On December 8, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported financial results for the fiscal first quarter 2017 (Press release, OncoSec Medical, DEC 8, 2016, View Source [SID1234517020]).

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"We are delivering on our commitment to address an unmet medical need in melanoma with ImmunoPulse IL-12. We are pleased with the early clinical response data presented from the melanoma combination trial, and we are focused on advancing our lead program – ImmunoPulse IL-12 – in anti-PD-1 non-responder advanced melanoma patients. Based on our current cash runway, we are positioned to meet our value-driving clinical and regulatory milestones into calendar 2018 and have a clear strategy to expand our therapeutic platform," noted Punit Dhillon, OncoSec President and Chief Executive Officer. "Our primary focus for the next year is to initiate a melanoma registration-directed clinical study. We believe we will generate meaningful data in 2017 and 2018 to support the discussions with the FDA and a future biologics license application (BLA) to attract a partner, who is ready to advance this innovative therapy."

FINANCIAL RESULTS
For the first quarter of fiscal 2017, OncoSec reported a net loss of $5.6 million or $0.29 per share, compared to a net loss of $7.0 million, or $0.47 per share for the same period last year. The decrease in net loss for the quarter ended October 31, 2016, compared with the same period in fiscal 2016, resulted primarily from (i) the completion of the melanoma monotherapy extension clinical trial, (ii) decreased engineering and lab supplies costs due to the completion of next-generation electroporation prototypes, (iii) decreased outside service fees due to leveraging in-house capabilities, and (iv) decreased stock-based compensation expense. There were no revenues for the quarter ended October 31, 2016 or October 31, 2015.

Research and development expenses were $3.1 million for the first quarter of fiscal 2017, compared to $3.7 million for the same period in fiscal 2016. General and administrative expenses were $2.5 million for the first quarter of fiscal 2017, compared to $3.4 million for the same period in fiscal 2016.

At October 31, 2016, OncoSec had $24.4 million in cash and cash equivalents, as compared to $28.7 million of cash and cash equivalents at July 31, 2016. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.

On December 8, 2016 Enzo Biochem, Inc. (NYSE: ENZ) reported strong operating results for the first fiscal quarter ended October 31, 2016, with significant operating profit achieved at Enzo Clinical Labs (Filing, Q1, Enzo Biochem, 2016, DEC 8, 2016, View Source [SID1234517012]).

Quarterly Highlights

· Consolidated revenues grew 4% and Clinical Labs revenue grew 9% over the prior year period as a result of demand for high margin molecular diagnostic services.
· Gross margin at Clinical Labs increased 100 basis points to 41% and consolidated gross margins increased to 46%.
· Non-GAAP net loss and Non-GAAP EBITDA registered steady quarterly progress, improving 35% and 53%, respectively, year-over-year. Both Clinical Labs and Life Science units remained profitable, in addition to generating positive cash flow.
· Balance sheet remains strong with cash and cash equivalents and working capital exceeding $67 million and $69 million, respectively. Remaining bank debt was eliminated following quarter’s end.
· Also post-quarter, federal court in Delaware set firm trial target dates for next year on three patent infringement cases.

Barry Weiner, President, Comments

"The year has gotten off to a good start, and we expect to see the year progress nicely as we continue to complete development and file for approval of additional proprietary low cost, high performance molecular diagnostic products designed to capitalize on reimbursement pressures facing diagnostic labs. Our strategic focus is paying off, notably at the Clinical Labs, where our molecular diagnostics services are increasing and our extensive and growing women’s health diagnostic services is experiencing increased usage. As we add to our product line-up in this field, we are providing cost savings that can ensue from our growing line of high performing competitive cost products. We are increasing marketing efforts to we expand into the national market."

"Meanwhile, we are operating at a highly efficient level, as underscored by steady improvement in gross margins as the Company moves to sustained profitability. We are holding expenses flat overall, while increasing our sales and marketing and development efforts. Life Sciences continues to see delayed orders and currency fluctuations that impact quarterly product revenues, however, it remains focused on developing medically relevant products that are of the highest quality and easily adaptable to market needs. For example, we recently introduced our PolyView Plus line of pathology-based detection systems which has been shown in a peer-reviewed publication to provide improved results to the marketplace. Furthermore, our product pipeline continues to be robust. We will shortly introduce extensions to our human papillomavirus (HPV) product line, providing our customers additional optionality. We also continue to progress on development of a comprehensive suite of women’s health infectious disease tests based on our AmpiProbe platforms, as well as a biomarker assay for the rapidly growing infertility market. The common thread connecting all of these products is that they are easily adaptable to open laboratory systems, providing our customers with the flexibility to offer such tests while reducing their cost of goods."

