On August 14, 2019 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense therapies to address genetic diseases, reported financial results for the three and nine month periods ended June 30, 2019, which only include the financial results for Ohr Pharmaceutical prior to the merger and associated financings (Press release, Ohr Pharmaceutical, AUG 14, 2019, View Source [SID1234538799]).

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"Over the past several months, we have positioned the Company with the capital and industry expertise required to advance our strategy to develop antisense oligonucleotide therapeutics by leveraging our PATrOL platform," said Dietrich Stephan, Ph.D., chairman and chief executive officer of NeuBase. "Looking ahead, we are developing next-generation antisense oligonucleotide therapeutics for rare genetic diseases with a goal of transforming patients’ lives. We are currently advancing several preclinical programs, including NT0100 to target Huntington’s Disease and NT0200 to target myotonic dystrophy."

Fiscal Third Quarter of 2019 and Recent Operating Highlights

●Shares of the Company’s common stock commenced trading on the Nasdaq Capital Market under the ticker symbol "NBSE" as of market open on July 15, 2019.
●Completed two financings raising an aggregate of approximately $14 million in gross proceeds, which occurred alongside the Nasdaq listing and included a $5 million investment from Greenlight Capital.
●Appointed four experienced executives from the biotechnology industry to the board of directors: Dr. Dov Goldstein, Dr. Diego Miralles, Dr. Franklyn Prendergast, and Eric Richman.
●Appointed Dr. Danith Ly, the primary inventor of NeuBase’s peptide nucleic acid (PNA) antisense oligonucleotide (PATrOL) platform technology, as the Company’s chief scientific officer.
●Expanded the scientific advisory board with the appointments of Dr. Samuel Broder (former National Cancer Institute Director) and Dr. George Church (Harvard Medical School professor).

Financial Results for the Three Months Ended June 30, 2019:

●For the three months ended June 30, 2019, the Company reported a net loss of approximately $1.1 million, or ($0.40) per share, compared to a net loss of approximately $0.5 million, or ($0.19) per share, in the three months ended June 30, 2018. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
●For the three months ended June 30, 2019, total operating expenses were approximately $1.1 million, consisting of approximately $0.9 million in general and administrative expenses, $0.1 million of research and development expenses, and $0.2 million in depreciation and amortization. This compares to total operating expenses of $1.2 million in the three months ended June 30, 2018, comprised of approximately $0.8 million in general and administrative expenses, $0.1 million in research and development expenses, and $0.3 million in depreciation and amortization.
●At June 30, 2019, the Company had cash and cash equivalents of approximately $1.4 million, compared to cash and equivalents of approximately $3.8 million at September 30, 2018. Subsequent to the end of the quarter, NeuBase completed two financings alongside the closing of the merger in July 2019, raising gross proceeds of approximately $14 million. The Company believes that its current cash balance will provide sufficient capital to fund operations through the end of fiscal 2020.

Financial Results for the Nine Months Ended June 30, 2019:

●For the nine months ended June 30, 2019, the Company reported a net loss of approximately $3.2 million, or ($1.12) per share, compared to a net loss of approximately $6.9 million, or ($3.36) per share, in the same period of 2018. Loss per share amounts have been retroactively adjusted for the reverse stock split effected on February 4, 2019.
●For the nine months ended June 30, 2019, total operating expenses were approximately $3.2 million, consisting of approximately $2.5 million in general and administrative expenses, $0.2 million of research and development expenses, and $0.5 million in depreciation and amortization. This compares to total operating expenses of approximately $7.5 million in the same period of 2018, consisting of approximately $2.9 million in general and administrative expenses, $4.2 million of research and development expenses, $0.8 million in depreciation and amortization, $0.7 million in impairment of goodwill, and $1.2 million in gain on settlement of accounts payable and long term liabilities.

On August 14, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,370,452 covering compositions and uses of effector T cells expressing a chimeric antigen receptor (CAR), where such T cells are derived from a pluripotent stem cell including an induced pluripotent stem cell (iPSC) (Press release, Fate Therapeutics, AUG 14, 2019, View Source [SID1234538739]). The foundational patent, which expires in 2034, is owned by Memorial Sloan Kettering Cancer Center (MSK) and is licensed exclusively to Fate Therapeutics for all human therapeutic uses.

