On August 8, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported financial results for the second quarter ended June 30, 2019 (Press release, ViewRay, AUG 8, 2019, View Source [SID1234538474]).

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Second Quarter 2019 Summary:

The Company is updating 2019 guidance and now anticipates total revenue in the range of $80 million to $95 million, and total cash usage to be in the range of $80 million to $90 million.
Total revenue was $30.2 million in the quarter, primarily from 5 revenue units, compared to $16.4 million, primarily from 3 revenue units, for the same period last year.
Received 3 new orders in the quarter for MRIdian systems totaling $18.1 million, compared to orders totaling $34.6 million for the same period last year.
Total backlog was $219.3 million as of June 30, 2019, compared to $199.7 million as of June 30, 2018.
Cash and cash equivalents were $122.1 million as of June 30, 2019.
Chief Financial Officer Ajay Bansal will be leaving the company effective September 30, 2019.
"We are disappointed to take down guidance for the year, but we believe it is prudent given the timing of installations around year-end," said Scott Drake, President and CEO. "We remain focused on the long-term opportunity versus short term variability and are confident that we will demonstrate the momentum of our growing pipeline and end-user demand moving forward. Today we are also announcing the departure of our Chief Financial Officer, Ajay Bansal. We thank him for his service over the last three years and wish him well. We are in the midst of a retained search to find his replacement."

Second Quarter 2019 Financial Results:

Total revenue for the three months ended June 30, 2019, was $30.2 million, compared to $16.4 million for the same period last year.

Total cost of revenue was $26.9 million, compared to $16.4 million for the same period last year.

Total gross profit was $3.2 million, compared to $0.1 million for the same period last year.

Total operating expenses were $29.5 million, compared to $18.3 million for the same period last year.

Net loss was $30.8 million, or $0.32 per share, compared to $22.0 million, or $0.30 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $122.1 million at June 30, 2019.

Financial Guidance:

The Company is updating 2019 guidance and now anticipates total revenue in the range of $80 million to $95 million, and total cash usage to be in the range of $80 million to $90 million.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, August 8, 2019 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 1695303. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at www.viewray.com.

After the live webcast, a replay of the webcast will remain available online on the investor relations page of ViewRay’s corporate website, www.viewray.com, for 14 days following the call. In addition, a telephonic replay of the call will be available until August 15, 2019. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 1695303.

On August 8, 2019 Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported financial results for the second quarter ended June 30, 2019 (Press release, ACCELERATED MEDICAL DIAGNOSTICS, AUG 8, 2019, View Source [SID1234538473]).

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"We achieved mixed results in the second quarter, as revenue and placements were both lighter than anticipated due to lower-than-expected capital sales in our EMEA region," commented Lawrence Mehren, President and CEO of Accelerate Diagnostics, Inc. "However, we were encouraged by our commercial progress during the quarter, highlighted by 30% sequential growth in consumable sales and by our signing of the Mayo Clinic as a key reference customer. We expect our increasingly strong customer pipeline to drive higher placements in the second half of the year, particularly in Q4, and are confident that consumable revenues will continue to ramp higher as an ever-increasing number of new customers go clinically live."

Second Quarter 2019 Highlights

Added 55 net new commercially contracted instruments, compared to 29 in the second quarter of 2018.
Net sales of $1.8 million, compared to $1.7 million in the second quarter of 2018. Instrument revenue decreased year-over-year while consumable revenue grew meaningfully over the same time period, reflecting the company’s change to a reagent rental business model starting Q3 of 2018. Consumable revenue grew by over 125% as compared the second quarter of 2018 and by approximately 30% over the prior quarter.
Gross margin was 50% for the quarter, compared to 58% in the second quarter of 2018. This decrease was the result of one-time inventory timing benefits in the prior year which did not repeat in the current year.
Selling, general, and administrative expenses for the quarter were $12.8 million, compared to $15.3 million in the second quarter of 2018. This decrease was driven by lower stock-based compensation expense in the current year.
Research and development (R&D) costs for the quarter were $6.1 million, compared to $6.1 million in the second quarter of 2018. R&D expense were materially unchanged due to a stable product development program.
Net loss was $20.8 million in the second quarter, or $0.38 per share, which included $2.9 million in non-cash stock-based compensation expense.
Net cash used in the quarter was $13.0 million, and the company ended the quarter with total cash, investments, and cash equivalents of $137.8 million.
Year to Date 2019 Highlights

