On March 22, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2018 (Press release, IntelGenx, MAR 22, 2019, View Source [SID1234534569]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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2018 Fourth Quarter Financial Summary:

Revenue was $650,000, compared to $1.5 million in the 2017 fourth quarter
Adjusted EBITDA was ($2.0 million), compared to ($600,000) in Q4-2017
Cash and short-term investments totaled $11.0 million as at December 31, 2018
2018 Full-Year Financial Summary:

Revenue was $1.8 million, compared to $5.2 million in 2017
Net comprehensive loss was $10.7 million, compared to net comprehensive loss of $2.7 million in 2017
Adjusted EBITDA was ($7.9 million), compared to ($1.4 million) in 2017
Recent Operational Highlights:

Announced U.S. Food and Drug Administration ("FDA") acceptance of the RIZAPORT New Drug Application ("NDA") resubmission and the Agency’s assignment of a Prescription Drug User Fee Act ("PDUFA") goal date of April 1, 2019
Partnered with Gensco Pharma to market RIZAPORT in the United States
Announced FDA pre-approval inspection of IntelGenx’s facility related to the RIZAPORT NDA
Granted Japanese patent for RIZAPORT VersaFilm
Began Montelukast VersaFilm dosing in patients with mild to moderate Alzheimer’s Disease in Phase 2a study
Announced Montreal’s Douglas Mental Health University Institute as ninth Montelukast VersaFilm Phase 2a clinical trial site
"The agreements we secured with Tilray and Gensco Pharma in 2018 represented an important inflection point for IntelGenx as we advanced our strategy to commercialize our pipeline of innovative oral film products with strong partners," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We have a very positive outlook for 2019 and 2020 and look forward to updating our stakeholders as we make progress towards achieving a number of key development and commercialization milestones."

Financial Results:

Total revenues for the three-month period ended December 31, 2018 amounted to $650,000, a decrease of $850,000 compared to $1.5 million for the three-month period ended December 31, 2017. The change is mainly attributable to a decrease in deferred revenues partially offset by an increase in R&D revenues. Operating costs and expenses were $2.9 million for the fourth quarter 2018, versus $2.3 million for the corresponding three-month period of 2017. For Q4-2018, the Company had an operating loss of $2.2 million, compared to operating income of $850,000 for the comparable period of 2017.

Total revenues for the twelve-month period ended December 31, 2018 amounted to $1.8 million, compared to $5.2 million for the twelve-month period ended December 31, 2017. Operating costs and expenses were $10.8 million for the full year 2018, versus $7.7 million for the corresponding 12-month period of 2017. For the twelve-month period of 2018, the Company had an operating loss of $9.0 million, compared to an operating loss of $2.5 million for the comparable period of 2017. Net comprehensive loss was $10.7 million, or $0.14 per basic and diluted share, for the twelve-month period of 2018, compared to net comprehensive loss of $2.7 million, or $0.04 per basic and diluted share, for the comparable period of 2017.

As at December 31, 2018, the Company’s cash and short-term investments totalled $11.0 million, compared with $4.9 million as at December 31, 2017.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2018 as well as the 2019 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, Friday, March 22, 2019.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2018 fourth quarter and full year financial results on Monday, March 25, 2019, at 8:00 a.m. EDT. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 1297963. The call will be also be webcast live and archived at www.intelgenx.com.

On March 22, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the year ended December 31, 2018 and provided a business update (Press release, Sellas Life Sciences, MAR 22, 2019, View Source [SID1234534552]).

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"In February, we initiated a review of a wide range of strategic alternatives to maximize shareholder value, such as a sale of the Company, a merger, or a strategic investment or financing," stated Dr. Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS. "We are currently actively exploring these alternatives with the goal of identifying a plan that will enhance shareholder value while advancing our novel cancer immunotherapy clinical pipeline."

