On November 13, 2018 OncoSec Medical Inc., (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that TAVO will be featured in two poster sessions during the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4-8 in San Antonio, Texas (Press release, OncoSec Medical, NOV 13, 2018, View Source [SID1234531248]). Posters include data on TAVO as a monotherapy and an initial project overview for KEYNOTE-890, a Phase 2 clinical trial in combination with Merck’s KEYTRUDA (pembrolizumab) for the treatment of late stage triple negative breast cancer (TNBC).

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"We are encouraged with the preliminary clinical observations we are seeing thus far, both in a monotherapy setting and in combination with checkpoint inhibitors," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "Based on this, we are excited to continue on the path toward developing novel treatment options for this large unmet medical need,"

Details on the poster presentations are as follows:

Presentation Title: Intratumoral tavokinogene telseplasmid and electroporation in pre-treated inoperable locally advanced or recurrent triple-negative breast cancer
Session Date & Time: Thursday, December 6, 7:00 – 9:00 a.m. CT (8:00 – 10:00 a.m. ET)
Session Title: Poster Session 2: Treatment: Immunotherapy (clinical)
Location: Hall 1, Henry B. Gonzalez Convention Center

Presentation Title: A phase 2 study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation with pembrolizumab in patients with inoperable locally advanced or metastatic triple negative breast cancer
Session Date & Time: Thursday, December 6, 5:00 – 7:00 p.m. CT (6:00 – 8:00 p.m. ET)
Session Title: Ongoing Clinical Trials: Immunotherapy
Location: Hall 1, Henry B. Gonzalez Convention Center

The abstracts for these presentations are now available online on the SABCS website at View Source

On November 13, 2018 Forty Seven Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported financial results for the third quarter ended September 30, 2018 and provided a business update (Press release, Forty Seven, NOV 13, 2018, View Source [SID1234531273]).

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"Our recent accomplishments reflect our commitment to establishing Forty Seven as a pioneer in the development of a new class of checkpoint therapies, which harness the innate immune system to help patients more effectively defeat their disease," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc.
"We were pleased to have the New England Journal of Medicine publish our Phase 1b NHL data for 5F9 in combination with rituximab earlier this month, which speaks to the potential of macrophage activation for the treatment of cancer.

"In addition to progressing our ongoing clinical trials of 5F9 toward data readouts in 2019, we advanced our pipeline in the third quarter with additional efforts on FSI-189 as our next development candidate," continued Dr. McCamish. "FSI-189 is an anti-SIRPα antibody, designed to interfere with CD47 activity through a distinct modality, which enables us to more fully exploit the potential of the CD47/SIRPα pathway as a novel oncology target. We look forward to building on this momentum in the coming months, as we work together with our newly appointed SAB to advance our pipeline and maximize our impact."

Upcoming Milestones:

Forty Seven plans to present preclinical data providing new insights into the mechanism of action of its priming and maintenance dose strategy for 5F9 in a poster session at the 60th ASH (Free ASH Whitepaper) Annual Meeting, which will be held December 1-4, 2018 in San Diego, California. Also at ASH (Free ASH Whitepaper), Forty Seven will present a poster detailing new preclinical data that supports the combination of 5F9 and azacitidine for the treatment of acute myeloid leukemia (AML). Patients with AML have already been dosed with this combination based on these promising preclinical results.

Third Quarter and Recent Business Highlights:

In October 2018, Forty Seven advanced FSI-189, an anti-SIRPα antibody, as its second product candidate for the treatment of cancer. SIRPα is the cognate receptor of CD47 and, in preclinical models, FSI-189 blocked SIRPα binding to CD47 and enhanced macrophage phagocytosis of cancer cells. SIRPα is only expressed on certain cells types, including macrophages. As a result, Forty Seven believes that FSI-189 may be effective at low doses. FSI-189 is currently in preclinical development, and Forty Seven plans to initiate IND-enabling studies in 2019.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

In October 2018, Forty Seven announced that proof-of-concept data from the Phase 1b portion of its Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab in patients with relapsed/refractory NHL were published in the New England Journal of Medicine. In the Phase 1b portion of the study, 5F9 demonstrated signs of clinical efficacy, and was safe and well-tolerated in the patients treated.

Corporate:

In October 2018, Forty Seven announced the formation of its SAB, including the appointment of four leading scientists in the fields of immunotherapy and oncology: 2018 Nobel Laureate for Medicine, James Allison, Ph.D.; Ronald Levy, M.D.; Padmanee Sharma, M.D., Ph.D.; and Louis Weiner, M.D.

