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8-K – Current report

On August 19, 2015 Immunomedics, Inc. (Nasdaq:IMMU) reported financial results for the fourth quarter and fiscal year ended June 30, 2015 (Filing, 8-K, Immunomedics, AUG 19, 2015, View Source [SID:1234507297]). The Company also highlighted recent key developments and planned activities for its clinical pipeline.

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Fourth Quarter Fiscal 2015 Results

Total revenues for the fourth quarter of fiscal year 2015, which ended on June 30, 2015, were $2.4 million as compared to total revenues of $1.2 million for the same quarter last fiscal year. The increase of $1.2 million in total revenues this quarter was primarily due to a $1.0 million license fee revenue earned upon reaching a clinical milestone in the Company’s Collaboration Agreement, as amended, with Bayer (formerly Algeta ASA). There was no license fee revenue recorded in the same quarter last fiscal year.

Total costs and expenses for the current quarter were $13.6 million, as compared to $13.1 million for the same period in 2014, representing an increase of $0.5 million, or 4%. This increase was driven primarily by $1.1 million higher research and development expenses from increased clinical trial cost for the Phase 3 PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan for the therapy of patients with advanced pancreatic cancer, and increased product development and manufacturing expenses related to the expansion of clinical studies for the two antibody-drug conjugate (ADC) programs. The increase in research and development expenses was partially offset by $0.4 million decreased general and administrative costs mainly from reduced legal and professional fees.

Interest expense this quarter related to the 4.75% Convertible Senior Notes was $1.4 million, including the amortization of $0.2 million debt issuance costs. There was no interest expense for the same quarter last fiscal year.

Net loss attributable to our stockholders this quarter was $12.4 million, or $0.13 per basic share, compared with a net loss attributable to our stockholders of $11.8 million, or $0.13 per basic share for the same quarter in fiscal 2014. The increase in net loss this quarter was primarily due to the increase in research and development expenses and interest expense, partially offset by the decrease in legal and professional fees, as described above.

Fiscal Year 2015 Results

Total revenues for fiscal year 2015 were $5.7 million as compared to $9.0 million for fiscal year 2014, representing a decrease of $3.3 million or 37%. The decrease in total revenues this fiscal year primarily resulted from $4.6 million of license fee revenue earned from the Bayer Collaboration Agreement during fiscal 2014, which was partially offset by the Agreement’s $1.0 million clinical milestone payment in fiscal year 2015.

Total costs and expenses for the fiscal year ended June 30, 2015 were $51.9 million, as compared to $44.6 million for fiscal 2014, representing an increase of $7.3 million, or 16%. This increase was driven primarily by $8.0 million higher research and development expenses from the continuing efforts of the Phase 3 PANCRIT-1 clinical trial in pancreatic cancer and increased clinical trial expenses and manufacturing costs for the ADCs’ clinical studies, as well as a $0.9 million increase in legal and professional fees, principally from the arbitration proceedings with Takeda-Nycomed. The increase in cost and expenses this fiscal year was partially offset by the prior year’s $1.2 million of cost from the recognition of manufacturing costs related to the Bayer Agreement, which did not recur in the current year.

Interest expense this fiscal year for the Convertible Senior Notes due 2020 was $2.1 million, including the amortization of $0.3 million debt issuance costs. There was no interest expense last fiscal year.

Net loss attributable to our stockholders for the fiscal year ended June 30, 2015 was $48.0 million, or $0.51 per basic share, as compared to net loss attributable to our stockholders of $35.4 million, or $0.42 per basic share, in fiscal year 2014. The increase in net loss of $12.6 million this fiscal year was primarily due to increased research and development costs attributable to clinical trials, increased legal and professional fees, interest expense, and lower license fee revenue from Bayer.

As of June 30, 2015, cash, cash equivalents, and marketable securities totaled $99.6 million.

"We are pleased to have a strong balance sheet to support the development of our clinical pipeline," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "To that end, cash requirements in fiscal year 2016 are expected to be in the range of $52 to $54 million, which include the production of sacituzumab govitecan for a Phase 3 registration trial in metastatic triple-negative breast cancer anticipated in calendar year 2016, the ongoing PANCRIT-1 trial, and interest on the convertible notes," Mr. Pfreundschuh added.