2018 and Recent Business Highlights

Corporate Developments

In February 2019, the Company announced that its Board of Directors is conducting a review of strategic options focusing on maximizing shareholder value. SELLAS has engaged Cantor Fitzgerald & Co. to act as its strategic and financial advisor for this process.
In March 2019, the Company entered into a warrant exchange agreement with a single investor, the proceeds of which are being used by the Company to further its development programs and business operations during the strategic alternatives evaluation process.
Clinical Pipeline

Galinpepimut-S (GPS)

In November 2018, following discussion with the U.S. Food and Drug Administration (FDA), the Company announced a streamlined clinical trial design and biostatistical plan for a Phase 3 registrational study for GPS in acute myeloid leukemia (AML). The planned Phase 3 registrational study will be a 1:1 randomized, open-label study comparing GPS in the maintenance setting to investigators’ choice of best available treatment in adult AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is overall survival and secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics over time and rates of achievement of measurable residual disease negativity. The study will have a planned interim safety and futility analysis after 80 events (deaths). The Phase 3 study is expected to enroll approximately 116 patients at approximately 50 clinical sites in the United States and Europe. The Company is completing preparations for the initiation of this study which is subject to the receipt of sufficient funding. This study is being led by Drs. Hagop Kantarjian of MD Anderson Cancer Center and Gert Ossenkoppele of Amsterdam University Medical Center (VUMC) and the HOVON network.
In December 2018, SELLAS initiated enrollment of the Phase 1/2 open-label, non-comparative, multicenter, multi-arm study of GPS in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with selected WT1-positive advanced cancers, including both hematologic malignancies and solid tumors. This study, which is being conducted under a Clinical Trial Collaboration and Supply Agreement with Merck (known as MSD outside the United States and Canada), will assess the efficacy and safety of the combination, with exploratory long-term follow-up for overall survival and safety, and is expected to enroll approximately 90 patients at up to 20 sites in the United States. The initial tumor types to be treated will be AML (patients unable to attain deeper morphological response than partial on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant) and ovarian cancer (second or third line), to be followed by triple negative breast cancer (TNBC) (second line), small cell lung cancer (second line), and colorectal cancer (third or fourth line). The study is being led by Drs. Richard Maziarz of Oregon Health and Science University and Roisin O’Cearbhaill of Memorial Sloan Kettering Cancer Center.
Nelipepimut-S (NPS)

In 2018, the Company announced positive data from a prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of NPS (NeuVax) + trastuzumab (Herceptin) targeting HER2 low-expressing breast cancer patient cohorts. In the study, NPS + trastuzumab demonstrated clinically and statistically significant efficacy in the cohort of patients with TNBC, with a p-value of 0.013 and a 75.2% reduction in risk of relapse or death.
A preplanned secondary efficacy analysis across human leukocyte antigen (HLA) allele subgroups from the Phase 2b study confirmed the therapeutic potential of NPS in patients with early-stage TNBC in the adjuvant setting across HLA types A-02, -03, -24 and -26, which cover approximately 80-85% of the North American/European populations and 86-90% of Asian/Pacific basin populations. Additional positive data from the Phase 2b study showed a clinically meaningful and statistically significant decrease in the number of clinically detectable relapses in the TNBC cohort with the combination of NPS + trastuzumab (7.5%) vs. trastuzumab alone (27.3%) (p=0.004). In addition, four pre-defined subgroups of TNBC patients in the NPS +trastuzumab arm demonstrated an average decrease of 84.2% in relative risk of relapse or death at 24 months (p=0.004-0.014).
Based on the Phase 2b data presented in 2018, as well as the unanimous recommendation of the Data Safety Monitoring Board to expeditiously seek regulatory guidance from the FDA for further development of NPS + trastuzumab in TNBC, SELLAS is currently in continuing active discussions with the FDA.
View Source End 2018 Financial Results

Cash Position: As of December 31, 2018, cash and cash equivalents were $5.3 million, compared to $2.3 million as of December 31, 2017. Net cash used in operating activities was $30.4 million for the year ended December 31, 2018, compared to $11.0 million for the year ended December 31, 2017. Net cash provided by financing activities was $23.1 million for the year ended December 31, 2018, primarily attributable to $31.5 million in net proceeds from the sale of equity securities, partially offset by $7.6 million in principal payments on previously outstanding debt. Net cash provided by financing activities for the year ended December 31, 2017 was $5.5 million, primarily attributable to $6 million in net proceeds from the sale of equity securities, partially offset by $0.5 million on previously outstanding long-term debt.

