On August 14, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2018 (Press release, Cel-Sci, AUG 14, 2018, View Source [SID1234528892]). The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients. Enrollment was completed in September of 2016. Based on published survival data, we believe top line results may be available as soon as early 2019. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint has been met. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database.
The US Patent and Trademark Office allowed two new patents to CEL-SCI for the Company’s LEAPS platform technology. Titled "Method for Inducing an Immune Response and Formulations Thereof" and " Method for Inducing an Immune Response against avian, swine, Spanish, H1N1, H5N9 influenza viruses and formulations", these patents relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.
CEL-SCI won the arbitration against the clinical research organization (CRO) that ran the Phase 3 head and neck cancer study from 2011-2013. The arbitrator ruled that the CRO materially breached its contract with CEL-SCI. The arbitrator’s decision has vindicated CEL-SCI. Many investment funds and analysts did not like the legal risk of this arbitration and now that the arbitration has been resolved in CEL-SCI’s favor, this should no longer be an impediment to investors and should result in renewed investment interest in CEL-SCI. With the arbitration completed, CEL-SCI moves forward with a clean slate.
"We are proud of having run the largest head and neck cancer Phase 3 study in the world, in an indication that has not seen a new drug approved by the FDA in over 60 years. This has not been easy for many reasons, including the fact that our approach to immunotherapy involves treating the patient when they first get diagnosed instead of using immunotherapy as a last ditch option for survival. Our approach meant a longer clinical trial period, with nearly one thousand patients enrolled. Despite the many challenges of this study, we believe the potential to bring a new immunotherapy to help save the lives of newly diagnosed cancer patients has been worth it," said CEL-SCI’s Chief Executive Officer, Geert Kersten. "As we look forward to a readout of the endpoint data which may happen in early 2019, we also continue to develop our LEAPS technology platform with the support of the U.S. National Institutes of Health. Should our Phase 3 results lead to marketing approval in head and neck cancer, we will also have the opportunity to purse clinical development and marketing approval of our immunotherapy in other cancer indications."

During the nine months ended June 30, 2018, the Company’s cash remained constant. Cash used in operations of approximately $9.1 million was offset by approximately $9.1 million in cash provided by financing activities. Sources of financing during the nine months included approximately $7.0 million in proceeds from the issuance of common stock and warrants and $2.1 million in proceeds from the exercise of warrants.

CEL-SCI reported an operating loss of ($4,070,363) for the quarter ended June 30, 2018 versus an operating loss of ($4,758,719) for the quarter ended June 30, 2017. The operating loss was ($13,187,538) for the nine months ended June 30, 2018 versus an operating loss of ($17,603,283) for the nine months ended June 30, 2017.

On August 14, 2018 ProMIS Neurosciences, Inc. (TSX: PMN; OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported its operational and financial results for the three and six months ended June 30, 2018 (Press release, ProMIS Neurosciences, AUG 14, 2018, View Source [SID1234528931]).

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"Over the first half of 2018, we focused on three key priorities to advance our business", stated ProMIS Executive Chairman, Eugene Williams. "First, to continue to push toward our goal of initiating the first clinical trial of PMN310 in the second half of 2019; second, to differentiate the oligomer selectivity of PMN310 as best in class profile for the treatment of Alzheimer’s disease (AD) versus other amyloid-beta directed therapies in development; and third, to expand our portfolio by developing therapeutic antibodies targeting toxic oligomers of alpha-synuclein for Parkinson’s disease (PD) and toxic aggregates of Tar-DNA binding protein (TDP43) for ALS. We are pleased to be on target to meet our objectives for the year and look forward to communicating our accomplishments."

Recent Corporate Highlights

On May 1, we announced completion of a private placement of 19,306,668 common share units at a price of $0.375 per unit, for gross proceeds of approximately $7,240,000. Each unit consisted of one common share and one-half of a common share purchase warrant. Each whole warrant is exercisable into one common share at a price of $0.48 per share for a 60-month exercise period, subject to earlier expiry on 30 days’ notice if, at any time after four months from closing, the 20-day volume-weighted average trading price of the Company’s common shares is greater than CDN$1.00. Net proceeds from the private placement will be used for working capital and general corporate purposes.
During the second quarter of 2018, we received proceeds of $1,550,204 related to the exercise of common stock warrants and stock options. The warrants were exercisable at $0.17, $0.20 and $0.30.
On April 10, we announced publication of a peer reviewed scientific paper describing a novel target on toxic oligomers of amyloid-beta in AD.
On June 12, we announced the initiation of producer cell line development for PMN310, our lead therapeutic antibody candidate for treatment of AD. Selexis, SA will carry out this critical first step in the manufacturing of antibody therapeutics using their proprietary Selexis SUREtechnology Platform.
On June 26, we announced that our unique discovery platform generated potential new antibody therapeutic candidates targeting toxic oligomers implicated in the development and progression of PD and ALS.
On June 28, we announced results of the Annual Meeting of Shareholders, whereby all of the resolutions announced in the Management Proxy Circular and placed before the Meeting were overwhelmingly approved by the shareholders.
Financial Results