Added 130 net new commercially contracted instruments year to date, compared to 40 for the same period from 2018.
Net sales of $3.6 million year to date, compared to $2.5 million for the same period from 2018. Instrument revenue decreased while consumable revenue grew steadily reflecting the company’s change to a reagent rental business model starting Q3 of 2018. Consumable revenue grew by over 125% year to date compared to the same period in the prior year.
Gross margin was 49% year to date, compared to 51% for the same period from 2018. This decrease was in part due to one-time inventory timing benefits in the prior year that did repeat in the current year. After excluding the impacts of pre-FDA inventory previously written off to R&D, gross margin improved by 300 basis points year to date to due to higher test kit production levels.
Selling, general, and administrative expenses were $25.6 million year to date, compared to $29.7 million for the same period from 2018. This decrease was driven by lower stock-based compensation expense in the current year.
Research and development (R&D) costs were $13.1 million year to date, compared to $12.8 million for the same period from 2018. R&D expense remain unchanged due to a stable product development program.
Net loss was $42.5 million year to date, or $0.78 per share, which included $6.3 million in non-cash stock-based compensation expense.
Net cash used year to date was $28.6 million, and the company ended the quarter with total cash, investments, and cash equivalents of $137.8 million.
Full financial results for the quarter ending June 30, 2019 will be filed on Form 10-Q through the Securities and Exchange Commission’s (SEC) website at View Source

Audio Webcast and Conference Call

The company will host a conference call at 4:30PM ET today to review its second quarter results. To participate in the conference call, dial +1.877.883.0383 and enter the conference ID: 8768870. International participants may dial +1.412.902.6506. Please dial in 10 to 15 minutes prior to the start of the conference call. A replay of the call will be available by telephone at +1.877.344.7529 (U.S.) or +1.412.317.0088 (international) using replay code 10132228 until August 29, 2019.

This conference call will also be webcast and can be accessed from the "Investors" section of the company’s website at axdx.com/investors. A replay of the audio webcast will be available until August 29, 2019.

On August 8, 2019 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the second quarter ended June 30, 2019 (Press release, Marker Therapeutics, AUG 8, 2019, View Source [SID1234538472]).

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"We are encouraged by the data generated to date with our MultiTAA T cell therapies—particularly in pancreatic cancer—a disease that has not seen meaningful improvements in treatment outcomes in more than 40 years," said Peter L. Hoang, President & CEO of Marker Therapeutics. "These data suggest that our therapy—which targets multiple antigens—continues to demonstrate epitope spreading, potentially contributing to the T cells’ ability to expand and produce a lasting anti-tumor effect, with no added toxicities. We will continue to follow these patients and enroll new patients to further evaluate durability."

Continued Mr. Hoang: "Encouraged by results from our investigator-sponsored trials, we are now looking forward to initiating our first Marker-sponsored trial with MultiTAA T cell therapies in patients with post-transplant acute myeloid leukemia, and look forward to continuing our discussions with the FDA regarding our Phase 2 trial."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Encouraging Interim Pancreatic Cancer Data Reported at AACR (Free AACR Whitepaper) Meeting in July
Marker recently reported interim data from an ongoing investigator-sponsored Phase 1/2 clinical trial led by Baylor College of Medicine (BCM), evaluating the Company’s MultiTAA T cell therapy in patients with pancreatic adenocarcinoma. Investigators plan to enroll a total of 45 patients with advanced or borderline resectable pancreatic cancer in the three-arm trial and a total of 19 patients had received infusions of MultiTAA T cell therapy as of July 5, 2019. The results from these patients—which were reviewed in an oral presentation during a plenary session at AACR (Free AACR Whitepaper)’s Cell Therapy meeting in July—suggested that MultiTAA T cell therapy may contribute to more durable responses without added toxicity when used in combination with standard-of-care chemotherapy, or as a second-line therapy for patients who are chemo-refractory. Additionally, in patients with borderline surgically resectable disease—a challenging setting due to the associated dense fibrotic tissue—interim data suggest that MultiTAA T cells are capable of meaningfully infiltrating the tumor. Marker plans to follow these patients and enroll new patients to further evaluate durability.

