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]).

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"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.

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]).

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"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.

On January 4, 2019 Flex Pharma, Inc. (NASDAQ: FLKS), and Salarius Pharmaceuticals, LLC, a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that the companies have entered into a definitive merger agreement under which privately-held Salarius will merge with a wholly-owned subsidiary of Flex Pharma (Press release, Flex Pharma, JAN 4, 2019, View Source [SID1234532463]). Management believes that the proposed transaction will position the combined company to recognize multiple value inflection points based on Salarius’ clinical pipeline, which targets rare, orphan cancers with no targeted treatments and cancers that have a high unmet need.

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Salarius recently completed a $6.4 million private placement, which combined with cash from Flex Pharma is expected to fund the combined company to mid-2020, allowing it to report early cohort data from an ongoing Phase 1 Ewing sarcoma trial. Upon the closing of the transaction, Flex Pharma stockholders will own approximately 19.9% of the combined company and current Salarius investors will own approximately 80.1% of the combined company. Flex Pharma stockholders will also receive a right to receive warrants, six months and one day following the closing date of the transaction, allowing them to purchase additional shares. The total value of these warrants will be calculated such that upon exercise Flex Pharma stockholders would own an additional 2.4%, or a total of 22.3%, of the value of the combined entity, subject to adjustment based on Flex Pharma’s net cash at closing. A live conference call and webcast is scheduled for today at 9:00 a.m. Eastern Time.

Upon closing of the transaction, Flex Pharma is expected to be renamed Salarius Pharmaceuticals, Inc. and be under the leadership of Salarius’ current management team, led by Chief Executive Officer, David Arthur. The Salarius clinical pipeline will become the lead assets of the company following the transaction. Flex Pharma President and Chief Executive Officer, William McVicar, Ph.D., is expected to join the Board of Directors of the combined company following the closing of the transaction.

"After completing a comprehensive and highly competitive selection process, we are confident that the proposed transaction with Salarius offers the best opportunity for significant near- and long-term value creation," stated Dr. McVicar. "We were impressed by the compelling science supporting Salarius’ novel drug, as well as the company’s strong financial position and management team. Based on our diligence, we believe Salarius could be poised to advance multiple potential product opportunities that address significant unmet needs in oncology. I look forward to supporting the company and being a member of the Salarius Board of Directors following the closing of the transaction. Finally, I would like to thank our stockholders for their support and patience during this strategic process and to reiterate that the entire team is fully committed to enhancing stockholder value with this transaction and beyond."

Salarius’ lead compound, Seclidemstat, targets the epigenetic dysregulation underlying Ewing sarcoma, a devastating pediatric, adolescent and young adult bone cancer for which no targeted therapies currently exist. Seclidemstat is a differentiated, reversible inhibitor of the lysine-specific demethylase 1 enzyme, or LSD1, which is a widely studied epigenetic enzyme and a validated drug target for clinical development. The company is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study, which is expected to conclude in 2020. Salarius is also preparing to initiate additional studies in advanced solid tumors, including prostate, breast and ovarian cancers.

Salarius’ Chief Executive Officer, David Arthur, commented, "This strategic transaction and Nasdaq listing represent a growth opportunity for both companies. As an emerging public company, we believe that the enhanced visibility and exposure to institutional investors will enable Salarius to showcase the potential of its clinical pipeline, and the progression of its programs should drive increased stockholder value. Our goal is to become a recognized leader in epigenetic cancer therapy."

Mr. Arthur is a seasoned life sciences executive with more than 25 years’ experience in biopharma leadership, building and leading multi-disciplinary teams, as well as launching and managing pharmaceutical and drug delivery device brands. For much of his career, he held executive roles at Eli Lilly and Boehringer-Ingelheim managing product development, business development and global commercialization.

About the Proposed Transaction

The transaction has been approved unanimously by the Board of Director of Flex Pharma and Board of Managers of Salarius. The proposed transaction is expected to close in the first half of 2019, subject to the approval of Flex Pharma stockholders at a special stockholder meeting and other customary conditions, including approval by Salarius’ members.

Flex Pharma’s strategic advisor in the transaction is Wedbush PacGrow. Healthios Capital Markets is serving as financial advisor to Salarius Pharmaceuticals. Dentons Canada LLP and Duane Morris LLP are serving as legal counsel to Flex Pharma and Pillsbury Winthrop Shaw Pittman LLP is serving as legal counsel to Salarius Pharmaceuticals.

Conference Call and Webcast

Flex Pharma and Salarius will host a joint conference call and simultaneous live audio webcast today at 9:00 a.m. Eastern Time to discuss the proposed transaction. The live call may be accessed by dialing:

(855) 780-7202 (U.S.)
(631) 485-4874 (international)
Conference ID: 4498626
A live audio webcast of the call will be available online from the investor relations section of the Flex Pharma website at www.flex-pharma.com and will be archived there for 30 days.