In August 2018, the European Patent Office Opposition Division ruled in favor of Forty Seven, rejecting challenges to the company’s licensed European patent, EP ‘512, which covers the use of CD47 antibodies designed to treat cancer through phagocytosis. This decision strengthens Forty Seven’s patent protection for 5F9 in Europe.

Third Quarter 2018 Financial Results:

Cash Position: As of September 30, 2018, cash, cash equivalents and short-term investments were $154.0 million, as compared to $88.1 million as of December 31, 2017. This increase reflects net proceeds of $116.3 million from Forty Seven’s initial public offering of common stock, which closed in July 2018. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into 2020.

R&D Expenses: R&D expenses were $18.0 million for the third quarter ended September 30, 2018, as compared to $8.8 million for the same period in 2017. This increase was primarily due to non-recurring upfront payments on two licensing deals of $6.3 million, as well as the continued advancement of the company’s clinical development efforts and preclinical and discovery programs. This increase was partially offset by $1.7 million in grant and cost-share funding recognized under the company’s grants from the California Institute of Regenerative Medicine, the Leukemia and Lymphoma Society and Merck KGaA.

G&A Expenses: G&A expenses were $4.4 million for the third quarter ended September 30, 2018, as compared to $2.1 million for the same period in 2017. This increase was primarily due to increased personnel costs and expenses incurred in connection with operating as a public company.

Net Loss: Net loss was $21.7 million for the third quarter ended September 30, 2018, or $0.71 per basic and diluted share, as compared to a net loss of $10.8 million, or $1.67 per basic and diluted share, for the same period in 2017.

On November 13, 2018 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported financial and operating results for the third quarter ended September 30, 2018 and provided a corporate update (Press release, Oncocyte, NOV 13, 2018, View Source [SID1234531301]).

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"During the third quarter and subsequent period, we made significant progress on our DetermaVu development plan by completing the transition to a new diagnostic testing platform that is yielding very consistent and reliable data," said William Annett, President and Chief Executive Officer. "Using this equipment, we have now run over half of the 700-blood samples that are being used in our Algorithm Development Study. This study will establish a proprietary mathematical algorithm that will be used to interpret test results for DetermaVu. Once all samples have been run, development of the algorithm will begin, and we expect its completion next month."

"After the new algorithm is derived, we will move on to an R&D Validation Study that should determine the accuracy of DetermaVu to within approximately plus or minus eight percentage points. By about the end of 2018 or early 2019 we anticipate finishing this study and will then be able to confirm with a high degree of certainty whether we have a commercially-viable diagnostic test poised to address the multi-billion-dollar market for a liquid biopsy lung cancer diagnostic test. On successful completion of the R&D Validation study we will be on-track to complete all of the necessary pre-launch development work in the first half of 2019. If the test’s accuracy is maintained in the planned studies, we plan to make DetermaVu commercially available in the second half of 2019."

Highlights

Following rigorous testing, completed transition to a new Next Generation Sequencing diagnostic testing platform and quality control testing of new custom panel reagents
Initiated a 700–blood sample Algorithm Development Study to develop the proprietary mathematical algorithm that will be used to interpret the results of DetermaVu
On-track to initiate an R&D Validation Study of 250 blinded, prospectively-collected patient blood samples with results expected by the end of this year or early 2019
Remaining Validation Pathway for DetermaVu:

Approximately yearend 2018: R&D Validation study – to confirm algorithm performance on a blinded sample set in an R&D setting
1H 2019: Analytical Validation study – to establish the performance characteristics of the assay system to be validated in OncoCyte’s CLIA laboratory
1H 2019: CLIA Validation study – to confirm that the assay has been successfully transferred to the CLIA lab
1H 2019: Clinical Validation study – approximately 300 blood sample study to establish the DetermaVu performance in an independent, blinded data set
2H 2019: Commercial availability of DetermaVu
Post-launch (2019/2020): Clinical Utility study – follow-on real world tracking study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system
Third Quarter 2018 Financial Results

At September 30, 2018, OncoCyte had $10.8 million of cash and cash equivalents in addition to marketable equity securities valued at $0.8 million for a total of $11.6 million of liquid assets. This cash balance includes $3.3 million raised during the third quarter, net of financing expenses, from an at-market registered direct offering of common stock and warrants.

For the third quarter ended September 30, 2018, OncoCyte incurred a net loss of $3.0 million, or $0.07 per share, compared to a net loss of $6.9 million, or $0.22 per share, in the third quarter of 2017.