The Company’s key clinical developments and future planned activities:

Epratuzumab

In July 2015, UCB announced that the two Phase 3 EMBODY clinical trials for epratuzumab in systemic lupus erythematosus did not meet the primary clinical efficacy endpoints in either dose in both studies. Treatment response in patients who received epratuzumab in addition to standard therapy was not statistically significant when compared to those who received placebo in addition to standard therapy. UCB is in the process of analyzing the full set of data from both studies. A high level review of the safety data did not identify any new safety concerns.
Sacituzumab Govitecan (IMMU-132)

Interim Phase 2 results with sacituzumab govitecan in patients with advanced, metastatic lung cancers will be reported in an oral presentation on Monday, September 7, 2015 at the 16th World Conference on Lung Cancer to be held in Denver, CO.

At the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO meeting"), updated results from a Phase 2 study of sacituzumab govitecan in patients with metastatic triple-negative breast cancer were presented. Among the 49 patients evaluated for response, 31%, or 15 patients, showed a reduction in tumor size of 30% or more. They included 2 patients with complete response. For the 48 responding patients who received the optimal doses of 8 or 10 mg/kg, the interim median progression-free survival, ("PFS"), was 6.0 months. The median prior cancer therapies for this group of patients was 4 (range, 1-11). (For more information on the updated results, please refer to the Company’s press release at View Source).

Sacituzumab govitecan also produced promising anti-tumor activity with durable responses in patients with metastatic lung cancer. For the 25 patients who responded to the ADC with either a 30% or more tumor shrinkage or stable disease, all 11 patients with small-cell lung cancer and 12 of 14 patients with non-small-cell lung cancer, or 86%, had a time to progression that was longer than their last therapy. These patients had previously failed a median of 2.5 (range, 1-7) and 3 (range, 1-8) cancer treatments, respectively. (View Source).

Also reported at the same ASCO (Free ASCO Whitepaper) meeting were results in patients with heavily-pretreated, metastatic gastrointestinal cancers. Even in this late-stage setting, a majority of patients, 57%, responded to sacituzumab govitecan with partial responses and durable stable disease, including 2 esophageal cancer patients and 1 colorectal cancer patient with a partial response. (View Source).
Labetuzumab Govitecan (IMMU-130)

Interim results from a Phase 2 study of labetuzumab govitecan in patients previously treated with at least one prior irinotecan-containing regimen for their metastatic colorectal cancer were reported in an oral presentation at the 2015 ASCO (Free ASCO Whitepaper) meeting. For the 33 patients who received the ADC once a week at the 8 or 10 mg/kg dose levels, the interim median PFS was 4.4 months, with 22% of these patients still benefiting from their cancer not progressing. In 32 patients with at least one response assessment following treatments, the disease control rate of 78%, with 1 partial response and 24 patients reporting stable disease as their best response. (View Source).
Clivatuzumab Tetraxetan

Final results from a Phase 1b study of yttrium-90-labeled clivatuzumab tetraxetan with or without low-dose gemcitabine in patients with metastatic pancreatic cancer after two or more prior therapies have been published online in the European Journal of Cancer. (View Source(15)00645-0/fulltext).
Veltuzumab

The Office of Orphan Products Development of the U.S. Food and Drug Administration has granted orphan status for the use of veltuzumab for the treatment of immune thrombocytopenia.

SignalRx Pharmaceuticals Inc. Announces First Pediatric Cancer Patient Treated with the PI-3 Kinase Inhibitor SF1126

On August 19, 2015 SignalRx Pharmaceuticals Inc., focused on developing more effective oncology drugs through molecular design imparting selective multiple target inhibition, reported that the first pediatric cancer patient has been dosed with the "first-in-pediatric-class" PI-3 kinase (PI3K) inhibitor SF1126 (Press release, SignalRx, AUG 19, 2015, http://www.ireachcontent.com/news-releases/signalrx-pharmaceuticals-inc-announces-first-pediatric-cancer-patient-treated-with-the-pi-3-kinase-inhibitor-sf1126-522259401.html [SID1234527328]). This represents a breakthrough for our strategy to leverage the novel anticancer agent SF1126, successfully evaluated in adult Phase I clinical trials, into helping children with cancer in an area of great unmet need: pediatric cancer treatment.

