On November 1, 2022 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the third quarter ended September 30, 2022 (Press release, ViewRay, NOV 1, 2022, View Source [SID1234622740]).

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Third Quarter 2022 Highlights

Total revenue for the third quarter 2022 was approximately $26.5 million, primarily from four revenue units, compared to approximately $19.2 million, primarily from three revenue units, in the third quarter of 2021.
Received eight new orders for MRIdian systems totaling $47.5 million, compared to seven new orders totaling $39.4 million in the third quarter 2021.
Total backlog increased to $370.5 million as of September 30, 2022, compared to approximately $295.1 million as of September 30, 2021.
Cash and cash equivalents, inclusive of a customer deposit reflected in restricted cash, was $146.9 million as of September 30, 2022. Cash usage for the three months ended September 30, 2022 was approximately $15.3 million.
"Our team delivered another solid quarter on orders, revenue growth, gross margin expansion, and operating expense discipline," said Scott Drake, President and CEO. "Customer reaction to our SMART Pancreas trial and the full 12 month MIRAGE data is outstanding. Our clinical data are driving demand for MRIdian therapy. We’re also very pleased by the customer response to our A3i launch which we are now broadening."

Three Months Ended September 30, 2022 Financial Results

Total revenue for the three months ended September 30, 2022 was $26.5 million, compared to $19.2 million for the same period last year.

Total cost of revenue for the three months ended September 30, 2022 was $22.0 million, compared to $17.3 million for the same period last year.

Total gross profit for the three months ended September 30, 2022 was $4.5 million, compared to $1.9 million for the same period last year.

Total operating expenses for the three months ended September 30, 2022 were $28.4 million, compared to $25.2 million for the same period last year.

Net loss for the three months ended September 30, 2022 was $26.1 million, or $(0.14) per share, compared to $25.3 million, or $(0.15) per share, for the same period last year.

ViewRay’s total cash and cash equivalents, inclusive of a customer deposit reflected in restricted cash, was $146.9 million as of September 30, 2022.

Nine Months Ended September 30, 2022 Financial Results

Total revenue for the nine months ended September 30, 2022 was $67.5 million, compared to $49.7 million for the same period last year.

Total gross profit for the nine months ended September 30, 2022 was $5.6 million, compared to $0.5 million for the same period last year.

Total operating expenses for the nine months ended September 30, 2022 were $86.8 million, inclusive of a $1.8 million impairment charge, compared to $75.0 million for the same period last year.

Net loss for the nine months ended September 30, 2022 was $79.5 million, or $(0.44) per share, compared to $83.0 million, or $(0.51) per share, for the same period last year.

Financial Guidance

The Company updated its 2022 guidance. The Company is again raising the bottom end of its revenue guidance from $90 million to $94 million, and reiterated the top end of the range of $104 million. This change is based on improved visibility and confidence in achieving the new revenue range.

The Company is revising its cash usage guidance to be in the range of $78 million to $92 million. This move is based on the Company’s year-to-date cash usage of nearly $73 million and risk in the timing of receipt of a couple large system related payments. System shipments for the year remain on track but, installation project timelines related to construction and permitting activities routinely change and can result in an impact on the interquarter timing of payments. The Company expects to collect these payments in 2023 and for those payments to benefit 2023 cash.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Tuesday, November 1, 2022 at 5:00 p.m. ET / 2:00 p.m. PT. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call.

On November 1, 2022 Focal Medical, Inc. (formerly Advanced Chemotherapy Technologies, Inc.), a privately held, biopharmaceutical company developing novel therapeutic products based on its innovative local drug delivery technology platform, reported the appointment of Michael Aldridge as the Company’s new Chief Executive Officer (Press release, Advanced Chemotherapy Technologies, NOV 1, 2022, View Source [SID1234622739]). Michael joins Focal Medical with more than 25 years of experience in the biopharma industry. He succeeds Tony Voiers, who assumes the role of Chief Operating Officer.

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Focal Medical is the new name of Advanced Chemotherapy Technologies. Focal Medical’s corporate rebranding is a function of a strategic shift towards broader product applications of its targeted drug delivery technology. To date, Focal Medical has raised over $20 million in equity and grant funding. Institutional investors include Khosla Ventures, Spectrum Financial and Piedmont Capital Partners.

Focal Medical’s patented iontophoresis delivery system enables the internal, site-specific, active delivery of drugs directly and selectively to diseased target tissue or organs. The technology thus addresses the significant challenges and limitations of traditional (primarily oral and intravenous) systemic drug delivery approaches including toxicity and first-pass metabolism.