Operating expenses for the three months ended September 30, 2018 were $3.0 million, as reported, and were $2.6 million, on an as adjusted basis. The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for the third quarter ended September 30, 2018 were $1.5 million compared to $1.8 million for the same period in 2017, a decrease of $0.3 million.

General and administrative expenses for the three months ended September 30, 2018 were $1.3 million compared to $4.3 million for the same period in 2017, a decrease of $3.0 million.

Cash used in operations was $2.5 million for the third quarter of 2018, which compares to cash used in operations of $3.5 million during the third quarter of 2017, the reduced cash used in operating activities in the current quarter mostly resulting from OncoCyte’s staff reductions and executive sabbatical programs implemented last quarter.

Conference Call

OncoCyte will host a conference call today, Tuesday, November 13, 2018, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is +1-201-493-6779. For all callers, please refer to Conference ID 13684100. To access the live webcast, go to the investor relations section on the Company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 844-512-2921 toll-free (from U.S./Canada); international callers dial +1-412-317-6671. Use the Conference ID 13684100. Additionally, the archived webcast will be available at View Source

About DetermaVu

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on market penetration and reimbursable pricing.

DetermaVu is a trademark of OncoCyte Corporation.

On November 13, 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 nine months ended September 30, 2018 (Press release, ProMIS Neurosciences, NOV 13, 2018, View Source [SID1234531345]).

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"Over the first three quarters of 2018, we focused on three key priorities to advance our business", stated ProMIS Executive Chairman, Eugene Williams. "First, to continue to advance PMN310, our lead therapeutic antibody for Alzheimer’s disease, toward the goal of generating initial clinical trial results in 2020. For this purpose, we anticipate using an innovative trial design with evaluation of novel biomarkers to support assessment of signs suggestive of early efficacy; second, to expand our portfolio by developing therapeutic antibodies targeting toxic oligomers of alpha-synuclein for Parkinson’s disease (PD), toxic aggregates of Tar-DNA binding protein (TDP43) for ALS and toxic forms of tau protein, implicated in the development of Alzheimer’s and other dementias; and third, to actively reach out to the pharmaceutical industry with a view to partnering one or more of these programs."

Recent Corporate Highlights

During the nine months ended September 30, 2018, we received proceeds of $1,797,640 related to the exercise of common stock warrants and stock options. The warrants were exercisable at either $0.17, $0.20 or $0.30.
On July 10, the Company presented preclinical data on its lead product candidate for Alzheimer’s disease, PMN310, at the 2018 Alzheimer’s Association International Conference (AAIC). Results indicated that PMN310 shows potential for best-in-class selectivity against toxic oligomers of amyloid beta, considered a root cause of Alzheimer’s disease.
On August 21, we announced that our lead antibody candidate for Alzheimer’s disease, PMN310, showed no binding to amyloid beta (Aβ) plaque in AD brain samples in stark contrast to BAN2401 and aducanumab which both displayed robust Aβ plaque reactivity. These findings extend the results ProMIS announced in January 2018, showing greater selectivity of PMN310 for Aβ oligomers compared to aducanumab. Binding of therapeutic antibodies to Aβ deposits in brain tissue, in particular blood vessels, is believed to underlie the development of ARIA (amyloid-related imaging abnormalities; brain swelling and microhemorrhages) in treated AD patients. Lack of PMN310 binding to amyloid deposits in Alzheimer’s brain tissue may eliminate dose-limiting brain swelling seen in clinical trials with BAN2401 and aducanumab.
On September 13, we announced the appointment of James Kupiec, MD, to the position of Chief Medical Officer. Over the past 17 years Dr. Kupiec has held positions of increasing responsibility at Pfizer, including Vice President, Neuroscience Research Unit, Pfizer Worldwide Research and Development, and Vice President, Global Clinical Leader for Parkinson’s Disease.
On October 11, we announced the identification of several potential antibody therapeutic candidates aimed at selectively targeting toxic oligomers of the protein α-synuclein, considered a root cause of Parkinson’s disease (PD).
Financial Results

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

The net loss for the three months ended September 30, 2018, was $2,912,244, compared to a net loss of $1,618,681 for the three months ended September 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, increased share-based compensation and general corporate expenditures.

Research and development expenses for the three months ended September 30, 2018, were $1,867,648, as compared to $1,233,323 in the three months ended September 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 September 30, 2018, were $1,044,596, as compared to $392,103 in the three months ended September 30, 2017. The increase in expenditures in the current period reflects higher consultant salaries and associated costs, other professional fees, investor/public relations, and stock-based compensation.