SF1126 is the first drug of its kind used to treat a child with cancer. The drug has been reported to have no dose limiting toxicity in adult cancer patient trials and was well tolerated with significant clinical benefit. The first pediatric patient to receive SF1126 was previously diagnosed with neuroblastoma and showed no side effects after their first treatment with SF1126. This agent holds a great potential to have a significant impact on the treatment of pediatric cancers in the future. We are excited to report this new pediatric cancer development in the clinic and the promise SF1126 brings to help kids with cancer.

The clinical evaluation of SF1126 in pediatric patients with neuroblastoma is being performed as part of the New Approaches to Neuroblastoma Therapy Consortium (NANT) Study, funded by the St. Balderick’s Foundation and the National Institutes of Health (NIH). SF1126 is a "first-in-pediatric class" targeted anticancer therapeutic agent being developed by SignalRx in collaboration with Donald L. Durden, MD PhD, at the UCSD/Moores Cancer Center and Rady Children’s Hospital.

SF1126 was designed to inhibit PI3K, a proven central nodal element in cancer cells. SF1126 has a unique inhibition profile that also includes the inhibition of the epigenetic reader bromodomain protein BRD4, a protein responsible for the transcription of the oncogene MYC. Since PI3K inhibition has also been shown to enhance degradation of MYC, our dual PI3K/BRD4 inhibitor SF1126 represents a unique approach in cancer treatment to block multiple synergistic pathways important to many cancers. "By benefit of this dual inhibition maximally blocking MYC, SF1126 may be most effective in patients whose cancers are highly dependent on cMYC or MYCN such as in certain neuroblastoma patients. SignalRx Pharmaceuticals is dedicated to bringing new dual targeted therapies, like SF1126, into pediatric oncology trials" said Dr. Durden.

United Therapeutics Corporation Agrees to Sell Priority Review Voucher to AbbVie for $350 Million

On August 19, 2015 United Therapeutics Corporation (NASDAQ: UTHR) reported that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of AbbVie Inc. (NYSE: ABBV) (Press release, United Therapeutics, AUG 19, 2015, View Source [SID:1234507296]). United Therapeutics received the PPRV when Unituxin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of neuroblastoma, a rare pediatric disease.

Upon closing of the transaction, United Therapeutics will receive $350 million in cash in exchange for the PPRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

"We are very pleased to monetize our PPRV, and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases," said Roger Jeffs, Ph.D., United Therapeutics’ President and Co-CEO.

The transaction is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

About the Rare Pediatric Disease Priority Review Voucher Program

The program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PPRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PPRV upon approval of the rare pediatric disease product application and it can be sold without limitation.

Pfizer, Provectus Biopharmaceuticals Awarded US Patent Protecting Use of PV-10 as Part of Combination Therapy for Cancer

On August 18, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus"), reported that it has received a patent from the US Patent and Trademark Office, U.S. Patent number 9,107,887 (Press release, Provectus Pharmaceuticals, AUG 18, 2015, http://www.pvct.com/pressrelease.html?article=20150818.1 [SID:1234507294]). The patent protects the use of PV-10 in combination with certain other types of drugs in the treatment of melanoma and cancers of the liver.

Specifically, the patent covers the use of PV-10 in combination with systemic inhibitors of immune system down-regulation, such as anti-CTLA-4, PD-1 and PD-L1 antibodies, along with enhancers of immune system up-regulation, such as IL-2 and interferon-gamma. Pre-clinical testing of PV-10 used in combination with these important classes of drugs demonstrated potential importance for treatment of advanced cancers.

Provectus believes that the intellectual property covered by the patent will aid it in realizing financial rewards if clinical research demonstrates that PV-10 used in combination with one or more of these classes of drugs improves patient outcomes.

Dr. Eric Wachter, CTO of Provectus, said, "This is a significant milestone in the development of PV-10 as an anti-cancer agent, and builds on our research into PV-10 used on its own. Medical science and our own preliminary studies suggest that it may benefit patients when used in conjunction with these other drugs."

