On May 9, 2019 EnGeneIC Limited, a clinical-stage biopharmaceutical company advancing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, reported that the first four patients have been dosed in a Phase I/IIa study using the Company’s tumor-targeting, immunogenic EDVs to deliver a cytotoxic drug payload directly to tumors of patients who have exhausted curative treatment options (Press release, EnGeneIC, MAY 9, 2019, View Source [SID1234536197]). The study is enrolling patients with advanced pancreatic cancer and other EGFR-expressing solid tumors in a second cohort, which is currently underway at Frankston Private Hospital in Victoria, Australia, with Professor Vinod Ganju, MBBS, FRACP, as the Principal Investigator.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

EnGeneIC’s second-generation EDV nanocells deliver an extremely cytotoxic nemorubicin derivative (D682) directly to solid tumors via EGFR targeting on the tumor cell surface, keeping healthy tissue protected from damage. The novel therapy also includes EDVs carrying an immune-boosting adjuvant to further augment the anti-tumor immune response stimulated by the bacterially-derived EDVs and perpetuated by tumor cell destruction.

Jennifer MacDiarmid, Ph.D., and Himanshu Brahmbhatt, Ph.D., joint-CEOs and Directors of EnGeneIC, stated, "We developed our second-generation EDVs to address multi-drug resistance in patients who have failed multiple lines of chemotherapy and therefore have the highest unmet need. D682 is an extremely potent drug that is far too toxic to be delivered systemically, but has proven safe in patients when encapsulated in our EDVs. We have named the study, the Carolyn Trial, after a close friend who had end-stage pancreatic cancer and was treated in a compassionate use case study. Carolyn was the first patient in the world to receive D682, and we observed highly encouraging results. Not only was survival extended, but quality of life improved considerably for the patient. Moreover, there was significant evidence of tumor regression coincident with a decrease in a key pancreatic cancer blood marker and a robust increase in anti-tumor CD8+ T cells and other anti-tumor immune cells. We are now executing a more rigorous clinical trial, not only for pancreatic cancer patients, but also for other advanced-stage patients with drug-refractory tumors."

Professor Ganju commented "Novel therapies for these late stage patients with drug-resistant tumors are desperately needed. Four patients have been enrolled on the study and so far we have been impressed with the tolerability and safety of this therapy. We will be getting some efficacy data in coming months."

About the Phase 1/2a Study

The two-cohort study will enroll up to 40 evaluable patients per cohort: 1) patients with advanced pancreatic cancer and 2) patients with EGFR-expressing solid tumors who have failed first- and second-line therapy or for whom standard therapies are not appropriate. The test article is EnGeneIC’s second-generation EGFR-targeted, D682-carrying EDV (EEDVD682) plus EDVs carrying an immune adjuvant (EDVadj) which acts to augment the anti-tumor immunity. Study objectives include assessing the safety and tolerability of EEDVD682 plus EDVadj, assessing anti-tumor response and overall survival. Exploratory objectives include biomarker assessment for immune response such as cellular immune response (CD8+ T cells, NK cells), and activated dendritic cells. In addition to the current clinical site, the study is expected to be opened in at least one other major cancer center in Sydney, Australia. For more information visit View Source;isReview=true

On May 9, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported financial results for the first quarter ending March 31, 2019 and provided a business update (Press release, Savara, MAY 9, 2019, View Source [SID1234536174]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are diligently preparing for the highly anticipated readout of our Phase 3 IMPALA study in June, which we expect to be followed by the submission of a Biologics License Application in the first half of 2020 and, if approved, a commercial launch of Molgradex later in 2020 or early 2021," said Rob Neville, Chief Executive Officer, Savara. "These pivotal results could be transformational for the Company and, more importantly, for patients with aPAP, a rare and progressive lung disease. Our commitment to improving the lives of people with orphan lung diseases, and accelerating the advancement of our innovative therapies, is unwavering. With multiple catalysts expected over the coming quarters, we are well positioned for sustained growth."

