On November 8, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its results for the third quarter ended September 30, 2021 (Press release, Radius, NOV 8, 2021, View Source [SID1234594782]).

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Q3, 2021 FINANCIAL HIGHLIGHTS:

TYMLOS Net Revenue: $57 million in Q3, 2021 vs. $50 million in Q3, 2020, +13% year-over-year
Total Company Headcount: 285 in Q3, 2021 vs. 317 in Q3, 2020 a 10% reduction
TYMLOS Net Revenue per commercial employee: 50% increase in productivity in Q3, 2021 vs. Q3, 2020
Total Net Revenue: $57 million in Q3, 2021 vs. $78 million in Q3, 2020, -27% year-over-year due to $27 million in upfront license revenue received from Menarini Group for the elacestrant asset
Total Company Adjusted EBITDA: ($11) million in Q3, 2021 vs. $9 million in Q3, 2020, down year-over-year as 2020 results included the elacestrant upfront license revenue
RAD011 expenses increased by $5.5 million driven by life cycle planning and key talent recruitment
Total Operating Expenses: $69 million in Q3, 2021 vs. $73 million in Q3, 2020
Liquidity position: $110 million of cash, cash equivalents and marketable securities as of 9/30/2021
Our shift from a general osteoporosis sales approach to one that focuses on – primarily – the fracture patient segment continues to evolve. We have made progress and expect to make more in the future. However, due to lower-than-expected year-to-date TYMLOS net revenue, the Company is making the following changes to full year 2021 forecasts:

TYMLOS Net Revenue FY 2021: now $210 to $220 million vs. previous forecast of $240 million
Total Company FY 2021 Adjusted EBITDA: now ($5) to ($15) million vs. previous forecast of $10 million
ELACESTRANT:

On October 20, 2021, Radius announced along with its partner the Menarini Group that EMERALD, a pivotal study evaluating elacestrant in breast cancer, was positive as a monotherapy vs. the standard of care for patients with ER+/HER2- advanced or metastatic breast cancer (mBC), including those with the Estrogen Receptor Mutation (ESR1). The study met both primary endpoints for the overall population as well as the ESR1 mutation subgroup.

Chhaya Shah, Senior Vice President and clinical program lead for Radius commented, "The study results were certainly encouraging for patients and their families, as the first oral selective estrogen receptor degrader to show positive topline data. We are working with our partner on progressing the program towards regulatory submission in the U.S. as well as Europe in 2022."

Kelly Martin, Chief Executive Officer of Radius, elaborated, "We work closely with the Menarini Group on all aspects of the elacestrant asset – they are a terrific partner. We are collectively enthusiastic about the opportunities to bring potential benefit to patients by progressing this molecule."

He added, "Given the significance of the positive topline data to Radius, it is important to outline key aspects of the molecule as well as the financial/business relationship that exists between the Menarini Group and ourselves."

Martin concluded, "Creating tangible value for our capital providers is a fundamental objective of our business and central to our management approach and operating philosophy. To that end, we intend to utilize a minimum of 50% of the up to $300 million in potential future sales milestones from elacestrant to strengthen the capital structure."

As to the detail – mentioned above – the following five (5) items are of particular relevance to Radius shareholders, capital providers, and other stakeholders:

Radius is eligible to receive:
Up to $20 million in development and regulatory milestone payments
Up to $300 million in sales milestones
A tiered net royalty up to 9% that is based on global net sales
Royalties and sales milestones are:
Based on global net sales of elacestrant
Inclusive of monotherapy as well as any/all utilization as a combination therapeutic
Inclusive of all other potential therapeutic applications
Intellectual Property – three (3) U.S. issued patents for elacestrant:
Composition of matter (August 2026, subject to patent term extension up to August 2030)
Method of treatment (October 2034)
Polymorph/Crystalline (January 2038)
Additional patents are pending
Exclusivity – as a new chemical entity, elacestrant has the potential to receive regulatory exclusivity of:
5 years in the U.S.
10 years in Europe
8 years in Japan, assuming no generic competitor entrant to the market
All the above are subject to regulatory approval(s)
Radius intends to utilize a minimum of 50% of the up to $300 million in potential future sales milestones from elacestrant to strengthen its capital structure
ABALOPARATIDE:

