On February 22, 2022 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that it will host a conference call and webcast on Monday, February 28, 2022 at 8:00 a.m. ET to report financial results for the fourth quarter and year ended December 31, 2021 and provide business updates (Press release, Mersana Therapeutics, FEB 22, 2022, https://ir.mersana.com/news-releases/news-release-details/mersana-therapeutics-host-conference-call-announcing-fourth-3 [SID1234608804]).

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To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 7999454. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On February 22, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) ("Kiniksa"), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported fourth quarter and full-year 2021 financial results and provided a corporate update (Press release, Kiniksa Pharmaceuticals, FEB 22, 2022, View Source [SID1234608803]).

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"The successful launch of ARCALYST in recurrent pericarditis has been marked by continuous growth in prescriber adoption, expansion in payer coverage, and strong patient adherence," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "In 2022, we anticipate continued robust commercial execution and the further advancement of our clinical-stage pipeline. We expect data from the Phase 2b study of vixarelimab in prurigo nodularis in the second half of this year and will continue to enroll the Phase 2 trial of KPL-404 in rheumatoid arthritis. Our collaboration with Huadong Medicine provides non-dilutive capital and the opportunity to accelerate the development of ARCALYST and mavrilimumab in areas complementary to our existing autoinflammatory cardiovascular business."

Corporate Update

·Kiniksa and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (Huadong Medicine) reported a strategic collaboration to develop and commercialize ARCALYST and mavrilimumab in the Asia Pacific Region, excluding Japan.
-Kiniksa will receive $22 million upfront and is eligible to receive up to approximately $640 million in specified development, regulatory and sales-based milestones. Kiniksa is also eligible to receive tiered percentage royalties ranging from the low-teens to the low-twenties on annual net sales.

Portfolio Execution

ARCALYST (IL-1α and IL-1β cytokine trap)

·ARCALYST net revenue was $18.7 million for the fourth quarter of 2021 and $38.5 million since launch on April 1, 2021.
·Kiniksa’s ARCALYST collaboration achieved profitability in the fourth quarter of 2021, following three quarters of commercial availability for recurrent pericarditis.
·More than 300 prescribers have written for ARCALYST for recurrent pericarditis since launch, with more than 50 repeat prescribers.
·Approximately 95% of completed patient enrollment cases for recurrent pericarditis were approved for coverage in the fourth quarter of 2021.
·Approximately 70% of recurrent pericarditis patients who started ARCALYST in the second quarter of 2021 were still on therapy at the end of 2021.

Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

·Kiniksa is evaluating the development of mavrilimumab in cardiovascular diseases where the granulocyte macrophage colony stimulating factor (GM-CSF) mechanism has been implicated and that have synergies with the company’s existing commercial infrastructure.
·Kiniksa does not plan to initiate a Phase 3 trial for mavrilimumab in giant cell arteritis (GCA).

Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

·Kiniksa expects data from the Phase 2b dose-ranging clinical trial of once-monthly subcutaneous vixarelimab in prurigo nodularis in the second half of 2022.
-Kiniksa previously reported that the Phase 2a clinical trial of vixarelimab in prurigo nodularis had achieved its primary and secondary efficacy endpoints.

KPL-404 (monoclonal antibody inhibitor of CD40-CD154 signaling)

·Kiniksa is conducting a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to enable potential development in a spectrum of autoimmune diseases believed to be mediated by the CD40-CD154 pathway.
·In January 2022, Kiniksa provided KPL-404 to the University of Maryland School of Medicine to be used experimentally as part of an immunosuppressive regimen administered in connection with a transplant of a genetically-modified pig heart into an adult human with end-stage heart disease who was not eligible for a standard allogeneic heart transplant.

Financial Results

·Net revenue from ARCALYST product sales in the fourth quarter and full-year 2021 was $18.7 million and $38.5 million, respectively.
-ARCALYST became commercially available through Kiniksa on April 1, 2021.
·Net loss for the fourth quarter of 2021 was $36.3 million, compared to a net loss of $53.7 million for the fourth quarter of 2020. Net loss for the full-year 2021 was $157.9 million, compared to a net loss of $161.4 million for the full-year 2020.
·Total operating expenses for the fourth quarter of 2021 were $54.9 million, compared to $52.9 million for the fourth quarter of 2020. Total operating expenses for the full-year 2021 were $195.2 million, compared to $157.4 million for the full-year 2020.
–Collaboration expense in the fourth quarter and full-year 2021 was $0.84 million. Kiniksa did not report a collaboration expense in 2020.
–Non-cash, share-based compensation expense for the fourth quarter of 2021 was $6.1 million, compared to $6.3 million for the fourth quarter of 2020. Non-cash, share-based compensation expense for the full-year 2021 was $25.2 million, compared to $20.9 million for the full-year 2020.
·Kiniksa ended 2021 with $182.2 million of cash, cash equivalents and short-term investments and no debt.