Recent Developments and Upcoming Highlights

Molgradex for aPAP
Expect top line results from the IMPALA study in June 2019. IMPALA is a global, pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of aPAP. Positive results would facilitate the submission of a Biologics License Application in the first half of 2020, with an anticipated commercial launch later in 2020 or early 2021.
Continued strong enrollment in IMPALA-X, an open-label, multicenter extension study to determine the long-term safety and utilization of Molgradex in patients with aPAP. At the end of Q1 2019, 25 out of 26 eligible patients had enrolled in the extension study.
Molgradex received Fast Track Designation by the FDA for the treatment of aPAP. A drug granted with this designation may be eligible for Priority and/or Rolling Review, if relevant criteria are met.
Molgradex for nontuberculous mycobacterial (NTM) lung infection
Initiated ENCORE, a Phase 2a clinical study of Molgradex for the treatment of NTM in people living with cystic fibrosis (CF).
Expect top line results from OPTIMA, a Phase 2a clinical study evaluating Molgradex for the treatment of NTM in non-CF patients in Q1 2020.

Molgradex manufacturing

Entered into a new commercial manufacturing and supply agreement with GEMA Biotech, the company that has produced the drug substance for all Molgradex non-clinical and clinical studies. Under the terms of the agreement, GEMA Biotech will exclusively supply the Company with GM-CSF expressed from Savara’s proprietary cell line.
AeroVanc
Enrollment continues in AVAIL, a pivotal, global Phase 3 clinical study of AeroVanc, an inhaled vancomycin hydrochloride powder for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF.
As of today, the study has enrolled 153 patients out of a target of 200. An approximate 50% screen failure rate with younger subjects (between 6-21 years of age) has slowed enrollment. The screen failures are largely due to exacerbations between time of screening and randomization.
Expect to complete patient enrollment in Q3 2019 with top line results in Q2 2020.
Exploratory Pipeline
The initial indication for the Phase 2-ready aerosolized amikacin/fosfomycin combination antibiotic will focus on non-CF bronchiectasis patients with chronic lung infection and frequent exacerbations. A Phase 2 study is expected to start enrolling in bronchiectasis patients with recurrent exacerbations later in 2019 or early 2020 and will evaluate amikacin/fosfomycin and Molgradex separately, and in combination, to reduce bacterial infection load.
First Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended March 31, 2019 was $12.1 million, or $(0.34) per share, compared with a net loss attributable to common stockholders of $26.8 million, or $(0.86) per share, for the three months ended March 31, 2018.

Research and development expenses were $10.0 million for the three months ended March 31, 2019, compared with $8.5 million for the three months ended March 31, 2018. The increase was primarily due to $1.9 million in increased development costs associated with the development of Molgradex, partially offset by a slight decrease in other program costs for the three months ended March 31, 2019.

General and administrative expenses for the three months ended March 31, 2019 were $2.8 million, compared with $1.8 million for the three months ended March 31, 2018. The increase was primarily due to increased personnel costs and other legal, accounting, insurance and operating activities.

As noted in the first quarter 2018 10-Q, during the quarter ended March 31, 2018, the Company recognized a $21.7 million impairment charge to the carrying value of acquired IPR&D related to a drug candidate previously assumed by Savara. For the first quarter ended March 31, 2019, there were no costs associated with this activity as the Company was no longer supporting or pursuing the drug candidate
.
Other income, net of other expense, increased by $0.1 million to $0.8 million for the three months ended March 31, 2019 from $0.7 million for the three months ended March 31, 2018 and was primarily related to a reduction of net interest expense.

Income tax benefit decreased by $4.5 million for the three months ended March 31, 2019 from the three months ended March 31, 2018 primarily due to the reversal of a deferred tax liability resulting from the impairment of certain acquired IPR&D during the first quarter of 2018.

As of March 31, 2019, Savara had a carrying value of its debt of approximately $24.7 million and had cash, cash equivalents, and short-term investments of approximately $105.2 million.

