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.

On August 13, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2021 and provided a business update (Press release, Anchiano Therapeutics, AUG 13, 2021, View Source [SID1234586537]).

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Recent Highlights

CM-101 Phase 2a SPRING trial in primary sclerosing cholangitis (PSC) continues to enroll patients in the UK and Israel. The SPRING study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose trial designed to evaluate CM-101’s anti fibrotic effect, as well as its safety, pharmacokinetics and pharmacodynamics in PSC patients. Due to challenges resulting from the evolving conditions caused by the COVID-19 pandemic, Chemomab is expanding the trial sites to include additional territories with significant recruitment potential, and anticipates data in the second half of 2022.

CM-101 Phase 2a SPLASH trial in liver fibrosis remains on track, with data expected in the first half of 2022. The SPLASH study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the anti-fibrotic effects of subcutaneous (SC) CM-101 in NASH patients with fibrosis stage F2-F3.

CM-101 Phase 2 clinical trial of CM-101 for the treatment of Systemic Sclerosis. Chemomab continues the preparations for the Phase 2 trial in Systemic Sclerosis. The trial is planned to be a multi-center, randomized, double-blind, placebo-controlled study designed to test CM-101’s effect on clinically relevant endpoints in diffuse Systemic Sclerosis patients. Chemomab expects to initiate the Phase 2 clinical trial in the first quarter of 2022.

Expanded partnership with AGC Biologics for the manufacture of CM-101. Under terms of the agreement, AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and Chemomab will work together to optimize, scale up and finalize the CM-101 manufacturing process under GMP conditions towards its testing in pivotal studies. AGC Biologics will manufacture the clinical trial materials at its site in Copenhagen to support Phase 2/3 clinical testing and launch readiness.

Presented a poster at the International Liver Congress 2021 (EASL) held virtually in June 2021. The poster, entitled: "The peri-ductular CCL24 rich niche promotes bile duct fibrosis related liver damage in primary sclerosing cholangitis" highlighted the pivotal role of CCL24 as a main driver of fibrosis in PSC-related pathophysiology and provided further support to the proposed CM-101 mechanism of action in PSC.

Chemomab is advancing in parallel three Phase 2 clinical trials with CM-101 in fibrotic indications; Systemic Sclerosis is planned to be initiated by early 2022 and clinical readouts from the ongoing clinical trials in PSC and liver fibrosis are expected during 2022.

"With two of our three planned Phase 2 trials enrolling patients and our strong cash position, we continue to make solid progress throughout our CM-101 pipeline. We remain highly focused on execution. In the beginning of 2022, we plan to initiate our third Phase 2 trial of CM-101 in Systemic Sclerosis and we look forward to anticipated data readouts in PSC and liver fibrosis in 2022." said Dr. Adi Mor, CEO of Chemomab. "Our agreement with AGC Biologics is an important step in ensuring the availability of clinical trial material for our future pivotal clinical studies and launch readiness. CM-101 is a very promising therapy with the potential to treat multiple severe and life-threatening inflammatory and fibrotic diseases and we believe we are well positioned to continue advancing our pipeline and executing upon our important milestones."

Second Quarter 2021 Financial Highlights

Cash and cash equivalents (including bank deposits) as of June 30, 2021 were $67 million compared to $58.2 million as of March 31, 2021 and $11.7 million as of December 31, 2020. The existing cash position is expected to fund the Company’s current operating plan until mid 2023.
Number of ADSs outstanding on a fully diluted basis as of June 30, 2021 was 12,584,362 (or 251,687,240 ordinary shares) which includes 699,806 ADSs (or 13,996,120 ordinary shares) sold during the quarter ended June 30, 2021 under the Company’s ATM program.
Research and Development expenses for the three months ended June 30, 2021 were $1.3 million, compared to $0.8 million for the three months ended June 30, 2020. The increase of $0.5 million was primarily related to clinical and pre-clinical activities. R&D expenses are expected to substantially increase over the next several quarters as Chemomab continues to advance the clinical programs.
General and administrative expenses were $1.4 million for the three months ended June 30, 2021, compared to $0.2 million for the three months ended June 30, 2020. The increase of $1.2 million is primarily derived from expenses associated with public company operations.
Basic and diluted net loss for the three months ended June 30, 2021 was $2.8 million or ($0.01) per ordinary share, compared to $1.1 million, or ($0.01) per ordinary share, for the prior year period.
For further details on the Company’s financial results, including the results for the six and three months ended June 30, 2021, refer to the Form 10-Q filed with the SEC.

