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Carisma Therapeutics Announces Multiple Abstracts Accepted for Presentation at the Society for Immunotherapy of Cancer 37th Anniversary Annual Meeting

On November 1, 2022 Carisma Therapeutics Inc. (Carisma Therapeutics), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today the acceptance of multiple abstracts to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Anniversary Annual Meeting in Boston, Massachusetts, which is being held November 8 to November 12, 2022 (Press release, Carisma Therapeutics, NOV 1, 2022, View Source [SID1234622744]). Accepted abstracts include: two abstracts of clinical trial data, including one for oral presentation; four abstracts of pre-clinical study data; and one abstract overviewing the design of a Phase 1 clinical trial for CT-0508.

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"We are excited to participate at the SITC (Free SITC Whitepaper) 37th Anniversary Annual Meeting so we can share the latest updates from our landmark CT-0508 trial," said Steven Kelly, Chief Executive Officer of Carisma Therapeutics. "Across the seven abstracts we will be presenting, we are eager to share the promising clinical and pre-clinical updates and the advances within the Carisma Therapeutics pipeline."

Presentation and posters will be available on the SITC (Free SITC Whitepaper) 37th Anniversary Annual Meeting portal for registered attendees. Details of the presentations are as follows:

Oral Presentation:
Title: Characterization of CT-0508, an anti-HER2 chimeric antigen receptor macrophage (CAR-M), manufactured from patients enrolled in the phase 1, first in human, clinical trial of CT-0508
Oral Presentation Abstract Number: 315
Date/Time: November 11, 2022, 12:18pm EST – 12:26pm EST
Poster Presentations:
Title: Chimeric antigen receptor macrophages (CAR-M) sensitize solid tumors to anti-PD1 immunotherapy
Poster/Abstract Number: 371
Date: November 10, 2022
Title: A Phase 1, First in Human (FIH) study of autologous macrophages containing an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors.
Poster/Abstract Number: 633
Date: November 10, 2022
Title: A phase 1, first-in-human (FIH) clinical trial of the anti-HER2 CAR macrophage CT-0508 in participants with HER2 overexpressing solid tumors.
Poster/Abstract Number: 634
Date: November 11, 2022
Title: Macrophages Engineered to Express Synthetic Cytokine Switch Receptors Act as Living Microenvironment Converters
Poster/Abstract Number: 376
Date: November 11, 2022
Title: Pre-clinical development of a CAR Monocyte platform for cancer immunotherapy
Poster/Abstract Number: 318
Date: November 11, 2022
Title: Pre-clinical development of CT-1119, a mesothelin targeting chimeric antigen receptor macrophage (CAR-M), for solid tumor immunotherapy
Poster/Abstract Number: 194
Date: November 11, 2022

Applied BioMath, LLC Announces Collaboration with SpringWorks Therapeutics, Inc. for Systems Pharmacology Modeling in Multiple Myeloma

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]).

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."

Novavax to Host Conference Call to Discuss Third Quarter 2022 Financial Results and Operational Highlights on November 8, 2022

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:

ViewRay Announces Third Quarter 2022 Results

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]).

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.

Michael Aldridge, Seasoned Biotech Executive, Appointed CEO of Focal Medical

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.

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.