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Delcath Systems, Inc. Announces First Quarter 2021 Results

On May 12, 2021 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the first quarter ended March 31, 2021 (Press release, Delcath Systems, MAY 12, 2021, View Source [SID1234579779]).

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Recent Business Highlights

During and since the first quarter the company:

Reported positive preliminary results from the FOCUS Clinical Trial (NCT02678572) for Patients with Hepatic Dominant Ocular Melanoma treated with HEPZATO KIT based on an analysis of currently evaluable patients. The preliminary analysis included 87% of treated patients and final results are expected later in the year.
The primary endpoint, overall response rate (ORR), exceeded the prespecified threshold for success by a large enough margin to ensure that final results based on 100% of patients will be positive.
Both prespecified ORR and Progression Free Survival comparative analyses versus the best alternative care arm demonstrated a statistically significant improvement.
The safety profile was consistent with the safety profile of CHEMOSAT treatment described in previous European single-center and multi-center publications with no new safety signals observed in this patient population and no treatment related deaths on study.
Announced that the United Kingdom’s National Institute for Health and Care Excellence, has updated its guidance for the Delcath CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT) in the treatment of patients with metastases in the liver from Ocular Melanoma. Under this designation, private insurance may be more likely to fund treatment with CHEMOSAT, some regional funding may be more accessible, and a process is now available to seek national reimbursement.
Announced an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held virtually June 4-8, 2021.
"The recently released preliminary results from the FOCUS trial strongly indicates that HEPZATO’s benefit risk ratio is a significant improvement versus an earlier generation of Delcath’s proprietary percutaneous hepatic perfusion system," said Gerard Michel, CEO of Delcath. "We look forward to continued progress in the balance of the year, as we prepare both to file an NDA in early 2022 and expand the development of HEPZATO into additional areas of high unmet need."

First Quarter 2021 Financial Results:

Income Statement Highlights.

Product revenue for the three months ended March 31, 2021 was approximately $0.4 million, compared to $0.3 million for the prior year period from our sales of CHEMOSAT procedures in Europe. Selling, general and administrative expenses were approximately $3.3 million compared to $2.3 million in the prior year quarter. Research and development expenses for the quarter were $3.7 million compared to $3.0 million in the prior year quarter. Total operating expenses for the quarter were $7.0 million compared with $5.3 million in the prior year quarter. First quarter expenses included approximately $2.2 million of stock option expense compared to no material stock option expense in the prior year quarter.

We recorded a net loss for the three months ended March 31, 2021, of $6.8 million, compared to a net income of $7.9 million for the same period in 2020

Balance Sheet Highlights.

At March 31, 2021, we had cash, cash equivalents and restricted cash totaling $26.7 million, as compared to cash, cash equivalents and restricted cash totaling $4.7 million at March 31, 2020. During the three months ended March 31, 2021 and March 31, 2020, we used $4.6 million and $5.2 million, respectively, of cash in our operating activities.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Curis Reports First Quarter 2021 Financial Results

On May 12, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2021 (Press release, Curis, MAY 12, 2021, View Source [SID1234579778]).

"The first quarter of 2021 saw continued momentum for our pipeline of next generation targeted cancer therapies designed to meaningfully improve and extend patients’ lives. We continued to make important progress with CA-4948, our first-in-class, small molecule inhibitor of IRAK4, now in three clinical trials after expanding into one new study earlier this year with the Phase 2 LUCAS IST for patients with lower-risk MDS, as well as expanding our previous Phase 1/2 study in patients with relapsed/refractory (R/R) NHL to include the combination of CA-4948 plus ibrutinib. We were also very pleased to announce that CA-4948 was granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of AML and MDS, highlighting the unique potential of our IRAK4 program," said James Dentzer, President and Chief Executive Officer of Curis. "We are especially excited about the AML/MDS data published today in the EHA (Free EHA Whitepaper) abstract, and we look forward to providing additional data from this study in the oral presentation at EHA (Free EHA Whitepaper) next month."

