On August 13, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the performance of its Oncoguard Liver liquid biopsy test is now published online in the peer-reviewed journal Clinical Gastroenterology and Hepatology (CGH) (Press release, Exact Sciences, AUG 13, 2021, View Source [SID1234586544]). The test delivers 82% early-stage sensitivity, and an overall 88% sensitivity and 87% specificity1 for the detection of hepatocellular carcinoma (HCC), the leading form of liver cancer.

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Oncoguard Liver test sensitivity highlights the potential for significant advances in early-stage HCC detection
An estimated 3 million2 Americans are eligible for HCC testing. Currently, only one in three3 at-risk patients receive recommended testing.

"The Oncoguard Liver test advances our work to defeat cancer through earlier detection and bring effective, accessible liquid biopsy tests to health care providers and patients," said Kevin Conroy, chairman and CEO of Exact Sciences. "The clinical validation study published in CGH is the third peer-reviewed publication for our liver test, reflecting Exact Sciences’ commitment to scientific rigor and innovation."

The newly published clinical validation study details the performance of the Oncoguard Liver test in a group representative of the U.S. population recommended for HCC surveillance. The sensitivity demonstrated by the Oncoguard Liver test highlights the potential for significant advances in early-stage HCC detection. Early-stage detection can increase five-year survival rates for HCC from less than 12%4, 5 to upwards of 70%.6

"We have been working for years to build a simple, high performing blood test for HCC surveillance, and these results indicate that the Oncoguard Liver test is poised to be the major advancement our patients deserve and need," said Dr. Naga Chalasani, interim chair of the Department of Medicine at Indiana University and lead author of the Clinical Gastroenterology and Hepatology-published paper. "The robust validation results were due to a rigorously conducted study, which could not have been possible without diligence and commitment of the entire study team and Exact Sciences’ commitment to developing early cancer detection biomarkers."

The current standard of care7 for HCC surveillance is visual monitoring via ultrasound, with or without an alpha-fetoprotein (AFP) blood test. These methods have variable sensitivity for detecting early-stage disease.5, 8

EARLY-STAGE HCC SENSITIVITY

Oncoguard Liver test: 82% 1
Alpha-fetoprotein: 40%1
Ultrasound: 47%6
Ultrasound with AFP: 63%6
The Oncoguard Liver test aims to bridge gaps in ongoing HCC testing. It offers a single, blood-based test analyzing a unique panel of DNA methylation and protein biomarkers. The test is intended as an aid in the detection of HCC for adults with liver cirrhosis and/or chronic hepatitis B who are at risk for HCC.

"The Oncoguard Liver test was created with the hope of enhancing early detection of liver cancer, thus putting improved outcomes within reach and empowering patients to stay current with recommended testing ordered by their health care provider," said Mayo Clinic’s Dr. Lewis Roberts, who helped develop the test. "It’s rewarding and exciting to be a part of the team that is bringing this new test to patient care."

The Oncoguard Liver test is currently available via an early access program designed to familiarize provider offices with the test and its Patient Engagement Program. The test identifies biomarkers associated with HCC. A positive Oncoguard Liver test should be followed with a conventional diagnostic work up.

To learn more about the Oncoguard Liver test visit www.OncoguardLiver.com.

The CGH article is available at: View Source(21)00866-1/fulltext#%20.

Investor Contact

Megan Jones, Exact Sciences, 608-535-8815, [email protected]
Media Contacts

Scott Larrivee, Exact Sciences, 608-287-9261, [email protected]
Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

On August 13, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted therapies for rare and difficult-to-treat cancers, reported it will present data on Rhenium-186 NanoLiposome (186RNL) from its Phase 1 ReSPECT clinical trial in recurrent glioblastoma (GBM) at the American Association of Neurological Surgeons 2021 Annual Scientific Meeting (AANS) being held virtually August 21-25, 2021 (Press release, Cytori Therapeutics, AUG 13, 2021, View Source [SID1234586543]).