Conference Call and Webcast
Savara will host a conference call today at 4:30 p.m. Eastern Time (ET) / 1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere outside the U.S. and request the "Savara Inc." call. A live webcast of the conference call will be available online in the Investors section of Savara’s website at View Source

Approximately one hour after the call, a replay of the webcast will be available on Savara’s website for 30 days, and a telephone replay will be available through May 16, 2019 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10130971.

On May 9, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its third quarter ended March 31, 2019 (Press release, MEI Pharma, MAY 9, 2019, View Source [SID1234536137]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As progress continues across our pipeline of four clinical-stage oncology candidates, including two in clinical studies that may support future submissions for FDA marketing approval, we are particularly excited with the expanding data set from the ME-401 intermittent dosing schedule as it continues to mature and we look forward to presenting the data at upcoming medical meetings, including next month at ASCO (Free ASCO Whitepaper)," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Our immediate focus for MEI-401 is twofold: executing the ME-401 follicular lymphoma global Phase 2 study, data from which we intend to submit as an accelerated approval marketing application with the FDA, and the expansion of our investigation of ME-401 in combination with Rituxan or zanubrutinib, a BTK inhibitor being investigated pursuant to our BeiGene collaboration, to earlier stages of follicular lymphoma as well as other B-cell malignancies."

Upcoming Program Milestones

Advancement of ME-401 Program for B-Cell Malignancies
Phase 1b study initiation of new arm to evaluate the combination of ME-401 with zanubrutinib under a clinical collaboration with BeiGene.
Updates and presentations of clinical data from the ME-401 clinical development program, including at 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper).
Final Clinical Results: ME-344 for Breast Cancer
Present complete results from the investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin) in patients with breast cancer at ASCO (Free ASCO Whitepaper) 2019.
Phase 1b Study Progress: Voruciclib for B-Cell Malignancies and AML
Report initial clinical results from ongoing Phase 1 study, including single agent dose ranging data and results from the combination with venetoclax in patients with B-cell malignancies and relapsed and refractory acute myeloid leukemia around year end 2019.
Phase 2 Results: Pracinostat for Myelodysplastic Syndrome
Results from the Phase 2 clinical trial, including response and 1-year survival, expected to be available around year end 2019.
Financial Highlights

As of March 31, 2019, MEI had $82.3 million in cash, cash equivalents and short-term investments, with no outstanding debt.
For the three months ending March 31, 2019, cash expenditures for operating activities were $11.3 million, compared to $6.2 million for 2018. For the nine months ending March 31, 2019, cash expenditures for operating activities were $31.4 million, compared to $17.6 million for 2018. The increase in cash used for the nine months ended March 31, 2019 primarily relates to costs associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 study.
Research and development expenses were $9.1 million for the quarter ended March 31, 2019, compared to $3.1 million for the same period in 2018. Research and development expenses primarily reflect increased costs associated with the development of ME-401.
General and administrative expenses were $3.6 million for the quarter ended March 31, 2019, compared to $2.5 million for the same period in 2018. The increase primarily relates to increased salary and share-based compensation associated with increased headcount, and increased professional services expenses.
The Company recognized revenue of $1.2 million for the quarter ended March 31, 2019, compared to $0.4 million for the same period in 2018. The increase is related to revenues from our agreement with KHK, and to higher levels of research and development activities performed pursuant to the Helsinn license agreement.
Net loss for the quarter ended March 31, 2019, was $17.4 million, or $0.24 per share compared to a net loss of $5.9 million, or $0.16 per share for the same period in 2018. The Company had 71,280,660 shares of common stock outstanding as of March 31, 2019, compared with 37,323,441 shares as of March 31, 2018.
The adjusted net loss, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure) for the quarter ended March 31, 2019, was $12.2 million.

