG-881.

Research and development (R&D) expense was $36.4 million, including $4.6 million of stock- based compensation expense in the second quarter of 2015, compared to $22.6 million, including $1.4 million in stock-based compensation expense for the comparable period in 2014. The increase in R&D expense was primarily due to increased costs to support advancement of the company’s lead investigational medicines toward later-stage development.

General and administrative (G&A) expense was $8.9 million, including $3.6 million of stock-based compensation expense, in the second quarter of 2015, compared to $4.2 million, including $1.0 million of stock-based compensation expense, for the comparable period in 2014. The increase in G&A expense was largely due to increased headcount and other professional expenses to support growing operations.

Net loss for the second quarter of 2015 was $31.9 million, compared to net loss of $18.3 million for the comparable period in 2014.

ADJUSTED FINANCIAL GUIDANCE FOR THE FULL YEAR 2015

Today Agios raised its previous year end cash guidance and now expects to end 2015 with more than $350.0 million of cash, cash equivalents and marketable securities. The anticipated year end 2015 cash position does not include any additional program-specific milestone payments. Agios expects that its cash, cash equivalents and marketable securities would be sufficient to fund its operating expenses and capital expenditure requirements until late 2017.

On August 6, 2015 Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair, provided a corporate update and reported financial results for the second quarter ended June 30, 2015 (Press release, Acceleron Pharma, AUG 6, 2015, View Source [SID:1234507052]).

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"In the second quarter, we presented promising new longer-term treatment data from our luspatercept programs. These results further reinforce our excitement about the potential of luspatercept to help patients with myelodysplastic syndromes and beta-thalassemia. We and our collaboration partner, Celgene, look forward to starting pivotal trials in both of these indications by the end of this year," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "At Acceleron, we remain focused on bringing innovative therapies to patients, and we are continuing to advance and expand our earlier stage pipeline as well. We have scheduled our first Research and Development Day for investors on October 23, 2015. At that meeting, we will review our clinical and preclinical programs, including a first look at top-line data from the phase 1 trial with our candidate muscle agent, ACE-083."

Recent Highlights and Current Updates

Development Programs

Hematology

Completed enrollment and treatment in the luspatercept phase 2 dose escalation study in myelodysplastic syndromes (MDS) – Enrollment and treatment ongoing in the phase 2 dose escalation beta-thalassemia study.

Long-term phase 2 extension studies ongoing with luspatercept in both MDS and beta-thalassemia – Patients who completed their 3-month treatment in the MDS or beta-thalassemia dose escalation studies were eligible to enroll in the 12-month MDS or beta-thalassemia extension study. Enrollment in the MDS extension study is complete and enrollment in the beta-thalassemia extension study is ongoing.

Presented luspatercept phase 2 data supporting the advancement to phase 3 clinical trials at the European Hematology Association (EHA) (Free EHA Whitepaper)’s annual meeting – In lower risk MDS patients, which represent a large majority of patients affected by the disease, longer-term treatment with luspatercept led to sustained increases in hemoglobin levels and transfusion independence. In both transfusion and non-transfusion dependent beta-thalassemia patients, luspatercept generated durable increases in hemoglobin levels, reductions in transfusion burden and improvements in iron overload. Based on these promising data, Acceleron and Celgene are advancing luspatercept to phase 3 clinical trials in MDS and beta-thalassemia.

Luspatercept granted Fast Track designations for beta-thalassemia – The United States Food and Drug Administration (FDA) has granted Fast Track Designations to luspatercept for two separate indications—the use of luspatercept for the treatment of patients with transfusion dependent beta-thalassemia and the use of luspatercept for the treatment of patients with non-transfusion dependent beta-thalassemia.

Oncology

Presented preliminary renal cell carcinoma (RCC) phase 2 data showing that the combination of dalantercept and axitinib generated encouraging, progression-free survival – In 2nd through 4th line RCC patients, the aggregate median progression-free survival (PFS) rate for the combination of dalantercept and axitinib across all three dose levels of dalantercept tested was 8.3 months. The median PFS has not yet been reached for the 0.9 mg/kg dose group, which has been chosen as the dose level for the randomized Part 2 stage of this study.