R&D Expenses: Research and development expenses were $8.8 million for the year ended December 31, 2018, as compared to $6.1 million for the year ended December 31, 2017. The $2.7 million increase was primarily due to increases in clinical and regulatory consulting and other clinical expenses related to startup costs for the Phase 1/2 basket trial of GPS in combination with pembrolizumab (Keytruda) in multiple tumor types during 2018, and ongoing costs incurred related to the Phase 2b trial of NPS in combination with trastuzumab (Herceptin). These increases were partially offset by decreases in compensation and benefits, including stock-based compensation, and manufacturing expenses.

G&A Expenses: General and administrative expenses were $12.8 million for the year ended December 31, 2018, as compared to $15.1 million for the year ended December 31, 2017. The $2.3 million decrease was primarily driven by a decrease in compensation and employee benefits, including stock-based compensation, and in banking and advisory fees partially offset by increases in outside services and public company costs, rebates and returns of former commercial products, and insurance premiums.

Net Loss: Net loss for the year ended December 31, 2018 was $27.7 million and loss attributable to common stockholders was $41.3 million, or a basic and diluted loss per share to common stockholders of $3.15, as compared to a net loss of $23.8 million and loss attributable to common stockholders of $24.4 million for the year ended December 31, 2017, or a basic and diluted loss per share to common stockholders of $10.44. Net loss and loss attributable to common stockholders for the year ended December 31, 2018 includes a $9.6 million one-time non-cash impairment charge of in-process research and development associated with the termination of a license agreement for anagrelide CR formulation (GALE-401).

Keytruda and Herceptin are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and Genentech, Inc., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

On March 22, 2019 Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule technologies, reported its financial results for the year ended December 31, 2018 (Press release, Neuralstem, MAR 22, 2019, View Source [SID1234534570]).

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Financial Results for the Year Ended December 31, 2018

Cash Position and Liquidity: At December 31, 2018, cash and investments was approximately $5.8 million as compared to approximately $11.7 million for the same period of 2017. The $8.9 million decrease is due to cash used in operations of approximately $7.7 million partially offset by the proceeds from our October 2017 registered direct offering of common stock and warrants.

Operating Loss: Operating loss for the year ended December 31, 2018 was $8.3 million compared to a loss of $13.3 million for the same period of 2017. The decrease in operating loss for the year was primarily due to a $4.0 million decrease in research and development expenses coupled with a $0.9 million decrease in general and administrative expenses.

Net Loss: Net loss for the year ended December 31, 2018 was $4.9 million, or $0.32 per share (basic), compared to a loss of $15.7 million, or $1.20 per share (basic), for year ended 2017. The decrease in net loss was primarily due to a $5.0 decrease in operating loss coupled with a $3.3 million non-cash gains related to the change in the fair value of our liability classified stock purchase warrants

R&D Expenses: Research and development expense for the year ended December 31, 2018 was $4.0 million as compared to $8.1 million for the same period of 2017. The decrease of $4.1 million, or 50% compared to the same period of 2017 was primarily attributable to (i) a $1.6 million decrease in costs related to our completed NS-189 Phase 2 clinical trial, (ii) a $1.0 million decrease in our personnel, facility and other expenses due to our ongoing corporate restructuring and cost reduction efforts (iii) a $1.0 million decrease in non-cash share-based compensation expense and (iv) a $0.5 million increase in reimbursements under our research grants.