Financial Guidance

·Kiniksa expects ARCALYST net revenue for the full-year 2022 to be between $115 million and $130 million.
·Kiniksa continues to expect that its cash and cash equivalents will fund its current operating plan into 2024.

Upcoming Scientific Conference Presentations

·Presentations of new rilonacept and recurrent pericarditis data are planned at the upcoming American College of Cardiology (ACC) 71st Annual Scientific Session & Expo, being held in Washington DC and virtually from April 2, 2022 to April 4, 2022. Details of the presentations are as follows:
–Paul Cremer, MD, Cleveland Clinic, will present a poster entitled, Neutrophil to Lymphocyte Ratio for Tracking Inflammation and Recurrence in Patients with Recurrent Pericarditis: Post Hoc Assessment of a Phase 3 Trial, RHAPSODY.
–Ajit Raisinghani, MD, University of California San Diego, will present a poster entitled, Real-World Experience and Unmet Needs in the Current Management of Recurrent Pericarditis: A Physician Survey and Medical Chart Review.

Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Tuesday, February 22, 2022, to discuss fourth quarter and full-year 2021 financial results and to provide a corporate update.

Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 8145539. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

On February 22, 2022 FORUS Therapeutics, a Canadian biopharmaceutical company dedicated to advancing differentiated, novel medicines for hematologic malignancies and other forms of cancer, reported it has secured $2.5M CAD in growth capital from Silicon Valley Bank (Press release, FORUS Therapeutics, FEB 22, 2022, View Source;utm_medium=rss&utm_campaign=forus-therapeutics-secures-2-5m-cad-in-growth-capital-from-silicon-valley-bank [SID1234608802]). FORUS Therapeutics officially launched in January 2021, bringing a new pharmaceutical company onto the Canadian landscape. With a highly-experienced and proven team, an FDA-approved product already in its pipeline, and significant financial investment secured, the Toronto-based company was created to bring innovative cancer therapies to Canadian patients, new treatment options for caregivers and physicians, and in the future, be a preferred partner for emerging Canadian-based research companies.

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This funding supports FORUS as the company advances the commercialization of important treatment options for adults with Multiple Myeloma and other cancers. Multiple Myeloma is the second most common blood cancer. Every year, 3,400 Canadians are diagnosed with Multiple Myeloma, and sadly 1,600 die from the disease.

"We are excited to work with a financial partner like Silicon Valley Bank who understands the needs of a fast-growing company like ours," said Kevin Leshuk, CEO of FORUS Therapeutics. "The team at SVB took the time to truly understand our business and our unique opportunity. This is a great step forward in delivering solutions to address our working capital requirements today and for the future."

"This debt agreement demonstrates our confidence in the FORUS leadership team, their broader business strategy, and their ability to advance game-changing cancer treatments," said Anne Woods, Managing Director of Life Sciences and Healthcare at Silicon Valley Bank.

On February 22, 2022 Code Biotherapeutics, Inc. (Code Bio), a biotechnology company pioneering targeted non-viral delivery of genetic medicines, reported a collaboration and option agreement with Takeda to leverage Code Bio’s proprietary targeted 3DNA non-viral genetic medicine delivery platform to design and develop gene therapies for rare disease indications (Press release, Takeda, FEB 22, 2022, View Source [SID1234608801]).

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Through the agreement, Takeda and Code Bio will design and develop a targeted gene therapy leveraging Code Bio’s 3DNA platform for a liver-directed rare disease program, plus conduct additional studies for central nervous system-directed rare disease programs. Takeda has the right to exercise options for an exclusive license for four programs. Under the terms of the agreement, Code Bio will receive double-digit million dollars in upfront, near-term milestone and research funding payments. Code Bio is also eligible to receive future development and commercial milestone payments plus tiered royalties with a potential total deal value over the course of the partnership of up to $2 billion if milestones for all four programs are achieved. Takeda and Code Bio will collaborate on research activities up to candidate selection. After option exercise, Takeda will assume responsibility for further development and commercialization.