Muscle Diseases

Completed enrollment and treatment in ACE-083 phase 1 clinical trial – The phase 1 study of ACE-083, a therapeutic candidate designed to selectively increase muscle mass and strength in the muscle into which it is administered, has completed enrollment and treatment in healthy volunteers.
Advanced and expanded pipeline – Acceleron is advancing several promising preclinical programs, particularly those designed to increase muscle mass and strength. Our goal is to advance a fifth, internally discovered therapeutic candidate into clinical trials by the end of 2016.

Upcoming Milestones and Events

Phase 3 clinical trials with luspatercept in MDS and beta-thalassemia expected to start by year-end – Acceleron and Celgene plan to initiate pivotal programs for luspatercept in beta-thalassemia and MDS by year-end.

Acceleron Research and Development (R&D) Day scheduled for Friday October 23, 2015 – Acceleron will hold its first R&D Day on Friday morning, October 23, 2015 in New York City.

ACE-083 phase 1 clinical data – Preliminary, top-line data from the ACE-083 phase 1 clinical trial will be presented at the Acceleron R&D Day on October 23.

Data from a new preclinical muscle program expected to be presented at the World Muscle Society annual meeting – Acceleron plans to present data from a new preclinical program, ACE-2494, at the World Muscle Society’s 20th International Congress in Brighton, UK, which runs from September 30 to October 4, 2015.

Financial Results

Cash Position – Cash, cash equivalents and investments as of June 30, 2015 were $156.6 million. As of December 31, 2014 the company had cash and cash equivalents of $176.5 million. Acceleron expects that its cash, cash equivalents and investments as of June 30, 2015 will be sufficient to fund the Company’s operations into the second half of 2017.

On August 6, 2015 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive metastatic breast cancer, reported its financial results for the second quarter ended June 30, 2015, and provided recent corporate highlights (Filing, 8-K, Radius, AUG 6, 2015, View Source [SID:1234507051]). As of June 30, 2015, Radius had $224.0 million in cash, cash equivalents and marketable securities, and on July 28, 2015, raised approximately $323.8 million of net proceeds in a follow-on public offering of its common stock.

"Radius has achieved a number of significant milestones in the second quarter of 2015, including announcing positive top-line data from the first six months of the ACTIVExtend trial, and adding to the talent of our management team and Board of Directors," said Robert Ward, President and Chief Executive Officer of Radius Health. "This progress as well as the success of our recent follow-on public offering positions us well to execute on our top priorities; submit an MAA and NDA by the end of this year for the investigational drug abaloparatide-SC, continue our partnering discussions as part of our preparation for the potential commercial launch of abaloparatide-SC, and to advance the development of RAD 1901 in multiple indications."

Recent Corporate Highlights

Follow On Public Offering

On July 28, 2015, Radius completed a public offering whereby it sold 4,054,054 shares of common stock at a public offering price of $74.00 per share, for aggregate proceeds, net of underwriting discounts, commissions, and estimated offering costs, of approximately $281.5 million. The underwriters purchased an additional 608,108 shares by exercising their option to purchase additional shares granted to them in connection with the offering. As a result of the public offering and exercise of the underwriters’ option to purchase additional shares, Radius received aggregate proceeds, net of underwriting discounts, commissions, and estimated offering costs of approximately $323.8 million. Radius plans to use these additional funds to expand the development of RAD1901 for potential use in metastatic breast cancer in combination with other approved therapies, to fund the continued development of the optimized abaloparatide transdermal patch and related manufacturing capabilities, and to continue to build the commercial infrastructure, inventory and manufacturing capabilities necessary for commercialization of abaloparatide-SC following regulatory approval.

