1stOncology™: Cancer Intelligence Service – Page 8674 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Omeros Corporation Reports Second Quarter 2021 Financial Results

On August 9, 2021 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, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, reported recent highlights and developments as well as financial results for the second quarter ended June 30, 2021, which include (Press release, Omeros, AUG 9, 2021, View Source [SID1234586114]):

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!

OMIDRIA revenues for the second quarter of 2021 were $28.8 million compared to $21.1 million in the first quarter. The 37 percent increase over the prior quarter primarily reflects growth in sales of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% in ambulatory surgery centers (ASCs).
Net loss in the second quarter of 2021 was $28.6 million, or $0.46 per share, including non-cash expenses of $3.9 million, or $0.06 per share. This compares to a net loss of $35.1 million, or $0.57 per share, which included non-cash expenses of $4.1 million, or $0.07 per share, for the previous quarter.
At June 30, 2021, Omeros had cash, cash equivalents and short-term investments available for operations of $73.7 million.
Omeros’ Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangipathy (HSCT-TMA or TA-TMA) is under priority review by the U.S. FDA with an action date of October 17, 2021 under the Prescription Drug User Fee Act (PDUFA).
Omeros announced preliminary results from the Phase 1 clinical trial of OMS906, the company’s MASP-3 inhibitor, which showed that (i) OMS906 was well tolerated at all doses tested and (ii) human pharmacokinetic and pharmacodynamic data are consistent with once-monthly or less frequent subcutaneous dosing.
"In the second quarter of 2021, Omeros achieved a number of important milestones," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "As OMIDRIA sales continue to grow, CMS in its recent OPPS Proposed Rule reaffirmed its determination that OMIDRIA receive separate payment when used in ASCs, and our MASP-3 inhibitor OMS906 is successfully advancing through its Phase 1 clinical trial. Several other important milestones should reach resolution in the near term – FDA’s decision on our pending BLA for narsoplimab in the treatment of patients with TA-TMA, results from narsoplimab in the COVID-19 I-SPY platform clinical trial, and the outcome of the NOPAIN Act, which, if enacted by Congress, would mandate Medicare separate payment for non-opioid surgical pain management drugs like OMDRIA not only in ASCs but also in hospital outpatient departments. The remainder of our pipeline also pressed ahead, including the GPR174 program, the core of our immuno-oncology platform – a platform that has expanded beyond GPR174 with new CAR-T and adoptive cellular therapy programs. Omeros’ momentum is building, and we look forward to seeing what the rest of the year brings."

Second Quarter and Recent Developments

Recent developments regarding OMIDRIA include the following:
In July 2021, the Centers for Medicare and Medicaid Services (CMS) released its Outpatient Prospective Payment System (OPPS) and ASC Payment System proposed rule for calendar year 2022, which reaffirmed its earlier decision that OMIDRIA, when used in the ASC setting, qualifies for separate payment under CMS’ policy regarding non-opioid pain management surgical drugs. This policy has been in effect since 2019.
Recent developments regarding narsoplimab, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in advanced clinical programs for the treatment of TA-TMA, immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and severely ill COVID-19 patients, include the following:
Omeros announced data from the second cohort of 10 critically ill COVID-19 patients treated with narsoplimab under compassionate use in Bergamo, Italy.
All of the patients had comorbidities and/or risk factors for poor outcomes, were mechanically ventilated, and had failed other therapies, including steroids.
90 percent of the patients were intubated prior to initiation of narsoplimab treatment.
80 percent of the patients recovered, survived and were discharged. The two deaths involved a 76-year-old who died of complications related to his pre-existing cardiomyopathy and a 68-year-old who began narsoplimab treatment after 13 days of intubation.
A manuscript from the Omeros-Cambridge Center for Complement and Inflammation Research (OC3IR) on the inhibition of the lectin pathway and MASP-2 as a potential treatment for severe COVID-19 was published in the peer-reviewed journal Frontiers in Immunology.
An abstract on the pharmacokinetic and pharmacodynamic modeling of lectin pathway inhibition by narsoplimab was accepted for presentation at the 16th International Symposium on IgA nephropathy.
Updates regarding Omeros’ other development programs and platforms include the following:
Omeros announced preliminary results from the Phase 1 clinical trial evaluating the pharmacokinetics/pharmacodynamics (PK/PD) and safety of OMS906 in healthy subjects. OMS906 inhibits MASP-3, the key activator of the alternative pathway of complement. MASP-3 is responsible for the conversion of pro-factor D to mature factor D. Data from the first five cohorts of the trial’s single-ascending dose stage show that (i) OMS906 was well tolerated at all doses tested (up to 5 mg/kg) and (ii) a single 3 mg/kg intravenous dose of OMS906 and a single dose of the lowest subcutaneous concentration tested each suppressed mature complement factor D below minimum detectable levels. The human PK/PD data were consistent with once-monthly or less frequent subcutaneous dosing. Following completion of the single- and multiple-ascending dose stages of the Phase 1 trial, Omeros plans to initiate a Phase 2 clinical trial.
A paper detailing the mechanism of action of PDE7 inhibition in nicotine addiction was published in the peer-reviewed Journal of Neuroscience and was selected for inclusion in the journal’s Featured Research page. Omeros has completed a successful Phase 1 trial with the lead compound in its PDE7 inhibitor program.
Financial Results