"On the legal front, the recent announcement by the federal court in Delaware setting trial dates should help progress the remaining patent infringement cases."

"We are highly encouraged and confident regarding the outlook for our business, and our exceptionally strong and debt free financial position assures us of the ability to move forward toward operational profitability and further growth."

October 2016 First Fiscal Quarter Results

Consolidated revenues increased 4%, to $26.3 million from $25.2 million. Gross profit increased to $12.1 million, or 8%, and gross margin advanced 100 basis points, to 46%. Selling, general and administrative (SG&A) expenses were $11.5 million, an increase of $1.2 million, or 12%, due largely to commissions, bonuses and salaries, along with increased administrative expenses related to the greater molecular diagnostics volume. The provision for uncollectible receivables, reflecting improved collection efforts, continues to decline, falling 5% for the quarter. Legal expenses were sharply lower at $0.4 million compared to $1.6 million, a decline of 77% from a year ago.

The Company reported an operating loss of $1.3 million compared to a year ago operating income of $4.6 million. The prior year period included a licensing and legal settlement of $6.8 million. Net loss amounted to $1.5 million or $0.03 per diluted share, compared to a year ago net income of $4.4 million or $0.10 per diluted share. Adjusted for licensing and legal settlements, the non-GAAP net loss was $1.5 million or $0.03 per diluted share compared to a loss of $2.3 million or $0.05 per diluted share in the prior year, an improvement of $0.8 million, or 35%. EBITDA (earnings before interest, taxes, depreciation and amortization) amounted to a loss of $0.6 million, compared with a positive $5.5 million a year ago (which included the licensing and legal settlement of $6.8 million, as noted above). Non-GAAP EBITDA was a loss of $0.6 million compared to a loss of $1.2 million, an improvement of 53% year over year.

On October 31, 2016, cash and cash equivalents totaled $67.2 million, and working capital was $69.7 million. Consolidated cash flows used in operation was only $334,000 in the current year quarter. With the retirement in December 2016 of our outstanding bank loan, the Company, apart from lease obligations, currently has no outstanding debt.

Segment Analysis

Enzo Clinical Labs continued to benefit from growing demand and new accounts for molecular diagnostics, especially in the women’s health marketplace. Service revenues were $18.6 million, an increase of $1.5 million, or 9%, from the year ago period. Gross profit improved 13%, to $7.7 million, and gross margin increased to 41%, from 40%, helped by an increasing menu of approved, laboratory-developed tests (LDTs) tests. Despite higher SG&A related to sales growth, operating income increased to approximately $1 million, compared to $0.8 million a year ago, a 31% increase.

Enzo Life Sciences reported revenue of $7.7 million compared to $8.1 million from the year ago period. The segment continues to rationalize its product offerings to higher valued items, while focusing on product development and sales and marketing efforts. Gross profit remained flat, at $4.1 million, and gross margin advanced 200 basis points, to 57%. SG&A declined to $2.9 million, or 4%. Operating income amounted to $0.8 million. The year ago period operating income totaled $7.6 million, including the aforementioned $6.8 million legal settlement, net.

Legal Developments

The federal court in Delaware in late November issued orders regarding certain pending patent infringement cases brought by Enzo against various defendants. For the cases involving Gen-Probe/Hologic, Becton Dickinson, and Roche, the court has set summary judgment briefing deadlines, a summary judgment argument hearing, and trial dates in October, November and December 2017. "We are encouraged to have our day in court regarding our claims of infringement, and look forward to presenting our cases, a similar number of which have already been resolved by settlements," said Mr. Weiner.

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On December 8, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology reported the oral presentation of data from a preclinical study evaluating poziotinib in lung cancer by scientists from MD Anderson Cancer Center at the 17th International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer which took place in Vienna, Austria, December 4-7, 2016 (Press release, Spectrum Pharmaceuticals, DEC 8, 2016, View Source [SID1234517006]).

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"We are honored to have an oral presentation on poziotinib presented at the 17th IASLC World Conference," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "These results show that poziotinib may work in a subset of non-small cell lung cancer patients that have exon-20 mutations. Tumors with exon-20 mutations have generally not been responsive to several other EGFR inhibitors. However, due to its smaller size poziotinib is hypothesized to inhibit cell growth of EGFR exon 20 insertions. These early results are very encouraging and have the potential to be a transforming therapy for patients who have little or no options and poor prognosis with median progression free survival of 1.5 months. We are working closely with the team at MD Anderson Cancer Center in expediting this research and evaluating ways of serving the unmet medical need in this area."