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Details of the ePoster presentation are as follows:

Title A two-part, Phase 1 study of Rhenium-186 NanoLiposome (186RNL) delivered by convection enhanced delivery for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG) and newly diagnosed diffuse intrinsic pontine glioma (DIPG)
Date Poster presentations will become available to conference participants on-demand beginning Saturday, August 21, 2021
Presenter Michael G. DeCuypere, MD, PhD, FAANS, Northwestern University Feinberg School of Medicine, and study investigator
A copy of the poster will be made available under the Presentations tab of the Investors section of the Company’s website at the time of the presentation at www.plustherapeutics.com.

On August 13, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system (CNS), reported its financial results for the quarter ended June 30, 2021 (Press release, CNS Pharmaceuticals, AUG 13, 2021, View Source [SID1234586541]). Additionally, the Company provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer.

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Recent Highlights

Commenced patient enrollment in potentially pivotal US-based trial evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM;
Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for lead investigational drug candidate, Berubicin, for the treatment of patients with recurrent GBM; and
"Over the course of the second quarter, our team continued to execute on corporate, clinical and regulatory strategies to drive our Berubicin program toward regulatory approval as fast as possible. We are guided by our passion to answer one of the most devastating unmet clinical needs in medicine: unbelievably, patients suffering today from recurrent GBM still cannot turn to a single approved treatment anywhere in the world for hope. Simply put, this must change and we are the company to change it. With the FDA’s recent award of Fast Track Designation for our lead program, we believe we are poised to finally bring a desperately-needed treatment to GBM patients potentially through this accelerated pathway. Building on a foundation of sixty years of successful anthracycline use against numerous deadly cancers as well as powerful data from our Phase 1 study of Berubicin, the only anthracycline which appears to cross the blood brain barrier in adults, we wholeheartedly believe in its potential to transform the current treatment landscape and the lives of patients," commented John Climaco, CEO of CNS Pharmaceuticals. "After a quarter of amazing progress we are well positioned for even more significant advancements of our development programs which we expect will continue to drive shareholder value in the near and long term."

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first drug of its kind which appears to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. The Company recently announced the commencement of its potentially pivotal US-based study evaluating the efficacy of Berubicin in the treatment of adult GBM, one of the most aggressive types of brain cancer. Patient dosing is expected to commence in the third quarter of 2021.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA. Taken together we believe these important designations can be seen as a recognition of the significance of not only the unmet clinical need in GBM, but of our Berubicin program.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Berubicin Upcoming Milestones

Berubicin Development in the U.S.

Commence patient dosing in potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM in Q3 2021.
Berubicin Development in the EU with Sublicensee Partner

Initiate Phase 2 multicenter clinical trial of Berubicin in adults with GBM in the second half of 2021;
Initiate Phase 1 pediatric study in the second half of 2021; and
Interim analysis of the first 18 patients in adult Phase 2 study expected in 2022.
WP1244 Portfolio – Novel class of DNA-binding agents

The Company continues to advance the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

WP1244 Upcoming Milestones

File IND in 2022.
Summary of Financial Results for Second Quarter 2021

The net loss for the six months ended June 30, 2021 was approximately $3.8 million compared to approximately $2.4 million for the comparable period in 2020. The change in net loss is attributable to increased personnel and activity associated with preparing for the Company’s clinical trials in 2021. The Company reported research and development expenses of $4.8 million for the six months ended June 30, 2021 compared to approximately $2.1 million for the comparable period in 2020. The expenses incurred during the period were related to drug manufacturing and labor related to the preparation of the Company’s Phase 2 study. General and administrative expense was approximately $2.5 million for the six months ended June 30, 2021 compared to approximately $2.3 million for the comparable period in 2020.

As of June 30, 2021, the Company had cash and subscription receivable (fully collected on July 1, 2021) of approximately $10.5 million and working capital of approximately $12.1 million. Our current expectation is that our cash on hand (including the subscription receivable collected in full on July 1, 2021) is sufficient to fund our operations into the second quarter of 2022. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.