Results of Operations – Nine months ended September 30, 2018 and 2017

The net loss for the nine months ended September 30, 2018, was $6,683,714, compared to a net loss of $4,894,280 for the nine months ended September 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, increased share-based compensation and general corporate expenditures.

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

Research and development expenses for the nine months ended September 30, 2018, were $4,096,729, as compared to $3,084,683 in the nine months ended September 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 nine months ended September 30, 2018, were $2,587,583, as compared to $1,812,160 in the nine months ended September 30, 2017. The increased expenditures in the current period reflect increased consultant salaries and associated costs, other professional fees, investor/public relations and higher stock-based compensation, offset by foreign exchange gains.

Outlook

The Company plans to further advance its AD portfolio, with a focus on the development of PMN310 with a goal of generating initial clinical trial results in 2020. 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. The Company also plans to pursue generation of selective antibodies targeting toxic forms of the protein tau for treatment of AD and other tau-related dementias.

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

On November 13, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the three and nine months ended September 30, 2018 (Press release, Altimmune, NOV 13, 2018, View Source [SID1234531387]).

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Recent Corporate Highlights

Raised gross proceeds of $41.9 million in equity funding through October 10, 2018. After deducting the underwriter discount, placement agent fees, and other offering expenses the Company received net proceeds of approximately $37 million.

Announced additional positive data from its Phase 2a clinical study of its NasoVAX intranasal influenza vaccine candidate. The new data showed that serum antibody levels for NasoVAX were stable over a six-month time period when compared to Fluzone’s antibody levels, which declined by over 50% during the same time period. Additionally, a significant mucosal immune response was observed one month after vaccination when compared to both placebo and Fluzone. As in the prior clinical studies, NasoVAX again had a clean safety profile. The Company previously announced positive results from the study in 60 healthy individuals, which demonstrated NasoVAX to be well-tolerated at all doses and showed 100% seroprotection at the two highest dose levels. Additionally, NasoVAX demonstrated the ability to elicit a significant T cell immune response as compared to Fluzone. These new data identify another potentially important type of immunity induced by NasoVAX and indicate that NasoVAX may have a higher likelihood of protection throughout the entire flu season.

Received an award of $2.5 million in additional BARDA funding to support NasoShield development. The funding is intended to allow vaccine characterization including key formulation parameters and batch consistency. Additionally, Altimmune will assay clinical samples from its ongoing Phase 1 clinical trial for mucosal immune response and compare different methods of administration in preclinical models.

Announced initial single-dose data from its Phase 1 study of NasoShield, an anthrax vaccine candidate. This portion of the ongoing study assessed the safety and immunogenicity of a single intranasal dose of NasoShield in four dose cohort levels and showed NasoShield to be safe and well-tolerated with no serious adverse events. The immunogenicity data suggest that NasoShield may require more than one dose for a robust immune response. The program is funded through a contract with the Biomedical Advanced Research and Development Authority ("BARDA") which runs through September 2021 and, if all options are exercised, is expected to provide funding through the end of Phase 2 development. Immunogenicity data for the two-dose cohort will be available in the fourth quarter of 2018.

"The proceeds provided by our recent financings will allow us to invest significantly in the development of NasoVAX and to support our Company going forward," said William J. Enright, Chief Executive Officer of Altimmune. "Our developing pipeline and novel approaches to vaccines are quite differentiated from other approaches making these large markets attractive opportunities for Altimmune."

Third Quarter 2018 Financial Highlights

During the quarter the Company received $4.3 million of net proceeds from a registered direct offering which brought September 30, 2018 cash on hand to approximately $8.0 million.

Subsequent to quarter end, the Company received additional net proceeds of approximately $32.7 million related to its October 2 Underwritten Public Offering and October 10 Registered Direct Offering.

Third quarter revenue was $2.6 million compared to $4.6 million in the prior year period. Revenue fluctuated in proportion to our research and development expenses for the NasoShield and SparVax-L programs.

Research and development expenses were $4.7 million compared to $5.9 million in the prior year period. The decrease is primarily attributable to lower spending on NasoShield manufacturing when compared to the same period in 2017.

General and administrative expenses were $2.0 million as compared with $3.0 million for the same period in 2017. The decrease is primarily attributable to 2017 professional services related to the integration of the newly merged entity that did not recur in 2018.

Other Income (expense) was $0.9 million compared to ($0.5) million for the same period in 2017. The change was primarily due to the release of warrant liability associated with warrant exchanges consummated during the quarter.

Net loss attributed to common stockholders was $2.3 million compared to $31.9 million for the same period in 2017. The increase was due primarily to $26.6 million goodwill impairment in 2017 in addition to the activity described above.