Abstract/Oral Presentation #6203: Drug Repurposing to Overcome De Novo Resistance of Non-Traditional EGFR Mutations: Poziotinib inhibits EGFR exon 20 insertion mutations in NSCLC

EGFR exon 20 insertions induce a shift in the structure of cancer cells that prevents binding of many EGFR inhibitors. In vitro, Ba/F3 cells with EGFR exon 20 insertions were screened against several EGFR inhibitors including erlotinib, gefitinib, afatinib, dacomitinib, neratinib, poziotinib, ibrutinib rocilentinib, EGF816, and osimertinib. In Ba/F3 cells with EGFR exon 20 insertions, most of the TKIs failed to inhibit growth of EGFR exon 20 insertions with IC50 values above 100nM. However, poziotinib significantly inhibited cell growth of all EGFR exon 20 insertions tested with an average IC50 value of 2.9nM, as compared to osimertinib and rocilentinib (IC50 values =103nM and 850nM, respectively). In vivo, poziotinib reduced ≥80% of tumor burden in multiple mouse models. Computational modeling suggests that its smaller structure gives poziotinib the potential to overcome the steric hindrance of the drug binding pocket. An investigator sponsored clinical trial testing poziotinib in EGFR exon 20 mutant NSCLC patients is expected to begin enrollment soon.

About Poziotinib

Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Currently, Poziotinib is being investigated by Hanmi in several mid-stage trials in different solid tumor indications including HER2-positive breast cancer. (Phase 2 sponsored by National OncoVenture, a funding initiative by the Korean government’s National Cancer Center).

On December 8, 2016 Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported data from two ongoing Phase 1 studies of RAD1901, an oral selective estrogen receptor degrader (SERD), in patients with estrogen receptor positive (ER+) breast cancer, which were presented this morning at the San Antonio Breast Cancer Symposium 2016 (Press release, Radius, DEC 8, 2016, View Source [SID1234517005]).

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As of the cut-off date of October 7, 2016, 20 patients have been treated in the RAD1901 Phase IB safety expansion cohort at the 400 mg dose. These patients are heavily pretreated ER+, HER2-negative advanced breast cancer patients who have received a median of 3 prior lines of therapy. Of the enrolled patients, 19 out of 20 had measurable disease at baseline and there were two confirmed partial responses by RECIST criteria. Across the Part A dose escalation (n=13) and safety expansion cohort (n=20), 14 patients were on study drug for greater than or equal to 4 months, 5 patients for greater than or equal to 6 months, and 7 patients remained on study drug. RAD1901 was well-tolerated with the most common adverse events being low grade nausea and dyspepsia.

In the ongoing European Phase I RAD1901 FES-PET trial, the first three-patients were enrolled at 400 mg as of the October 7th cut-off date and achieved a reduction in 18F-FES uptake ranging from 79%-91% at day 14 compared to baseline. One patient had a confirmed partial response by RECIST criteria. All three patients remained on study drug with mean duration of treatment of 5.64 cycles. Adverse events reported to date have been grade 1 and 2 and manageable. This study will enroll 5 additional patients in the 400 mg QD cohort followed by 8 patients in the 200 mg QD cohort. No dose limiting toxicities have been reported across any of the studies in the RAD1901 program.

"The single-agent clinical activity and duration of response demonstrated with RAD1901 in the heavily pretreated population may be important in addressing the major challenge of resistance facing patients with ER positive advanced breast cancer," said Dr. Virginia Kaklamani, Professor of Medicine, UT Health Science Center San Antonio, leader of the Breast Cancer Program, Cancer Therapy & Research Center, and investigator on the study.

"An oral, well-tolerated and effective SERD could become an important adjunct in combination therapy for patients and we look forward to the results of additional studies," said Professor George W. Sledge Jr., Professor and Chief of Medical Oncology at Stanford University Medical Center, and member of Radius’ Oncology Clinical Advisory Board.

Dr. Virginia Kaklamani and Dr. George Sledge will participate in a Radius hosted investor meeting and webcast later today to highlight the RAD1901 data presented at SABCS at 8 p.m. CT. The webcast and a replay can be accessed on the company’s website, www.radiuspharm.com.

