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.

On November 13, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported updated clinical and biomarker data from ongoing Phase 1/1b studies of its lead programs, CPI-444 and CPI-006 (Press release, Corvus Pharmaceuticals, NOV 13, 2018, View Source [SID1234531349]). Updated results from its Phase 1/1b clinical trial of CPI-444 in patients with treatment-refractory renal cell carcinoma (RCC) demonstrated an overall survival (OS) of 88 percent at more than 20 months follow-up with CPI-444 administered in combination with atezolizumab. The clinical data were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C., by Lawrence Fong, M.D., study investigator and leader of the Cancer Immunotherapy Program at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

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Additionally, CPI-444 biomarker data from the Phase 1/1b study showing that expression of a novel adenosine gene signature was significantly associated with tumor regression were presented both in the oral presentation and in a poster session at the SITC (Free SITC Whitepaper) meeting. Early clinical data from an ongoing Phase 1/1b study evaluating CPI-006 as a monotherapy showing evidence of immune activation of B cells were presented in a poster session.

CPI-444, Corvus’ lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. It is currently being evaluated in Phase 1/1b and 1b/2 clinical trials in patients with various solid tumors as a monotherapy and in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody. CPI-006 is a humanized monoclonal antibody directed against CD73. It is currently being evaluated in a Phase 1/1b three-arm clinical trial in patients with a variety of solid tumors as a monotherapy, in combination with CPI-444, and in combination with pembrolizumab, an anti-PD-1 antibody.

"The newest data on our two lead programs further establish a promising foundation for the application of adenosine blockade in cancer therapy," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "The longer-term follow-up data from our Phase 1/1b study of CPI-444 showed objective tumor responses and prolonged survival in a larger group of patients with treatment-refractory RCC, which is highly encouraging given such advanced disease."

He added, "With this study, we also discovered an adenosine gene signature that can be obtained from tumor biopsies and potentially could be used as a predictive biomarker for patient selection. This signature is expected to be an important factor as we design our CPI-444 pivotal trials. Furthermore, the biomarker and clinical data in anti-PD-(L)1 resistant, refractory patients enhance our understanding of the tumor biology. By blocking adenosine in the tumor microenvironment from binding with the A2A receptor, CPI-444 enables anti-PD-(L)1 therapies to stimulate T cell function to attack cancer cells. The biomarker data add to our understanding of the mechanism of action, which makes combination therapy very attractive since CPI-444 appears to inhibit an important anti-PD-(L)1 resistance mechanism."

Key CPI-444 Clinical Results Presented at SITC (Free SITC Whitepaper)
Study investigator Dr. Fong presented updated efficacy and safety data at SITC (Free SITC Whitepaper) from the ongoing Phase 1/1b clinical study of CPI-444 in RCC patients with progressive disease (presentation slides available on the Corvus website in the "Publications and Presentations" section, which can be found here). Study participants had advanced refractory disease and a poor prognosis. They had been treated with a median of three prior therapies (range: 1 to 5), and approximately 72 percent had failed prior anti-PD-(L)1 therapy. For more than 60 percent of patients, the protocol treatment represented a fourth, fifth or sixth line of therapy. Data from 33 patients receiving CPI-444 as a monotherapy and 35 receiving CPI-444 in combination with atezolizumab who were evaluable for response showed:

Disease control for more than 6 months was achieved in 35 percent and 17 percent of patients receiving combination therapy and monotherapy, respectively.
For patients receiving combination therapy, 11 percent experienced a confirmed partial response (PR; as determined by RECIST criteria). Several additional patients experienced tumor regression not meeting the criteria for a PR. For patients receiving monotherapy, one patient experienced a confirmed PR, one experienced an unconfirmed PR, and several patients experienced tumor regression not meeting the PR criteria.
Responses were seen in both the combination therapy and monotherapy arms, and in patients who failed prior anti-PD-(L)1 therapy.
Progression-free survival (as assessed by RECIST criteria) was 5.9 months with combination therapy and 4.0 months with monotherapy.
OS was 88 percent at 20+ months with combination therapy and 65 percent at 16+ months with monotherapy.
Combination therapy was superior to monotherapy with respect to OS, response rate, disease control rate and progression-free survival.
Evaluation of pre- and on-treatment tumor biopsies showed a statistically significant correlation between treatment-induced CD8+ T cell infiltration in tumors and response (p<0.016).
The recently described adenosine signature showed a statistically significant correlation with tumor response and disease control rates (p<0.008).
CPI-444 continues to be well tolerated to date, with observed adverse events similar to previous reports. In the combination arm, adverse events were generally consistent with other anti-PD-L1 therapies. In the monotherapy arm, grade 3 adverse events were infrequent and reversible.
Key CPI-444 Biomarker Results Presented at SITC (Free SITC Whitepaper)
Biomarker analysis, performed on tumor tissue from biopsies of 30 RCC patients treated with monotherapy or combination therapy in the ongoing Phase 1/1b study of CPI-444, showed:

Expression of the adenosine gene signature in pre-treatment tumor biopsies was significantly associated with tumor response to treatment with CPI-444 (p<0.008).
The adenosine gene signature identified a group of chemokines and cytokines that are associated with myeloid-derived suppression.
Adenosine induces the production of these chemokines and cytokines, which inhibit anti-tumor immunity. CPI-444 blocks the production of these substances.
"Our other lead program, CPI-006, is different from other previously described anti-CD73 antibodies that we are aware of," said Joseph J. Buggy, Ph.D., co-founder and executive vice president of research of Corvus. "Early clinical data from our Phase 1/1b trial presented at SITC (Free SITC Whitepaper) showed that CPI-006 inhibited CD73 enzymatic activity and stimulated intracellular signaling to activate B cells, which appears to cause the migration of lymphocytes to lymphoid tissues. This activity is independent of adenosine and could be important in stimulating anti-tumor immunity."

Key CPI-006 Clinical Results Presented at SITC (Free SITC Whitepaper)
Initial data from an ongoing Phase 1/1b clinical trial of CPI-006 administered as a monotherapy or as combination therapy in patients with various cancers who have failed standard therapies were presented at SITC (Free SITC Whitepaper). Results from nine patients who received ascending doses of CPI-006 (1, 3 and 6 mg/kg; N=3 at each dose) showed that CPI-006:

Targeted a novel epitope on CD73
Blocked production of adenosine by inhibiting the enzymatic active site of CD73
Activated peripheral blood B cells leading to increased expression of CD69 independent of adenosine
Affected B lymphocyte trafficking as shown by transient decreases of circulating B cells
Was well tolerated at the doses evaluated with no dose-limiting toxicities
In this study, dose escalation continues with CPI-006 as a monotherapy and in combination with the adenosine A2A receptor antagonist CPI-444.

About CPI-444
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

About CPI-006
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme. Clinical study results have indicated that CPI-006 has also stimulated activation of lymphoid cells in an adenosine-independent manner.

On November 13, 2018 RadioMedix Inc. (a Texas-based clinical stage biotechnology company) and Orano Med (a nuclear biotechnology company) reported that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AlphaMedixTM for the treatment of neuroendocrine tumors (NETs) (Press release, RadioMedix, NOV 13, 2018, View Source [SID1234531347]). AlphaMedixTM is a 212Pb-labeled somatostatin analogue used for the targeted alpha therapy (TAT) of neuroendocrine tumors (NETs).

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"TAT has brought new hope to our patients with cancer, and the range of available therapies in this area will only increase in the near future. We are pleased to conduct the first TAT clinical trial in the U.S. for neuroendocrine cancers, with the aim of registration of the drug," said Dr. Ebrahim S. Delpassand, CEO of RadioMedix and Medical Director of the clinical studies. "We are hoping that AlphaMedixTM will provide a breakthrough therapy that will benefit our patients soon," added Dr. Delpassand. "We are excited about the progress of our dose escalation studies of AlphaMedixTM", echoed Dr. Izabela Tworowska, Ph.D., CSO of RadioMedix.

The mechanism of action of AlphaMedixTM relies on the delivery of a cytotoxic load of alpha-emitters to SSTR-overexpressing neuroendocrine tumors. Alpha- emitters are highly energetic radioactive particles that can cause irreversible damage to the cancer cells. RadioMedix and Orano Med initiated the Phase 1 clinical trial of the safety and preliminary efficacy of AlphaMedixTM in February of 2018 (NCT03466216); the study is currently recruiting patients at the Excel Diagnostics and Nuclear Oncology Center in Houston, TX U.S.

"FDA’s decision to grant Orphan drug Designation is an important regulatory milestone for AlphaMedixTM, a key program in our pipeline of 212Pb-labeled compounds," said Julien Dodet, CEO of Orano Med. "We believe TAT with 212Pb represents a promising new approach and that AlphaMedixTM has the potential to have a meaningful impact on patients".

Orphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. The designation provides certain benefits to drug developers such as seven-year marketing exclusivity upon FDA approval, tax credits for qualified clinical testing or prescription drug user fee exemption.

About Neuroendocrine Tumors

Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors (SSTRs).

About AlphaMedixTM

AlphaMedixTM is a radiolabeled SSTR-targeting therapeutic investigational drug for the treatment of NETs patients. The product consists of SSTR-targeting peptide complex radiolabeled with 212Pb and serve as an in vivo generator of alpha-emitting particles. 212Pb isotope is particularly suitable for SSTR therapy applications based upon its half-life, energy and decay properties.