For the second quarter of 2021, OMIDRIA revenues were $28.8 million compared to $21.1 million for the first quarter.

Total costs and expenses for the second quarter of 2021 were $52.8 million compared to $51.7 million for the first quarter. The increase was primarily due to increased selling, general and administrative expenses in preparation for the anticipated U.S. launch of narsoplimab and additional employee-related costs. Research and development costs decreased quarter over quarter due to the timing of narsoplimab manufacturing-related costs, which are expensed rather than included as inventory until the initial marketing approval for narsoplimab is certain.

For the three months ended June 30, 2021, Omeros reported a net loss of $28.6 million, or $0.46 per share, which included non-cash expenses of $3.9 million, or $0.06 per share. This compares to a net loss in the previous quarter of $35.1 million, or $0.57 per share, which included non-cash expenses of $4.1 million, or $0.07 per share.

As of June 30, 2021, the company had $73.7 million of cash, cash equivalents and short-term investments. The company also has a line of credit, which permits borrowing up to the lesser of $50.0 million and 85 percent of eligible accounts receivable less certain reserves. Omeros also has an "at the market" program in place that allows the company to sell, from time to time, up to $150.0 million of its common stock.

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 4195376. 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 4195376.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at View Source

QIAGEN and OncXerna Therapeutics Sign Licensing and Master Companion Diagnostic Agreements

On August 9, 2021 QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) and OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna’s product candidate, Navicixizumab, and a non-exclusive license to the Xerna TME panel (Press release, OncXerna Therapeutics, AUG 9, 2021, View Source [SID1234586113]).

QIAGEN and OncXerna have agreed to collaborate to advance the Xerna TME panel towards IVD (in-vitro diagnostic) regulatory approval as a NGS companion diagnostic for Navicixizumab, which is being developed by OncXerna as a treatment for patients with ovarian cancer. The diagnostic will be used to determine if patients with ovarian cancer whose dominant tumor biology is driven by angiogenesis are more likely to benefit from treatment with navicixizumab.

The Xerna TME panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the dominant biology of their cancer so that patients can be matched with therapies that directly address these biologies. Pursuant to the non-exclusive license, which is for research use only ("RUO") and clinical development programs, OncXerna has granted QIAGEN the rights to integrate the Xerna TME panel into their NGS workflow solutions, which broadens QIAGEN’s NGS CDx custom panel development capabilities.

"We are very pleased to complete these agreements with QIAGEN, which we see as providing important external validation for the Xerna TME panel and our broader RNA-based biomarker platform," stated Dr. Laura Benjamin, OncXerna Founder and CEO. "As an NGS industry-leader in precision medicine diagnostics with impressive global development, manufacturing and commercial capabilities, we believe QIAGEN is uniquely positioned to help advance the Xerna TME panel towards regulatory approval as an NGS companion diagnostic and, if approved, drive the panel’s adoption. Moreover, integration of the Xerna TME Panel into their workflow solutions could enable QIAGEN to provide a new RNA-based offering to strengthen their overall immune oncology solutions for biopharma customers."

"We believe that the Xerna TME panel that we can now offer our customers will further enhance our strong portfolio in companion diagnostics. Through this agreement, we aim to foster additional NGS-based collaborations with pharmaceutical companies for the development of drug treatments for immune oncology and promote early clinical adoption of precision medicine diagnostics such as our therascreen portfolio and the Xerna TME panel." said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. "We are also thrilled to have the master CDx agreement in place and look forward to working with OncXerna to develop an NGS companion diagnostic for Navicixizumab based on our extensive track record with the development of companion diagnostics for a variety of cancers."

