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Generex Biotechnology Provides Update on NuGenerex Immuno-Oncology

On January 4, 2019 Generex Biotechnology Corporation (OTCQB:GNBT) is reported to provide an update on operational and strategic developments at NuGenerex Immuno-Oncology (previously Antigen Express), a wholly-owned subsidiary (Press release, Generex, JAN 4, 2019, View Source [SID1234532468]).

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The protocol for the Phase II clinical trial of pembrolizumab (Keytruda) in combination with the AE37 Peptide Vaccine in patients with metastatic triple negative breast cancer is under review at the Institutional Review Board (IRB) with oversight of this NSABP Foundation managed study. Site selection has begun, and study drugs are being packaged for shipment to study sites.

"With the initiation of the AE37/PD-1 Inhibitor combination trial and the advancement of the company’s clinical development partnership with Shenzhen BioScien for AE37 in prostate cancer, we have validated the Ii-Key technology, as a viable immunotherapy platform," said Richard Purcell, SVP of R&D at Generex. "The Ii-Key can activate a CD-4 T-cell immune response against any peptide to which it is linked. Given the advances in immunotherapy in the last couple of years, and the potential combinations with checkpoint inhibitors like pembrolizumab, NuGenerex Immuno-Oncology is positioned, with years of clinical experience in immunotherapy of cancer, to explore a range of opportunities for the Ii-Key technology in personalized medicine using tumor-associated antigens and neo-antigens for tumor-specific cancer therapy. To that end, Generex has initiated partnering discussions with synergistic companies to explore co-development and collaborative R&D opportunities for immunotherapeutic product development."

NuGenerex Immuno-Oncology Spin-Out & Stock Dividend

Generex President & Chief Executive Officer Joe Moscato stated, "NuGenerex Immuno-Oncology is being established to not only advance the NuGenerex Immuno-Oncology core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. As part of our strategy, we are exploring opportunities to spin-out NuGenerex Immuno-Oncology as a separate DTC-eligible SEC registered company." Mr. Moscato stated that following the spin-out, NuGenerex Immuno-Oncology is expected to seek to list its common stock on a national stock exchange. "The spin-out of NuGenerex Immuno-Oncology into a separate, publicly traded entity has been the focus of the Generex strategic development plan in cancer drug development," Mr. Moscato indicated. "The Ii-Key technology has been underappreciated for too long, as we have advanced the immunotherapy field with the largest breast cancer vaccine study ever conducted, and now the results of that trial have led to an exciting combination Phase II trial with AE37 plus Ketruda in triple negative breast cancer. We believe this spin-out will help to unlock the true value of the Ii-Key technology for our stockholders as it creates a pure play in immunotherapy, which will foster investment and collaboration."

The spin-out will be accomplished by the issuance of one or more dividends of NuGenerex Immuno-Oncology stock to Generex stockholders. The record dates in respect of such dividends are yet to be determined and will be announced in due course. The stock dividends will enable Generex stockholders to directly participate in the promising future of NuGenerex Immuno-Oncology as well as create a large shareholder base with the potential for substantial liquidity on an immediate basis. That liquidity will be further enhanced should NuGenerex Immuno-Oncology be successful in attaining a national stock exchange listing, and should provide NuGenerex Immuno-Oncology with ready access to the capital markets to finance its on-going clinical and regulatory initiatives.

Following the issuance of stock dividends, Generex expects to retain a controlling interest in NuGenerex Immuno-Oncology, but the exact proportion of the shares to be held by Generex has not yet been determined.

Subject to market conditions and the satisfaction of regulatory requirements, it is expected that the NuGenerex Immuno-Oncology spin-out will occur sometime following the upcoming Annual Meeting of the Generex stockholders. Generex has formed a committee to seek qualified professionals to populate NuGenerex Immuno-Oncology’s Board of Directors, Scientific Advisory Board, and executive management team. Further announcements in respect of the status of the spin-out are expected to be made over the course of the coming months.

