On November 12, 2019 Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported recent highlights and developments as well as financial results for the third quarter ended September 30, 2019 (Press release, Omeros, NOV 12, 2019, View Source [SID1234550970]).

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Third Quarter 2019 Financial Highlights

3Q 2019 revenues were $29.9 million, another quarter of record sales of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%. This compares to $26.8 million in 2Q 2019, an increase of $3.1 million, or 12 percent.

Net loss in 3Q 2019 was $16.5 million, or $0.33 per share. This compares to a net loss $14.5 million, or $0.29 per share, in 2Q 2019. Net loss in each period included non-cash expenses of $6.3 million, or $0.13 per share.

At September 30, 2019, Omeros had cash, cash equivalents and short-term investments available for operations of $27.3 million, a decrease of $4.5 million from June 30, 2019. Accounts receivable at September 30, 2019 were $29.9 million.

Omeros has a $50-million revolving line of credit facility with Silicon Valley Bank. The line of credit provides for borrowing availability of up to the lesser of $50 million and 85 percent of eligible accounts receivable, subject to applicable reserves. As of September 30, 2019 there were no borrowings outstanding.

Recent Business Highlights

Submitted to the U.S. Food and Drug Administration (FDA) the nonclinical sections of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Received from the Pediatric Committee of the European Medicines Agency (EMA) a positive opinion on the pediatric investigation plan for narsoplimab in the treatment of HSCT-TMA.

Reported positive results from a Phase 1 study of the lead compound in Omeros’ OMS527 program focused on development of phosphodiesterase 7 (PDE7) inhibitors for the treatment of addiction and compulsive disorders. In the double blind, randomized Phase 1 study, the study drug, referred to as OMS182399, met the primary endpoints of safety and tolerability and showed a favorable pharmacokinetic profile supporting once-daily dosing.

Presented data on a series of discoveries showing that GPR174, a member of the family of G protein-coupled receptors (GPCRs), controls a new axis in cancer immunity. In addition to demonstrating the potential of GPR174 as a standalone anti-cancer agent, these data show that the combined inhibition of both GPR174 and the adenosine pathway synergistically enhances T-cell response. This synergistically enhanced T-cell response could significantly improve the effectiveness of checkpoint inhibitors and other anti-cancer drugs.

Scientists from Omeros along with academic collaborators from the University of Toronto were awarded the Prix Galien Canada Research Award for 2019 in recognition of their development of the drug discovery technologies underlying Omeros’ GPCR platform. The Prix Galien is the most prestigious award in the field of Canadian pharmaceutical research and innovation and recognizes the research team judged to have made the most significant contribution.

"Initiating submission of our rolling BLA for narsoplimab in stem cell transplant-associated TMA is a significant milestone on our path to becoming a multi-product commercial biopharmaceutical company and, more importantly, is a major advance in our mission to treat these patients," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "We are on track to complete submission of our BLA in the first half of 2020 and preparations for the anticipated commercial launch of narsoplimab are also progressing. We continue to grow utilization of OMIDRIA, delivering record quarterly sales in Q3 and projecting a new all-time high in the fourth quarter. The remainder of our pipeline assets are also progressing – OMS527 has successfully completed its Phase 1 trial in our addiction program, our MASP-3 inhibitor OMS906 is on track to enter the clinic in the first half of next year, and our GPR174 immuno-oncology program continues to generate exciting new in vivo data, which will be presented for the first time later this month at the AACR (Free AACR Whitepaper) conference in Boston."

Other Business Updates and Developments

Recent developments regarding OMIDRIA include the following:

The new product-specific permanent J-code for OMIDRIA became effective October 1, 2019. J-codes standardize the submission and payment of insurance claims across Medicare, Medicare Advantage, Medicaid and commercial insurance plans. The J-code has been broadly uploaded to Medicare and commercial payer systems nationwide and is expected to expand reimbursement to commercial, Medicare Advantage and Medicaid insurers that would not reimburse for OMIDRIA under the prior C-code and to enable access to the increasing number of cataract procedures performed in the physician office setting.