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"The breadth of this newly-issued patent, which is not restricted by the signaling domain of the CAR construct nor by the antigen to which the CAR targets and binds, covers off-the-shelf, iPSC-derived CAR T cell therapy for the treatment of cancer, infectious disease and immune disorders," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "This patent is a testament to the prescient work of MSK’s Dr. Michel Sadelain in combining CAR and iPSC technologies in an effort to overcome the significant challenges that limit the widespread adoption of patient- and donor-sourced engineered T-cell immunotherapy."

Fate Therapeutics and MSK are conducting research and development of T-cell product candidates derived from iPSCs. These activities include the conduct of IND-enabling studies for FT819, an off-the-shelf CAR T-cell product candidate derived from a clonal master engineered iPSC line with complete elimination of T-cell receptor (TCR) expression and a novel 1XX CAR targeting CD19 inserted into the T-cell receptor alpha constant (TRAC) locus. Fate Therapeutics recently expanded its laboratory operations to New York City to support its research and development of off-the-shelf, iPSC-derived T cells.

Fate Therapeutics has built a dominant intellectual property position broadly covering iPSC technology and iPSC-derived cell products. Its proprietary portfolio includes compositions and methods for generating iPSCs, including engineering their biological properties using CRISPR and other nucleases, and for producing genetically edited cells of the hematopoietic lineage, including NK cells and T cells, from iPSCs. Fate Therapeutics’ iPSC product platform is supported by over 250 issued patents and 150 pending patent applications.

About FT819
FT819 is an off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell product candidate manufactured from a clonal master iPSC line that is undergoing IND-enabling activities in collaboration with Memorial Sloan Kettering Cancer Center (MSK). FT819 is manufactured from a clonal master engineered iPSC line with complete elimination of TCR expression and a novel 1XX CD19-specific CAR inserted into the T-cell receptor alpha constant (TRAC) locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient’s healthy tissue, and to regulate CAR expression to enhance the therapeutic potency and durability of CAR T cells. Scientists from the Company and MSK have presented preclinical data demonstrating that FT819 lacks TCR expression, is highly cytotoxic and specific to CD19 antigen and controls tumor progression comparable to peripheral blood CAR19 T cells in a mouse model of acute lymphoblastic leukemia.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy.

On August 14, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter of 2019 (Press release, Y-mAbs Therapeutics, AUG 14, 2019, View Source [SID1234538780]).

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"We are very pleased with our second quarter results, highlighted by prudent spending combined with notable progress in the preparation of the initial portions of our rolling BLAs for our two lead product candidates, naxitamab and omburtamab, for submission to the FDA later this year. We continue to solidify our position as a leader in pediatric oncology and as a company focused on rapidly developing therapies to extend and enhance the lives of those living with rare pediatric cancers," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We believe our recent pre-BLA meeting with the FDA supports our ambition of initiating submission of a rolling BLA for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma in the fourth quarter of 2019, with the expectation that the final portion will be submitted in early 2020. We are also excited to initiate the submission of a rolling BLA for omburtamab for the treatment of central nervous system/leptomeningeal metastasis from neuroblastoma by the end of 2019, and expect to submit the two rolling BLAs almost concurrently. These are exciting times for Y-mAbs."

Second Quarter 2019 and Recent Corporate Developments

Subsequent to the end of the second quarter, on July 8, 2019, Y-mAbs announced that it has completed a successful pre-BLA meeting with the FDA regarding a potential pathway for FDA approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. During the meeting, the Company reached alignment with the FDA on an Accelerated Approval Pathway for naxitamab along with a rolling BLA submission. The Company expects to submit the Clinical/Safety portion and the non-Clinical portion of the BLA in November 2019. For the Chemistry, Manufacturing and Controls (CMC) portion, the Company believes it will have sufficient data from the Process Performance Qualification (PPQ) batches to complete the CMC portion in early 2020. Y-mAbs continues to evaluate potential avenues to accelerate the submission of the CMC portion, and hopes to comply with FDA requirements at an earlier time.