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. QIAGEN has ten PCR based companion diagnostic indications that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients.

About OncXerna Therapeutics, its Xerna RNA-based Biomarker Platform, and Xerna TME Panel

OncXerna is a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates. OncXerna is working to expand next-generation precision medicine to a larger group of cancer patients by leveraging the company’s Xerna platform to prospectively identify patients based on the dominant biology of their cancer. OncXerna’s approach pairs those patients with OncXerna’s clinical-stage therapeutic candidates and known mechanism of action that directly address these biologies, with the goal to substantially improve patient outcomes. The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME), and has been developed as a clinical assay. The Xerna TME Panel is an investigational assay that has not been approved, and has not been demonstrated to be safe or effective for any use.

About Navicixizumab

Navicixizumab is an anti-DLL4/VEGF bispecific antibody product candidate that demonstrated antitumor activity in patients who were previously treated with Avastin (bevacizumab) in a Phase 1b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal, or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with Avastin. Navicixizumab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

INOVIO Reports Second Quarter 2021 Financial Results

On August 9, 2021 INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, teported financial results for the quarter ended June 30, 2021 (Press release, Inovio, AUG 9, 2021, View Source [SID1234586112]). 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. The business update includes INOVIO’s COVID-19 vaccine development efforts that address both current and future variants of concern ("VOC"), accompanied with recent developments associated with INOVIO’s various therapeutic programs relating to its DNA medicines platform. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "With COVID-19 rates surging again globally and an increasing number of breakthrough infections, INOVIO recognizes the need for additional safe and effective first-line vaccines, particularly those which could offer potential boosting capabilities, to combat the spread of the virus and emerging variants, including the rapidly spreading delta variant. INO-4800’s ability to generate CD8 T cells are important to mitigating against variants of concern, including the delta variant. Findings from a study using clinical samples showed that INO-4800 maintained a robust T cell level against the delta variant when compared to T-cell responses from the original wildtype strain. These findings further complement our previously published Phase 1 and 2 trial data for INO-4800. As a reminder, the key advantages of INOVIO’s DNA medicines platform include the ability to generate a balanced immune response that includes engagement of both T cells and B cells, coupled with a favorable transport, thermostability, and tolerability profile. These advantages continue to be integral to our ongoing discussions with countries expected to participate in the global INNOVATE Phase 3 trial for INO-4800, some of which are also considering INO-4800 for both clinical trials and the eventual emergency use authorization (EUA)."

Dr. Kim continued, "In parallel with our global INNOVATE Phase 3 trial, we continue to prepare INOVIO’s next-generation, pan-COVID vaccine candidate, INO-4802, in a Phase 1/2 trial entitled IMPACT (INOVIO INO-4802 Multi-variant Pan-COVID-19 Vaccine Trial), where the goal is to induce cross-reactive immune responses against current and emerging viral variants as either a first-line vaccine, or as a boost."

INOVIO Key Updates & Second Quarter 2021 Highlights

Key Updates

INOVIO expanded its partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine") to jointly conduct the global Phase 3 segment of the ongoing Phase 2/3 trial called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) in multiple countries.

Subsequent to the quarter end, INOVIO and Advaccine received regulatory allowance to conduct two clinical trials in China investigating heterologous boosting with INO-4800 through partner and trial-sponsor Advaccine, together with Sinovac Biotechnology ("Sinovac"). The studies will evaluate the safety and efficacy of heterologous prime-boost sequential immunizations using INO-4800 and CoronaVac, an inactivated virus COVID-19 vaccine developed by Sinovac and validated by the World Health Organization (WHO) for emergency use.

INO-4800 vaccination maintained a similar level of T cell responses against the delta variant when compared to the T cell responses to the original wildtype strain and showed a similar level of reduced neutralizing antibody activity against the delta variant by the mRNA vaccines. These findings build on previously published results showing that INO-4800 provided broad, cross-reactive immune responses in humans against alpha, beta and gamma VOC.

INOVIO published pre-clinical data as a pre-print for INO-4802 demonstrating cross-reactive immune responses against current and emerging viral variants that shows the potential INOVIO’s next-generation, pan-COVID-19 vaccine candidate, as either a first-line vaccine or potentially as a booster for individuals previously immunized with various wildtype-matched vaccines. INO-4802 induced potent neutralizing antibodies, T cell responses, and protection in a pre-clinical model against the original wildtype strain as well as against the alpha, beta, gamma and, in subsequent research, the delta variant.