The posters presented this morning from the RAD1901 clinical development program were:

Abstract Title: A Phase 1 Study of RAD1901, a Novel, Oral, Selective Estrogen Receptor Degrader, for the Treatment of ER-Positive Advanced Breast Cancer, Poster # 1454

Abstract Title: A Phase 1 Study of RAD1901, an Oral Selective Estrogen Receptor Degrader, to Determine Changes in the F-FES Uptake and Tumor Responses in ER-Positive, HER-2-Negative, Advanced Breast Cancer Patients, Poster # 1604

Radius will also present later the following poster later today from the RAD1901 preclinical program:

Abstract Title: RAD1901 Demonstrates Anti-Tumor Activity in Multiple Models of ER-Positive Breast Cancer Treatment Resistance, Poster # 1378
Poster Session 3
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2016
Session Time: 5:00 PM — 7:00 PM
Location: Hall 1

On Decenber 8, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported that interim results from a Phase II clinical trial of Puma’s investigational drug PB272 (neratinib) were presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas (Press release, Puma Biotechnology, DEC 8, 2016, View Source [SID1234517004]). The presentation entitled, "Incidence and severity of diarrhea with neratinib plus intensive loperamide prophylaxis in patients with HER2-positive early-stage breast cancer (EBC): Interim analysis from the multicenter, open-label, phase II CONTROL trial" was presented as a poster presentation.

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The main adverse event that has been seen to date in clinical trials of neratinib is diarrhea and more specifically grade 3 diarrhea. In the Phase III ExteNET trial of neratinib as extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with adjuvant Herceptin, 95.4% of the patients experienced all grade diarrhea and 39.8% of the patients experienced grade 3 or higher diarrhea (there was one event of grade 4 diarrhea). The CONTROL trial is an international, open-label, phase II study investigating the use of loperamide prophylaxis with or without other agents in the prevention and reduction of neratinib-associated diarrhea and more specifically grade 3 diarrhea.

In the trial, patients with HER2-positive early-stage breast cancer who had completed trastuzumab-based adjuvant therapy received neratinib daily for a period of one year. High dose loperamide prophylaxis was given for the first 2 cycles (56 days) of treatment. Initially, the loperamide dosing used was 16 mg on day 1, then 12 mg on days 2 and 3 and then 6-8 mg on days 4-56 (original dosing). The protocol was later amended to simplify the regimen such that patients took 12 mg on days 1-14 and 8 mg on days 15-56 (modified dosing). The CONTROL trial has recently been expanded to include prophylaxis with the combination of loperamide and budesonide, a locally acting corticosteroid that the Company believes targets the inflammation identified in a preclinical model of neratinib-induced diarrhea.

The interim analysis of the trial presented in the poster included a total of 135 patients who received neratinib plus loperamide prophylaxis (28 patients taking the original dosing and 107 patients taking the modified dosing) and 40 patients who received neratinib plus loperamide prophylaxis for 2 cycles and budesonide for 1 cycle.

The results of the trial showed that the incidence of grade 3 diarrhea for the total 135 patients who received the loperamide prophylaxis was 28.1%. For the 28 patients who received loperamide using the original dosing regimen the grade 3 diarrhea rate was 25.0% and for the 107 patients who received the modified loperamide dosing regimen the grade 3 diarrhea rate was 29.0%. For the patients in the original dosing group, 71% of the patients who experienced grade 3 diarrhea were known to be non-compliant with the loperamide regimen and for the patients in the modified loperamide dosing regimen, 35% of the patients were known to be non-compliant with their loperamide dosing regimen. For the 135 patients who received the loperamide prophylaxis, the median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 3 days. For the 135 patients who received loperamide prophylaxis, 18.5% discontinued neratinib due to diarrhea.

For the 40 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 15.0%. None of the patients who experienced grade 3 diarrhea were non-compliant with the loperamide plus budesonide regimen. The median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 2.5 days. For the 40 patients who received loperamide plus budesonide prophylaxis, 5.0% discontinued neratinib due to diarrhea. Further information is provided in Table 1 below:

Table 1: Characteristics of Treatment-Emergent Diarrhea

Study
CONTROL

ExteNET
Loperamide cohort

Budesonide
cohort
Neratinib
arm
Prophylaxis Original Modified Loperamide Loperamide + Loperamide
schedule schedule total budesonide prn
(n=28) (n=107) (N=135) (N=40) (N=1408)
Diarrhea, %
Any grade 82.1 73.8 75.6 65.0 95.4
Grade 1 35.7 21.5 24.4 32.5 22.9
Grade 2 21.4 23.4 23.0 17.5 32.5
Grade 3a 25.0 29.0 28.1 15.0 39.8
Grade 4 0 0 0 0 0.1