Results of Operations – Three months ended June 30, 2018 and 2017

The net loss for the three months ended June 30, 2018 was $2,214,861, compared to a net loss of $1,903,396 for the three months ended June 30, 2017. The increased loss in the current period reflects the costs associated with operating the Company’s AD therapeutics program, increased contract research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Research and development expenses for the three months ended June 30, 2018 were $1,531,075, as compared to $1,132,258 in the three months ended June 30, 2017. Costs were higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the three months ended June 30, 2018 were $683,786, as compared to $768,696 in the three months ended June 30, 2017. The decreased in expenditures in the current period reflect reduced investor relations expenses and foreign exchange expense, offset by higher consultant salaries and associated costs, other professional fees, and stock-based compensation.

Results of Operations – Six months ended June 30, 2018 and 2017

The net loss for the six months ended June 30, 2018 was $3,771,733, compared to a net loss of $3,275,599 for the six months ended June 30, 2017. The increased loss in the current period reflects the costs associated with operating the Company’s AD therapeutics program, increased contracted research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Revenues for the six months ended June 30, 2018 and 2017 were nominal and relate to legacy technologies.

Research and development expenses for the six months ended June 30, 2018 were $2,229,082, as compared to $1,851,360 in the six months ended June 30, 2017. Costs are higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the six months ended June 30, 2018 were $1,542,656, as compared to $1,420,056 in the six months ended June 30, 2017. The increased expenditures in the current period reflect increased consultant salaries and associated costs and higher stock-based compensation, offset by foreign exchange gains.

Outlook

The Company plans to further advance its AD portfolio, with a focus on development of PMN310 for clinical trial initiation in the second half of 2019. Based on the highly selective binding of PMN310 to the toxic Aβ oligomers and lack of off-target binding to non-toxic forms of Aβ (monomer, plaque), the ProMIS AD program will continue to develop data further supporting potential best in class safety and efficacy versus other Aβ-directed therapies currently in development.

Finally, using its unique technology platform, we will advance work to identify and validate selective antibody therapies for the toxic oligomers of alpha synuclein in PD and TDP43 in ALS, with a view to partnering these assets.

On August 14, 2018 Ohr Pharmaceutical, Inc. (Nasdaq: OHRP), a pharmaceutical company developing therapies for ophthalmic diseases, reported financial results for its fiscal third quarter ended June 30, 2018 (Press release, Ohr Pharmaceutical, AUG 14, 2018, View Source [SID1234528877]).

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"We continue to work with our advisor to pursue strategic alternatives with the goal of maximizing shareholder value," said Dr. Jason Slakter, chief executive officer of Ohr Pharmaceutical. "We look forward to updating the market on our progress."

Financial Results for the Third Quarter ended June 30, 2018

For the quarter ended June 30, 2018, the Company reported a net loss of approximately $0.5 million, or ($0.01) per share, compared to a net loss of approximately $3.9 million, or ($0.07) per share in the same period of 2017.
For the quarter ended June 30, 2018, total operating expenses were approximately $1.2 million, consisting of $0.8 million in general and administrative expenses, $0.1 million of research and development expenses, and $0.3 million in depreciation and amortization. This compares to total operating expenses of $3.9 million in the same period of 2017, consisting of $1.4 million in general and administrative expenses, $2.2 million of research and development expenses, and $0.3 million in depreciation and amortization.
At June 30, 2018, the Company had cash and cash equivalents of approximately $4.4 million, compared to cash and equivalents of approximately $12.8 million at September 30, 2017.
Financial Results for the Nine Months Ended June 30, 2018