Marker Preparing for Company-Sponsored Phase 2 Clinical Trial in AML
The multicenter trial will evaluate clinical efficacy of Marker’s MultiTAA T cell therapy in patients with AML in both the adjuvant and active disease setting following an allogeneic hematopoietic stem cell transplant (HSCT). The dose in the Phase 2 trial is expected to be the maximum tolerated dose currently determined in the BCM-sponsored Phase 1 trial. In the adjuvant setting, patients will be randomized to either MultiTAA T cell therapy at approximately 90 days post-transplant or standard-of-care observation, while the active disease patients will receive MultiTAA T cells upon relapse as part of a single-arm group.

T Cell-Based Vaccines

The Company continues to advance its T cell-based vaccine programs in ovarian cancer and triple negative breast cancer.

Phase 2 Ovarian Cancer Clinical Trial Highlights

TPIV200 is being studied as a maintenance therapy for patients in their first remission after surgery and platinum-based chemotherapy.
Trial is fully enrolled, with a total of 120 patients randomized and treated at 17 clinical sites.
Company expects to reach planned interim analysis trigger of 55 patients who have progressed before the end of 2019 and to report results of this interim analysis in the fourth quarter of 2019.
Phase 2 Triple Negative Breast Cancer Trial Highlights

Based on preliminary analysis of 34 patients evaluated to date in the dose-finding, four-arm trial—including low and high-dose TPIV200 with or without cyclophosphamide—31 showed meaningful immune response to the vaccine treatment (subject to final review by independent biostatistical analysis).
Of 80 patients treated at 11 clinical sites, 14 have shown disease progression, as of June 30, 2019, following treatment with TPIV200.
CORPORATE UPDATE

On August 6, Steve Elms was appointed to Marker’s Board of Directors. Mr. Elms currently serves as Managing Partner at Aisling Capital.
SECOND QUARTER 2019 FINANCIAL RESULTS

Net loss for the quarter ended June 30, 2019 was $5.6 million, compared to a net loss of $4.8 million for the quarter ended June 30, 2018.

Research and development expenses were $3.2 million for the quarter ended June 30, 2019, an increase of $1.4 million, compared to $1.8 million for the quarter ended June 30, 2018. The increase was primarily attributable to increases in personnel-related expenses, including stock-based compensation expenses and consulting expenses, relating to the build-up of Marker’s internal infrastructure as the Company advances the clinical development of its MultiTAA T cell product candidates.

General and administrative expenses were $2.7 million for the quarter ended June 30, 2019, a decrease of $0.4 million, compared to $3.1 million for the quarter ended June 30, 2018. The decrease was primarily attributable to $1.2 million of merger-related expenses incurred during the three months ended June 30, 2018, offset by increased expenses relating to $0.3 million of headcount-related expenses, $0.4 million of non-merger-related legal and other professional expenses and $0.1 million of office-related and insurance expenses.

CASH POSITION AND GUIDANCE
At June 30, 2019, Marker had cash and cash equivalents of $53.4 million. The Company believes that its existing cash and cash equivalents will fund the Company’s current operations into late 2020.

On August 8, 2019 Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for the three and six months ended June 30, 2019 and provided a business update (Press release, Eiger Biopharmaceuticals, AUG 8, 2019, View Source [SID1234538471]).

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"Eiger is advancing a late stage pipeline with three breakthrough therapy designations towards key milestones in 2019, including submission of the first ever NDA and MAA for Progeria and Progeroid Laminopathies," said David Cory, Eiger President and Chief Executive Officer. "In addition, enrollment of D-LIVR, the first-ever international Phase 3 study in Hepatitis Delta Virus infection, is ongoing, and we expect FDA registration guidance on our Lambda and Avexitide programs by year end. Eiger is poised for future growth."

Recent Highlights

Peginterferon Lambda (Lambda) in Hepatitis D Virus (HDV)

Positive Phase 2 LIMT (Lambda mono therapy) study results (N=33): 36% durable virologic response at 24 weeks post-treatment reported at The International Liver Congress 2019
Avexitide in Post-Bariatric Hypoglycemia (PBH) Program

Breakthrough Therapy Designation granted by FDA
Corporate Activity

Mark Mannebach, PhD, RPh, appointed as Vice President, Global Regulatory Affairs
Jeysen Yogaratnam, MB.BCh, BAO, MRCSEd, PhD, MBA, appointed as Vice President, Global HDV Clinical Development
Anticipated 2019 Milestones

FDA Guidance for Avexitide in PBH
Phase 2 LIFT (Lambda combination therapy with Lonafarnib and Ritonavir) end-of-treatment study results in HDV at AASLD
End of Phase 2 meeting for Lambda in HDV
NDA and MAA submissions in Progeria and Progeroid Laminopathies in Q4 2019
Phase 3 D-LIVR study in HDV (N=400) enrollment update
Second Quarter 2019 Financial Results

Cash, cash equivalents, and short-term investments as of June 30, 2019 totaled $125.3 million compared to $85.8 million at March 31, 2019, an increase of $39.5 million.

