On January 10, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported its 2023 financial guidance and commented on its outlook for the upcoming year (Press release, Halozyme, JAN 10, 2023, View Source [SID1234626179]).

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"In 2022, we project we achieved record revenue of greater than $655 million and we completed the acquisition of Antares Pharma, opening up an expanded set of opportunities for our subcutaneous drug delivery business," said Dr. Helen Torley, president and chief executive officer. "In 2023, we project record revenue of $815 to $845M and greater than 30% growth in EBITDA to $415 to $440 million. As our ENHANZE pipeline advances, we are excited about the future royalty revenue opportunities represented in 2023 by the potential for two new commercial launches, SC efgartigimod and SC atezolizumab."

Anticipated 2023 Key Events:

•Projected growth of >20% in the Company’s high-margin, recurring revenue stream from royalties to approximately $445 to $455 million driven by continued strength in Wave 2 products, including DARZALEX SC (daratumumab) and Phesgo (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE technology, as well as full year auto-injector royalty contribution.
•Two ENHANZE subcutaneous (SC) approvals and commercial launches by collaboration partners, including SC efgartigimod and SC atezolizumab.
•Four Phase 3 study data readouts from products utilizing ENHANZE by the Company’s collaboration partners
•SC efgartigimod in CIDP, ITP and Pemphigus (autoimmune disorders of the nervous system, blood and skin)
•SC ocrelizumab for certain patients with multiple sclerosis
•At least 2 new products utilizing ENHANZE entering Phase 1 development by the Company’s collaboration partners.
•At least one new collaboration and licensing agreement for ENHANZE, for a partner to test our developmental large volume auto-injector plus ENHANZE, and for our small volume auto-injector.
•Initiation of a clinical study to continue to evaluate the feasibility testing of our large volume auto-injector.

•Up to $150 million in share repurchases, dependent on market conditions and other factors, as part of the $750 million three-year share repurchase plan authorized by Halozyme’s board of directors in December 2021 demonstrating the Company’s continued commitment to a balanced capital allocation strategy.
2023 Financial Guidance:

•Revenue: Halozyme expects total revenue of $815 million to $845 million, representing growth of >20% over 2022 expected total revenue. The Company expects revenue from royalties to increase >20% over expected revenue from royalties in 2022, to a range of $445 million to $455 million.
•EBITDA: Halozyme expects EBITDA of $415 million to $440 million, representing growth of >30% over 2022 expected EBITDA and excludes the impact of amortization costs in 2023 related to the Antares Pharma acquisition.
•Earnings per Share: Halozyme expects Non-GAAP diluted earnings per share of $2.50 to $2.65. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Table 1. 2023 Financial Guidance
Guidance Range
Total Revenue $815 to $845 million
Royalty Revenue $445 to $455 million
EBITDA $415 to $440 million
Non-GAAP Diluted EPS $2.50 to $2.65

On January 10, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported a global collaboration with Karyopharm Therapeutics Inc. to develop FoundationOneCDx as a companion diagnostic for selinexor, which is being evaluated as a front-line maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer (Press release, Foundation Medicine, JAN 10, 2023, View Source [SID1234626171]).

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Endometrial cancer is the most common cancer of the female reproductive organs in the U.S.1 Roughly 50% of patients with advanced or recurrent disease have p53 wild-type tumors.2 Karyopharm’s phase 3 study (EC-042; NCT03555422) is a multicenter, blinded, placebo-controlled, randomized study evaluating the efficacy and safety of selinexor as a maintenance therapy following systemic therapy in patients with advanced or recurrent TP53 wild-type endometrial cancer. The study is utilizing Foundation Medicine’s tissue-based next generation sequencing test to identify and enroll patients whose tumors are TP53 wild-type.

"We’re looking forward to partnering with Karyopharm as they work to advance this exciting new treatment option for patients living with advanced endometrial cancer," said Sanket Agrawal, Chief Biopharma Business Officer, Foundation Medicine. "Our deep understanding of cancer biology and global regulatory expertise, combined with their innovative approach to developing cancer therapies puts us in a strong position to help more patients living with this devastating condition."