For the nine months ended June 30, 2018, the Company reported a net loss of approximately $6.9 million, or ($0.12) per share, compared to a net loss of approximately $18.6 million, or ($0.45) per share in the same period of 2017.
For the nine months ended June 30, 2018, total operating expenses were approximately $7.5 million, consisting of $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. This compares to total operating expenses of $18.5 million in the same period of 2017, comprised of approximately $4.6 million in general and administrative expenses, $13.2 million in research and development expenses, $0.9 million in depreciation and amortization, and $0.1 million in gain on settlement of accounts payable.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and we undertake no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to identify, execute and conclude any strategic alternatives to maximize shareholder value, the financial resources available to us and risk that we may not be able to obtain sufficient funding as needed and as a result be forced to cease operations and liquidate, the ability to negotiate and conclude a strategic partnership, the future success of any scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for any future products, legislative, regulatory and competitive developments, uncertainty related to our ability to continue as a going concern, the impact of significant reductions in our operations, our ability to maintain compliance with the Nasdaq Capital Market continued listing standards and policies and to maintain the listing and trading of our common stock on a national securities exchange, and general economic conditions. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition.

On August 13, 2018 ArQule, Inc. (Nasdaq:ARQL), reported the publication of preclinical study data for ARQ 531, the Company’s rationally-designed, reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK) (Press release, ArQule, AUG 13, 2018, View Source [SID1234532694]). The studies, published in Cancer Discovery, were conducted in collaboration with researchers at The Ohio State University. Data from these studies demonstrated efficacy in in vitro and in vivo hematologic malignancy models that recapitulate the most common mechanisms of resistance to irreversible BTK inhibitors, including ibrutinib.

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Highlights from the manuscript (link here) include:

Differentiated Crystal Structure and Biochemical Profile

The crystal structure of ARQ 531 bound to BTK elucidates the mechanism of BTK inhibition that is not dependent on the specific amino acid residue at position 481 (eg. C or S)
Recombinant BTK biochemical assays of ARQ 531 and ibrutinib show similar inhibition for wild type BTK, however ibrutinib has dramatically lower inhibition, binding affinity and residence time for mutant BTK
"Relapsed and refractory patients that develop resistance to ibrutinib have poor outcomes and limited treatment options," said Brian Schwartz, M.D., Chief Medical Officer and Head of R&D at ArQule. "ARQ 531 was rationally-designed and selected to address this unmet need by inhibiting both wild type and mutant BTK. The published crystal structure and biochemistry clearly demonstrate the mechanism by which ARQ 531 maintains binding and inhibition of mutant BTK in conditions where ibrutinib cannot."

Established Activity in Multiple Cellular and Murine Models of Hematological Malignancies

Exhibited dose dependent toxicity in human primary CLL cells (mutant and wild type)
Inhibited CLL cell migration in vitro
Established superiority to ibrutinib in an engraftment murine model of CLL
Showed activity against other B-cell signaling pathways
Demonstrated efficacy in a murine model of Richter’s transformation
John Byrd, M.D., the Warren Brown Chair of Leukemia Research at The Ohio State University stated, "The inhibition profile of ARQ 531 may confer distinct advantages over ibrutinib, potentially expanding the patient population beyond those with a C481S mutation who may benefit from treatment. Targeting multiple kinases in the B cell activation pathway may provide more durable responses to treatment while also delaying the emergence of treatment resistance. Jennifer Woyach, M.D., Associate Professor of Medicine at The Ohio State University, added, "I am particularly encouraged by the CLL mouse model data which established the superior efficacy of ARQ 531 compared to ibrutinib and the efficacy of ARQ 531 in the model of Richter’s transformation as this is an extremely aggressive disease with very few treatment options."

On August 13, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T Cell Receptor (ACTR) technology platform, reported that an investigational new drug (IND) application is now active for ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers (Press release, Unum Therapeutics, AUG 13, 2018, View Source [SID1234528936]). This represents the first solid tumor product candidate based on Unum’s novel, universal ACTR technology, and the fourth clinical trial program for the Company.

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"We are very happy to reach this important milestone for patients and for Unum," said Chuck Wilson, Chief Executive Officer of Unum. "ACTR represents a promising novel technology that can be used to target different tumor types and it’s exciting to expand its application to target solid tumors. We are committed to developing ACTR for patients with HER2+ advanced cancers who need better treatment options."

Under this IND, Unum is preparing to initiate a multi-center Phase I trial, called ATTCK-34-01, by the end of 2018 in patients with HER2+ advanced cancers. ATTCK-34-01 is designed as a dose escalation study where both the ACTR T cell drug product and trastuzumab doses are escalated in order to define the safety, tolerability, and anti-tumor activity of the combination. Expansion at the recommended Phase 2 dose is planned.