The Company reported net losses of $17.5 million, or $0.75 per share for second quarter 2019, as compared to $9.9 million, or $0.82 per share, for the same period in 2018.

Research and Development expenses were $12.9 million for second quarter 2019, as compared to $6.4 million for the same period in 2018, an increase of $6.5 million. The increase was primarily due to expenditures related to our clinical programs and licenses and other fees.

General and Administrative expenses were $4.2 million for second quarter 2019, as compared to $3.2 million for the same period in 2018, an increase of $1.0 million. The increase was primarily due to additional employee-related costs, including stock-based compensation, and external professional services as Eiger continued to build its infrastructure to support the development and potential commercialization of its clinical programs.

Second quarter 2019 operating expenses include total non-cash expenses of $1.8 million, as compared to $1.4 million for the same period in 2018.

In April 2019, Eiger completed a public offering of 5,175,000 shares of its common stock, including 675,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock, at a price of $11.00 per share. The offering was made under Eiger’s effective shelf registration statement and resulted in net proceeds to the company of approximately $53.2 million, after deducting underwriting discounts and commissions and offering expenses.

As of June 30, 2019, Eiger had 24.4 million of common shares outstanding.

On August 8, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative biotechnology company focused on the discovery, development and commercialization of synthetic DNA technology targeted against cancers and infectious diseases, reported financial results for the second quarter ended June 30, 2019 (Press release, Inovio, AUG 8, 2019, View Source [SID1234538470]). 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/HPV-Related Diseases
Inovio completed enrollment of 198 participants for its primary Phase 3 registration trial (REVEAL 1) of VGX-3100 for the treatment of high-grade cervical dysplasia (cervical HSIL) caused by human papillomavirus (HPV). Inovio is currently enrolling its confirmatory Phase 3 trial (REVEAL 2).

VGX-3100 was granted an Advanced Therapy Medicinal Product Certificate for quality and non-clinical data by the European Medicines Agency (EMA), which confirms that Inovio’s chemistry, manufacturing and controls (CMC) data and nonclinical results available to date overall comply with the scientific and technical standards for evaluating an EU Marketing Authorization.

Inovio and QIAGEN announced a collaboration to co-develop a liquid biopsy-based companion diagnostic to identify patients who could benefit from VGX-3100.

Inovio completed enrollment for its Phase 2 trial of VGX-3100 for the treatment of high-grade vulvar dysplasia (vulvar HSIL) in July. Inovio intends to report interim clinical data from this study, along with interim results from the Phase 2 study for high-grade anal dysplasia (anal HSIL), before the year end.

In July, Inovio executed a strategic refinement to focus on the commercial development of its late-stage HPV assets, which includes VGX-3100, and reallocate capital to develop fast-to-market product candidates, such as INO-3107 (previously called INO-3106) to treat RRP (recurrent respiratory papillomatosis). RRP is a rare, orphan disease caused by HPV 6 and 11 infections, for which clinical benefit was recently demonstrated in a pilot study. Inovio plans to initiate the next clinical trial of INO-3107 within the next 12 months.

Cancer Combination Trials
Inovio received a third Phase 2 milestone payment from AstraZeneca for MEDI0457 in combination with durvalumab for dosing patients in the third HPV-related cancer indication; two previous milestone payments resulted from initiating Phase 2 combination trials targeting head and neck and cervical cancers. AstraZeneca continues to expand and evaluate MEDI0457 in three different Phase 2 trials that target HPV caused cancers. Subsequent to the quarter, AstraZeneca completed planned enrollment of its Phase 2 study in head and neck cancer (ClinicalTrials.gov Identifier: NCT03162224).

Inovio completed enrollment of its Phase 1/2 immuno-oncology trial in 52 patients with newly diagnosed glioblastoma three months ahead of schedule. Interim results evaluating safety, immunological impact, progression-free survival and overall survival from this study are expected by the end of 2019.