Subsequent to the quarter end, INOVIO dosed the first subject in its Phase 2 clinical trial for INO-4700, its DNA vaccine candidate for Middle East Respiratory Syndrome ("MERS"), a disease in the coronavirus family for which there are no approved vaccines. The study, which is sponsored by INOVIO and funded by the Coalition for Epidemic Preparedness Innovations ("CEPI"), is evaluating the safety, tolerability and immunogenicity of INO-4700 in approximately 500 healthy adult volunteers in Jordan and Lebanon.

In 2Q 2021, the University of Pennsylvania enrolled its first patient in a Phase 1b investigator-sponsored trial of INOVIO’s DNA vaccine candidate INO-5401 alone or INO-5401 in combination with INO-9012 delivered with INOVIO’s CELLECTRA smart device, in adult cancer and non-cancer patients with BRCA1 or BRCA2 mutations.

INOVIO Second Quarter 2021 Program Updates

DNA Vaccine Candidates

INO-4800: INNOVATE Phase 3 Trial

INOVIO expanded its partnership with Advaccine to jointly conduct a global Phase 3 trial for INO-4800. Under the terms of the collaboration, INOVIO and Advaccine intend to share equally, subject to specified limitations and conditions, the total cost of the planned global Phase 3 trial, which is estimated to be approximately $100 million. This is an extension of an existing relationship between the two companies, including an exclusive agreement announced in January 2021 under which Advaccine has the exclusive rights to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of mainland China, Hong Kong, Macao and Taiwan. Under the expanded partnership, Advaccine obtained rights to additional Asian countries outside of Greater China. The companies intend to evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization in healthy men and non-pregnant women 18 years and older across several countries, with a focus on Latin America, Asia and Africa. The 2.0 mg dose was selected from the Phase 2 segment, where INO-4800 was shown to be generally well-tolerated and immunogenic across all adult age groups. In particular, the geometric mean fold rise of binding and neutralizing antibody levels was statistically significant and greater in the 2.0 mg dose group versus the 1.0 mg dose group. Notably, the T cell immune responses measured by the ELISpot assay were also higher in the 2.0 mg dose group as compared to the 1.0 mg dose group. The primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 cases, and INOVIO anticipates the first regulatory approval next month.

During the second quarter of 2021, INOVIO released as a pre-print results from a study using clinical samples showing that INO-4800 provided broad cross-reactive immune responses in humans against VOC. The study showed the T cell responses induced by INO-4800 vaccination were fully maintained against the alpha, beta, and gamma variants when compared to the T cell responses to the original wildtype strain. Despite recent reports showing a reduction in neutralizing activity against the gamma variant by the mRNA or viral vector vaccines, INO-4800 generated robust neutralizing antibodies at levels against the gamma variant that were comparable to those observed against the wildtype strain. Taken together with the data showing the maintenance of T cell activity, the results reported in this study provide a comprehensive overview of cross-reactive cellular and humoral immune responses against SARS-CoV-2 variants for INO-4800 vaccinated individuals, showing the potential of INO-4800 to combat emerging as well as future variants of concern. The study, entitled, "INO-4800 DNA Vaccine Induces T Cell Activity and Neutralizing Antibodies Against Global SARS-CoV-2 Variants," is available via pre-print in bioRxiv.

Subsequent to this published work, INO-4800 vaccination was also found to maintain a similar level of T cell responses against the delta variant when compared to the T cell responses to the original wildtype strain, while it showed a similar level of reduced neutralizing antibody activity against the delta variant by the mRNA vaccines.

INOVIO continues to evaluate and assess the impact the new circulating strains of SARS-CoV-2 have on the immune profile elicited by INO-4800, as well as assessing boosting capabilities of INO-4800.

INO-4800: Heterologous Prime-Boost Trials

This morning, INOVIO announced the regulatory allowance in China to conduct two clinical trials investigating heterologous boosting with INO-4800 through its partner and trial-sponsor Advaccine, together with Sinovac. The trials will evaluate the safety and efficacy of heterologous prime-boost sequential immunizations using INO-4800 and CoronaVac, an inactivated virus COVID-19 vaccine developed by Sinovac and validated by the WHO for emergency use. China’s Center for Drug Evaluation of the National Medical Products Administration has allowed two Advaccine-sponsored open-label, positive-control trials to evaluate the safety, tolerability and immunogenicity of mixed boosted regimens. Both studies, which will be conducted in China, are anticipated to begin this fall and will involve healthy adult subjects 18 years of age or older.