Mr. Dentzer added, "We are also pleased with the continuing dose escalation in our ongoing Phase 1 study of CI-8993, our first-in-class monoclonal anti-VISTA antibody for the treatment of patients with R/R solid tumors and look forward to providing initial data from this study later this year."

First Quarter 2021 and Recent Operational Highlights

Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):

Today, EHA (Free EHA Whitepaper) released the Curis abstract reporting interim data from the ongoing Phase 1/2 study of CA-4948 in patients with R/R AML and MDS. The data are from 15 patients as of February 8, 2021 (the cut-off date) and are consistent with previously announced findings, including marrow blast reductions observed at all tested doses in 8 of 9 (89%) evaluable patients with elevated blast counts at baseline, with 1 patient experiencing a full hematologic recovery complete response, 1 complete remission with incomplete hematologic recovery (CRi) with negative minimal residual disease, and 2 bone marrow complete responses (CRs).
All 3 patients presenting with SF3B1 or U2AF1 spliceosome mutations achieved marrow CR or better
All patients with objective responses also saw signs of hematologic recovery
Updated safety, pharmacodynamic, and efficacy data, as well as data from additional trial participants, will be featured in an oral presentation at EHA (Free EHA Whitepaper) on Friday, June 11 at 9:00 am CEST (3:00 am EDT).
Curis updated that the 500mg BID dosing regimen in the AML/MDS study has exceeded the maximum tolerated dose according to protocol guidelines. Two patients in the cohort were observed to have dose-limiting toxicities, one of whom had Grade 3 rhabdomyolysis and the other experienced Grade 3 syncope. Both AEs resolved after discontinuation of dosing. Current enrollment is exploring lower dose levels to determine the appropriate recommended phase 2 dose (RP2D).
Also today, Curis reported non-clinical data to be presented in a poster at EHA (Free EHA Whitepaper) demonstrating synergistic antitumor activity of CA-4948 in combination with azacitidine and venetoclax in leukemia cells, providing supportive rationale for evaluation of the combinations in a clinical setting for AML and MDS patients.
The Phase 1/2 study of CA-4948 in AML and MDS was expanded to include both a combination dose escalation and a monotherapy dose expansion:
Combination dose escalation, which will start at 200mg BID, will include two cohorts:
1) CA-4948 + azacitidine, for patients with AML or MDS who are naïve to hypomethylating agents (HMA)
2) CA-4948 + venetoclax, for patients with AML or MDS after first line therapy who are naïve to venetoclax
Monotherapy dose expansion, which will begin after the RP2D is determined, will include four cohorts:
1) MDS patients, R/R to HMA, with spliceosome mutations
2) MDS patients, R/R to HMA, without spliceosome mutations
3) R/R AML patients with FLT3-ITD mutation
4) R/R AML patients with FLT3 WT
In April 2021, Curis announced that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug designation for CA-4948 for the treatment of AML and for treatment of MDS.
Also in April, Curis presented updated data on a potentially predictive biomarker demonstrating target engagement in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021.
In February, Curis announced the dosing of the first patient in its Phase 1/2 combination study of CA-4948 plus ibrutinib, for the treatment of patients with R/R NHL or other hematologic malignancies. In preclinical models, CA-4948 demonstrated synergistic anti-cancer activity when combined with a potent BTK inhibitor such as ibrutinib. Curis expects to report initial data from this study in the second half of 2021.
Earlier in February, Curis announced the initiation of the investigator-sponsored Phase 2 LUCAS study of CA-4948 for the treatment of anemia in patients with very low, low, or intermediate-risk MDS. The study is expected to start recruitment in the second quarter of 2021.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

Curis continues to enroll patients in the ongoing Phase 1 dose escalation study of its first-in-class monoclonal anti-VISTA antibody for the treatment of R/R solid tumors and expects to report initial clinical data in the second half of 2021.
Upcoming 2021 Planned Milestones