Clinical and Regulatory

Resubmitted abaloparatide-SC dossier to the EMA for potential approval in the EU on November 4, 2021
Announced that the ATOM study evaluating abaloparatide-SC for use in males with osteoporosis met its primary endpoint as well as key secondary endpoints with plans to submit a sNDA in Q1, 2022
Previously announced an update to the MOA section of the TYMLOS label following data from the histomorphometry study that showed TYMLOS stimulated new bone formation in humans
Assist partner, Paladin Labs Inc., in the abaloparatide regulatory submission in Canada (Q4, 2021)
Commercial

Added 4,461 new patients on TYMLOS in Q3, 2021, +10% vs. Q3, 2020
Top 500 TYMLOS prescribers represent 50% of total new patients in Q3, 2021
Top 50 TYMLOS prescribers had new patient growth of 15% vs. Q2, 2021
Full year TYMLOS Net Revenue projection has been adjusted to $210 to $220 million vs. $240 million
Our focus on continuing to position TYMLOS for additional growth:
Increase depth vs. breadth in the fracture patient segments
Emphasis on best people and talent aligned to the opportunity
Properly utilize data – with larger institutions – for patient identification, tracking, and interface
Prepare for the possibility of adding male indication to TYMLOS
Plan for abaloparatide-TD following pivotal data readout expected in Q4, 2021
RAD011:

All remains on track as previously communicated for Prader-Willi Syndrome (PWS). The seamless pivotal trial (SCOUT) is expected to commence in Q4, 2021 or early Q1, 2022.

We will provide a further update on the RAD011 molecule in the near term. We plan to add at least two additional neurological orphan disease indications and progress those forward with pivotal trials.

Third Quarter 2021 Financial Results

Three Months Ended September 30, 2021

Net Loss
For the three months ended September 30, 2021, Radius reported a net loss of $22.0 million, or $0.47 per share, compared to a net loss of $6.3 million, or $0.14 per share, for the three months ended September 30, 2020.

For the three months ended September 30, 2021, non-GAAP adjusted net loss, was $15.3 million, or $0.32 per share, compared to non-GAAP adjusted net income of $7.0 million, or $0.15 per share, for the three months ended September 30, 2020.

Revenue
For the three months ended September 30, 2021, TYMLOS net product revenues were $56.8 million compared to $50.4 million for the three months ended September 30, 2020.

For the three months ended September 30, 2021, no license revenue was recognized compared to $27.4 million recognized for the three months ended September 30, 2020.

Costs and Expenses
For the three months ended September 30, 2021, research and development expense was $34.7 million compared to $39.5 million for the three months ended September 30, 2020, a decrease of $4.7 million, or 12%. This decrease was primarily driven by a decrease of $7.6 million in abaloparatide-TD program costs, a decrease of $1.0 million in RAD140 expenses, a $0.7 million decrease in compensation expense, which is comprised of a $2.2 million increase in compensation expense related to headcount and $2.9 million of billed reimbursable expenses, and a $9.9 million decrease in elacestrant program costs, which is comprised of a $6.0 million decrease in gross program expenses as well as a decrease of $3.9 million in billed reimbursable expenses. These decreases were offset by a $6.1 million increase in abaloparatide-SC program costs, a $3.2 million increase in RAD011 program costs, a $4.6 million increase in professional fees and other expenses, and a $0.2 million increase in occupancy and depreciation costs.

For the three months ended September 30, 2021, selling, general and administrative expenses were $34.3 million compared to $33.7 million for the three months ended September 30, 2020, an increase of $0.6 million, or 2%. This increase was primarily the result of a $4.3 million increase in professional support costs. This increase was offset by a $2.1 million decrease in wages and employee benefit costs due to a decrease in headcount and a $1.9 million decrease in occupancy and depreciation costs and other operating costs.