Focal Medical’s lead product candidate uses its patented iontophoresis system for the local delivery of gemcitabine (an FDA approved chemotherapeutic) actively and directly to the tumor to treat advanced unresectable pancreatic cancer. In preclinical studies, 100% of pancreatic cancer tumors treated with gemcitabine using the system shrunk by an average of 40%, while tumors treated with intravenous gemcitabine grew an average of 140%i. Focal Medical expects to file an IND with the FDA and initiate its first clinical trial in 2023.

Focal Medical’s pipeline expansion plans include products targeting other inoperable solid tumors and products utilizing its innovative technology to deliver gene therapy drugs.

"As we prepare for our first clinical trial in pancreatic cancer and progress exciting new research in treating additional solid tumors and genomics medicine products, the future is very promising," commented Joseph M. DeSimone, Focal Medical Founder and Non-executive Chairman.

"To position ourselves to leverage the extraordinary value of this platform technology, I am excited to announce the new company name, Focal Medical, as well as our new CEO, Michael Aldridge. Michael brings a great breadth of experience to the position, having led successful life science startups and growth stage companies including Peplin, Questcor Pharmaceuticals, Codexis, and most recently Hexima. I’d also like to thank Tony Voiers for his service as CEO these past six years and for his future service as COO," he continued.

"I’m thrilled and humbled to be joining the Focal Medical team as CEO," added Aldridge. "The team has been outstanding, demonstrating the potential of Focal Medical’s local drug delivery platform and we are well positioned to take a giant leap forward into new product opportunities. I’m excited to lead the Company into a new era of innovative therapeutic products based on Focal Medical’s energy-based delivery platform particularly in oncology and gene therapy."

"I’m extremely proud of the progress we have made on our local drug delivery platform to bring us to this point, and I’m excited to be working with Michael to lead the growth and development of Focal Medical into our next chapter," commented Voiers.

On November 1, 2022 Exelixis, Inc. (Nasdaq: EXEL) and Sairopa B.V. (Sairopa) reported that the companies have entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRPα (Press release, Exelixis, NOV 1, 2022, View Source [SID1234622738]). SIRPα expressed on myeloid cells interacts with CD47 present on the surface of cancer cells and blocks the ability of macrophages to clear tumor cells via phagocytosis and inhibits tumor antigen presentation to T-cells. Blocking SIRPα has the potential to improve the immune system’s ability to attack tumors by addressing a significant immune-suppressive component of the tumor microenvironment. ADU-1805 is active against all human alleles of SIRPα, which may allow it to address a broader patient population than other SIRPα-directed therapies. ADU-1805 has also been optimized to bind preferentially to SIRPα vs. other SIRP family members, which may enhance its ability to stimulate immune cells.

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"With a track record of success in advancing and commercializing novel therapies in diverse oncology indications, Exelixis was our partner of choice for realizing the broad potential of ADU-1805 and achieving our shared mission to improve outcomes for patients living with cancer."

"ADU-1805 is a promising antibody that has been carefully optimized to maximize the potential benefit of blocking the SIRPα – CD47 checkpoint, while minimizing potential toxicities and allowing for treatment of the broadest population of appropriate patients. We believe that ADU-1805 represents a differentiated and potentially best-in-class approach to this pathway," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer, Exelixis. "With an Investigational New Drug filing anticipated in the first quarter of 2023, this agreement provides an exciting opportunity to expand our clinical pipeline. There is a strong scientific rationale for blockade of this pathway in multiple solid tumor types and for combining ADU-1805 with XL092, our novel tyrosine kinase inhibitor, and with approved immune checkpoint inhibitors, further expanding the potential clinical and commercial value of ADU-1805."

"Sairopa was founded to develop a portfolio of therapeutic antibodies that modulate immune system activity to provide benefit to cancer patients. The preclinical data we have generated to date for ADU-1805 are compelling and suggest that this novel antibody has best-in-class potential, both as a single agent and in combination with other novel therapies or immune checkpoint inhibitors," said Dharminder Chahal, Managing Director, Sairopa. Commenting on the news, Gurvinder Chahal, Sairopa’s Chief Business Officer, added: "With a track record of success in advancing and commercializing novel therapies in diverse oncology indications, Exelixis was our partner of choice for realizing the broad potential of ADU-1805 and achieving our shared mission to improve outcomes for patients living with cancer."