Report additional clinical data at the EHA (Free EHA Whitepaper) 2021 Virtual Congress from the Phase 1/2 monotherapy study of CA-4948 in patients with AML and MDS, including patients with spliceosome mutations that result in aberrant splicing of oncogenic IRAK4-L.
Initiate dosing in the Phase 1/2 combination study of CA-4948 plus azacitidine and CA-4948 plus venetoclax in patients with R/R AML and MDS.
In the second half of 2021, report initial data from the ongoing Phase 1/2 combination study of CA-4948 plus ibrutinib in patients with R/R NHL.
In the second half of 2021, report initial data from the ongoing Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid tumors.
First Quarter 2021 Financial Results

For the first quarter of 2021, Curis reported a net loss of $9.9 million or $0.11 per share on both a basic and diluted basis, as compared to a net loss of $9.7 million, or $0.28 per share on both a basic and diluted basis for the same period in 2020.

Revenues for the first quarter of 2021 and 2020 were $2.2 million and $2.7 million, respectively.

Operating expenses for the first quarter of 2021 were $11.0 million, as compared to $11.2 million for the same period in 2020, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the first quarter of 2021 and 2020.

Research and Development Expenses. Research and development expenses were $6.8 million for the first quarter of 2021 as compared to $7.5 million for the same period in 2020. The decrease in direct research and development expenses for the quarter is primarily attributable to the upfront license fee expense from our option and license agreement with ImmuNext that occurred during the first quarter of 2020. These costs were partially offset by a $0.3 million increase in employee related costs.

General and Administrative Expenses. General and administrative expenses were $4.1 million for the first quarter of 2021, as compared to $3.6 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation and professional and consulting services, partially offset by lower legal services costs during the three months ended March 31, 2021.

Other Expense, Net. For the first quarter of 2021 and 2020, net other expense was $1.1 million and $1.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments.

As of March 31, 2021, Curis’s cash, cash equivalents and investments totaled $168.4 million, and there were approximately 91.5 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, May 12, 2021, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

Curis Reports Updated Data in Two Abstracts for CA-4948 Accepted for Presentation at the European Hematology Association 2021 Virtual Congress

On May 12, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that two abstracts for CA-4948, a novel, small molecule IRAK4 inhibitor, have been accepted for oral and poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress (EHA) (Free EHA Whitepaper), which will be held virtually from June 9-17, 2021 (Press release, Curis, MAY 12, 2021, View Source [SID1234579777]). The abstracts include updated data from a February data-cut for its ongoing open-label, single arm, Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).

"We are very pleased to report this clinical update on our first-in-class IRAK4 kinase inhibitor, CA-4948, as an anticancer agent for patients with acute myeloid leukemia and myelodysplastic syndromes for whom multiple prior lines of therapy have been unsuccessful," said James Dentzer, President and Chief Executive Officer of Curis. "The clinical data published in the abstract this morning are consistent with our preliminary findings reported late last year showing that CA-4948 has, in addition to encouraging safety characteristics, clear potential to reduce leukemic blasts in late-line patients, along with early signs of hematologic recovery. We look forward to providing updated safety, pharmacodynamic, and efficacy data, as well as data from additional patients and nonclinical combination synergy data at EHA (Free EHA Whitepaper) next month."