Nine Months Ended September 30, 2021

Net Loss
For the nine months ended September 30, 2021, Radius reported a net loss of $54.6 million, or $1.16 per share, compared to a net loss of $87.8 million, or $1.89 per share, for the nine months ended September 30, 2020.

For the nine months ended September 30, 2021, non-GAAP adjusted net loss, was $34.3 million, or $0.73 per share, compared to non-GAAP adjusted net loss of $51.6 million, or $1.11 per share, for the nine months ended September 30, 2020.

Revenue
For the nine months ended September 30, 2021, TYMLOS net product revenues were $153.9 million compared to $148.4 million for the nine months ended September 30, 2020.

For the nine months ended September 30, 2021, license revenue was $11.0 million compared to $27.4 million recognized for the nine months ended September 30, 2020.

Costs and Expenses
For the nine months ended September 30, 2021, research and development expense was $93.1 million compared to $123.3 million for the nine months ended September 30, 2020, a decrease of $30.2 million, or 24%. This decrease was primarily driven by a decrease of $21.6 million in abaloparatide-TD program costs, a $1.2 million decrease in RAD140 program costs, a $12.9 million decrease in compensation expense, which is comprised of a $3.5 million decrease in compensation expense related to headcount and $9.4 million of billed reimbursable expenses, and a $24.3 million decrease in elacestrant program costs, which is comprised of a $0.3 million decrease in gross program expenses offset by $23.8 million of billed reimbursable expenses. These decreases were offset by a $12.2 million increase in abaloparatide-SC program costs, a $10.3 million increase in RAD011 program costs, and a $7.1 million increase in professional fees and other expenses.

For the nine months ended September 30, 2021, selling, general and administrative expenses were $100.5 million compared to $108.4 million for the nine months ended September 30, 2020, a decrease of $7.9 million, or 7%. This decrease was primarily the result of a $6.3 million decrease in wages and employee benefit costs due to a decrease in headcount, a $1.8 million decrease in stock-based compensation expense and a $1.9 million decrease in other operating costs. These decreases were offset by an increase of $2.3 million in professional support costs.

Webcast and Conference Call

In connection with today’s reporting of Third Quarter 2021 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, November 8, 2021, to review the commercial, research and development, and financial highlights and provide a Company update.

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

A replay of the conference call will be available on November 8 at 11:30 a.m. ET and the audio webcast of the call will be archived on the Company’s website for ninety days. To access the replay, dial (855) 859-2056 or (404) 537-3406 for International, using conference ID number 9322858. The live audio webcast of the call can be accessed from the Investors section of the Company’s website, View Source The full text of the announcement and financial results will also be available on the Company’s website.

Use of Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), we use the following non-GAAP financial measures in this press release: non-GAAP adjusted net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with Radius’ GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Radius’ operating performance and can enhance investors’ ability to identify operating trends in our business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Radius’ operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three months ended September 30, 2021 and 2020 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

On November 8, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Vaccinex, NOV 8, 2021, View Source [SID1234594781]).

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"We made steady progress on our pepinemab clinical programs since our last quarterly update. Enrollment is now underway in the Phase 1b/2 head and neck cancer trial and the Phase 1/2a Alzheimer’s disease trial, two of the serious indications in which SEMA4D is overexpressed and is believed to contribute to disease pathology," stated Maurice Zauderer, Ph.D., President and Chief Executive Officer.

"As presented at the September European Huntington’s Disease Network meeting, we believe post-hoc analysis of the Phase 2, SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD) supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild advanced disease. We are engaged in discussions with potential partners for the advancement of this important program."

Pepinemab Clinical Updates:

Head and Neck Cancer. Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in advanced recurrent or metastatic head and neck cancer.

The study will enroll up to 65 subjects across 18 U.S. trial sites and will assess whether combination therapy can improve responses in this population. Key endpoints of the study will include objective response, progression free survival and overall survival. Vaccinex anticipates data from this study in the second half of 2022.

Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, there is strong rationale for development in this indication.

Alzheimer’s Disease. Patient screening and enrollment have been initiated in the Phase 1/2a clinical trial of pepinemab in Alzheimer’s disease. The Alzheimer’s trial is being funded in part by the Alzheimer’s Drug Discovery Foundation by the Alzheimer’s Association under the 2020 Part the Cloud Program.