Also subsequent to the end of the second quarter, on July 1, 2019, Y-mAbs announced the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of central nervous system/leptomeningeal metastasis (CNS/LM) from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma. As of June 30, 2019, all of the 18 planned omburtamab patients had been enrolled in the study. The Company believes it remains on track to start submission of a rolling BLA in 2019 under the Breakthrough Therapy Designation that the Company previously received from the FDA. For naxitamab, more than 30 patients of a planned total of 37 patients in the Company’s Study 201 had been enrolled in the study as of June 30, 2019.

After the close of the second quarter, on July 1, 2019, Y-mAbs announced that the Company has entered into a development, manufacturing and supply agreement with SpectronRx in South Bend, Indiana, to secure access to clinical and commercial scale radiolabeling capacity for omburtamab. Under the terms of the agreement, SpectronRx has agreed to establish a manufacturing unit designated for Y-mAbs within its existing facilities, at which Y-mAbs believes both clinical and commercial supply of radiolabeled omburtamab can be produced.

On June 26, 2019, Y-mAbs announced the acceptance of two oral presentations and five poster presentations at the International Society of Pediatric Oncology (SIOP) Annual Congress for its two lead product candidates, naxitamab and omburtamab.

On May 15, 2019, Y-mAbs announced the acceptance of three poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for its two lead product candidates, naxitamab and omburtamab.

On May 14, 2019, Y-mAbs announced an update on its GD2-GD3 Vaccine program for relapsed high-risk neuroblastoma. A total of 230 patients have received the GD2-GD3 Vaccine to date and Y-mAbs plans to begin using a newly manufactured Current Good Manufacturing Practice (cGMP) drug product in the fourth quarter of 2019.
Second Quarter 2019 Financial Results

Y-mAbs reported a net loss of $18.0 million, or $0.53 per basic and diluted share, for the three months ended June 30, 2019, compared to a net loss of $10.3 million, or $0.39 per basic and diluted share, for the three months ended June 30, 2018.

For the six months ended June 30, 2019, Y-mAbs reported a net loss of $34.0 million, or $0.99 per basic and diluted share, compared to a net loss of $17.8 million, or $0.66 per basic and diluted share, reported for the six months ended June 30, 2018.

Operating Expenses

Research and Development
Research and development expenses were $14.5 million for the three months ended June 30, 2019, compared to $8.3 million for the three months ended June 30, 2018, an increase of $6.2 million. The increase in research and development expenses primarily reflects the following:

$2.9 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
$2.2 million increase in outsourced research and supplies to support expanding development activities; and
$0.7 million increase in personnel costs.
Research and development expenses were $27.0 million for the six months ended June 30, 2019, compared to $14.5 million for the six months ended June 30, 2018, an increase of $12.5 million. The increase in research and development expenses primarily reflects the following:

$7.2 million increase in outsourced manufacturing for our two lead product candidates, naxitamab and omburtamab;
$3.5 million increase in outsourced research and supplies to support expanding development activities; and
$1.4 million increase in personnel costs.
General and Administration
General and administrative expenses were $4.1 million for the three months ended June 30, 2019, compared to $2.0 million for the three months ended June 30, 2018, an increase of $2.1 million. Such increase in general and administrative expenses primarily reflects the following:

$1.4 million increase in personnel costs; and
$0.5 million increase in commercial infrastructure.
General and administrative expenses were $7.9 million for the six months ended June 30, 2019, compared to $3.2 million for the six months ended June 30, 2018, an increase of $4.7 million. Such increase in general and administrative expenses primarily reflects the following:

$2.8 million increase in personnel costs; and
$0.8 million increase in commercial infrastructure costs.
Cash and Cash Equivalents
The Company had approximately $120.2 million in cash and cash equivalents as of June 30, 2019, compared to $147.8 million as of December 31, 2018. The decrease of $27.6 million was primarily attributable to the increased costs of operation as the Company prepares for its submission of rolling BLAs for naxitamab and omburtamab and the build-up of the Company’s commercial infrastructure.