In October, a manuscript authored by Keith Walter, M.D. of Wake Forest University, was accepted for publication in the peer-reviewed Journal of Cataract and Refractive Surgery. Dr. Walter’s study consisted of a retrospective analysis of 504 eyes (357 patients) on whom he had performed cataract surgery using OMIDRIA plus only a topical non-steroidal anti-inflammatory drug (NSAID), assessing the incidence of CME. The control group consisted of a collection of single and meta-analytic studies published in the peer-reviewed literature in which steroids, with and without topical NSAIDs, were used in cataract surgery in the absence of OMIDRIA. Of the 504 eyes treated with OMIDRIA, only two developed postoperative CME, an incidence of 0.39 percent, which is 3- to 12-fold lower than the CME rates in the published peer-reviewed studies.

On November 1, 2019, the Centers for Medicare and Medicaid Services (CMS) issued the 2020 final rule for its outpatient prospective payment system (OPPS). CMS had described criteria that must be met in order for products to be eligible for separate payment under legislation requiring CMS to review its OPPS payments with a goal of ensuring that there are not financial incentives to use opioids for pain management instead of non-opioid alternatives. Although Omeros submitted to CMS data for OMIDRIA that meet the criteria, CMS declined in its 2020 final rule to grant separate payment for OMIDRIA beyond the expiration of its current pass through status on September 30, 2020. CMS indicated it would continue to analyze evidence and monitor utilization of OMIDRIA and Omeros intends to continue its administrative and legislative efforts to secure ongoing separate payment for OMIDRIA.

On November 4, 2019 the results of an independent investigator study of the effect of OMIDRIA use on the utilization of fentanyl, an opioid, in cataract surgery were published in the peer-reviewed journal Clinical Ophthalmology. The article, The Effect of Phenylephrine/Ketorolac Intracameral Solution 1%/0.3% on Pain and Opioid Use During Cataract Surgery, is authored by the study investigator Eric D. Donnenfeld, M.D., Clinical Professor of Ophthalmology at New York University and recent past president of the American Society of Cataract and Refractive Surgery. The prospective, controlled study showed that use of OMIDRIA in cataract surgery had a direct, clinically meaningful and statistically significant effect on reduction in fentanyl use (77% reduction, p = 0.006) while reducing visual analog scale (VAS) pain scores by approximately 50 percent (p < 0.0001).

Recent developments regarding narsoplimab, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in Phase 3 clinical programs for the treatment of HSCT-TMA, Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:

In October, Omeros submitted to FDA the nonclinical (i.e., pharmacology, pharmacokinetics and toxicology) data, study reports, overview and summary sections of its rolling BLA for narsoplimab to treat HSCT-TMA. Once all clinical data collection, dataset compilation and data analyses are complete, the clinical sections of the BLA

will be submitted, followed by the quality (i.e., chemistry, manufacturing and controls) sections. Submission of the clinical and quality sections remains on track for scheduled completion in the first half of next year.

The Pediatric Committee of the EMA issued a positive opinion for Omeros’ pediatric investigation plan (PIP) for narsoplimab in the treatment of HSCT-TMA. Agreement with the pediatric committee on a PIP outlining a development program for the investigational product in the pediatric population is a prerequisite to EMA’s acceptance of a Marketing Authorization Application (MAA) for the product. Omeros received a deferral for completion of its pediatric plan until after EMA approval of the MAA planned for submission to EMA for narsoplimab in the treatment of HSCT-TMA. With successful completion of the PIP, narsoplimab would be eligible for up to an additional two years of marketing exclusivity.

Omeros’ Phase 3 trial evaluating narsoplimab for IgA nephropathy, referred to as ARTEMIS-IGAN, continues enrollment at an increasing number of sites in the U.S. and internationally.

A manuscript prepared by Omeros’ Academic Leadership Committee detailing the clinical data from the Phase 2 IgA nephropathy program is expected to be published in a peer-reviewed journal. In addition, a report detailing the response to narsoplimab treatment by a patient with IgA vasculitis-associated nephritis and rapidly progressive glomerulonephritis has been submitted for publication.

Updates regarding Omeros’ other development programs and platforms include the following:

IND-enabling toxicology studies have begun for OMS906, Omeros’ MASP-3 inhibitor, in advance of clinical entry slated for the first half of next year. Targeting subcutaneous dosing of twice-monthly or less frequently, this program is initially targeting paroxysmal nocturnal hemoglobinuria.

Omeros continues life-cycle management within its MASP-2 program. These efforts are directed to development of a longer-acting second-generation antibody against MASP-2 as well as an orally available small-molecule inhibitor of MASP-2, both targeted for clinical entry in 2021.