Abaloparatide-SC

On July 14, 2015, we announced that four abaloparatide abstracts will be presented at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting, October 9-12, 2015. Dr. Felicia Cosman will make an Oral Plenary presentation titled "Eighteen Months of Treatment with Abaloparatide Followed by Six Months of Treatment with Alendronate in Postmenopausal Women with Osteoporosis – Results of the ACTIVExtend Trial". Dr. Cosman is a Professor of Clinical Medicine at Columbia University in New York and also serves as a Clinical Director at the National Osteoporosis Foundation. Dr. Lorraine Fitzpatrick will make an oral presentation titled "Effects of Abaloparatide on Major Osteoporotic Fracture Incidence in Postmenopausal Women with Osteoporosis – Results of the Phase 3 ACTIVE Trial". Dr. Fitzpatrick recently joined Radius where she holds the position of Chief Medical Officer. Additional posters on the results from the abaloparatide-SC responder analysis and transdermal development programs will be presented.

In June 2015, we announced new data from our ACTIVE trial, as well as the top-line data from the first six months of ACTIVExtend, the 24-month extension trial of the Phase 3 ACTIVE trial in which patients from the abaloparatide-SC and placebo groups of the ACTIVE trial received an approved alendronate therapy for osteoporosis management. The results from the ACTIVExtend study showed that the group previously treated with abaloparatide had no new vertebral fractures during the first six months of receiving alendronate. From the start of the ACTIVE study, this group showed a statistically significant 87% reduction in new vertebral fractures (p<0.0001), a 52% reduction in non-vertebral fractures (p=0.0168), a 48% reduction in clinical fractures (p=0.0139), and a 58% reduction in major osteoporotic fractures (p=0.0122) over the 25-month period, as compared to placebo. This group also achieved a 12.8% increase in BMD at the lumbar spine, a 5.5% increase in BMD at total hip, and a 4.5% increase in BMD at the femoral neck. In addition, 20.4% of patients achieved a 6% increase or greater in BMD at all three sites (i.e., lumbar spine, total hip and femoral neck).

A recent exploratory analysis of the ACTIVE trial showed that, for major osteoporotic fractures, there was a statistically significant 67% reduction in major osteoporotic fractures (p=0.0014) for the abaloparatide treatment group versus placebo, and a statistically significant 53% reduction in major osteoporotic fractures (p=0.0437) for the abaloparatide treatment group as compared to teriparatide over the 18-month period.

The results from the ACTIVE trial and the first six months of the ACTIVExtend trial will form the basis of Radius’ planned submission of a marketing authorization application ("MAA") to the European Medicines Agency ("EMA") and of a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA"), by the end of 2015.

During the second quarter, Radius continued the non-human primate pharmacokinetic studies of the investigational drug abaloparatide-TD, a short wear time transdermal patch form of abaloparatide. In December 2014, Radius reported that a prototype achieved a desirable pharmacokinetic profile, with comparable AUC, Cmax, Tmax and T1/2 relative to abaloparatide-SC.

RAD1901

Radius is continuing to enroll and dose patients in the United States in its Phase 1 clinical trial of the investigational drug RAD1901 for potential use in the treatment of metastatic breast cancer. The Phase 1 study is a multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer that is designed to determine the recommended dose for a Phase 2 clinical trial and includes a preliminary evaluation of the potential anti-tumor effect of RAD1901. Radius expects to report further progress on this study in the second half of 2015. Radius plans to commence Phase 1 clinical development in metastatic breast cancer patients in the European Union in 2015.

On July 15, 2015, Radius announced that early but promising preclinical data show that its investigational drug RAD1901, in combination with Pfizer’s palbociclib, a CDK4/6 inhibitor, or Novartis’ everolimus, an mTOR inhibitor, was effective in shrinking tumors. In patient-derived xenograft (PDx) breast cancer models with either wild type or mutant ESR1, treatment with RAD1901 resulted in marked tumor growth inhibition, and the combination of RAD1901 with either agent, palbociclib or everolimus, showed anti-tumor activity that was significantly greater than either agent alone.

Radius Expects the Following Upcoming Milestones

· Abaloparatide-SC

· Three abstract presentations at American Society of Bone Mineral Research (ASBMR) October 9-12, 2015, in Seattle, Washington.

· Submit an MAA and NDA for abaloparatide-SC by the end of 2015.

· Abaloparatide-TD

· Poster presentation at ASBMR titled "Optimization of the Pharmacokinetic Profile in Cynomologus Monkeys".