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 wild-type endometrial cancer who may be eligible for selinexor.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

On January 10, 2023 -NextPoint Therapeutics, a biotechnology company developing a new world of precision immuno-oncology, reported that it raised $80 million in Series B financing co-led by Leaps by Bayer, the impact investment arm of Bayer AG, and Sanofi Ventures, the strategic venture capital arm for Sanofi (Press release, NextPoint Therapeutics, JAN 10, 2023, View Source [SID1234626170]). The financing will be used to advance NextPoint’s two lead precision immuno-oncology programs into the clinic, both targeting the newly discovered HHLA2 pathway to activate anti-tumor immune responses.

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Additional new investors in the round include Invus, Catalio Capital Management, Sixty Degree Capital and PagodaTree Partners. Existing investors that took part in the financing include MPM Capital Management, Binney Street Capital/Dana-Farber Cancer Institute and NextPoint founder Gordon Freeman, PhD. As part of the financing, Rakhshita Dhar, Senior Director of Venture Investments Health at Leaps by Bayer, and Paulina Hill, Partner at Sanofi Ventures, will join the NextPoint Board of Directors.

NextPoint’s programs aim to deliver monotherapies for cancer patients without viable treatment options. While immune checkpoint inhibitors targeting PD-1/L1 have revolutionized cancer treatments, many patients do not benefit from these medications and require novel therapeutic strategies. Similar to PD-L1, the tumor antigen HHLA2 is a member of the B7 receptor family, is highly expressed on certain hard-to-treat cancers, and drives avoidance of detection from the immune system. Importantly, HHLA2 is independent of PD-L1 and is often most strongly expressed in PD-L1-negative cancers. NextPoint’s approach re-activates immune cells in tumors that are suppressed by HHLA2-driven immune evasion.

NextPoint originated from the combined expertise of its academic founders, Gordon Freeman, PhD, of the Dana-Farber Cancer Institute, and XingXing Zang, PhD, of Albert Einstein College of Medicine. Drs. Freeman’s and Zang’s independent discovery and characterization of the HHLA2 pathway formed the basis of the NextPoint approach. The company and its founders have shown in preclinical models and with analysis of existing clinical datasets that the HHLA2 pathway is an important tumor-suppressive mechanism in many patients1,2.

"NextPoint is building a deep understanding of the HHLA2 tumor-specific immune-escape mechanism, with the ultimate goal of establishing standalone treatments in cancers with high HHLA2 expression," said Detlev Biniszkiewicz, PhD, Chief Executive Officer of NextPoint Therapeutics. "The support of our new investors along with the continued commitment of our existing investors and founders emphasizes our momentum and progress in defining precision immuno-oncology for new patient segments."

Juergen Eckhardt, MD, Head of Leaps by Bayer, commented, "Leaps by Bayer was founded to help solve ten of the world’s biggest challenges in health and agriculture, including preventing and curing cancer. We are thrilled to support NextPoint, an exciting addition to our oncology portfolio, as it works to redefine the treatment landscape of immuno-oncology."

On January 10, 2023 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported it favorable results from the CRC-PREVENT trial – a pivotal clinical trial evaluating the efficacy of its noninvasive, stool-based, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals (Press release, Geneoscopy, JAN 10, 2023, View Source [SID1234626168]). In the trial, Geneoscopy’s stool-based screening test met the clinical endpoints across all primary outcome measures, including sensitivity and specificity for CRC and AA.

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The CRC-PREVENT trial included 8,289 individuals with diverse racial, ethnic, and socioeconomic backgrounds across more than 2,900 zip codes in all lower 48 states, with colonoscopies performed in more than 3,800 endoscopy centers, which reflect the diversity of gastroenterology practices across America. Efficacy results from the study include:

94% sensitivity for detecting CRC
45% sensitivity for detecting AA
88% specificity for no findings on a colonoscopy
These sensitivity results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date. Of note, CRC-PREVENT is the first prospective clinical study wherein a stool-based test demonstrated the ability to detect CRC amongst 45-49-year-olds in a US population.1 Additionally, CRC and AA sensitivity performance results for Geneoscopy’s test exceed those recently reported from a large clinical study for a blood-based test.2 Moreover, a recent study suggests, when given a choice, patients are more willing to comply with a stool-based screening test than a blood-based test. This was primarily attributed to the greater ability to complete a stool test at home.3

Importantly, given Geneoscopy’s decentralized clinical trial approach, the demographics of the patients who enrolled and completed the CRC-PREVENT study are more reflective of the socioeconomic and racial diversity of the country than most conventional, centralized trials. The diversity of the patient cohort confirms the test’s performance across different demographic groups and advances the important goal of increased access to healthcare innovation for historically underserved populations.