Median cumulative duration, days
Grade ≥2 5.0 4.0 4.0 3.0 10.0
Grade ≥3b 2.0 3.0 3.0 2.5 5.0

Median diarrhea episodes/patient
Any grade 2 2 2 2 8
Grade ≥2 2 1 2 1 3
Grade ≥3b 1 1 1 1 2

Action taken, %
Dose hold 7.1 12.1 11.1 7.5 33.9
Dose reduction 10.7 7.5 8.1 5.0 26.4
Discontinuation 28.6 15.9 18.5 5.0 16.8
Hospitalization 0 1.9 1.5 0 1.4

Duration of neratinib treatment, months
Median 9.7 7.4 7.5 1.8 11.6
Range 0.1‒13.1 0.1‒12.8 0.1‒13.1 0.1‒6.3 0.03‒13.3

a
Non-compliance with loperamide prophylaxis in patients with grade 3 diarrhea was 71% with the original loperamide schedule, 35% with the modified loperamide schedule, and 0% with loperamide prophylaxis plus budesonide.

b
No grade 4 events in the CONTROL study; one grade 4 event in the ExteNET study.

In the ExteNET trial, higher grade (grade 2 and grade 3) diarrhea occurred early and persisted throughout the duration of the 12-month treatment period. In the CONTROL trial, in both the loperamide prophylaxis and loperamide plus budesonide prophylaxis arms, the results showed that higher grade diarrhea (grade 2 and 3) occurred early but did not typically recur. This is shown in more detail in Figure 1: Treatment Emergent Diarrhea, which is attached to this news release.

The grade 3 diarrhea rates seen in the loperamide cohort have increased over what was previously reported in December 2015 (n=50, grade 3 diarrhea rate 16%). During the course of the CONTROL trial there has been an increase in the proportion of patients previously treated with pertuzumab (mainly in the neoadjuvant setting). More specifically in the data reported in December 2015, 18% (9 of 50 patients) had previously received pertuzumab. In the current data set 40% (54 of 135 patients) of the patients in the combined loperamide prophylaxis arms received prior pertuzumab and 55% (22 of 40 patients) received prior pertuzumab in the budesonide arm.

For the 54 patients in the loperamide prophylaxis cohort who received prior pertuzumab, the grade 3 diarrhea rate was 35.2% (Table 2). For the 81 patients who did not receive prior pertuzumab, the grade 3 diarrhea rate was 23.5%. For the 22 patients in the budesonide cohort who received prior pertuzumab, the grade 3 diarrhea rate was 13.6%. For the 18 patients in the budesonide cohort who did not receive prior pertuzumab, the grade 3 diarrhea rate was 16.7%. This analysis suggests that prior pertuzumab exposure may have led to a higher rate of grade 3 diarrhea in CONTROL that was not effectively managed by loperamide prophylaxis alone but was more effectively managed by loperamide plus budesonide.

Table 2: Incidence of Grade 3 Diarrhea in CONTROL by Prior Pertuzumab Treatment

Loperamide Cohort

Budesonide Cohort

Yes No Yes No
(n = 54)
(n = 81)
(n = 22)
(n = 18)

Grade 3 Diarrhea 35.2% 23.5% 13.6% 16.7%

Dr. Carlos H. Barcenas, Assistant Professor, Department of Breast Oncology and Associate Medical Director, Breast Cancer Survivorship for the University of Texas MD Anderson Cancer Center, said, "We are pleased to see the reduction in incidence, severity and duration of neratinib-associated diarrhea when using the loperamide prophylaxis and the loperamide plus budesonide prophylaxis. When using either the loperamide prophylaxis or the loperamide plus budesonide prophylaxis there appears to be a reduction in the incidence and severity of grade 3 diarrhea with neratinib. Importantly, the severe grade 2 and grade 3 diarrhea, when using the prophylaxis, appears to be acute, self-limiting and manageable. We look forward to completing the loperamide plus budesonide cohort and to the testing of additional investigational agents as well."

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased to see the reductions in the incidence of severe neratinib-related diarrhea in the CONTROL trial when using the loperamide and/or loperamide plus budesonide combination. We are further pleased to see the severe diarrhea become more acute, whereby it does not typically recur after the first month."