· Commence the clinical evaluation of the optimized abaloparatide-TD patch in the second half of 2015.

· RAD1901

· Commence Phase 1 clinical development in the European Union for RAD1901 in metastatic breast cancer patients in 2015.

· Commence a Phase 2b clinical trial for low-dose RAD1901 as a selective estrogen receptor modulator (SERM) for the potential treatment of vasomotor symptoms in the second half of 2015.

Radius Expects To Make Presentations At The Following Upcoming Conferences:

· Canaccord Genuity Growth Conference, August 12-13, 2015, InterContinental in Boston, MA.

· Multiple oral and poster presentations at the American Society for Bone and Mineral Research 2015 Annual Meeting, October 9-12, 2015, Seattle, WA, including an oral presentation at the Plenary Session of the 25-month ACTIVE and ACTIVExtend trial data.

· San Antonio Breast Cancer Symposium, December 8-12, 2015, San Antonio, Texas.

Recent Corporate Highlights

· On August 4, 2015, Radius paid all amounts owed under its Loan and Security Agreement with Solar Capital Ltd. and Oxford Finance LLC. After consideration of relevant fees required under the Loan and Security Agreement, the total payment amounted to approximately $26.5 million.

· On July 28, 2015, Radius completed a public offering of 4,662,162 shares of common stock at a public offering price of $74.00 per share, raising aggregate proceeds, net of underwriting discounts, commissions and estimated offering costs, of approximately $323.8 million.

· On July 27, 2015, Radius announced that it hired Dr. Lorraine A. Fitzpatrick as Chief Medical Officer of Radius. Dr. Fitzpatrick was previously Medicine Development Leader at GlaxoSmithKline of an international clinical development team for denosumab responsible for clinical development, regulatory, manufacturing, commercial operations epidemiology, and global health outcomes. Previously, Dr. Fitzpatrick led the clinical development of novel agents to treat musculoskeletal diseases and women’s health at GlaxoSmithKline. Before joining GlaxoSmithKline, Dr. Fitzpatrick was Executive Director at Amgen, where she worked in the fields of osteoporosis and oncology.

· On July 20, 2015, Radius announced that Debasish Roychowdhury, M.D., who previously served as Seragon’s Acting Chief Medical Officer, was elected to the Company’s Board of Directors. Dr. Roychowdhury is a leader in the pharmaceutical industry with a strong background in oncology research and development, and regulatory and commercial operations, having previously served in key senior leadership roles at Sanofi, GlaxoSmithKline and Eli Lilly. Dr. Roychowdhury played a key role in the development and advancement of Seragon’s selective estrogen receptor degraders (SERDs) platform for breast cancer and other hormone-driven cancers.

· On July 20, 2015, Radius announced that it has formed an Oncology Clinical Advisory Board (OCAB). The board is currently comprised of renowned leaders in the field of oncology: Professor Mitch Dowsett, FMedSci, Ph.D., Head of the Academic Department of Biochemistry and Head of the Centre for Molecular Pathology at the Royal Marsden Hospital in London, UK; Dr. George W. Sledge Jr., Professor and Chief of Medical Oncology at Stanford University Medical Center; and Martine Piccart, M.D., Ph.D., Professor of Oncology at the Université Libre de Bruxelles, Director of Medicine and Head of Chemotherapy at the Institut Jules Bordet in Brussels, Belgium, and President of the European Organisation for Research and Treatment of Cancer (EORTC).

· On July 15, 2015, Radius announced that early but promising preclinical data showed that its investigational drug RAD1901, in combination with Pfizer’s palbociclib, a CDK4/6 inhibitor, or Novartis’ everolimus, an mTOR inhibitor, was effective in shrinking tumors. In patient-derived xenograft (PDx) breast cancer models with either wild type or mutant ESR1, treatment with RAD1901 resulted in marked tumor growth inhibition, and the combination of RAD1901 with either agent, palbociclib or everolimus, showed anti-tumor activity that was significantly greater than either agent alone.