On August 13, 2021 Cardinal Health (NYSE: CAH) reported that it is sending an irrevocable notice of early redemption to the holders of all of the Company’s 2.616% notes due June 2022 that are outstanding as of the early redemption date (aggregate principal amount of $572,171,000) (Press release, Cardinal Health, AUG 13, 2021, View Source [SID1234586539]). The early redemption date is set to September 15, 2021, pursuant to the June 2, 2008 indenture and the 2.616% notes.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

With respect to the 2.616% notes, in accordance with the terms and conditions set forth in the indenture and the 2.616% notes, the 2.616% notes will be redeemed at a redemption price equal to the greater of (i) 100% of the principal amount of the notes to be redeemed or (ii) the sum of the present values of the remaining scheduled payments of principal and interest on the notes to be redeemed that would be due if the notes of such series matured on May 15, 2022 (exclusive of interest accrued to the date of redemption) discounted to the date of redemption on a semiannual basis (assuming a 360-day year consisting of twelve 30-day months) at the Adjusted Treasury Rate (as defined in the 2.616% notes) plus 15 basis points, plus, in either case, accrued and unpaid interest on the amount of the 2.616% notes being redeemed to, but excluding, the date of redemption.

This press release shall not constitute a notice of redemption of the 2.616% notes, and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On August 13, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2021 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 13, 2021, View Source [SID1234586538]).

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"Throughout the second quarter and in recent weeks, we’ve made tremendous progress advancing our entire DNAbilize portfolio. In June, we were delighted to announce a new patent related to our BP1003 program which further bolsters our intellectual property portfolio," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Throughout the balance of the year, we look forward to executing on our clinical development plans, including the advancement of our Phase 1 clinical trial evaluating BP1002 in refractory/relapsed acute myeloid leukemia patients."

Recent Corporate Highlights

Granted Key Mechanism of Action U.S. Patent for BP1003. In June, Bio-Path announced that the United States Patent and Trademark Office has granted a new patent relating to the Company’s BP1003 program, a novel liposome-incorporated oligodeoxynucleotide inhibitor against Signal Transduction and Activator of Transcription-3 (STAT3). The new patent builds on earlier patents that have been granted that protect the platform technology for DNAbilize, the Company’s novel RNAi nanoparticle drug platform.

Announced Publication in Biomedicines. In April, Bio-Path announced the publication of an analysis highlighting the potential of prexigebersen (BP1001) within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines.

Presented BP1002 Data at 2021 AACR (Free AACR Whitepaper) Annual Meeting. In April, Bio-Path presented a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. The data presented in the AACR (Free AACR Whitepaper) poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.

Successfully Completed Safety Cohort of Triple Combination in Stage 2 of Phase 2 Clinical Trial in AML. In April, Bio-Path announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.
Financial Results for the Second Quarter Ended June 30, 2021

The Company reported a net loss of $1.8 million, or $0.26 per share, for the three months ended June 30, 2021, compared to a net loss of $2.0 million, or $0.55 per share, for the three months ended June 30, 2020.

Research and development expense for the three months ended June 30, 2021, decreased to $0.8 million, compared to $1.0 million for the three months ended June 30, 2020, primarily due to timing of activities related to our clinical trials for BP1002 in lymphoma, prexigebersen in AML and prexigebersen-A in solid tumors.

General and administrative expense for the three months ended June 30, 2021, were $1.0 million, consistent with the comparable period in 2020.

As of June 30, 2021, the Company had cash of $28.1 million, compared to $13.8 million at December 31, 2020. Net cash used in operating activities for the six months ended June 30, 2021, was $4.2 million compared to $6.0 million for the comparable period in 2020. Net cash provided by financing activities for the six months ended June 30, 2021, was $18.6 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 4739446. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.