On January 28, 2020 Syndivia, a biotechnology company focused on the development of new therapeutic modalities for solid cancers based on a specific targeting of the tumour microenvironment and anatomical hallmarks, reported that it has been granted an exclusive, worldwide license by SATT Conectus for a technology (DARx) that opens access to a wide range of previously inaccessible biologics formats, such as antibody–drug, antibody–oligonucleotide, and antibody–interleukin conjugates with a defined degree of conjugation of 1 (Press release, Syndivia, JAN 28, 2020, View Source [SID1234553634]). This minimum possible degree of conjugation was found to have important advantages for addressing solid cancer indications in vivo. The development of this technology for both therapeutic and diagnostics applications will be carried out by Syndivia in Strasbourg, France.

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Commenting on this news, Dr Sasha Koniev, Syndivia’s CEO, said, "The unique feature of DARx is that it allows us to readily link in a straightforward way any off-the-shelf antibody with virtually any payload to generate 1-to-1 immunoconjugates. The results we have obtained to date in the ADC and AOC domains look very promising, namely in in vivo models of highly heterogenic solid tumours."

Caroline Dreyer, Conectus’ CEO, shares that enthusiasm: "Cutting-edge academic research has been the cornerstone of Syndivia’s success story thanks to the scientific excellence of the BioFunctional Chemistry (BFC) team at the CNRS/Université de Strasbourg led by Alain Wagner and with the support of Conectus. Today, Syndivia is expanding its capabilities with this new enabling technology. Conectus has once again demonstrated the relevance of its investment in the proof-of-concept of DARx technology, showcasing its broad application scope. After a first technology transfer at Syndivia’s inception, this new license also illustrates the virtuous circle of our collaborative co-conception model, whereby the BFC team, Syndivia, and Conectus work jointly and as a result can create economic and innovative momentum."

Syndivia will undertake further development of the technology and the resulting drug candidates in exchange for undisclosed upfront and milestone payments to Conectus.

On January 28, 2020 SenesTech, Inc. (NASDAQ: SNES), a developer of proprietary technologies for managing animal pest populations through fertility control, reported the closing of its previously announced registered direct offering of 3,550,000 shares of its common stock, at a purchase price of $0.40 per share, for gross proceeds of $1.42 million (Press release, SenesTech, JAN 28, 2020, View Source [SID1234553633]). In a concurrent private placement, the Company also issued to the same investors unregistered warrants to purchase up to an aggregate of 3,550,000 shares of common stock at an exercise price of $0.45 per share. The unregistered warrants will be exercisable commencing six months following the date of issuance and will expire five and one-half years following the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offerings.

SenesTech intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by SenesTech pursuant to a "shelf" registration statement on Form S-3 previously filed with the Securities and Exchange Commission (the "SEC") on August 14, 2018 and declared effective by the SEC on August 24, 2018 and a prospectus supplement and accompanying prospectus filed with the SEC on January 24, 2020. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

On January 28, 2020 Accuray Incorporated (NASDAQ: ARAY) reported its financial results for the second quarter of fiscal 2020 ended December 31, 2019 (Press release, Accuray, JAN 28, 2020, View Source [SID1234553632]).

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Recent Company Highlights

Gross orders of $98.6 million, including 11 orders from China
Net orders of $89.9 million, an increase of 30% year over year
Total backlog increased 12 percent year over year to $539.4 million
Net revenue of $98.8 million, net income of $10.7 million, Adjusted EBITDA of $7.1 million
"Financial and operational results for our second fiscal quarter and for the first half of fiscal year 2020 were solid," commented Joshua H. Levine, president and chief executive officer of Accuray. "Gross orders for the second quarter exceeded our internal expectations heading into the quarter, including a solid order contribution from China. We expect revenue growth to improve in the second half of fiscal 2020 as we believe revenue recognition of China Type A systems will start in our fourth fiscal quarter. In addition, we have confirmed that the tariff exemption for medical linear accelerators is applicable to all of our systems. We believe that this exemption will support our commercial momentum and expand access to our innovative radiation therapy solutions for hospitals and patients in China. In light of recent events with the coronavirus outbreak in China, we do not believe that the outbreak affects the longer-term demand outlook for radiotherapy equipment in China. China remains the world’s fastest growing market for radiation oncology systems where we have a highly differentiated strategy to drive significant revenue growth in the coming years."