INOVIO, Advaccine, and Sinovac have completed cross prime-boost pre-clinical animal tests using INO-4800 and CoronaVac, demonstrating that the prime-boost strategy can stimulate high-level of antigen specific binding antibodies, neutralizing antibodies by both live-virus neutralization assay and hACE2 receptor blocking assay, and antigen-specific T cell immune response.

IMPACT (INOVIO INO-4802 Multi-variant Pan-COVID-19 Vaccine Trial):

In parallel with INO-4800, INOVIO is also developing a second generation, pan-COVID vaccine candidate, INO-4802, which is designed to protect against current and future VOC. INO-4802 could potentially offer boosting capabilities in addition to an initial vaccination regimen with INO-4800 and/or other first-generation vaccines, including both adenovirus and mRNA-based platforms.

In 2Q and then updated subsequent to the quarter, INOVIO released a manuscript as a preprint in bioRxiv entitled, "Design and Immunogenicity of a Pan-SARS-CoV-2 Synthetic DNA Vaccine," which demonstrated cross-reactive immune responses against current and emerging viral variants using INOVIO’s next-generation pan-COVID-19 vaccine candidate, INO-4802, as either a first-line vaccine, or potentially as a booster for individuals previously immunized with various wildtype-matched vaccines. Specifically, INO-4802 generated potent neutralizing antibodies, T cell responses, and protection in a preclinical model against the original wildtype strain as well as against the alpha, beta, gamma and delta variants.

Infectious Diseases: Middle East Respiratory Syndrome ("MERS") and Lassa Fever

INOVIO dosed the first subject in its Phase 2 clinical trial for INO-4700, its DNA vaccine candidate for MERS. MERS, which currently has no approved vaccine, is a coronavirus that is about 100 times deadlier than COVID-19 and fatal to approximately 34% of those infected.

The Phase 2 trial is being conducted at sites in Jordan and Lebanon, where MERS cases have been reported. The randomized, double-blinded, placebo-controlled, multi-center trial, which is sponsored by INOVIO and funded by CEPI, evaluates the safety, tolerability and immunogenicity of INO-4700 administered using INOVIO’s CELLECTRA smart device in approximately 500 healthy adult volunteers.

INOVIO’s pursuit of a MERS vaccine is funded by a previously announced $56 million grant from CEPI, under which INOVIO will develop vaccine candidates through Phase 2 against MERS and Lassa fever. INOVIO and CEPI plan to pursue a stockpile of MERS vaccines available for emergency use as soon as possible following Phase 2 testing.

Subsequent to the quarter end, CEPI announced in July 2021 that it is providing $10.3 million in funding to partners in Benin, Guinea, Liberia, and Sierra Leone to participate in the epidemiological research program entitled Enable, which will enroll up to 23,000 participants, including in Nigeria, which began collecting participant data in December 2020. The Enablestudy aims to better understand the rate, location, and spread of Lassa virus across the region. CEPI has supported the development of six Lassa vaccine candidates, including INOVIO’s INO-4500. INO-4500 is the first Lassa vaccine candidate to enter Phase 1 trial in the U.S., and in the first quarter INOVIO dosed the first subject in a Phase 1b clinical trial for INO-4500 in Africa. It remains INOVIO’s and CEPI’s goal to making INO-4500 available for possible emergency use as a stockpile product after successful completion of the Phase 2 trial.

HPV-related Diseases

VGX-3100: Cervical, Vulvar, and Anal HSIL

REVEAL 1 / REVEAL 2 (Cervical HSIL)

INOVIO continues to follow subjects in REVEAL 1 (Randomized Evaluation of VGX-3100 and Electroporation for the treatment of Cervical HSIL), a Phase 3 pivotal trial evaluating VGX-3100 for the treatment of cervical high-grade squamous intraepithelial lesions caused by HPV-16 and/or HPV-18, for safety and durability of response for 18 months following the last administration. INOVIO expects to present its findings at a scientific meeting later this year and anticipates full subject-level unblinding for REVEAL 1 in the second half of 2021, which is expected to facilitate better analysis of individual, patient-level data.

Additionally, INOVIO is continuing its partnership with QIAGEN to co-develop an in-vitro diagnostic based on RNA sequencing technology to guide clinical decision-making for the use of VGX-3100 in cervical HSIL. INOVIO expects to report QIAGEN’s findings later this year.