Webcast and Conference Call

The Company will host a conference call today at 4:30 pm Eastern Time. To participate in the call, please dial (877) 407-0792 (domestic) or (201) 689-8263 (international) and reference the access code 13693605. A webcast will be available at: View Source

On August 14, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the second quarter ended June 30, 2019 (Press release, Cleveland BioLabs, AUG 14, 2019, View Source [SID1234538834]).

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Cleveland BioLabs reported a net loss of $(0.6) million, excluding minority interests, for the second quarter of 2019, or $(0.05) per share, compared to a net loss, excluding minority interests, of $(0.9) million, or $(0.08) per share, for the same period in 2018. The decrease in net loss was primarily due to reduced research and development expenses related to the oncology applications of the entolimod family of compounds, a decrease in General and Administrative costs, and a decrease in the non-cash adjustment to our warrant liabilities, partially offset by reduced revenues.

As of June 30, 2019, the Company had $2.6 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into June 2020.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our main priority and focus."

Further Financial Results

Revenue for the second quarter of 2019 decreased to $0.28 million compared to $0.39 million for the second quarter of 2018. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure and by decreased revenue from our service contract with Incuron.

Research and development costs for the second quarter of 2019 decreased to $0.60 million compared to $0.91 million for the second quarter of 2018. The reduction in research and development costs is due to a $0.36 million decrease in expenses related to the oncology applications of the entolimod family of compounds, partially offset by a $0.05 million increase in spending for biodefense applications of entolimod.

General and administrative costs for the second quarter of 2019 decreased to $0.45 million compared to $0.55 million for the second quarter of 2018. This decrease was primarily attributable to a $0.03 million decrease in CBLI’s legal and professional fees, a $0.03 million decrease in travel expense, and a $0.03 million decrease in personnel and subcontractor expenses relating to outsourced assistance.

On August 14, 2019 AstraZeneca reported that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults (Press release, AstraZeneca, AUG 14, 2019, View Source [SID1234538721]).1

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José Baselga, Executive Vice President, Oncology R&D, said: "This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile."

The FDA granted the BTD based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials. Together the trials showed that Calquence alone or in combination significantly increased the time patients lived without disease progression or death, with safety and tolerability that was consistent with its established profile.

This is the 10th BTD that AstraZeneca has received from the FDA since 2014. An FDA BTD is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically-significant endpoint over currently-available medicines.

Calquence is currently approved for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) in the US, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina and recently Singapore and is being developed for the treatment of CLL and other blood cancers. The positive results from both the ELEVATE-TN and ASCEND trials will serve as the foundation for regulatory submissions later this year.

About ELEVATE-TN

ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence alone or in combination with obinutuzumab vs. chlorambucil in combination with obinutuzumab in previously-untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity).2

The primary endpoint is progression-free survival (PFS) in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints include objective response rate, time to next treatment and overall survival.2

About ASCEND

ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously-treated patients with CLL.2 In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received physician’s choice of either rituximab in combination with idelalisib or rituximab in combination with bendamustine.3,4

The primary endpoint is PFS assessed by an IRC, and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.3,4

About Calquence

Calquence (acalabrutinib) was granted accelerated approval by the US FDA in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Calquence is an inhibitor of Bruton tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.5 In beta (B) cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 26 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström macroglobulinaemia, follicular lymphoma, and multiple myeloma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating acalabrutinib vs. ibrutinib in patients with previously-treated high-risk CLL, and ACE-CL-311 evaluating acalabrutinib in combination with venetoclax and with/without obinutuzumab in patients with previously-untreated CLL without 17p deletion or TP53 mutation.

About chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is one of the most common type of leukaemia in adults, with an estimated 105,000 new cases globally and 20,720 new cases in the US annually, and prevalence that is expected to grow with improved treatment.1,6,7,8 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.1 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.1 This could result in anaemia, infection and bleeding.1 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

About AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Company’s haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZeneca’s haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

In October 2018, AstraZeneca and Innate Pharma announced a global strategic collaboration that included Innate Pharma licensing the US commercial rights of Lumoxiti (moxetumomab pasudotox-tdfk), and with support from AstraZeneca, will continue EU development and commercialisation, pending regulatory submission and approval.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of

new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline

of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.