"We are proud to collaborate with Takeda, a world leader in the fields of genetic medicine and rare diseases," said Code Bio Chairman, Chief Executive Officer, and Co-Founder Brian P. McVeigh. "This collaboration will further enhance our capabilities by bringing together Takeda’s expertise in gene therapy and rare diseases with our expertise in delivering genetic medicines as we drive forward on our mission to bring meaningful treatments and cures to patients suffering from serious and life-threatening genetic diseases."

Code Bio’s targeted 3DNA non-viral genetic medicine delivery platform is designed to overcome key limitations of other genetic medicine delivery approaches and fully unlock the potential of genetic medicines. The synthetic, multivalent design of the 3DNA platform enables cell specific targeting, the delivery of large genetic payloads, and the potential for re-dosability. Extensive preclinical data have demonstrated that targeted formulations are highly specific and effective at delivering genetic cargo to targeted cells and tissues with no evidence of off-target effects or safety concerns related to the platform seen.

"We aim to provide functional cures to patients with rare genetic and hematologic diseases through next-generation gene therapy programs," said Madhu Natarajan, Head of the Rare Diseases Drug Discovery Unit at Takeda. "Code Bio’s 3DNA platform will allow us to build upon the foundation we have established through our internal capabilities and external partnerships and will hopefully enable us to develop re-dosable and durable gene therapies that will be superior to current approaches."

On February 22, 2022 Exact Sciences Corp. (Nasdaq: EXAS), a leader in advanced cancer diagnostics, reported that the company generated revenue of $473.8 million for the fourth quarter ended Dec. 31, 2021 and $1,767.1 million for the full year ended Dec. 31, 2021 (Press release, Exact Sciences, FEB 22, 2022, View Source [SID1234608800]).

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"Cologuard and Oncotype DX are off to a great start in 2022, with strong momentum from the fourth quarter carrying over to the new year," said Kevin Conroy, chairman and CEO of Exact Sciences. "We have a team of talented people dedicated to defeating cancer. You’ll see the results of their dedication this year as we test more patients and share evidence supporting our pipeline of innovative tests across the cancer continuum."

Fourth Quarter 2021 Financial Results

For the three-month period ended Dec. 31, 2021, as compared to the same period of 2020 (where applicable):

Total revenue was $473.8 million, an increase of 2 percent
Total revenue, excluding COVID-19 testing, increased 16 percent
Screening revenue was $277.7 million, an increase of 11 percent
Precision Oncology revenue was $149.0 million, an increase of 27 percent
COVID-19 testing revenue was $47.1 million, a decrease of 52 percent
Gross margin including amortization of acquired intangible assets was 70 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 75 percent
Net loss was $220.6 million or $1.28 per share, compared to a net loss of $418.3 million or $2.67 per share
EBITDA was $(175.1) million and adjusted EBITDA was $(122.2) million
Cash, cash equivalents, and marketable securities were $1,030.5 million at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products and therapy selection products, including oncomapTM and oncomapTM ExTra, formerly known as Oncotype MapTM and GEM ExTra, respectively.

2022 Outlook

The company anticipates revenue of $1,975-$2,027 million during 2022, assuming:

Screening revenue of $1,340-$1,367 million, including $40-$42 million from PreventionGenetics,
Precision Oncology revenue of $595-$610 million, and
COVID-19 testing revenue of $40-$50 million
Non-GAAP Disclosure

In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

Fourth Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, February 22, 2022, at 5 p.m. ET to discuss fourth quarter and full year 2021 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

About Cologuard

The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

About Oncotype DX

The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With nearly 1.5 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

About Exact Sciences’ Therapy Selection Program

Exact Sciences’ therapy selection program includes two comprehensive genomic profiling (CGP) tests to help physicians identify the genomic mutations driving advanced cancers, leading patients to better care through targeted cancer treatments. The oncomap ExTra test, formerly known as GEM ExTra, detects damage in tumor genes and provides a complete biological picture of certain refractory, rare, or aggressive cancers. With an extensive panel of approximately 20,000 genes and 169 introns, the oncomap ExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. The oncomap ExTra test provides physicians, academic medical centers, and biopharma researchers with vital interpreted information to understand changes to a patient’s tumor genomic profile and recommend therapeutic treatment plans.2 For patients with advanced and metastatic cancer, the company offers the oncomap test, formerly known as Oncotype MAP, a rapid, comprehensive tumor profiling panel, which delivers results in three to five business days and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials.

About PreventionGenetics

Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome and whole exome sequencing test, PGxome. PreventionGenetics was acquired by Exact Sciences in December 2021.