On May 9, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the first quarter ended March 31, 2019 (Press release, IntelGenx, MAY 9, 2019, View Source [SID1234536136]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

2019 First Quarter Financial Summary:

Revenue increased to $416,000, compared to $239,000 in the first quarter of 2018
Adjusted EBITDA was ($2.1 million), compared to ($1.8 million) in Q1-2018
Cash and short-term investments totaled $8.6 million as at March 31, 2019
Recent Developments:

Appointed André Godin to the position of President and Chief Financial Officer
Entered into a definitive worldwide agreement with Aquestive Therapeutics, Inc. for the co-development and commercialization of Tadalafil oral films for the treatment of erectile dysfunction
Received from the United States Patent and Trademark Office a patent covering design and manufacturing of topical oral films for the topical treatment of diseases of the oral mucosa using mucocoadhesive particles
Presented an overview of the Company’s business at the 2019 Bloom Burton & Co. Healthcare Investor Conference
Promoted the Company’s VersaFilm and VetaFilm oral film contract development and manufacturing organization, or CDMO, services capabilities at CPhI North America
Filed a non-provisional U.S. patent application for oil-based active ingredients
Promoted VetaFilm oral film technology at the Human Biotech & Animal Health Business Partnering Summit
Presented two Montelukast poster presentations at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases
Received a Complete Response Letter requesting additional information, but no new bioequivalence study, from the U.S. Food and Drug Administration related to its resubmitted RIZAPORT new drug application ("NDA"); Company’s objective is to resubmit the RIZAPORT NDA before the end of Q3-2019
Received a Japanese patent for RIZAPORT VersaFilm
Announced Montreal’s Douglas Mental Health University Institute as an additional Montelukast VersaFilm Phase 2a clinical trial site in Canada
Appointed Dr. Rodolphe Obeid to the position of Vice President, Operations
"The agreement we secured with Aquestive represents a continuation of IntelGenx’s commitment to commercialize our pipeline of innovative oral film products with strong partners," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We look forward to updating our stakeholders as we execute on a number of major objectives over the next several quarters."

Financial Results:

Total revenues for the three-month period ended March 31, 2019 amounted to $416,000, an increase of $177,000 compared to $239,000 for the three-month period ended March 31, 2018. The increase is mainly attributable to an increase in R&D milestone revenues offset by a decrease in R&D revenues.

Operating costs and expenses were $2.7 million for the first quarter 2019, versus $2.3 million for the corresponding three-month period of 2018. The increase for the three-month period ended March 31, 2019 is mainly attributable to a $424,000 increase in Selling, General and Administrative expenses.

For Q1-2019, the Company had an operating loss of $2.3 million, compared to operating loss of $2.0 million for the comparable period of 2018.

Net comprehensive loss was $2.3 million, or $0.03 on a basic and diluted per share basis, for both the three-month period ended March 31, 2019 and the comparable period of 2018.

As of March 31, 2019, the Company’s cash and short-term investments totalled $8.6 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 first quarter financial results today on May 9, 2019, at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 4695936. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

On May 9, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative biotechnology company focused on the discovery, development and commercialization of its synthetic nucleic technology targeted against cancers and infectious diseases, reported financial results for the first quarter ended March 31, 2019 (Press release, Inovio, MAY 9, 2019, View Source [SID1234536135]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Inovio Highlights

VGX-3100/INO-3106; HPV-related Pre-cancers
Inovio’s Phase 3 trials for VGX-3100, REVEAL 1 and REVEAL 2, are both up and running and are executing on track. REVEAL 2 began recruitment in March while REVEAL 1 is anticipated to be fully enrolled with 198 patients by mid-2019. Additionally, Inovio expects interim data from its two Phase 2 trials with VGX-3100 in patients with vulvar and anal dysplasia later this year.

Inovio recently announced that VGX-3100 has been granted an Advanced Therapy Medicinal Product certificate by the European Medicines Agency’s (EMA) Committee for Advanced Therapies following an extensive evaluation of its chemistry, manufacturing and controls (CMC) data and nonclinical results. Since the inception of the program in 2009, only 11 ATMP Certifications have been awarded by the EMA. This certificate is an important developmental milestone for VGX-3100 as it will facilitate the preparation, filing, and review of a future European market application for VGX-3100.

In April, VGX-3100 was selected at the World Vaccine Congress as the 2019 "Best Therapeutic Vaccine."