REVEAL 2 continues to enroll across 48 sites globally, with projected total enrollment of approximately 198 adult women with histologically confirmed cervical HSIL. Participants will be evaluated for evidence of cervical HSIL on histology as well as evidence of HPV-16 and/or HPV-18 in cervical samples by type-specific HPV testing at the Week 36 visit accompanied with a one-month safety follow-up.

Immuno-oncology

INO-5401

Glioblastoma Multiforme

INOVIO, along with Regeneron, continues to evaluate its findings from the Phase 1/2 novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo (cemiplimab) – which is being jointly developed by Regeneron and Sanofi – for the treatment of newly diagnosed Glioblastoma Multiforme ("GBM"). The companies anticipate sharing two-year (24 months) overall survival data, including correlative immunology and tissue data, at an oncology conference in the fourth quarter of 2021.

Breast Cancer

Separately, the University of Pennsylvania enrolled its first patient in a Phase 1b investigator-sponsored study of INO-5401 alone or INO-5401 in combination with INO-9012 delivered with INOVIO’s CELLECTRA smart device in adult cancer and non-cancer patients with BRCA1 or BRCA2 mutations. This study, which is being conducted at the University of Pennsylvania, will enroll approximately 44 subjects and will test INO-5401, which contains genes that are active in human cancers (hTERT, PSMA, and WT1) and are believed to be good targets for the immune system for both individuals with cancer or at increased risk of getting cancer. ClinicalTrials.gov identifier: NCT04367675

Manufacturing

Update on Global Manufacturing Consortium

Thermo Fisher, a member of INOVIO’s global manufacturing consortium, announced in July that it opened a new cGMP plasmid DNA manufacturing facility in Carlsbad, California with INOVIO as its first client. The new facility enables Thermo Fisher and its partners to meet anticipated demand for plasmid DNA and other nucleic-acid based therapies.

Second Quarter 2021 Financial Results

Total revenue was $273,000 for the three months ended June 30, 2021, compared to $267,000 for the same period in 2020. Total operating expenses were $83.5 million compared to $33.4 million for the same period in 2020.

INOVIO’s net loss for the three months ended June 30, 2021 was $82.1 million, or $0.39 per basic and diluted share, compared to net loss of $128.7 million, or $0.83 per basic and diluted share, for the three months ended June 30, 2020.

Operating Expenses

Research and development ("R&D") expenses for the three months ended June 30, 2021, were $70.8 million compared to $22.4 million for the same period in 2020. The increase in R&D expenses was primarily attributable to manufacturing scale-up activities for INO-4800. These INO-4800 activities included the acquisition and installation of manufacturing equipment, drug manufacturing, outside services and clinical study expenses. Other increases included engineering services and expensed equipment related to our CELLECTRA 3PSP device array automation project, employee and contractor compensation and drug manufacturing expenses related to our RRP trial. These increases were offset by an increase in contra-research and development expense recorded from grant agreements of $8.1 million, among other variances.

General and administrative ("G&A") expenses were $12.7 million for the three months ended June 30, 2021, compared to $11.1 million for the same period in 2020. The increase in G&A expenses was primarily related to an increase in employee compensation, including non-cash stock-based compensation, partially offset by lower expenses for work performed related to corporate marketing and communications, among other variances.

Capital Resources

As of June 30, 2021, cash and cash equivalents and short-term investments were $443.7 million compared to $411.6 million as of December 31, 2020. As of June 30, 2021, INOVIO had 210.1 million common shares outstanding and 226.7 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 balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the three months ended June 30, 2021, 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

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with COVID-19 and MERS. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, which is designed to overcome a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device is designed to ensure that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response. INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

With more than 3,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

Ziopharm Oncology Provides Second Quarter 2021 Corporate Updates

On August 9, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP),reported that corporate updates for the second quarter of 2021, ended June 30, 2021 (Press release, Ziopharm, AUG 9, 2021, View Source [SID1234586111]). The Company will host a conference call and webcast today at 4:30 pm EDT.

"Since our last update, the Company has made tremendous progress across multiple fronts," said Heidi Hagen, Interim Chief Executive Officer. "The Company has built significant positive momentum in our TCR-T Library clinical trial enabling activities and in our efforts to strengthen the balance sheet. This quarterly update reflects the Company doing exactly what we said we would do earlier in the year and this is very exciting to see. The appointment of a permanent CEO is also something we look forward to in the very near future. The strong science underlying our work continues to provide us with confidence as we move forward. On behalf of the Board and management team, I want to thank all our dedicated researchers, scientists, partners, and the entire organization for their commitment to our mission."