Peter Culpepper, CFO and COO of Provectus, noted, as just one example, a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) [SITC] 29th Annual Meeting in November 2014. The poster, presented by Dr. Shari Pilon-Thomas of the Moffitt Cancer Center, titled "Efficacy of Intralesional Injection with PV-10 in Combination with Co-Inhibitory Blockade in a Murine Model of Melanoma," showed that combination of PV-10 with anti-CTLA-4, PD-1 and PD-L1 antibodies led to improved tumor response and enhanced anti-tumor immunity of T-cells.

Pfizer Inc. is a joint owner of the patent.

Study Suggests Non-Invasive Stereotactic Body Radiation Therapy Is Feasible For Treating Large Non-Small Cell Lung Cancer Tumors

On August 18, 2015 Varian Medical Systems reported that non-invasive stereotactic body radiation therapy (SBRT), which precisely delivers a high-dose beam of radiation to target tumors while minimizing dose to the surrounding healthy tissue, is effective and well-tolerated by patients with inoperable non-small cell lung cancer (NSCLC) tumors that are larger than 5 cm but had not spread from the lung to the lymph nodes or outside of the chest (i.e. "early stage" or "node negative"), according to a study published in the International Journal of Radiation Oncology Biology Physics (Press release, InfiMed, AUG 18, 2015, View Source [SID:1234507292]).1

The study involved the use of SBRT for the treatment of frail patients with large inoperable lung tumors and without lymph node involvement. SBRT, which makes it possible to complete treatments in fewer sessions than conventional radiation therapy, has not typically been used to treat large tumors. Results from SBRT were compared with literature on outcomes from conventional lung surgery. The research suggests that non-invasive SBRT may be a viable treatment alternative to conventional surgery for some patients with larger lung tumors.

"Our study shows that lung SBRT can be used to safely treat localized node-negative inoperable NSCLC tumors larger than 5 cm, with low rates of recurrence at the primary tumor site and with minimal side effects," said Gregory M. M. Videtic, MD, CM, FRCP, from the Department of Radiation Oncology at the Cleveland Clinic Taussig Cancer Institute, and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.

Prior to the emergence of lung SBRT, frail medically compromised patients with node-negative inoperable NSCLC were often treated with external beam radiation therapy which delivers lower doses over a higher number of treatment sessions. However, these patients often experienced a high rate of disease recurrence along with significant side effects. Lung SBRT has become routine for treating small NSCLC tumors, typically less than 3 cm, because of its high rate of local control and limited toxicity. The research by Dr. Videtic and his colleagues is one of the few studies on the use of lung SBRT in larger tumors.

In their retrospective study, Dr. Videtic and his team evaluated the outcomes of 40 patients with node-negative medically inoperable NSCLC whose primary tumors were greater than 5 cm and who were treated with SBRT between December 2003 and June 2014.

The study reviewed patients’ outcomes at 18 months after treatment. Local control, which means there was no evidence of disease at the original tumor site, was achieved in 91.2 percent of the cases. The percentage of patients who experienced distant failure where cancer had spread to other parts of the body was 32.5 percent. When these results were compared to published surgical studies, lung SBRT appeared to have similar rates of local control and similar rates of distant failure.

Disease-free survival in patients who had no lung cancer present at 18 months after treatment was 34.6 percent. The overall survival rate at 18 months, including disease-free patients and those who still had evidence of lung cancer, was 59.7 percent. "The overall survival rates are lower in medically inoperable patients receiving lung SBRT compared to operable surgical patients," said Dr. Videtic. "However, the lower survival rate in medically inoperable patients may be due to the presence of other non-cancer related conditions, such as chronic obstructive pulmonary disease, commonly found in inoperable patients."

The percentage of SBRT patients who were free of side effects was 70.5 percent. Side effects observed from SBRT included mild chest wall pain and modest inflammation in lung tissue. In two severe cases, patients experienced excessive fluid build-up in the lung and a lung collapse due to inflammation that blocked the airways.

The research team concluded: "Lung SBRT for medically inoperable node negative NSCLC tumors larger than 5 cm provides excellent local control with limited toxicity. With appropriate patient selection, SBRT is safe and efficacious for larger tumors."

"While this is a retrospective study that included only a fairly small number of patients who were followed for less than two years, the results look promising and certainly warrant additional investigation," said Dee Khuntia, Varian’s vice president for medical affairs.