On November 13, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the
development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell ("CAR T")
technology and gene therapies for rare diseases, reported financial results and recent corporate highlights for the third quarter ended September 30, 2018 (Press release, Mustang Bio, NOV 13, 2018, View Source [SID1234531346]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The third quarter of 2018 and recent months have been marked by clinical progress and a key addition to our management team with the appointment of Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer. Notably, we expanded our pipeline into gene therapy by securing an exclusive worldwide license agreement with St. Jude Children’s Research Hospital ("St. Jude") for the development of a first-in-class, ex vivo, clinical-stage lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency ("X-SCID"). Data from a multicenter Phase 1/2 trial led by St. Jude in infants under the age of two years old are extremely encouraging. Eight patients under the age of two with X-SCID have been treated to date, with results presented at the 21st Annual Meeting of the American Society of Gene & Cell Therapy in May 2018. The therapy was well tolerated. In addition, six patients achieved reconstituted immune systems within three to four months following treatment, with the remaining two patients continuing to progress favorably in earlier stages of recovery. Four of these six patients have discontinued monthly infusions of intravenous immunoglobulin, and the remaining patients, at earlier stages of recovery, continue to progress favorably. In three patients who had disseminated infections prior to therapy, all infections resolved completely. In addition, the therapy is being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health ("NIH"), with equally encouraging data and an excellent safety profile to date. The two patients with the longest follow-up have seen sustained restoration of antibody production after immunization, and all five patients treated experienced a decrease in viral infections and overall clinical improvement."

Dr. Litchman continued, "We also recently announced updates on two Phase 1 clinical trials at City of Hope using our
HER2-specific CAR T cell therapy, including a first-of-its-kind trial using intraventricular delivery of CAR T cells to brains of patients with HER2-positive breast cancer with brain metastases. As we look ahead to the fourth quarter of 2018, we look forward to filing our first Investigational New Drug (IND) application to support a Phase 1/2 trial of MB-102 in acute myeloid leukemia ("AML"), blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome."

Recent Corporate Highlights:
• In July 2018, Mustang completed a pre-IND meeting with the U.S. Food and Drug Administration ("FDA") for MB102 (CD123 CAR T). Based on the meeting, Mustang expects to file an IND in the fourth quarter of 2018 to support a Phase 1/2 trial of MB-102 in AML, blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic
syndrome.
• In August 2018, Mustang announced that it entered into an exclusive worldwide license agreement with St. Jude
for the development of a first-in-class ex vivo lentiviral gene therapy for the treatment of X-SCID, also known as
bubble boy disease. The therapy is currently being evaluated in a Phase 1/2 multicenter trial in infants under the
age of two. This study is the world’s first lentiviral gene therapy trial for infants with X-SCID. The therapy is also
being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health
("NIH").
• In October 2018, Mustang appointed Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer.
• Also in October 2018, Mustang announced that a first-of-its-kind Phase 1 clinical trial evaluating the safety and
effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer
with brain metastases has been initiated at City of Hope. In addition, Mustang announced that City of Hope dosed
the first patient in a Phase 1 clinical trial of HER2-specific CAR T cells in treating recurrent or refractory grade IIIIV
glioma. The trial will evaluate the side effects and best dose of HER2-specific CAR T cells in treating patients
with grade III-IV glioma that has come back or does not respond to treatment.
Financial Results:
• As of September 30, 2018, Mustang’s consolidated cash, cash equivalents, short-term investments (certificates of
deposit) and restricted cash totaled $41.3 million, compared to $47.2 million as of June 30, 2018, and $61.5 million
as of December 31, 2017, a decrease of $5.9 million for the quarter and a decrease of $20.2 million year-to-date.
• Research and development expenses were $5.3 million for the third quarter of 2018, compared to $2.2 million for
the third quarter of 2017. Non-cash, stock-based compensation expenses included in research and development
were $0.7 million for third quarter of 2018, compared to $0.3 million for the third quarter of 2017.
• Research and development expenses from license acquisitions were $1.0 million for the third quarter of 2018,
compared to $0.3 million for the third quarter of 2017.
• General and administrative expenses were $1.3 million for the third quarter of 2018, compared to $4.6 million for
the third quarter of 2017. Non-cash, stock-based compensation expenses included in general and administrative
expenses were $0.2 million for the third quarter of 2018, compared to $0.5 million for the third quarter of 2017.
• Net loss attributable to common stockholders was $7.5 million, or $0.28 per share, for the third quarter of 2018,
compared to $6.9 million, or $0.27 per share, for the third quarter of 2017. Net loss attributable to common
stockholders was $18.9 million, or $0.70 per share, for the first nine months of 2018, compared to $15.7 million,
or $0.63 per share, for the first nine months of 2017.

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