Key findings from a cutoff date of February 8, 2021 in 15 patients (8 MDS and 7 AML) include:

Bone marrow blast reductions observed at all tested doses in 8 of 9 (89%) evaluable patients (at least one malignancy assessment following first cycle) with elevated blast counts at baseline
Objective responses observed included 1 patient experiencing a full hematologic recovery complete response, 1 CRi with negative minimal residual disease, and 2 bone marrow CRs
All 3 patients with SF3B1 or U2AF1 spliceosome mutation achieved marrow CR or better
All patients with objective responses also saw signs of hematologic recovery
Details of the presentations are as follows:

Oral Presentation:

Title: A Phase 1, Dose Escalation Trial with Novel Oral IRAK4 Inhibitor CA-4948 in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome – Interim Report
Author: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
Session Name: 10. Myelodysplastic syndromes – Clinical
Presentation Time: Friday, June 11, 2021, 09:00 CEST (3:00 am ET)
Q&A Session: Wednesday, June 16, 2021, 17:00 CEST (11:00 am ET)
Poster Presentation

Title: IRAK4 Inhibitor CA-4948 Potentiates Antitumor Effects of Azacitidine and Venetoclax in Human Acute Myeloid Leukemia
Session Name: 01. Acute lymphoblastic leukemia – Biology & Translational Research
Session Date & Time: Friday, June 11, 2021, 09:00 CEST (3:00 am ET)
Virtual KOL Event

Virtual event to be hosted Friday, June 11 at 8:00 am ET, featuring Dr. Guillermo Garcia-Manero, Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center
Discussion of the EHA (Free EHA Whitepaper) presentation data from the ongoing Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia and myelodysplastic syndromes
A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.
Additional meeting information can be found on the EHA (Free EHA Whitepaper) website at www.ehaweb.org/congress. Each presentation will also be available under "Events and Presentations" in the Investors section of the Company’s website at www.curis.com

About CA-4948

CA-4948 is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with AML and MDS. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1.

Vertex and CRISPR Therapeutics to Present New Clinical Data on Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001™ For Severe Hemoglobinopathies at the Annual European Hematology Association Virtual Congress

On May 12, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) reported two abstracts detailing updated data from the ongoing CTX001 clinical trials have been accepted for presentation during the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress (Press release, CRISPR Therapeutics, MAY 12, 2021, View Source [SID1234579776]).

Abstract #EP736 entitled "CTX001 for Sickle Cell Disease: Safety and Efficacy Results from the Ongoing CLIMB SCD-121 Study of Autologous Crispr-Cas9-Modified CD34+ Hematopoietic Stem and Progenitor Cells," will be made available on the virtual platform as an e-poster Friday, June 11 at 9:00 CEST. The abstract posted online today includes data on patients with severe sickle cell disease with more than 3 months of follow-up, as of the interim data cut on January 28, 2021. Data will be updated and information on additional patients will be included for the congress.

Abstract #EP733 entitled "CTX001 for Transfusion-Dependent Β-Thalassemia: Safety and Efficacy Results from the Ongoing CLIMB Thal-111 Study of Autologous Crispr-Cas9-Modified CD34+ Hematopoietic Stem and Progenitor Cells," will be made available on the virtual platform as an e-poster Friday, June 11 at 9:00 CEST. The abstract posted online today includes data on patients with transfusion-dependent beta thalassemia (TDT) with more than 3 months of follow-up, including patients with the most severe genotypes, as of the interim data cut on January 21, 2021. Data will be updated and information on additional patients will be included for the congress.

The accepted abstracts are now available online on the EHA (Free EHA Whitepaper) website.

CTX001 is being investigated in two ongoing clinical trials as a potential one-time curative therapy for patients suffering from TDT and severe SCD.

About CTX001
CTX001 is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD, in which a patient’s hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for patients with TDT and reduce painful and debilitating sickle crises for patients with SCD. Earlier results from these ongoing trials were published as a Brief Report in The New England Journal of Medicine in January of 2021.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. CTX001 has also been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both TDT and SCD.

Among gene-editing approaches being investigated/evaluated for TDT and SCD, CTX001 is the furthest advanced in clinical development.

About CLIMB-111
The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with TDT. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-121
The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with severe SCD. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-131
This is a long-term, open-label trial to evaluate the safety and efficacy of CTX001 in patients who received CTX001 in CLIMB-111 or CLIMB-121. The trial is designed to follow participants for up to 15 years after CTX001 infusion.