On August 13, 2021Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical stage biopharmaceutical company developing drugs to improve the survival and/or quality of life for patients who have an unmet medical need condition, reported that financial results for the quarter ended June 30, 2021, and provides corporate update (Press release, Processa Pharmaceuticals, AUG 13, 2021, View Source [SID1234586520]).

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Dr. David Young, CEO and chairman of Processa, commented, "During the second quarter we made significant progress advancing our clinical programs, in-licensed another clinical asset – RX-3117 – and will have four clinical programs with addressable markets of $500 million to $1.5 billion. Looking at upcoming milestones, we have begun to develop the biomarker assays for 3117 in pancreatic cancer patients with the expectation that the assay validation will be completed in the first half of 2022. We also anticipate filing an IND in September for PCS12852 with site initiation beginning before year end. Additionally, we expect interim data for PCS6422 in the fourth quarter of 2021 and interim data for PCS499 during the first half of 2022. Taken altogether, we see a consistent cadence of upcoming catalysts and tremendous amount of near-term value creation."

Recent Highlights and New Developments

Dosed our first two patients in the PCS499 Phase 2B ulcerative Necrobiosis Lipoidica (NL) trial. NL is a rare, chronic, idiopathic, granulomatous disease that can significantly effect a patient’s quality of life and is caused by a number of diverse pathophysiological changes in a patient. There are no approved treatments for NL or ulcerative NL and no acceptable standard of care. Approximately 30% of NL patients have the ulcerative form of NL.
Dosed our first patient in our Phase 1B trial evaluating the safety and PK of PCS6422 and capecitabine when administered to patients with advanced, refractory GI cancer. The combination of PCS6422 and capecitabine is expected to improve the benefit-risk profile of capecitabine by improving capecitabine safety and/or efficacy.
Licensed in PCS3117 (formerly RX-3117), an oral, anticancer agent with an improved pharmacological profile relative to gemcitabine. PCS3117 has a family of patents extending into 2036 as well as U.S. Food and Drug Administration (FDA) Orphan Designation for the treatment of Pancreatic Cancer. Processa has begun to develop biomarkers assays to better predict which patients with pancreatic or non-small cell lung cancer are more likely to benefit from PCS3117 over gemcitabine and other chemotherapeutic agents.
Joined the Russell Microcap , resulting in automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
Upcoming Clinical Drug Development Milestones

Second half of 2021

Complete enrollment of 8-10 patients for the PCS499 Phase 2B interim analysis
Submit PCS12852 IND application to FDA for Gastroparesis and initiate sites
Begin assay development of biomarkers for PCS3117 in pancreatic cancer
Complete interim analysis of PCS6422 Phase 1B trial in GI cancer
2022

Interim analysis of PCS499 Phase 2B trial in ulcerative NL
Final analysis of PCS499 Phase 2B trial in ulcerative NL
Enroll and complete PCS12852 Phase 2A gastroparesis trial
Complete assay validation of biomarkers for PCS3117 and initiate sites for Phase 2B pancreatic cancer trial
Determine the maximum tolerated dose for capecitabine in the PCS6422-capecitabine combination Phase 1B GI cancer trial
Financial Results for the second quarter of 2021

Our cash and cash equivalents totaled $20.8 million as of June 30, 2021, compared to $15.4 million as of December 31, 2020 and we had 15.6 million shares of common stock outstanding as of August 2, 2021.

Our research and development expenses for the three months ended June 30, 2021 were $1.6 million compared to $427 thousand for the three months ended June 30, 2020. General and administrative expenses for the three months ended June 30, 2021 were $1.3 million compared to $375 thousand for the three months ended June 30, 2020. Our total stock-based compensation included in general and administrative expenses for the three months ended June 30, 2021 was $674 thousand compared to $87 thousand for the three months ended June 30, 2020. We reported a net loss for the three months ended June 30, 2021 of $3.2 million compared to a net loss for the comparable prior year period of $733 thousand. Our net loss per share for the three months ended June 30, 2021 was $0.20 compared to net loss per share for the three months ended June 30, 2020 of $0.13.

Conference Call Information

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