A presentation entitled "Phosphatidylserine suppresses T cells through GPR174, and co-inhibition of adenosine receptors and GPR174 synergistically enhances T cell responses" will be made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference on Tumor Immunology and Immunotherapy to be held in Boston, November 17-20, 2019. It will include additional animal data that validate GPR174 inhibition for cancer immunotherapy. The company’s GPR174 program has also been selected for participation in the 2019 Immuno-Oncology Congress of the European Society for Medical Oncology to be held in Geneva, December 11-14, 2019.

Financial Results

3Q 2019 revenues, all related to sales of OMIDRIA, were $29.9 million, a new record high. On a sequential quarter-over-quarter basis, OMIDRIA revenues increased by $3.1 million, or 12 percent, from the $26.8 million achieved in 2Q 2019. The increase is due to a growing number of purchasing accounts as well as deeper penetration within accounts across hospitals, ASCs, Veterans Administration and other government payers.

Gross-to-net deductions in 3Q 2019 remained consistent with those in 2Q 2019 at 28 percent

3Q 2019 costs and expenses were $41.0 million compared to $36.1 million for Q2 2019. The increase reflected incremental narsoplimab manufacturing costs associated with the commencement of full-scale drug substance manufacturing in 3Q 2019 together with increased manufacturing scale-up costs in our OMS906 program in advance of planned clinical entry next year. Selling, general and administrative expenses were $16.9 million for both 2Q and 3Q 2019.

For 3Q 2019, Omeros reported a net loss of $16.5 million, or $0.33 per share, compared to a net loss of $14.5 million, or $0.29 per share, in 2Q 2019. Net loss in both 2Q 2019 and 3Q 2019 included non-cash expenses of $6.3 million ($0.13 per share).

As of September 30, 2019, Omeros had $27.3 million of cash, cash equivalents and short-term investments available for operations, a decrease of $4.5 million from June 30, 2019. Accounts receivable at September 30, 2019 were $29.9 million.

Omeros has a $50-million revolving line of credit facility with Silicon Valley Bank. The line of credit provides for borrowing availability of up to the lesser of $50 million and 85 percent of eligible accounts receivable, subject to applicable reserves. As of September 30, 2019, there were no borrowings outstanding.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 9699377. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9699377.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On November 12, 2019 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported financial results for the third quarter ended September 30, 2019, and provided an overview of recent developments (Press release, Atreca, NOV 12, 2019, View Source [SID1234550969]).

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"We continued to make strong progress this quarter with our Investigational New Drug (IND) application for our lead product candidate, ATRC-101 and expect to initiate a Phase 1b clinical trial in patients with solid tumors early next year," said John Orwin, Chief Executive Officer. "To highlight our progress we recently presented a poster at the annual SITC (Free SITC Whitepaper) meeting describing the discovery and preclinical evaluation of ATRC-101, underscoring both our ability to leverage the human immune response to find novel antibody-target pairs, as well as the potential of ATRC-101 to become an important treatment option for patients with a variety of solid tumor cancers."

Recent Developments and Highlights

Atreca presented a poster describing the preclinical evaluation of ATRC-101 at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019). The poster included preclinical data highlighting ATRC-101’s robust and persistent anti-tumor activity as both monotherapy and in combination with PD-1 checkpoint inhibitors.

In August 2019, Atreca appointed Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, to the company’s Board of Directors, who brings more than 20 years of drug development experience to the company.
In August 2019, the period for centralized opposition of patent rights at the European Patent Office (EPO) ended with respect to European Patent EP2702146B1, entitled "Identification of Polynucleotides Associated with a Sample", which was granted by the EPO in November 2018. This patent is part of the portfolio of patents and patent applications exclusively licensed by the Board of Trustees of the Leland Stanford Junior University to Atreca that relates to Atreca’s proprietary Immune Repertoire Capture technology.
Upcoming Milestones

Atreca anticipates completion of the IND process with the U.S. Food and Drug Administration for ATRC-101 by late 2019 and expects to initiate a Phase 1b clinical trial in patients with solid tumors in early 2020.
Third Quarter 2019 Financial Results

As of September 30, 2019, cash and cash equivalents and short-term investments totaled $201.0 million.

Research and development expenses for the three months ended September 30, 2019 were $12.8 million, including non-cash share-based compensation expense of $920,000.

General and administrative expenses for the three months ended September 30, 2019 were $4.9 million, including non-cash share-based compensation expense of $958,000.

Atreca reported a net loss of $15.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.57, for the three months ended September 30, 2019.