Significant Progress in Company’s TCR-T Library Clinical Program

Since the last quarterly update, the Company achieved several key milestones in its TCR-T Program. Importantly, the Company remains on track to begin dosing patients in its Phase I/II TCR-T Library trial during the second half of 2021, and now anticipates dosing the first patient during the fourth quarter of this year. The trial initially targets six individual solid tumor indications: cholangiocarcinoma, pancreatic cancer, ovarian cancer, endometrial cancer, colorectal cancer, and lung cancer, which were selected due to the frequency of KRAS and / or TP53 mutations. The Company intends on expanding into additional indications in the future.

The clinical trial will open for enrollment upon establishing clinical manufacturing readiness. During 2020, the Company successfully transferred the manufacturing process for its TCR-T cell products to KBI Biopharma, a previously undisclosed contract manufacturing organization with cGMP cell therapy manufacturing facilities in The Woodlands, TX. TCR-T batch data generated at both KBI and the Company’s own laboratory were the basis of the Chemistry, Manufacturing and Controls portion of the Investigational New Drug Application (IND) filed earlier this year. KBI is now working to complete the process qualification and aseptic process validation to facilitate clinical manufacturing.

Additionally, the Company has been implementing a strategy to build in-house cGMP clinical production capabilities at the Company’s facility in Houston, TX. This is being done to provide greater flexibility and control of this important aspect of clinical development and the Company is moving forward rapidly to establish these manufacturing capabilities. The commissioning of the Company’s clinical production unit (CPU), as well as aseptic process validation, were completed this past quarter, which are meaningful steps in establishing the CPU’s capabilities. The team is completing process qualification, which will support the opening of the facility to manufacture TCR-T cells for the clinical trial. The ability to use both its in-house facility and KBI’s facility for manufacturing will provide the Company a strong degree of risk mitigation and greater capacity as the Company scales up clinical trial activities.

The Company continues to qualify TCRs in its Library and plans to amend the IND during the second half of 2021 to include these additional TCRs. The Company expects that the supplemental TCRs will expand the potential utility, applicable patient population, and addressable commercial market for the Library, and may include additional KRAS and / or TP53 mutations or other genetic hotspots associated with solid tumors such as EGFR.

During the second quarter, the Company presented a poster at the annual American Association of Cancer Research (AACR) (Free AACR Whitepaper) meeting, entitled "Hotspot mutations in KRAS targeted by TCR-T cells genetically modified with the Sleeping Beauty transposon/transposase system". The poster highlighted preclinical work regarding the Company’s TCR-T program and demonstrated that multiple TCRs with unique specificities targeting recurrent p53 and KRAS substitutions in frequent HLA haplotypes could be stably expressed using Sleeping Beauty transposition to re-direct peripheral blood T-cells towards tumor cells. The Company plans on providing additional preclinical data further demonstrating the strong science behind the program later this year at a scientific conference.

"Our TCR-T program continues to build momentum scientifically and clinically, and we remain poised to begin dosing during the fourth quarter of this year. We have begun pre-screening patients and based on initial data from investigators, we are very optimistic that we will consistently find mutation / HLA combinations within the targeted patient populations that match TCRs in our Library," said Raffaele Baffa, MD, Ph.D., Chief Medical Officer. "I thank the team for their tremendous efforts as they work to ensure success."

Closing of Venture Debt Financing with Silicon Valley Bank

The Company reported that it has closed a venture debt facility with Silicon Valley Bank in the aggregate amount of $50 million. The Company will draw down an initial $25 million tranche from this facility immediately. A second $25 million tranche is available contingent on the achievement of certain clinical milestones and other conditions.

The initial $25 million tranche extends the Company’s cash runway into the fourth quarter of 2022, well beyond the time required to generate and assess the initial clinical data from the Company’s Phase I/II TCR-T Library trial.

Holger Weis, member of the Board of Directors and Chair of the Audit Committee, commented, "We have developed a very strong relationship with Silicon Valley Bank and are happy to have its partnership and support on this funding. This debt vehicle will be used in a prudent and judicious manner and extends the Company’s cash runway significantly. This is a clear demonstration that the Company is being guided by strong consideration of shareholder impact and a desire to support expanding shareholder value through our capital strategy and tactics."