G&A Expenses: General and administrative expense for the year ended December 31, 2018 was $4.6 million as compared to $5.5 million for the same period of 2017. The decrease of $1.1 million, or 20% compared to the same period of 2017 was primarily attributable to a decrease in personnel, facility and related expenses due to our ongoing corporate restructuring and cost reduction efforts.

Liquidity: The Company expects its existing cash, cash equivalents and short-term investments to fund its operations based on our current operating plans, into the third quarter of 2019.

On March 21, 2019 Exscientia, a world-leading Artificial Intelligence (AI)-driven drug discovery company, reported that it has entered a three-year AI drug discovery partnership with leading biopharma company Celgene, including an initial $25 million upfront payment and eligibility to receive substantial milestones based on the clinical, regulatory and commercial success of the program (Press release, Exscientia, MAR 21, 2019, View Source [SID1234553912]). In addition, Exscientia is due to receive tiered royalties on net sales on any product resulting from the collaboration. Exscientia will apply its full-stack AI drug discovery capabilities to the execution of the entire project – from gene to the drug candidate.

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The collaboration will use AI to accelerate the discovery of small molecule therapeutic drug candidates for three therapeutic programmes for Celgene in the areas of oncology and autoimmunity.

Exscientia will use its cutting-edge Centaur Chemist AI drug discovery platform, which has demonstrated its unparalleled capabilities on multiple projects and its ability to reduce the timelines by at least three-quarters to discover pre-clinical drug candidates. Applying AI to improve the speed of delivery of new treatments for patients is a key goal of this collaboration.

This deal extends Exscientia’s list of partnerships with blue chip pharma and biotech companies, with existing collaborations involving Roche, GSK, Sanofi and Evotec, cementing Exscientia’s reputation as the partner of choice in the rapidly developing field of AI-driven drug discovery. At the start of this year, the Oxford based Exscientia secured a $26 million Series B investment to expand its capabilities, develop its platform and build its proprietary drug pipeline.

Professor Andrew Hopkins, CEO of Exscientia, commented: "We’re incredibly proud to collaborate with Celgene and to sign another partnership with a key industry player, reinforcing our place at the forefront of AI drug discovery. Today, patients can wait more than ten years from initial drug discovery to its availability as a treatment. With autoimmune diseases and cancer rates increasing, the pharmaceutical industry’s R&D productivity needs to dramatically improve – and technology is a key part of this. Since our pioneering Nature papers in the field, we have been developing our AI platform on the principle that AI combined with human creativity can significantly accelerate the drug discovery process and thus drastically improve access of new drugs to the market. We’re excited to work with Celgene to drive this transformational change in new therapeutic areas."

On March 21, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that interim clinical data from its Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the International Society of Ocular Oncology (ISOO) 2019 Annual Meeting being held March 22-26, 2019, in Los Angeles (Press release, Aura Biosciences, MAR 21, 2019, View Source [SID1234534532]).

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"These 18-month safety and efficacy data demonstrate that light-activated AU-011 is well-tolerated, including with multiple administrations, and has shown initial evidence of tumor control and preservation of visual acuity even in high risk patients whose tumors are close to the fovea and optic disk," said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School, and lead author of the presentation.

"Light-activated AU-011 continues to show a compelling degree of tumor control, tolerability and vision preservation as a potential first line treatment option for patients with small choroidal melanoma and indeterminate lesions, especially given the lack of targeted treatment options for these patients," commented Cadmus Rich, M.D., Chief Medical Officer of Aura. "It is also remarkable that no drug-related severe adverse events, serious adverse events or dose limiting toxicities have been observed in the study to date. We are excited to share these data with the medical community at ISOO this year."

This open-label, multicenter trial is designed to investigate single and multiple ascending doses of light-activated AU-011 in approximately 52 adult subjects with clinically diagnosed primary choroidal melanoma. The details for the ISOO 2019 presentation are as follows:

Title: Eighteen Month Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Date and time: Sunday, March 24, 2019; 11:10-11:15am PT
Location: The Ritz-Carlton Marina del Rey

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.