On November 12, 2019 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the third quarter 2019 (Press release, Cue Biopharma, NOV 12, 2019, View Source [SID1234550968]).

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"The third quarter was marked by the dosing of the first patient in our Phase 1 clinical study of CUE-101, which represents a transformative milestone for the company as we continue to grow and develop as a clinical stage company," said Daniel Passeri, chief executive officer. "As part of this continued evolution, the promotion of Dr. Suri to President and CSO helps enhance our productivity and effectiveness by further integrating operational functions and fostering close coordination of preclinical translational studies with clinical development."

Dr. Suri stated, "We have made significant progress on several key programs in addition to CUE-101, including CUE-102, a program selected with our collaboration partner, LG Chem Life Sciences, as well as our early-stage program in auto-immune disease, through our collaboration with Merck. With our first immuno-oncology candidate now in the clinic and additional candidates in lead optimization, Cue Biopharma is well positioned for the potential of significant value inflection over the coming months."

Recent News & Business Updates

Recently initiated dosing a Phase 1 clinical trial to investigate the safety and efficacy of CUE-101 in the treatment of HNSCC. The trial is a multi-center, open-label, Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and

immunogenicity of CUE-101 as a monotherapy in approximately 50 patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype.

Extended cash runway through an at-the-market equity offering sales agreement for aggregate gross proceeds of up to $30 million with Stifel Nicolaus & Company, Inc. ("Stifel"), who acts as sales agent. As of September 30, 2019, the Company had sold 2,084,615 shares of common stock under the sales agreement for total proceeds of approximately $15.7 million, net of commissions paid, but excluding estimated transaction expenses.

Promoted Anish Suri, Ph.D., to the role of president in addition to his current role as chief scientific officer. As president, Dr. Suri will assume operational and management oversight of corporate functions, as well as research and development activities. Building upon the recent success of entering clinical development with its lead drug candidate CUE-101, the company plans to augment its senior management team with a number of key hires through 2020.

On Friday, November 8, 2019, Cue Biopharma presented a poster on its lead program, CUE-101, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (SITC 2019) titled, "CUE-101, a novel HPV16 E7:pMHC:IL-2:Fc fusion protein, enhances tumor antigen specific T cell activation for the treatment of HPV16-driven malignancies."

Third-Quarter Results & Financial Highlights

The Company reported collaboration revenue of approximately $1.0 million and $0.4 million for the three months ended September 30, 2019 and 2018, respectively.

Research and development expenses were $5.3 million and $10.3 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in research and development expenses of $5.0 million was primarily due to a reduction in headcount, operational efficiencies and a decrease in drug substance manufacturing cost as our full clinical supply for the CUE-101 Phase 1 monotherapy trial was manufactured during 2018.

General and administrative expenses were $2.8 million and $2.9 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in general and administrative expense of $0.1 million was primarily due to a reduction in headcount.

As of September 30, 2019, the Company had approximately $31.3 million in cash and cash equivalents compared with $39.2 million as of December 31, 2018.

The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About CUE-101

CUE-101, our lead program from the CUE-100 series, contains IL-2 and a pMHC composed of HLA-A*02:01 complexed with a dominant peptide derived from the human papilloma virus 16 E7 protein (HPV16-E7). The drug is a fusion protein designed to target and activate antigen-specific T cells present in the patient’s body to attack HPV16-driven cancers. CUE-101 is currently being tested in a Phase 1 clinical trial for the treatment of HPV16-driven recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). For more information about the trial, please visit clinicaltrial.gov.

About Immuno-STAT

Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-stimulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, stimulated and expanded outside the body (ex vivo), and reinfused in an activated state.

On November 12, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative biotechnology company focused on the discovery, development, and commercialization of synthetic DNA products for treating cancers and infectious diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Inovio, NOV 12, 2019, View Source [SID1234550967]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update.

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Inovio Highlights

VGX-3100/MEDI0457/INO-3107/HPV-Related Diseases
REVEAL 1 Phase 3 trial of VGX-3100 for HPV-related high-grade cervical dysplasia, which completed enrollment of 198 patients in the second quarter of 2019, is on schedule to read out top-line efficacy data by the fourth quarter of 2020. Enrollment for the second Phase 3 trial for this program, REVEAL 2, remains on track, with expanded sites both within the United States and globally, including new sites recently opened in Argentina, Lithuania, and Spain.

Inovio completed enrollment of 33 patients for its Phase 2 trial of VGX-3100 for HPV-related high-grade vulvar dysplasia (vulvar HSIL).