Fiscal Second Quarter Results

Gross orders totaled $98.6 million compared to $100.2 million for the prior year period. Backlog as of December 31, 2019 was $539.4 million, an increase of 12 percent compared to $482.2 million for the prior year period.

Total net revenue was $98.8 million compared to $102.3 million for the prior year period. Product revenue totaled $43.8 million compared to $48.1 million in the same prior fiscal year period, while service revenue totaled $55.1 million compared to $54.3 million in the same prior fiscal year period.

Total gross profit for the fiscal 2020 second quarter was $37.9 million, or 38.4 percent of net revenue, comprised of product gross margin of 44.0 percent of product revenue and service gross margin of 33.9 percent of service revenue. This compares to total gross profit of $38.4 million, or 37.5 percent of net revenue, comprised of product gross margin of 39.5 percent of product revenue and service gross margin of 35.7 percent of service revenue for the prior fiscal year second quarter.

Operating expenses were $34.3 million, a decrease of 13 percent compared to $39.2 million in the prior fiscal year second quarter.

Net income was $10.7 million, or $0.12 per share, compared to a net loss of $4.6 million, or ($0.05) per share, for the prior fiscal year period. Net income included a non-cash, special gain of $13.0 million related to the value of the Company’s capital contribution to the China joint venture in exchange for the Company’s 49% equity interest in the joint venture. This gain was recorded as non-operating, other income in the second quarter.

Adjusted EBITDA, which excludes the non-cash, special gain related to the Company’s capital contribution to the China joint venture, for the second quarter of fiscal 2020 was $7.1 million, compared to $4.1 million in the prior fiscal period.

Cash, cash equivalents and short-term restricted cash were $99.1 million as of December 31, 2019 compared with $86.7 million as of September 30, 2019.

Fiscal Six Months Results

For the six months ended December 31, 2019, gross product orders totaled $177.0 million compared to $161.6 million for the same prior fiscal year period. Ending product backlog was $539.4 million, approximately 12 percent higher than backlog at the end of the prior fiscal year second quarter.

Total net revenue for the six months ended December 31, 2019 was $188.4 million compared to $198.1 million in the same prior fiscal year period. Product revenue for the six months ended December 31, 2019 totaled $81.4 million compared to $89.6 million, while service revenue totaled $107.0 million compared to $108.6 million in the same prior fiscal year period.

Total gross profit for the six months ended December 31, 2019 was $70.8 million, or 37.6 percent of net revenue, comprised of product gross margin of 43.4 percent of product revenue and service gross margin of 33.2 percent of service revenue. This compares to total gross profit of $76.3 million, or 38.5 percent of net revenue, comprised of product gross margin of 40.2 percent of product revenue and service gross margin of 37.1 percent of service revenue for the same prior fiscal year period.

Operating expenses for the six months ended December 31, 2019 were $71.5 million, a decrease of 13 percent compared with $81.8 million in the same prior fiscal year period.

Net income was $1.4 million, or $0.02 per share, for the six months ended December 31, 2019, compared to a net loss of $13.8 million, or ($0.16) per share, for the same prior fiscal year period. Net income included a non-cash, special gain of $13.0 million related to the value of the Company’s capital contribution to the China joint venture in exchange for the Company’s 49% equity interest in the joint venture. This gain was recorded as non-operating, other income in the second quarter.

Adjusted EBITDA for the six months ended December 31, 2019 was $6.1 million, compared to $8.1 million in the prior fiscal year period.

2020 Financial Guidance

The Company is reaffirming revenue guidance provided on August 15, 2019 and updating adjusted EBITDA guidance for fiscal year 2020. Total revenue for fiscal year 2020 is expected to range between $410.0 and $420.0 million. The Company expects to generate revenue growth during the second half of fiscal year 2020 compared to the second half of the prior fiscal year. Adjusted EBITDA for fiscal year 2020 is expected to range between $21.0 to $26.0 million, which includes approximately $1.0 million of the Company’s share of expected loss from the joint venture operations in China. This is adjusted from the previous range of $19.0 million to $24.0 million.