OncoNano Receives Authorization to Proceed from FDA for IND Application and Fast Track Designation for ONM-100, Intraoperative Imaging Agent to Detect Tumors and Metastatic Lymph Nodes That Often Go Undetected During Surgery

On January 4, 2019 OncoNano Medicine, Inc. reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ONM-100, an intravenously administered imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery (Press release, OncoNano Medicine, JAN 4, 2019, View Source [SID1234532467]). In addition, OncoNano received Fast Track designation from the FDA for ONM-100.

ONM-100 is the first product from a platform based upon the OncoNano’s library of unique micelles that respond to pH variability. Specifically, ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which will allow surgeons to visualize the tumor during surgery using existing infrared-based surgical cameras. The OncoNano micelle platform is also being used to develop therapeutics, cancer nanovaccines and immune therapies. OncoNano is currently concluding the Phase 1 clinical trial for ONM-100 in the Netherlands.

"These two positive responses from the FDA reflect the progress that we have made on ONM-100," said Kathy Rath, Vice President, Regulatory Affairs at OncoNano Medicine. "The Fast Track designation will allow us to have an ongoing, open dialogue with the FDA with the goal to make this important technology available to surgeons and their patients at the earliest possible time."

"We are excited for the opportunity to work closely with the FDA while developing this critical solution to the problems surgeons face every day," said Yalia Jayalakshmi, Vice President, Clinical Development at OncoNano Medicine. "With these responses and the emerging clinical data demonstrating the potential of the product in multiple types of solid tumors, including breast, head and neck, esophageal and colorectal cancers, we are well positioned to advance ONM-100 into a Phase 2 clinical study in 2019."

Relay Therapeutics to Present at the 37th Annual J.P. Morgan Healthcare Conference

On January 4, 2019 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported that Sanjiv Patel, M.D., president and chief executive officer, is scheduled to present an overview of the company’s business and scientific objectives at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 10, 2019 at 11:00 a.m. PT (2:00 p.m. ET) (Press release, Relay Therapeutics, JAN 4, 2019, View Source [SID1234532466]).

C4 Therapeutics Announces Transformation of Strategic Collaboration to Discover and Develop Degrader-Based Medicines with Roche

On January 4, 2019 C4 Therapeutics (C4T) reported the transformation of its ongoing research and development partnership with Roche focusing on new cancer treatments based on C4T’s targeted protein degradation technology (Press release, C4 Therapeutics, JAN 4, 2019, View Source [SID1234532465]).

"We are excited to see our partnership with Roche evolve and further accelerate our efforts to bring degrader-based medicines into the clinic," said Andrew Phillips, PhD, President and CEO of C4 Therapeutics. "Roche has been a valued and excellent partner since we started our collaboration in 2016. This transformed partnership reflects how much both parties believe in the potential of degraders as a new treatment modality for patients."

Under the terms of the expansion, C4T will lead efforts from discovery through defined preclinical or early clinical milestones, depending on the program. Upon C4T reaching these milestone events, Roche will have exclusive options for worldwide rights to continue development and commercialize drugs from these programs. In addition, C4T will have the option to co-develop and co-promote in the U.S. on selected programs. C4T will receive a significant upfront payment and near-term preclinical milestones. Upon success C4T may also receive royalties and potential clinical, regulatory, and commercial milestone payments totaling over $900 million.

AngioDynamics Reports Fiscal 2019 Second Quarter Financial Results

On January 4, 2019 AngioDynamics, Inc. (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the second quarter of fiscal year 2019, which ended November 30, 2018 (Press release, AngioDynamics, JAN 4, 2019, View Source [SID1234532464]).