The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 14 U.S. trial sites. Vaccinex anticipates topline data from this study in late 2022 or early 2023.
Huntington’s disease. We believe that post-hoc analysis of the Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD) supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild cognitive deficits.
Highly significant improvement (p=0.007) in the (Huntington’s Disease Cognitive Assessment Battery (HD-CAB) Composite score, a widely employed measure comprised of 6 different cognitive assessments.
Significant benefit in reducing apathy severity (p=0.017, 1-sided), a problem behavior that has previously been correlated with cognition in both HD and AD.
Striking increase in brain metabolic activity as measured by FDG-PET in most brain regions. Decline in FDG-PET signal has been reported to correlate with cognitive decline in several studies of AD.
The company continues to actively explore advancing pepinemab into a Phase 3 HD trial in collaboration with a biopharmaceutical partner; discussions are ongoing.

Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" studies in head and neck cancer and melanoma.
Upcoming Anticipated Milestones:

H2:2022– Meaningful data from open label head and neck cancer trial
Late 2022/Early 2023 – Topline data from randomized Alzheimer’s trial
ActivMAb Updates:

As previously announced, we have entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb antibody discovery platform to address difficult to drug G-protein Coupled Receptors (GPCRs) known to be strongly associated with diseases. "We believe this enabling technology will allow us and our collaborators to address significant market opportunities," said Ernest S. Smith, Ph.D., Chief Scientific Officer.

Financial Results for the Three Months Ended September 30, 2021:

Research and Development Expenses. Research and development expenses for the three months ended September 30, 2021 were $3.6 million as compared to $7.3 million for the comparable period in 2020.

General and Administrative Expenses. General and administrative expenses for the three months ended September 30, 2021 were $1.5 million as compared to $1.9 million for the comparable period in 2020.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on September 30, 2021 were $13.8 million, as compared to $10.6 million as of December 31, 2020.

On November 8, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported that Brian Wong, M.D., Ph.D., President and CEO, will present at the following investor conferences in November (Press release, RAPT Therapeutics, NOV 8, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-participate-upcoming-investor-conferences [SID1234594780]):

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Stifel 2021 Virtual Healthcare Conference – Company presentation on Monday, November 15, 2021, at 2:00 p.m. ET
Piper Sandler 33rd Annual Virtual Healthcare Conference – Pre-recorded fireside chat available on-demand Monday, November 22, 2021, at 10:00 a.m. ET
To access the live webcast or subsequent archived recordings of the company presentations, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

On November 8, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported that the U.S. Patent and Trademark Office has issued multiple patents covering composition of matter for the company’s therapeutic product candidate TPST-1495, an orally available small molecule designed to selectively block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway (Press release, Tempest Therapeutics, NOV 8, 2021, View Source [SID1234594779]).

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"We have shown in pre-clinical studies that our approach to inhibit signaling through both EP2 and EP4 receptors with our TPST-1495 dual antagonist confers significantly increased potency compared to single EP4 inhibitors, as well as improvement over other prostaglandin-inhibition approaches including NSAIDs, and could represent an important evolution in the targeting of this pathway in oncology," said Tom Dubensky, president of Tempest. "Prostaglandin signaling drives a wide range of cancers as well as resistance to immune checkpoint inhibitor therapies, so we are excited about the potential of our ongoing clinical evaluation of TPST-1495. The intellectual property portfolio covering TPST-1495 and its uses is important to protect the differentiated properties of this molecule."

The patent portfolio now includes U.S. Patent Numbers 10,968,201 and 11,066,405, as well as a number of pending applications in the United States and other markets outside of the United States. The pending applications cover compositions of matter and methods of use, which further strengthen Tempest’s intellectual property for the combined inhibition of EP2 and EP4 prostaglandin PGE2 receptor signaling.