On January 4, 2019 Ribon Therapeutics, a biotechnology company developing first-in-class therapeutics targeting novel enzyme families activated under cellular stress conditions, reported the closing of a $65 million Series B financing (Press release, Ribon Therapeutics, JAN 4, 2019, View Source [SID1234532462]). Proceeds will be used to advance lead programs from the company’s growing pipeline into clinical testing, including small molecule monoPARP inhibitors.

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The financing was led by the Novartis Venture Fund, with participation from new investors JJDC and Celgene Corporation, as well as existing investors, The Column Group, Deerfield Management, U.S. Venture Partners, Osage University Partners, Takeda Ventures and Euclidean Capital.

"We are delighted to have the support of such a distinguished group of investors who share our commitment to bringing novel therapies to cancer patients and excitement for the therapeutic potential of modulating cellular stress responses," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "Leveraging landmark discoveries made by our scientific founders, which ushered in a better understanding of the molecular action and biological function of novel enzyme classes beginning with monoPARPs, we are applying our expertise in drug discovery to develop novel and effective treatments for defined patient populations with limited therapeutic options."

Targeting MonoPARPs

MonoPARPs are key regulators of stress responses that enable cancer cells to survive and also evade immune detection, and emerging science has linked their activity with disease development. Ribon has built an integrated technology platform to interrogate monoPARPs to develop first-in-class, small molecule therapeutics. The company’s initial focus is in oncology, however, the 12 distinct monoPARPs function across a variety of stress responses relevant to disease development in cancer, inflammatory diseases and neurodegenerative diseases, giving Ribon’s approach broad utility. The focus of Ribon’s lead program is on advancing the science of PARP7 inhibitors for the treatment of cancer, beginning with squamous cell carcinoma of the lung.

"We have been following Victoria and her team for more than a year and are impressed by Ribon’s tremendous progress and ability to execute," said Anja Koenig, Head of the Novartis Venture Fund, who will be joining the Ribon board of directors as part of the Series B financing along with an investor from JJDC. "Ribon has developed a novel platform with the flexibility and rigor to investigate and exploit new targets providing the opportunity to build a diverse and attractive pipeline of first-in-class therapeutics."

On January 4, 2019 Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, reported that Bahija Jallal has been appointed as Chief Executive Officer and Director of the Board (Press release, Immunocore, JAN 4, 2019, View Source [SID1234532461]).

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With more than 25 years of international leadership experience within the pharmaceutical industry, Bahija joins Immunocore from AstraZeneca, where she is President of MedImmune, its global biologics research and development arm, and a member of the senior executive team reporting to the CEO.

Since joining MedImmune in 2006, Bahija has overseen the development of several new medicines, including Imfinzi, Fasenra, Lumoxiti, Siliq and FluMist Quadrivalent. Under Bahija’s leadership, MedImmune has significantly boosted its pipeline, expanding from 40 to more than 130 molecules in research and development targeting cancer; respiratory, inflammation, and autoimmunity; cardiovascular, renal and metabolic; and infectious diseases. Bahija has fostered an entrepreneurial culture that resulted in hundreds of patent applications and significant growth in the publication of MedImmune science in high impact journals. She forged industry-first collaborations and led efforts to acquire four independent biotech, big data and technology companies. Bahija also laid the foundation for the creation of an inflammation and autoimmunity carve out as an independent biotech.

Bahija has authored more than 70 peer-reviewed publications and holds more than 15 patents. She serves on the Board of Anthem, Inc. in Indianapolis, Indiana and on the Board of Trustees of the Johns Hopkins University in Baltimore, Maryland. She is a member of the Government-University-Industry Research Roundtable (GUIRR) of the National Science Foundation and is the immediate past President of the board of the Association of Women in Science. In 2017, Bahija was named Woman of the Year by the Healthcare Businesswomen’s Association.

Sir John Bell, Chairman of Immunocore, said: "Bahija is the ideal candidate to lead Immunocore at this transformational point in its development. A champion for science and diversity, Bahija is a highly seasoned pharmaceutical executive with considerable experience in biologics R&D and immuno-oncology. Her appointment will significantly strengthen Immunocore as we advance our lead candidate, IMCgp100, towards commercialisation, and our growing pipeline of TCR candidates through clinical development. I would like to extend my thanks also to Andrew Hotchkiss, who has been a highly capable interim CEO of Immunocore, for his support."

"I am excited to have the opportunity to head Immunocore, the leader in cutting-edge TCR bispecifics," said Bahija Jallal, incoming Chief Executive Officer of Immunocore. "With its strong platform, with potential to be applicable in multiple therapy areas, Immunocore has successfully translated its innovative science into the clinic with ongoing pivotal trials in uveal melanoma and clinical and pre-clinical stage programs in other disease areas. I am looking forward to helping the company, and its talented employees, bring innovative T cell receptor-based medicines to patients."