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 Genprex, Inc.("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, reported that it closed its previously announced common stock offering priced at-the-market under Nasdaq rules (Press release, Genprex, JAN 28, 2020, https://www.genprex.com/news/genprex-inc-announces-closing-of-8-million-at-the-market-common-stock-offering/ [SID1234553617]). The Company sold an aggregate of 7,620,000 shares of its common stock at a price of $1.05 per share for gross proceeds to the Company of $8 million, before deducting commissions and estimated offering expenses. There were no warrants issued in the offering.

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A.G.P./Alliance Global Partners acted as the lead placement agent for the offering, and Joseph Gunnar & Co., LLC acted as co-placement agent for the offering.

The Company intends to use the net proceeds from the offering to advance its lead clinical programs in non-small cell lung cancer (NSCLC) and for working capital and general corporate purposes.

"The successful closing of this transaction is further evidence that our corporate vision and proprietary technology in the gene therapy cancer treatment market are gaining traction with institutional investors," commented Rodney Varner, Chief Executive Officer at Genprex. "This offering significantly improves our balance sheet and allows us the financial flexibility to further develop our pipeline and advance our clinical trials in NSCLC for our lead drug candidate, Oncoprex, in combination with already approved lung cancer therapies. We are excited to generate additional clinical data in NSCLC from Oncoprex’s novel mechanisms of action."

The securities were offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233774) previously filed and declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 28, 2019.

A prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from either A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, New York 10022 or by email at [email protected] or Joseph Gunnar & Co. LLC, 30 Broad Street, 11th Floor, New York, New York 10004 or by email at [email protected].

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities described herein, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.61 per share of the company’s common stock for the second quarter of 2020 (Press release, Merck & Co, JAN 28, 2020, View Source [SID1234553618]). Payment will be made on April 7, 2020 to shareholders of record at the close of business on March 16, 2020.

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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.