SIRPα is expressed on the surface of macrophages and other myeloid cells, which are a significant component of the tumor microenvironment and are believed to contribute to an immune-suppressive environment. SIRPα interacts with CD47 expressed on the surface of cancer cells to inhibit antibody-dependent cellular phagocytosis (ADCP), the process by which the immune system clears tumor cells that have therapeutic antibodies bound to them from the body. Inhibition of ADCP can limit the efficacy of antibody-based therapies. SIRPα blockade also enhances tumor antigen uptake induced by tumor cytotoxic approaches such as radiotherapy or chemotherapy and enhances antigen presentation, which when combined with other immune checkpoint inhibitors is believed to enhance the anti-tumor immune response. Several CD47-targeted therapies are in development and have shown clinical efficacy both as single agents and in combination with opsonizing antibodies. However, the broad expression of CD47 in healthy tissues and CD47 inactivation of T-cells has resulted in significant toxicities, including anemia and thrombocytopenia. In contrast, SIRPα has a more limited pattern of expression that excludes red blood cells and platelets and has the potential for an improved safety profile compared with anti-CD47 therapies.

Financial Considerations

Under the terms of the agreement, Exelixis will make an upfront payment to Sairopa of $40 million and an additional $70 million in near-term milestones for an option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies, and for certain expenses to be incurred by Sairopa in conducting prespecified phase 1 clinical studies of ADU-1805 during the option period. Sairopa is eligible to receive additional success-based development milestone payments during the option period. Following the completion of the prespecified clinical studies, Exelixis has the right to exercise its option for an option exercise fee of $225 million. If Exelixis exercises the option, Sairopa is eligible to receive additional payments upon achievement of specified clinical, commercial and net sales milestones, as well as tiered royalties on net sales worldwide.

On November 1, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported the appointment of Daniel O’Connor as Chief Executive Officer (Press release, Ambrx, NOV 1, 2022, View Source [SID1234622737]).

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"On behalf of the board of directors and management team, I would like to welcome Dan to Ambrx. I very much look forward to working with him to execute on Ambrx’s new strategic direction," said Katrin Rupalla, Chair of Ambrx’s Board of Directors. "Dan is the ideal candidate for the role of CEO, given his extensive leadership experience in oncology drug development, strategic partnership formation, and streamlining operations within the biotech industry. I would also like to thank Kate Hermans, our interim CEO and board member, for her hard work, dedication, and leadership over the past several months to reprioritize Ambrx’s development pipeline."

"I am thrilled by the opportunity to lead Ambrx as the company focuses on the development of ARX517, potentially the first PSMA-targeting ADC therapy for prostate cancer," said Daniel O’Connor, chief executive officer of Ambrx. "Ambrx’s proprietary EPB platform enables us to produce biologic product candidates with highly stable, site-specific conjugation, thereby overcoming the inherent limitations of conventional drug conjugation approaches. This has the potential to play a key role in changing the current treatment paradigm for cancer patients. I look forward to working together with the Ambrx management team to bring the promise of Ambrx’s technology to cancer patients currently underserved by the standard of care."

Mr. O’Connor has over 23 years of executive experience and leadership in all aspects of the biopharmaceutical industry, including CEO leadership of two public oncology-focused companies, OncoSec Medical and Advaxis, Inc., as well as C-Suite leadership roles at ImClone Systems, Bracco Diagnostics, and PharmaNet, Inc. (today, Syneos Health). He has a proven record of accomplishment in oncology drug development, with a focus on business strategy, clinical execution, product development, business transformation and corporate development. He has overseen the successful initiation of several early phase oncology clinical trials, including combination trials with several different FDA approved checkpoint inhibitors. Additionally, he has led numerous life science licensing transactions and drug development collaborations with major pharmaceutical companies and has raised hundreds of millions in the capital marketplace. Mr. O’Connor earned a J.D. from the Dickinson School of Law of Pennsylvania State University and a B.A. from Boston University.

On November 1, 2022 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported it will host a conference call on Tuesday, November 8, 2022, to discuss its third quarter 2022 financial results. The call will begin at 4:30 PM Eastern Time (Press release, Quanterix, NOV 1, 2022, View Source [SID1234622735]). It will be hosted by Masoud Toloue, the Company’s President and Chief Executive Officer, and Michael Doyle, the Company’s Chief Financial Officer.

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Quanterix will issue a press release regarding the third quarter 2022 earnings prior to the conference call. The press release will be posted on the Quanterix website at View Source

Please click here to pre-register for the conference call and obtain your dial in number and passcode. You can also visit this link to listen to the call via live webcast. You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.