Conference Call Information

Accuray will host a conference call beginning at 1:30 p.m. PT/4:30 p.m. ET today to discuss results for the second fiscal quarter as well as recent corporate developments. Conference call dial-in information is as follows:

U.S. callers: (855) 867-4103
International callers: (262) 912-4764
Conference ID Number (U.S. and international): 8598970
Individuals interested in listening to the live conference call via the Internet may do so by logging on to Accuray’s website, www.accuray.com. In addition, a taped replay of the conference call will be available beginning approximately two hours after the call’s conclusion and available for seven days. The replay telephone number is (855) 859-2056 (USA) or (404) 537-3406 (International), Conference ID: 8598970. An archived webcast will also be available at Accuray’s website until Accuray announces its results for the third quarter of fiscal 2020.

On January 28, 2020 Aflac Incorporated (NYSE: AFL) reported that it will release fourth quarter financial results after the market closes on February 4, 2020 (Press release, Aflac, JAN 28, 2020, View Source [SID1234553631]).

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In conjunction with the earnings release, Aflac Incorporated will webcast a conference call scheduled for 9:00 a.m. (ET) on February 5, 2020. During the teleconference, the company will discuss fourth quarter results and its outlook. The following executives will be available to answer questions: Aflac Incorporated Chairman and Chief Executive Officer Daniel P. Amos; President and Chief Operating Officer of Aflac Incorporated Frederick J. Crawford; Executive Vice President and Chief Financial Officer of Aflac Incorporated Max K. Brodén; President of Aflac International and Chairman and Representative Director of Aflac Life Insurance Japan Charles D. Lake II; President and Representative Director of Aflac Life Insurance Japan Masatoshi Koide; Director, Executive Vice President and Director of Sales and Marketing of Aflac Life Insurance Japan Koji Ariyoshi; President of Aflac U.S. Teresa L. White; Executive Vice President and Global Chief Investment Officer of Aflac Incorporated and President of Aflac Global Investments Eric M. Kirsch; Director, Executive Vice President and Chief Financial Officer of Aflac Life Insurance Japan J. Todd Daniels; Executive Vice President and Chief Distribution Officer Richard L. Williams Jr.; and Senior Vice President; Global Chief Risk Officer and Chief Actuary Albert A. Riggieri.

On January 28, 2020 Kite, a Gilead Company (Nasdaq: GILD), reported that the company’s Marketing Authorization Application (MAA) for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), has been fully validated and is now under evaluation by the European Medicines Agency (EMA) (Press release, Kite Pharma, JAN 28, 2020, View Source [SID1234553630]).

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The MAA is supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19 (median follow-up of 12.3 months). In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented during an oral session at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando.

"Relapse rates in mantle cell lymphoma remain overwhelmingly high and there is a significant need for new therapies that may improve patients’ prognosis," said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. "The EMA validation of our marketing application brings us closer to delivering on the promise of our industry-leading cell therapy development program, with the hope that we can bring KTE-X19 to appropriate patients in Europe as quickly as possible."

Kite submitted a Biologics License Application (BLA) for KTE-X19 to the U.S. Food and Drug Administration (FDA) on December 11, 2019 for the treatment of adult patients with relapsed or refractory MCL. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the EMA.

KTE-X19 is investigational and not approved anywhere globally. Its efficacy and safety have not been established. More information about clinical trials with KTE-X19 is available at www.clinicaltrials.gov.

About MCL

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the "mantle zone" of the lymph node and typically affects men over the age of 60.

About ZUMA-2

ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib. The objectives of the study are to evaluate the efficacy (60 patients) and safety (68 patients) after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate (ORR). ORR in this trial is defined as the combined rate of complete responses and partial responses as assessed by an IRRC.

Secondary endpoints include duration of response, progression-free survival, overall survival, incidence of adverse events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score. The study is ongoing.

About KTE-X19

KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy. KTE-X19 uses the XLP manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. KTE-X19 is currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).