· On June 17, 2015, Radius announced top line data from the first six months of ACTIVExtend and the 25-month combined data from ACTIVE and ACTIVExtend clinical trials, as well as new data from an exploratory analysis of major osteoporotic fractures in the ACTIVE trial.

· On June 1, 2015, Radius announced that it engaged Myrtle Potter & Company, LLC to support the development of the future global commercial strategy for its lead investigational drug abaloparatide-SC for the potential treatment of post-menopausal osteoporosis.

Second Quarter 2015 Financial Results

For the three months ended June 30, 2015, Radius reported a net loss of $23.0 million, or $0.61 per share, as compared to a net loss of $12.6 million, or $2.22 per share for the three months ended June 30, 2014. The net loss per share calculation for the three months ended June 30, 2015 includes the impact of the conversion of Radius’ convertible preferred stock into common stock upon the completion of its initial public offering in June 2014. The increase in net loss for the three months ended June 30, 2015 as compared to the three months ended June 30, 2014 was primarily due to an increase in research and development and general and administrative expenses, which were partially offset by a decrease in other (expense) income, net.

Research and development expenses for the three months ended June 30, 2015 were $16.3 million, compared to $10.6 million for the same period in 2014. The increase for the 2015 period as compared to the 2014 period was primarily attributable to an increase in compensation costs, including non-cash stock-based compensation costs, due to an increase in our research and development headcount and an increase in stock-based compensation expense for non-employees due to the significant increase in the Radius stock price. This increase was also driven by an increase in consulting costs incurred to support Radius’ NDA submission for abaloparatide-SC and an increase in contract service costs associated with the development of RAD1901. These increases were partially offset by a decrease in the costs associated with the abaloparatide-SC Phase 3 ACTIVE clinical trial.

General and administrative expenses for the three months ended June 30, 2015 were $6.0 million, compared to $3.1 million for the same period in 2014. The increase for the 2015 period as compared to the 2014 period was primarily attributable to an increase in professional support costs and legal fees, including the costs associated with growing Radius’ headcount and preparing for the potential commercialization of abaloparatide-SC, subject to a favorable regulatory review. This increase can also be attributed to higher compensation costs, including non-cash stock-based compensation expense, due to an overall increase in employee headcount.

For the three months ended June 30, 2015, other expense, net of income was $(78) thousand, as compared to other income, net of expense $1.7 million for the same period in 2014. Other (expense) income, net, for the 2014 period reflected changes in the fair value of Radius’ stock liability and other liability.

As of June 30, 2015, Radius had $224.0 million in cash, cash equivalents and marketable securities. Based upon Radius’ cash, cash equivalents and marketable securities balance following the public offering of shares of its common stock in July 2015, Radius believes that, prior to the consideration of revenue from the potential future sales of any of its investigational products, it has sufficient capital to fund its development plans, U.S. commercial scale-up and other operational activities into 2018.

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On August 6, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), reported its results of operations and financial condition for the second quarter ended June 30, 2015 (Filing, 8-K, Provectus Pharmaceuticals, AUG 6, 2015, View Source [SID:1234507050]).

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Provectus will also hold its quarterly business update conference call at 4 p.m. (EDT) today to provide a business update on PV-10 and PH-10 to the investment community and answer questions from investors.

Those who wish to participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337, approximately 15 minutes before the call. A webcast will also be available at: www.pvct.com.
A digital replay will be available by telephone approximately two hours after the completion of the call until September 30, 2015 and may be accessed by dialing 877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID#13614501.

Second Quarter Financial Results and Balance Sheet Highlights

The Company’s cash and cash equivalents were $23,117,144 at June 30, 2015, compared with $17,391,601 at December 31, 2014.

Therefore, the Company’s ability to continue as a going concern is reasonably assured due to its cash and cash equivalents on hand at June 30, 2015. Given the Company’s current rate of expenditures and its ability to curtail or defer certain controllable expenditures, the Company has sufficient cash on hand to last well into 2017.

Stockholders’ equity at June 30, 2015, was $30,246,789. This compares to stockholders’ equity at December 31, 2014, of $25,189,876.

For additional information regarding Provectus’ results of operations and financial condition for the second quarter ended June 30, 2015, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2015.