About the Gene-Editing Process in These Trials
Patients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patient’s cells will be edited using the CRISPR/Cas9 technology. The edited cells, CTX001, will then be infused back into the patient as part of a stem cell transplant, a process which involves, among other things, a patient being treated with myeloablative busulfan conditioning. Patients undergoing stem cell transplants may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of CTX001. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of CTX001 on multiple measures of disease and for safety.

About the Vertex-CRISPR Collaboration
Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first potential treatment to emerge from the joint research program. Under a recently amended collaboration agreement, Vertex will lead global development, manufacturing and commercialization of CTX001 and split program costs and profits worldwide 60/40 with CRISPR Therapeutics. This amendment is subject to customary closing conditions and clearances, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.

Context Therapeutics® and Jefferson Health Announce First Patient Dosed in Phase 2 Trial of ONA-XR in Advanced Endometrial Cancer

On May 12, 2021 Context Therapeutics, a women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and the Sidney Kimmel Cancer Center – Jefferson Health, reported the first patient has been dosed in the Phase 2 ONWARD 221 trial in patients with metastatic endometrial cancer (Press release, Context Therapeutics, MAY 12, 2021, View Source [SID1234579775]).

The trial, sponsored by Jefferson Health, is a clinical collaboration between Context and Jefferson Health’s Sidney Kimmel Cancer Center (SKCC) to evaluate the effect of the addition of progesterone receptor (PR) antagonist onapristone extended release (ONA-XR) to the antiestrogen, anastrozole, on outcomes for patients with metastatic endometrial cancer who have failed prior therapy. ONA-XR is an orally-administered full antagonist of the PR, a key unchecked mechanism in women’s cancers. ONA-XR is currently being evaluated in ongoing Phase 2 clinical trials in hormone-driven breast, ovarian and endometrial cancers.

"The majority of endometrial cancer patients have hormone-driven cancer. Both estrogen and progesterone drive progression in those patients, and antiestrogens, most often anastrozole, have proven, albeit limited, activity," said Russell Schilder, MD, Co-Principal Investigator and Director of the Gynecologic Medical Oncology Program at SKCC. "We will evaluate whether combining anastrozole with ONA-XR will achieve more complete hormone blockade compared with anastrozole alone, which may lead to better outcomes for patients."

The trial will enroll up to 25 patients who express the ER and/or PR biomarker (ER+ &/or PR+) and who have received prior chemotherapy treatment. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. Secondary endpoints will include duration of response, clinical benefit rate and progression-free survival (PFS). In addition, the trial will evaluate the safety and pharmacological profile, as well as biomarker analyses to explore predictive factors of response to complete hormone blockade to inform additional ongoing Phase 2 trials of ONA-XR and a planned future Phase 3 trial.

"Context is humbled by the support and enthusiasm of Dr. Schilder and his colleagues at SKCC, one of the premier gynecologic oncology programs in the country based right here in Philadelphia," said Martin Lehr, CEO of Context Therapeutics. "Patients with advanced endometrial cancer currently have limited therapeutic options. Recent preclinical and Phase 1 data give us reason to believe ONA-XR can make a powerful addition to the current standard of care in hormone-driven endometrial cancer. Together, we look forward to exploring the potential of this combination to improve the lives of patients with this devastating disease."

About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in the United States with an incidence that continues to increase each year. More than 60,000 women were diagnosed with endometrial cancer in 2018 and this disease contributes to more than 10,000 deaths annually. Unopposed estrogen production and obesity are the most common risk factors for the development of endometrial cancer. The majority of patients with recurrent endometrial cancer have limited therapeutic options and the development of second-line therapies that result in improved response is an unmet clinical need.

About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently being evaluated in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in PR+ breast, ovarian and endometrial cancers, as well as in two Phase 0 biomarker pharmacodynamic trials in breast cancer. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.