"We are very pleased with our second quarter financial results, which are marked by growth across all of our business segments, expanding gross margins, and improved profitability. Our quarterly performance was positively impacted by our recent acquisitions, validating our portfolio optimization strategy and enhancing our value proposition within oncology. In addition, we continue to make progress toward obtaining a pancreatic cancer indication for NanoKnife and recently received notification from the FDA that NanoKnife will be considered a Category B IDE once we receive approval to begin our DIRECTtm NanoKnife study for Stage III pancreatic cancer," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We are encouraged by these accomplishments and are well positioned to achieve our financial targets for the full year."

Second Quarter 2019 Financial Results

Net sales for the second quarter of fiscal 2019 were $91.5 million, an increase of 5.5%, compared to $86.7 million a year ago. During the quarter, each of the Company’s three businesses posted growth, led by the Oncology business.

Currency did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $15.3 million, an increase of 19.8% from $12.8 million a year ago, as strong NanoKnife sales in both capital and disposables and positive contributions from the two recent acquisitions more than offset decreased sales of the Company’s Thermal Ablation products. The comparison of year-over-year results within the Company’s Oncology business was negatively impacted by the timing of the prior-year Acculis Microwave ablation system market withdrawal. Excluding the impact of this transition from the Company’s Acculis Microwave product to its Solero Microwave product, the Oncology business grew 28.7% year over year.
Vascular Interventions and Therapies net sales in the second quarter of fiscal 2019 were $52.5 million, an increase of 2.2%, compared to $51.4 million a year ago, as strong growth in Fluid Management and AngioVac were partially offset by a decelerating decline in the Venous Insufficiency business.
Vascular Access net sales were $23.7 million, an increase of 5.1% from $22.6 million a year ago, as strong sales of Ports and Dialysis products were slightly offset by a decline in sales of PICCs.
U.S. net sales in the second quarter of fiscal 2019 were $71.9 million, an increase of 5.2% from $68.3 million a year ago, and International net sales were $19.6 million, an increase of 6.6% from $18.4 million a year ago.

Gross margin for the second quarter of fiscal 2019 expanded 440 basis points to 53.7% from 49.3% a year ago, consistent with the trending improvements related to the Company’s core operational enhancements, as well as higher gross margins associated with our portfolio optimization strategy.

The Company recorded net income of $2.1 million, or $0.06 per share, in the second quarter of fiscal 2019. This compares to net income of approximately $0.2 million, or $0.01 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2019 was $8.4 million, or $0.22 per share, compared to adjusted net income of $6.3 million, or $0.17 per share, in the second quarter of fiscal 2018.

Adjusted EBITDAS in the second quarter of fiscal 2019, excluding the items shown in the reconciliation table below, was $16.3 million, compared to $13.3 million in the second quarter of fiscal 2018.

In the second quarter of fiscal 2019, the Company generated $13.0 million in operating cash flow and had capital expenditures of $0.7 million. As of November 30, 2018, the Company had $42.8 million in cash and cash equivalents and $145.0 million in debt, excluding the impact of deferred financing costs.

Six Months Financial Results

For the six months ended November 30, 2018:

Net sales were $176.8 million, an increase of 2.7%, compared to $172.1 million for the same period a year ago.
The Company’s net income was $1.7 million, or $0.04 per share, compared to net income of $0.2 million, or $0.01 per share, a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $14.6 million, or $0.38 per share, compared to adjusted net income of $11.3 million, or $0.30 per share, a year ago.
Adjusted EBITDAS, excluding the items shown in the reconciliation table below, was $28.9 million, compared to $24.6 million for the same period a year ago.
Fiscal Year 2019 Financial Guidance

The Company reiterates its previously announced financial guidance, continuing to expect fiscal year 2019 net sales in the range of $354 to $359 million and free cash flow in the range of $26 to $31 million. Additionally, the Company continues to expect adjusted earnings per share in the range of $0.82 to $0.86.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its second quarter 2019 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13685683.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Friday, January 4, 2019, until 11:59 p.m. ET on Friday, January 11, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13685683.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDAS, adjusted net income, adjusted earnings per share and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.