Extending its portfolio into additional HPV-related diseases, Inovio announced its novel therapy, INO-3106, against the human papilloma virus type 6 (HPV 6) demonstrated clinical efficacy in a pilot clinical study of two patients with recurrent respiratory papillomatosis (RRP), a rare orphan disease. Results presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) demonstrated that following both patient’s last dose of INO-3106, the patients have been surgery-free, due to lack of tumor recurrence. One patient has not needed surgery for over two years; the other has been surgery-free for over one year. A complete study report is being prepared for publication in a medical journal, and Inovio plans to further develop INO-3106 as a novel, non-invasive immunotherapy for the treatment of RRP, for both adult and pediatric populations.
MEDI0457 (VGX-3100 + IL-12; licensed to AstraZeneca)
Inovio achieved a third cancer indication milestone under its collaboration with AstraZeneca, triggered by AstraZeneca dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (formerly called INO-3112) in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, targeting cervical, anal, penile, and vulvar cancers associated with human papilloma virus (HPV). AstraZeneca continues to evaluate MEDI0457 in combination with durvalumab in multiple Phase 2 trials in patients with HPV-related cancers.

In January, Inovio announced that two patients with HPV-related head and neck cancer, who were treated with MEDI0457 in a Phase 1 trial, achieved a sustained complete response (full remission) following subsequent treatment with a PD-1 checkpoint inhibitor.
INO-5401 – Cancer Combination Trials
Inovio completed enrollment of its Phase 1/2 immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM). The enrollment of 52 patients was achieved three months ahead of schedule. The trial is designed to evaluate Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens expressed by GBM and INO-9012, an immune activator encoding IL-12, in combination with cemiplimab-rwlc (also known as Libtayo or REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals in collaboration with Sanofi. Interim results evaluating safety, immunological impact, progression-free survival and overall survival from this study are expected before the end of this year.
DNA-Encoded Bi-specific T Cell Engagers (dBTEs)
Inovio presented pre-clinical results at a major cancer conference (AACR) (Free AACR Whitepaper) on the company’s novel DNA-encoded Bi-specific T Cell Engagers (dBTE) technology. Inovio, with its collaborators at The Wistar Institute, developed a novel dBTE targeting the HER2 molecule which was tested in therapeutic models for the treatment of ovarian and breast cancers. Importantly, just a single dose of Inovio’s HER2 dBTE resulted in high levels of corresponding BiTE in mice for four months, far exceeding what is typically displayed with conventional BiTE’s short half-life of only a few hours. The HER2 dBTE effectively killed HER2-expressing tumor cells resulting in a near-complete tumor clearance. Also presented was Inovio’s CD19 dBTE which can kill B cell cancers by targeting B cell specific marker CD19.

These results were subsequently published in a JCI Insight journal article entitled, "DNA-encoded bi-specific T cell engagers and antibodies present long-term antitumor activity."
DNA-Encoded Monoclonal Antibody (dMAb)
In February, the company dosed a subject in the first-ever human study of Inovio’s DNA-encoded monoclonal antibody (dMAb) technology evaluating the ability of our technology to express Zika virus-specific mAbs. This study is being fully funded by The Bill and Melinda Gates Foundation. While the trial’s focus is on evaluating the dMAb for Zika infection, the clinical results are intended to help advance Inovio’s dMAb and dBTE programs in infectious diseases and cancer.
Infectious Diseases
Phase 1 data for INO-4201, the company’s Ebola vaccine, was published in The Journal of Infectious Diseases, further supporting the advancement of the intradermal delivery platform for vaccines. Significantly, the study demonstrated that intradermal (skin) administration with Inovio’s CELLECTRA efficacy enhancing device resulted in 100% of evaluable subjects generating antigen-specific antibody responses that persisted for more than one year in most subjects and generated robust T cell responses. The published data further validates the safety, potency, and product stability advantages of Inovio’s immunotherapy platform.
Geneos Therapeutics, Inc.
In February, Inovio’s personalized cancer vaccine subsidiary Geneos, secured a Series A financing round with potential proceeds of up to $10.5 million. With this funding, Geneos is fully operational as a standalone entity in its efforts to develop the next generation of neoantigen-targeting cancer immunotherapies. Geneos has an exclusive license to Inovio’s immunotherapy platform in the area of personalized cancer immunotherapy; Inovio holds majority equity position in Geneos and continue to develop and commercialize all global population-based (non-personalized) cancer immunotherapies based on its proprietary SynCon design. Geneos is now focused on initiating its first clinical study in 2019.
Management and Board Updates
During the first quarter, Inovio announced the appointment of Jacqueline E. Shea, PhD, as Inovio’s Chief Operating Officer (COO) and Executive Vice President. Dr. Shea will be responsible for Inovio’s manufacturing, commercial, business development, and alliance management operations as well as serving as a key member of the executive team along with the CFO and CSO in formulating and implementing overall corporate strategy.

