Janux Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights

On March 10, 2023 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update (Press release, Janux Therapeutics, MAR 10, 2023, View Source [SID1234628523]).

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"Janux made great strides in 2022 as we transitioned to a clinical-stage company by dosing the first patient with our PSMA-TRACTr and advancing our pipeline utilizing our novel TRACTr and TRACIr platforms. We recently received IND clearance from the FDA for our EGFR-TRACTr, keeping us on track to enter a second program into the clinic. Importantly, this milestone underscores our ability to reproducibly bring novel immunotherapies through development and deliver them to patients. Two of our core values at Janux are ‘collaboration’ and ‘urgency,’ and both were on display in connection with hitting these milestones," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

Janux has prioritized its programs to enable sufficient funding to provide key clinical data assessments for its lead programs. Janux is aware of recent media reports related to the closure of Silicon Valley Bank ("SVB"). Janux considers its exposure to any liquidity concern at SVB as immaterial and will have no impact on its short- or long-term objectives. In addition, none of Janux’s investment portfolio contains direct exposure to SVB.

Lead program PSMA-TRACTr (JANX007) continues to enroll in first-in-human Phase 1 clinical trial in prostate cancer patients.
Janux received U.S. Food and Drug Administration (FDA) clearance for an IND application for EGFR-TRACTr (JANX008).
PD-L1xCD28 TRACIr (JANX009) on-track for an IND submission in 2023.
TROP2-TRACTr evaluations to support development candidate selection are ongoing.
Janux anticipates providing an interim clinical update from the PSMA-TRACTr (JANX007) trial in the second half of 2023. In addition, Janux expects to select a development candidate for its TROP2-TRACTr in 2023.

FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS:

Cash and cash equivalents and short-term investments: As of December 31, 2022, Janux reported cash and cash equivalents and short-term investments of $327.0 million, compared to $375.0 million at December 31, 2021.
Research and development expenses: Research and development expenses were $15.4 million for the quarter and $53.4 million for the year ended December 31, 2022, compared to $11.2 million and $26.2 million for the same quarter and year in 2021.
General and administrative expenses: General and administrative expenses were $5.7 million for the quarter and $22.3 million for the year ended December 31, 2022, compared to $3.9 million and $10.3 million for the same quarter and year in 2021.
Net loss: Net loss was $16.1 million for the quarter and $63.1 million for the year ended December 31, 2022, compared to $13.4 million and $32.7 million for the same quarter and year in 2021.
Janux’s TRACTr and TRACIr Pipeline

Janux’s lead candidate, JANX007, is being investigated in a phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a TRACTr that targets PSMA, a protein expressed in prostate cancer tumors and the vasculature of tumors, and a validated target for treating mCRPC. Similarly, JANX008 is a TRACTr that targets EGFR and is being studied in a phase 1 trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux’s TRACIr drug candidate JANX009 is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.

Agilent Announces Digital Pathology Scanner Distribution Agreement with Hamamatsu

On March 10, 2023 Agilent Technologies Inc. (NYSE: A) reported it has partnered with Hamamatsu Photonics K.K., a leading provider of whole slide imaging systems, to incorporate their NanoZoomer range including the S360MD Slide scanner system into the Agilent end-to-end digital pathology solution (Press release, Agilent, MAR 10, 2023, View Source [SID1234628522]). With the addition of the NanoZoomer Slide scanner systems, which converts glass slides into high-resolution digital data by high-speed scanning, Agilent completes its offering of an open and agnostic digital pathology workflow designed to accelerate breakthroughs in precision medicine.

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Today’s pathology labs face increasing pressure to manage greater patient and test loads with fewer pathologists, compounded by the growing trend toward remote work situations. To meet this challenge, many pathology laboratories are seeking new ways to improve workflow efficiency and facilitate remote analysis. These circumstances have highlighted the need for a digital pathology solution to increase laboratory efficiency, clinical utility, and test quality.

By incorporating Hamamatsu’s slide scanning capability into its digital pathology solution, Agilent takes a significant step forward in its quest to support pathologists with an advanced platform that can reduce time-to-diagnostic and help improve patient outcomes. This scalable digital pathology workflow features scanners, an image management system, and digital pathology applications that are compatible with Agilent pathology solutions as well as other technology and laboratory information systems (LIS), allowing forward-thinking labs to benefit from flexible, future-proof technology that positions them for growth as requirements evolve.