In addition, the company completed enrollment in its open-label, 24 patient, Phase 2 trial of VGX-3100 in patients with HPV-related high-grade anal dysplasia (anal HSIL).

Inovio plans to present interim results for both vulvar HSIL and anal HSIL clinical trials at a medical conference in the first quarter of 2020.

In a global partnership with AstraZeneca, MEDI0457 (formerly INO-3112) in combination with durvalumab, an anti-PD-L1 checkpoint inhibitor, continues to be evaluated in multiple Phase 2 studies in patients with HPV-related head and neck, cervical, anal, penile, and vulvar cancers. Inovio is eligible to receive future milestone payments and double-digit tiered royalties on MEDI0457 product sales.

Inovio continues to prepare to initiate a pivotal clinical trial of INO-3107 for HPV-caused recurrent respiratory papillomatosis (RRP), which the company plans to advance as a rare, orphan product, within the first half of 2020.

INO-5401/Glioblastoma Multiforme (GBM) Phase 2 Trial
Inovio reported positive interim data from its ongoing Phase 2 trial of newly diagnosed glioblastoma multiforme (GBM), which combines Inovio’s INO-5401, a T cell-activating immunotherapy encoding for three tumor-specific antigens (hTERT, WT1, and PSMA), and INO-9012, an immune activator encoding IL-12, in combination with Libtayo, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi.

Key interim data from the 52-patient clinical trial showed that 80% (16 of 20) of MGMT gene promoter methylated patients and 75% (24 of 32) of unmethylated patients were progression-free at six months (PFS6) measured from the time of their first dose, substantially exceeding historical standard-of-care data (approximately 60% of MGMT promoter methylated patients and 40% of unmethylated patients historically were progression-free at six months). The data was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. Inovio will report 12- and 18-month overall survival data next year.

INO-5151/Prostate Cancer Combination Trial
INO-5151 was featured in a trial-in-progress poster at SITC (Free SITC Whitepaper) 2019. INO-5151, which is a combined formulation of INO-5150 (with SynCon antigens encoding for PSA and PSMA) and INO-9012, is being tested in one arm (Cohort C) of this exploratory platform study along with nivolumab, a PD-1 inhibitor (Bristol-Myers Squibb), and CDX-301 (Celldex). This study is being conducted and funded by the Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), as part of Inovio’s previously established clinical collaboration agreement (ClinicalTrials.gov Identifier: NCT03835533).

DNA-encoded monoclonal antibodies (dMAb)/DNA-encoded Bi-specific T Cell Engagers (dBTE)
Inovio and its collaborator, The Wistar Institute, received a $4.6 million grant from the National Institutes of Health (NIH) in support of innovative research of antimicrobial resistance (AMR) and continued development of Inovio’s DNA-encoded monoclonal antibodies (dMAb) platform.

Using direct local delivery into the body by the CELLECTRA platform, the synthetic genetic codes provided by the dMAbs instruct the body’s cells to become a customized patient-specific factory that manufactures its own therapeutic antibody products, enabling a major leap in antibody technology. Traditional monoclonal antibodies represent the largest segment of pharmaceutical markets today, accounting for more than $100 billion in pharmaceutical sales each year, with treatments spanning cancer, infectious diseases, inflammation, and cardiovascular diseases. With its synthetic design and in-patient production, dMAb products represent a disruptive and innovative entrant to this important class of pharmaceuticals. Collectively, dMAb and dBTE offer the opportunity to provide improved yet cost-effective therapeutic options across cancer and infectious diseases.

Earlier this year, Inovio advanced its first dMAb candidate INO-A002 (for preventing or treating Zika virus infection) to a Phase 1 dose-escalation trial to assess safety and tolerability and expression of dMAb-produced antibodies with full funding from the Bill & Melinda Gates Foundation.

Cash Position
As of September 30, 2019, cash and cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018.

In August, Inovio closed a private placement of 1.0% convertible bonds due 2024 with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15.0 million based on the exchange rate on the date of issuance) issued to a group of institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm. These bonds are convertible into Inovio’s Korean Depositary Receipts (KDRs) assuming Inovio has completed a secondary listing of its securities on the KOSDAQ Market of the Korea Exchange in the form of KDRs, or otherwise shares of common stock if KDRs are not listed at the time of conversion. Net proceeds from the offering were approximately $14.5 million after deducting offering expenses payable by Inovio.