Also in the first quarter, the Company announced that Mr. Simon X. Benito, former Merck Vaccines executive, was appointed Chairman of Inovio’s Board of Directors. In addition, the Company appointed Ms. Lota Zoth, former CFO of MedImmune, and Dr. Ann C. Miller, former commercial executive with Merck, Amgen, Eisai and Sanofi, to its Board of Directors.
Cash Position
As of March 31, 2019, cash and cash equivalents and short-term investments were $128.0 million compared to $81.2 million as of December 31, 2018. In the first quarter 2019, the Company completed a private placement of $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024, or the Notes. The Notes were sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Net proceeds from the offering were approximately $75.7 million, after deducting the initial purchasers’ discount and offering expenses payable by the Company.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "The last several months have been extremely productive for Inovio by validating the company’s versatile technology platform. We ended the first quarter by featuring positive data from our Phase 1 Ebola study in a prestigious publication. Inovio further highlighted its capabilities in treating HPV-associated disease after presenting positive data from patients diagnosed with RRP, where we demonstrated a clinical benefit for these patients. Additionally, we initiated the first ever clinical study for our dMAb platform during the first quarter and unveiled an exciting new component within our platform involving our novel dBTE technology, which we’re working towards rapidly advancing the first product into clinical testing. Inovio enters the second quarter well-financed following the February raise, placing us in a prime position to continue to deliver on our game-changing clinical programs."

First Quarter 2019 Financial Results

Total revenue was $2.8 million for the three months ended March 31, 2019, compared to $1.5 million for the same period in 2018. Total operating expenses were $31.4 million compared to $34.3 million for the same period in 2018.

Inovio’s net loss for the quarter ended March 31, 2019 was $29.2 million, or $0.30 per basic and diluted share, compared to $32.4 million, or $0.36 per basic and diluted share, for the quarter ended March 31, 2018.

Revenue

The year over year increase in revenue under collaborative research and development arrangements was primarily due to the milestone payment recognized in the first quarter 2019 from AstraZeneca.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2019 were $24.4 million compared to $24.6 million for the same period in 2018. The decrease in R&D expenses was primarily related to a sub-license expense of $1.9 million recorded in 2018 related to the ApolloBio collaboration, partially offset by an increase of $1.2 million related to Inovio’s VGX-3100 Phase 3 clinical trials, among other variances.

General and administrative (G&A) expenses were $7.0 million for the three months ended March 31, 2019 versus $9.7 million for the same period in 2018. The decrease in G&A expenses was primarily related to the foreign non-income taxes and advisory fees incurred in connection with the ApolloBio upfront payment Inovio received in 2018.

Capital Resources

As of March 31, 2019, cash and cash equivalents and short-term investments were $128.0 million compared to $81.2 million as of December 31, 2018. As of March 31, 2019, the Company had 97.9 million common shares outstanding and 125.3 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, restricted stock units, convertible preferred stock and convertible notes.

In the first quarter 2019, the Company completed a private placement of $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024. Net proceeds from the offering were approximately $75.7 million.

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 March 31, 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 the Company’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 10131163.