"Increasing cancer cases and tests have driven pathology labs towards the implementation of digital pathology," said Lou Welebob, vice president and general manager of Agilent’s Pathology division, Diagnostics and Genomics Group. "This distribution agreement strengthens Agilent’s open and agnostic end-to-end digital pathology offering and demonstrates our commitment to providing superior digital pathology solutions for our customers."

"Time is critical for patients and clinicians when awaiting a diagnosis. At Hamamatsu, our NanoZoomer Slide scanner digital pathology product line will help revolutionize the diagnostic process, enabling fast turnaround times, more efficient workflows, and more collaboration among pathologists worldwide. We are committed to facilitating the adoption of this transformative technology to help pathologists improve patient care and patient outcomes for every patient and, ultimately, anywhere in the world," said Laura Pagano, vice president of Sales at Hamamatsu Corporation.

Hamamatsu Photonics K.K. is a leading provider of whole slide imaging systems and related technology such as optical sensors, light sources, and complex instrument systems that use them. The FDA has recently granted 510(k) clearance to market their NanoZoomer S360MD slide scanner system for primary diagnostic use in the US market.

Akumin to Host Year-end 2022 Financial Results Call on March 17, 2023

On March 10, 2023 Akumin Inc. (NASDAQ: AKU) (TSX: AKU) ("Akumin" or the "Company") reported that it will host a conference call at 8:30 a.m. Eastern Time, March 17, 2023, to discuss its year-end 2022 financial results (Press release, Akumin, MAR 10, 2023, View Source [SID1234628521]). The financial results are expected to be available on Thursday, March 16, 2023.

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To access the conference call, participants may join by using an appropriate dial-in number available through View Source or via webcast at View Source A related presentation will be available from Akumin’s website (www.akumin.com). Participants are asked to connect at least 10 minutes prior to the beginning of the call to ensure participation. The webcast archive will be available for 90 days. A replay of the presentation will also be available until Friday, March 24, 2023 by calling 647-436-0148 or toll-free 1-888-203-1112, using passcode number 6212460.

Heron Therapeutics to Report Fourth Quarter and Full Year 2022 Financial Results on Thursday, March 23, 2023

On March 10, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that the company will host a conference call and live webcast on Thursday, March 23, 2023 at 4:30 p.m. ET to report fourth quarter and full year 2022 financial results and discuss recent business highlights (Press release, Heron Therapeutics, MAR 10, 2023, View Source [SID1234628520]).

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The conference call can be accessed by dialing (646) 307-1963 in the U.S. or (800) 715-9871 internationally. Please provide the operator with the passcode 7469717 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

Sumitovant Biopharma Completes Acquisition of Myovant Sciences

On March 10, 2023 Sumitovant Biopharma Ltd. ("Sumitovant") and Myovant Sciences Ltd. ("Myovant") reported that Sumitovant has successfully completed its acquisition of Myovant originally announced October 23, 2022 (Press release, Myovant Sciences, MAR 10, 2023, https://investors.myovant.com/news-releases/news-release-details/sumitovant-biopharma-completes-acquisition-myovant-sciences [SID1234628518]). Sumitovant has acquired all outstanding shares of Myovant not already owned by Sumitovant in an all-cash deal with a total transaction value of approximately $1.7 billion. With the completion of the acquisition, Myovant will be delisted from the New York Stock Exchange, and its shares will no longer be publicly traded.

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"We are excited to have officially completed our acquisition of Myovant and look forward to working together to address unmet needs in women’s health and prostate cancer," said Myrtle Potter, CEO of Sumitovant. "By combining our unique expertise, platforms and resources, we will be better positioned to drive the growth of Myovant’s products and accelerate the development of our robust combined pipeline."

"I am confident that bringing together the capabilities and strengths of Sumitovant and Myovant will best position us to continue delivering innovative therapies to patients sooner and accelerate the potential opportunities for ORGOVYX and MYFEMBREE," said Hiroshi Nomura, CEO of Sumitomo Pharma.

"I look forward to all we will be able to achieve with the support of Sumitovant and Sumitomo Pharma to expand the impact of our differentiated therapies and advance our clinical programs," said David Marek, CEO of Myovant. "We remain steadfast in our commitment to advance life-changing medicine and health equity for the patient communities we serve."

Advisors
J.P. Morgan Securities LLC served as financial advisor and Sullivan & Cromwell LLP served as legal counsel to Sumitovant and Sumitomo Pharma. Goldman Sachs & Co. LLC served as financial advisor to the Special Committee of the Board of Directors of Myovant and Skadden, Arps, Slate, Meagher & Flom LLP served as legal counsel to the Special Committee.