As part of the strategic organizational restructuring announcement in July, Inovio discontinued its Phase 1/2 clinical trial of INO-5401 in patients with advanced bladder cancer. The decision to discontinue the trial was made because of the recognition that several new therapeutic alternatives have been approved, or are likely to be approved, for study patients since the trial’s design and inception, and because of the high expense of the trial.

INO-5151, Inovio’s prostate cancer immunotherapy, will be combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration-resistant prostate cancer in a Parker Institute for Cancer Immunotherapy (PICI) sponsored platform study. As part of Inovio’s clinical collaboration agreement with PICI and in collaboration with the Cancer Research Institute, INO-5151 is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design (PORTER Study: ClinicalTrials.gov Identifier: NCT03835533).

DNA-encoded Bi-specific T Cell Engagers (dBTEs)
Preclinical data results for Inovio’s transformative dBTE technology were published in JCI Insight. The current bi-specific T cell engager product has only a few hours of half-life and requires several weeks of continuous intravenous infusion. Inovio developed a novel dBTE targeting the HER2 molecule which was tested successfully in therapeutic models for the treatment of ovarian and breast cancers. A single injection of the HER2 dBTE candidate produced bi-specific antibodies that lasted for several weeks and effectively killed HER2-expressing tumor cells resulting in a near-complete tumor clearance. Inovio plans to rapidly advance its dBTE technology.

Infectious Diseases
Inovio dosed its first patients in its Phase 1 clinical study evaluating safety, tolerability and immune responses to INO-4500 in patients with Lassa fever. INO-4500 is the world’s first Lassa fever virus vaccine candidate. The INO-4500 program is fully funded through a global partnership with the Coalition for Epidemic Preparedness Innovations (CEPI).

In July, positive clinical trial results from the world’s first clinical testing of a vaccine against the Middle East Respiratory Syndrome Coronavirus (MERS) were published in The Lancet Infectious Diseases. Inovio’s MERS DNA vaccine INO-4700 was well-tolerated and 94% of patients demonstrated overall high levels of antibody responses, while 88% of study participants demonstrated broad-based T cell responses. A Phase 2 field trial is being planned in the Middle East through the partnership with CEPI.

Cash Position
As of June 30, 2019, cash and cash equivalents and short-term investments were $106.0 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.

Dr. J. Joseph Kim, Inovio’s President & CEO said, "Inovio is well-positioned to advance its later-stage HPV programs while devoting more resources to develop fast-to-market product candidates. Through its recent strategic organizational restructuring the company has sharpened its focus to create a more efficient organization with greater financial flexibility and a longer runway. We continue to make excellent progress on expanding our treatment capabilities within the areas of HPV related diseases and we’re excited that before year-end we plan to have interim data from our Phase 2 studies involving VGX-3100 targeting vulvar HSIL and anal HSIL, and plan to initiate the next clinical trial of INO-3107 targeting RRP within 12 months."

Second Quarter 2019 Financial Results

Total revenue was $136,000 for the three months ended June 30, 2019, compared to $24.4 million for the same period in 2018. Total operating expenses were $28.3 million for the three months ended June 30, 2019, compared to $29.7 million for the same period in 2018.

Inovio’s net loss for the quarter ended June 30, 2019 was $29.4 million, or $0.30 per basic and diluted share, compared to $6.6 million, or $0.07 per basic and $0.08 per diluted share, for the quarter ended June 30, 2018.

Revenue

The year over year decrease in revenue under collaborative research and development arrangements was primarily due to the recognition of the gross up-front payment from ApolloBio of $23.0 million during the second quarter of 2018 (approximately $19.4 million was received after payment of required taxes).

Operating Expenses

Research and development (R&D) expenses were $22.5 million for the three months ended June 30, 2019 and June 30, 2018.

Contributions received from current grant agreements and recorded as contra-research and development expense were $2.6 million for the three months ended June 30, 2019 compared to $1.9 million for the same period in 2018.

General and administrative (G&A) expenses were $5.9 million for the three months ended June 30, 2019 versus $7.2 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 June 30, 2019, cash and cash equivalents and short-term investments were $106.0 million compared to $81.2 million as of December 31, 2018. As of June 30, 2019, Inovio had 98.6 million common shares outstanding and 125.5 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 notes.

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 June 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 10133668.