Geneoscopy’s test, performed in its St. Louis laboratory, uses a novel, proprietary method to stabilize and extract eukaryotic RNA biomarkers from stool samples that may allow for improved diagnosis and management of gastrointestinal diseases such as CRC. The FDA granted the test its Breakthrough Designation in January 2021.

"The use of our patented RNA biomarker technology is a first in CRC screening. The large-scale prospective clinical study data demonstrate that this noninvasive CRC screening test can accurately detect if people have cancer and if they have advanced adenomas that put them at higher risk of developing cancer. These results provide further evidence that our test may allow patients to get appropriate treatment, in some cases, even before cancer develops," said Dr. Erica Barnell, Chief Science Officer and Geneoscopy’s co-founder. "Our sincerest gratitude goes to all who participated in or were involved with this trial. We look forward to submitting a Premarket Approval application to the FDA to make this cutting-edge innovation available to the millions of Americans eligible to be screened for CRC."

Despite CRC being this country’s second leading cause of cancer death, millions of eligible Americans do not get screened – many due to a lack of access or avoidance of invasive options like colonoscopies.

"Colonoscopy screening rates declined during the pandemic, stressing the need for noninvasive screening options. That’s why noninvasive tests, allowing for collection to be done at home, have become a critical tool in the battle against CRC, as they make screening easier and more accessible," noted Dr. David Lieberman, Professor of Medicine, Division of Gastroenterology and Hepatology, Oregon Health Sciences University School of Medicine, and past president of the American Gastroenterology Association.4 "Geneoscopy’s test and the positive clinical trial results are promising because patients need additional convenient options that will accurately detect colon cancer, as well as advanced adenomas, before patients have cancer. If we can identify patients with advanced adenomas and remove those lesions, many cancers can be prevented. I’m hoping to have a new and highly reliable test available for patients soon – one that will allow them to conveniently screen for CRC in their own homes."

Geneoscopy’s test is not yet available for sale and is not yet approved by the U.S. Food and Drug Administration (FDA). A Premarket Approval submission to the FDA is planned for the first quarter of 2023.

About CRC-PREVENT

CRC-PREVENT was a Phase 3 prospective, single-arm study designed to evaluate the efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to detect colorectal cancer and advanced adenomas in average-risk individuals aged 45 years and older. Using a collection kit, participants submitted self-collected stool samples via express delivery and underwent an optical colonoscopy examination. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology. A comparative analysis was conducted to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies with no findings.

About Colorectal Cancer & Screening

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. Yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and potential time away from work. Currently available noninvasive screening methods demonstrate lower sensitivity to detect early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are estimated to be a precursor in 95 percent of CRC cases.

On January 10, 2023 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing biologics for the treatment of cancer and neuropathy, reported that the first adult patient has been dosed in the Phase 1b/2 Placebo Controlled, Double Blinded Study on the Efficacy and Safety of BXQ-350 in Combination with mFOLFOX7 and Bevacizumab in Newly Diagnosed Metastatic Colorectal Carcinoma (ASIST) (Press release, Bexion, JAN 10, 2023, View Source [SID1234626169]).

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The study will assess the safety and efficacy of BXQ-350 plus modified FOLFOX7 (mFOLFOX7) and bevacizumab in participants who have newly diagnosed metastatic adenocarcinoma of the colon/rectum. The study will also evaluate if the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish chemotherapy induced peripheral neuropathy (CIPN), enabling participants to receive the total and planned doses of mFOLFOX7.

"Dosing our first patient in this trial is a major milestone for Bexion," stated Scott Shively, President and CEO. "BXQ-350 combined with its observed safety profile, potential efficacy, and possible neuropathy benefit makes BXQ-350 a worthwhile candidate to use in combination with standard of care treatment for mCRC to not only enhance the treatment of mCRC, but also to evaluate its ability to alleviate side effects related to CIPN."

Initial launch of the trial includes 6 sites with expansion up to 15 sites in the United States.