On November 1, 2022 Applied BioMath (www.appliedbiomath.com), the industry-leader in providing model-informed drug discovery and development (MID3) support to help accelerate and de-risk therapeutic research and development (R&D), reported their collaboration with SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, for the development of a systems pharmacology model in multiple myeloma (Press release, Applied BioMath, NOV 1, 2022, View Source [SID1234622743]).

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In this collaboration, Applied BioMath is developing a model of SpringWorks’ investigational oral selective small molecule gamma secretase inhibitor (GSI), nirogacestat, in combination with an agent that targets B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.

"Our goal is to lead the scientific understanding of the pharmacodynamic interactions between nirogacestat and BCMA-targeted agents in order to advance therapies more efficiently to help patients with multiple myeloma," said Todd Shearer, PhD, Vice President, Clinical Pharmacology at SpringWorks Therapeutics. "We are pleased to work with Applied BioMath given their expertise in building systems pharmacology models for biopharmaceutical companies and we look forward to working with them to further advance our BCMA efforts."

Applied BioMath offers software and services to help de-risk and accelerate drug R&D. Their solutions, which focus on quantitatively integrating knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms, are leveraged across the entire R&D spectrum from early research through to clinical trials. Their approach involves working with clients to develop the appropriate mathematical strategy for each unique project, with common strategies encompassing systems pharmacology, mechanistic modeling. bioinformatics, biosimulation, and clinical pharmacology.

"Applying mathematical and engineering approaches to translational medicine allows us to integrate knowledge about the therapeutic with an understanding of its mechanism of action in the context of human disease mechanisms," said John Burke, PhD, Co-founder, President and CEO at Applied BioMath. "This enables project teams developing therapeutics to answer more questions earlier and advance programs more efficiently."

On November 1, 2022 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported it will report its third quarter 2022 financial results and operational highlights on Tuesday, November 8, 2022, following the close of U.S. financial markets (Press release, Novavax, NOV 1, 2022, https://www.prnewswire.com/news-releases/novavax-to-host-conference-call-to-discuss-third-quarter-2022-financial-results-and-operational-highlights-on-november-8-2022-301665315.html [SID1234622741]). Details of the event and replay are as follows:

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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.