On January 28, 2020 Beckman Coulter, a global leader in clinical diagnostics, reported that its Access PCT assay has received FDA 510(k) clearance and is now available for sale in the United States (Press release, Beckman Coulter, JAN 28, 2020, View Source [SID1234553636]). The sensitivity of the Access PCT assay helps physicians assess critically ill patients in danger of progression to severe sepsis or septic shock—with test results available in under 20 minutes.

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"When it comes to sepsis, every minute counts. Bringing the Access PCT Assay into our core laboratory automated workflow makes it possible to streamline procalcitonin testing into our routine service to clinical teams," said Dr. Bernard C. Cook, Ph.D., Chemistry Division Head and Director of Automated Core Laboratory Operations at Henry Ford Hospital in Detroit, Michigan. "In addition, our early evaluations confirmed that the assay has the accuracy and low-end sensitivity needed to help clinicians determine the best treatment options for patients with sepsis and other infections."

Despite advances in modern medicine, sepsis remains the primary cause of death from infection, affecting more than 30 million people worldwide each year1.

"Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections, and also with the probability of a positive blood culture, making it a clinically useful marker in the assessment of patients with possible sepsis or at risk of progressing to septic shock. The ability to rapidly diagnose suspected sepsis patients and determine care and treatment is critical, as earlier administration of appropriate antibiotics is highly correlated with increased patient survival," said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter.

The Access PCT assay enables healthcare providers to integrate procalcitonin testing analysis into their routine sepsis workups on core laboratory analyzers, as a primary or reflex test programmed though Beckman Coulter’s REMISOL Advance middleware. Such integration simplifies laboratory workflow and optimizes institutional sepsis management protocols while reducing the operational expense of maintaining costly dedicated instrumentation.

"Laboratories count on Beckman Coulter to provide a broad menu of solutions to help treat the most prevalent and costly health conditions," said Kathleen Orland, senior vice president and general manager for Beckman Coulter’s chemistry and immunoassay business. "We are proud to offer the industry’s most extensive portfolio of in-vitro diagnostic solutions for sepsis identification and management across multiple disciplines, including the Early Sepsis Indicator, the only hematology-based biomarker FDA cleared specifically for augmenting the diagnosis of sepsis. In the fight against sepsis, every minute counts. Our Access PCT assay is a key component in sepsis identification and treatment, and underscores our ongoing commitment to developing the solutions physicians need to know sooner to act faster."

Access PCT is available for use on Beckman Coulter’s Access Family of Immunoassay Systems including the Access 2, UniCel DxI 600 and UniCel DxI 800. For more information regarding the Access PCT assay or Beckman Coulter’s full suite of solutions for sepsis diagnosis and management, www.BeckmanCoulter.com/Sepsis.

On January 28, 2020 EcoGen Laboratories (EcoGen), the leading vertically-integrated manufacturer and supplier of hemp-derived specialty ingredients, proprietary formulations, and private-label finished products in the United States, reported the closing of a $40 million private placement (Press release, Ecogen, JAN 28, 2020, View Source [SID1234553635]).

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"We are very encouraged by the strong support we’ve received from the institutional marketplace," said Alexis Korybut, Co-Founder of EcoGen. "This investment is an important step forward that will allow us to further grow and expand our business."

Since inception in 2016, EcoGen has expanded rapidly, resulting in growth that exceeded $80 million in revenue for 2019. Poised to capitalize on a rapidly changing market, EcoGen has developed a growth strategy to support this recent raise which includes further developing facilities, focusing on research and development to increase product offerings, and expanding marketing and sales divisions to widen its global footprint.

"With engineering as a passion and also my background, the prospect of new innovation is what led me to this industry," says Joseph Nunez, Co-Founder of EcoGen. "When we first started, we were on a mission to create a state-of-the-art process to produce exceptionally pure CBD that set the standard for the industry. We’re proud to say that goal was quickly achieved and this capital raise will allow us to expand that success into other verticals of the business."

New technologies, advanced seeds and genetics, in addition to expanding private label finished goods, are also on the horizon for 2020.

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.