In July, Inovio implemented a strategic cost-reduction plan (including a 28% staff reduction and cessation of several R&D and clinical programs), which resulted in an approximately 25% reduction in annual burn. The reallocation of resources focuses the company’s commercialization efforts for its lead asset, VGX-3100, while also developing high-value, fast-to-market product candidates, such as INO-3107 to treat RRP and INO-5401 for GBM.

Dr. J. Joseph Kim, Inovio’s President & CEO, said, "Our recently presented INO-5401 data demonstrated promising efficacy results, in terms of progression-free survival rates, against a very difficult to treat cancer in GBM and highlighted the potential of our immunotherapies utilizing tumor-associated antigens in cancer treatments. Looking ahead, the next 12 months should be a transformational period for Inovio, as we expect to have data readouts from multiple Phase 3 and Phase 2 programs. With our sharpened focus on advancing and commercializing products for HPV-related diseases and fast-to-market opportunities, the company is uniquely positioned to bring multiple products to the market."

Dr. Kim further stated, "We continue to advance our HPV treatment capabilities, where we will have efficacy results from our Phase 3 VGX-3100 REVEAL 1 trial and Phase 2 VIN/AIN programs next year. Additionally, we plan to initiate a pivotal clinical trial of INO-3107 for HPV-caused RRP, which we expect to move forward rapidly as a rare, orphan product. In cancer, you can expect overall survival data from our INO-5401 cancer combination trial with Regeneron for GBM, building upon the promising PFS6 data. Finally, the fully enrolled head and neck cancer Phase 2 trial sponsored by our partner AstraZeneca, combining MEDI0457 with AstraZeneca’s checkpoint inhibitor should be completed by the third quarter. Collectively, these anticipated data readouts in 2020 all point to great promise for Inovio’s product pipeline, and further solidify Inovio as the leader in synthetic DNA immunotherapy."

Third Quarter 2019 Financial Results

Inovio’s total revenue was $867,000 for the three months ended September 30, 2019, compared to $2.0 million for the same period in 2018. Inovio’s total operating expenses were $24.8 million for the three months ended September 30, 2019, compared to $28.6 million for the same period in 2018.

Inovio’s net loss for the quarter ended September 30, 2019 was $23.1 million, or $0.23 per basic and $0.25 per diluted share, compared to $25.0 million, or $0.27 per basic and diluted share, for the same period in 2018.

Revenue

The year-over-year decrease in revenue under collaborative research and development arrangements was primarily due to a decrease in reimbursed drug manufacturing activities related to our partnership with AstraZeneca.

Operating Expenses

R&D expenses were $19.1 million for the three months ended September 30, 2019, as compared to $21.9 million for the same period in 2018. The decrease in R&D expenses was primarily related to decreases in employee compensation expense, drug manufacturing expense related to our partnership with AstraZeneca and engineering and lab supplies, among other variances. These decreases were offset by a personnel-related restructuring charge in connection with the one-time employee termination costs incurred during the third quarter of 2019.

Contributions received from current grant agreements and recorded as contra-R&D expense were $2.8 million for the three months ended September 30, 2019, compared to $2.6 million for the same period in 2018.

General and administrative (G&A) expenses were $5.7 million for the three months ended September 30, 2019, versus $6.8 million for the same period in 2018. The decrease in G&A expenses was primarily related to decreases in employee compensation, allocated depreciation expense, and legal expenses, among other variances.

Capital Resources

As of September 30, 2019, cash and cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018. As of September 30, 2019, Inovio had 99.0 million common shares outstanding and 129.5 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

Inovio’s condensed consolidated balance sheet and statement of operations are provided below. Additional information is included in Inovio’s quarterly report on Form 10-Q for the quarter ended September 30, 2019, which can be accessed at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting Inovio’s website at View Source Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll-free) or 412-317-0088 (international toll) using replay access code 10136605.

On November 12, 2019 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company’s management will present a Company overview and update, as well as host investor meetings, at the following November conferences (Press release, Supernus, NOV 12, 2019, View Source [SID1234550966]):

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Stifel 2019 Healthcare Conference
Date: November 19, 2019
Time: 1:50 p.m. ET
Place: Lotte New York Palace Hotel, New York

Jefferies 2019 London Healthcare Conference
Date: November 21, 2019
Time: 2:40 p.m. GMT / 9:40 a.m. ET
Place: Waldorf Hilton, London, UK
Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live webcast of the presentations can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days on the Company’s website after the respective conferences.