About TPST-1495

TPST-1495 is an orally-available small molecule designed to block the EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but differentially active EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed both to enhance tumor progression and promote immune suppression. Tempest has conducted head-to-head preclinical studies comparing TPST-1495 to single antagonists of EP2 and EP4 and observed significantly enhanced activity of TPST-1495 in both overcoming PGE2-mediated suppression of human immune cells in vitro, as well as significantly increased anti-tumor activity in mouse models of human colorectal cancer. Tempest is currently evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and possible anti-tumor activity of TPST-1495 in a multicenter Phase 1a/1b dose and schedule optimization study in subjects with advanced solid tumors, with the potential to expand in indications known to be prostaglandin-driven, including colorectal cancer, or CRC, and in a tumor indication-agnostic, biomarker-selected cohort.

On November 8, 2021 Bayer Pharmaceuticals, working with The Life Raft Group (LRG), reported that they have extended a research collaboration to broaden access to comprehensive genomic testing for Gastrointestinal Stromal Tumor (GIST) patients (Press release, Bayer, NOV 8, 2021, View Source [SID1234594768]). This collaboration aims to advance precision medicine in oncology and use comprehensive genomic testing to identify patients in the United States (U.S.) who may benefit from personalized care.

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Comprehensive genomic testing, also known as biomarker testing or molecular testing, is a crucial step in understanding the genomic factors that play a role in establishing a GIST diagnosis. There are different types of comprehensive genomic testing: the most common tests are basic mutational testing and advanced next-generation sequencing. These tests may help identify alterations, or changes, within DNA and/or RNA of cancer cells that determine how a tumor behaves or why it grows. Basic mutational testing focuses on testing specific genes like c-KIT, PDGFRA, and BRAF. Advanced next-generation sequencing may test a broader range of genes, usually between 5 – 500+ genes, including neurotrophic receptor tyrosine kinase (NTRK) gene fusions. The results can help healthcare providers match patients with available treatment options or clinical trials. Finding the right therapeutic can be a turning point in the treatment journey of a GIST patient.

GISTs are a type of soft tissue sarcoma – cancers that develop in connective or supporting tissues – that affect an estimated 3,000 to 5,000 people in the U.S. each year.1 One genomic alteration that can drive the growth and spread of GIST is called an NTRK gene fusion. There are currently treatments for GIST driven by NTRK gene fusions approved in the U.S.

Criteria for patients to participate in this program include: be a U.S. resident, be or become a part of The Life Raft Group GIST Patient Registry, have a treating oncologist, must not have had any type of prior comprehensive genomic testing (basic mutational testing or next-generation sequencing), or have previously been identified with wildtype c-KIT or PDGFRA results from basic mutational testing.

The Life Raft Group, based in Wayne, New Jersey, is a global leader in GIST, focused on educating patients, providing resources, and launching initiatives for the community for better patient outcomes. This collaboration is an example of the vital role patient advocacy groups play in bridging the gap between researchers and motivated patient populations willing to be part of innovative studies.

"As part of our commitment to precision oncology, we believe identifying NTRK patients early through comprehensive genomic testing is a critical step in the cancer diagnosis of oncology patients experiencing metastatic disease, as it helps physicians understand the underlying drivers of tumor growth and can inform the treatment approach," said Iain Webb, M.D., Vice President, U.S. Medical Affairs, Oncology at Bayer. "That is why we are pleased to collaborate with The Life Raft Group to increase the availability of comprehensive genomic testing for GIST patients to potentially uncover NTRK gene fusions and provide options for those who may benefit from precision oncology treatments."

This collaboration builds on Bayer’s existing commitment to advance precision oncology, which includes research to find targets and pathways that drive cancer growth, and how these findings can impact the way cancer is treated.

"We are excited to be a part of this groundbreaking opportunity to work with great organizations to pave the road towards precision medicine and to help us to reach our goal of increasing the testing rate among GIST patients," said Denisse Montoya, Patient Registry Director at The Life Raft Group. "By offering comprehensive genomic testing with no charge, many patients will have the opportunity to know what genes are driving their GIST and benefit from genetic-informed care. Results from this testing collaboration will help us understand more traits and patterns within GIST that will help us with our aim of accelerating GIST cancer research."

Healthcare professionals with eligible patients can find additional information here.