Update on Phase I CD19 RPM CAR-T Trial Being Conducted by Eden BioCell in Taiwan

As previously disclosed, in March 2021, Eden BioCell, the Company’s Joint Venture in Taiwan with TriArm Therapeutics, began treating patients in a clinical trial with the Company’s investigational CD19 RPM CAR-T cell therapy, under the Phase I IND cleared by the Taiwan Food and Drug Administration in December 2020. The Company today provided an update on this program.

Two patients have been treated in the trial. The lead investigator at National Taiwan University in Taipei has reported no serious adverse safety events in either of these patients. Laboratory results continue to support, as previously published, that non-viral Sleeping Beauty gene transfer is effective in genetically modifying autologous T-cells. Patients were infused two days after gene transfer, thus shortening the turnaround time and providing a clear advantage over viral methods.

However, based on laboratory data generated from the first two patients between March and May 2021, the TriArm/Eden BioCell team concluded, in concert with the lead investigator and with the support from the team at Ziopharm, that further process development work is required. This additional work is intended to optimize and refine the manufacturing process in order to manufacture cells more consistently in the desired clinical dose range seeking to be studied.

Per the terms of the Joint Venture agreement, the TriArm/Eden BioCell team will work towards the necessary process development improvements before infusing additional patients. The length of time to do so is unknown and maybe require up to 12 months. The ongoing COVID-19 outbreak in Taiwan presents added uncertainty, as the operational activities in the manufacturing facility are currently limited due to employee restrictions related to the pandemic. These restrictions are impacting clinical trials broadly in Taiwan.

Additionally, consistent with its strategic focus on TCR, the Company is seeking and considering broader partnerships to enable further development of the investigational CD19 RPM CAR-T cell therapy. Several parties have expressed interest in such a partnership, including TriArm Therapeutics. The Company will carefully consider all options regarding the future of the Joint Venture, the technology, and the global development pathway, in order to maximize shareholder value.

The Company noted the distinctions between the CAR-T program and the TCR-T program. "As we have previously described, the TCR and CAR-T processes are intrinsically different and follow very separate process development pathways," commented Dr. Baffa. "While both involve Sleeping Beauty gene transfer, the constructs, and manufacturing processes are very distinct. The unique clinical presentations and challenges associated with the treatment of blood cancers and solid tumors also reflect differences and we believe the recent findings from CAR-T do not read through to the TCR-T program."

Update on Search for Permanent Chief Executive Officer

The Company expects to make an announcement regarding its permanent CEO position in the near future.

Robert Postma, member of the Board of Directors, said, "We have seen and considered a number of very strong and qualified candidates during the search, and the Board is in the final stages of selecting our new CEO."

Cash Position

As of June 30, 2021, the Company had approximately $76.7 million of cash and cash equivalents. This amount is unaudited and preliminary, and does not present all information necessary for an understanding of our financial condition as of June 30, 2021, which will be presented in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.

Additionally, a prepayment of approximately $1.8 million remains for work to be conducted by the Company at MD Anderson under the Company’s research and development agreements.

The $25 million drawdown of the Silicon Valley Bank debt facility is not included in the above figure as it was closed subsequent to June 30, 2021.
Conference Call and Webcast

Ziopharm will host a conference call and webcast for the investment community today, August 9, 2021, at 4:30 p.m. EDT. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or 201-389-0879 (International). The passcode for the conference call is 13721210. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. The call will be recorded and available for replay on the Company’s website for approximately 90 days after the call.

Precigen Reports Second Quarter and First Half 2021 Financial Results

On August 9, 2021 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported second quarter and first half 2021 financial results (Press release, Precigen, AUG 9, 2021, View Source [SID1234586110]).

"We have made significant progress in the first half of 2021 and are well on our way to meet or exceed the goals we set at the beginning of the year. We are excited about the advancement of our portfolio and look forward to providing further clinical updates and data readouts at a planned R&D call on November 4th as well as at medical congresses in the fourth quarter of the year," said Helen Sabzevari, PhD, President and CEO of Precigen. "We see 2021 as a pivotal year for the UltraCAR-T, ActoBiotics and AdenoVerse platforms with significant new clinical data on our most advanced therapeutic candidates from these core therapeutic platforms."

Business Highlights:

R&D Update Call

Precigen will host an R&D call on November 4th that will be dedicated to reviewing progress made in advancing the Company’s clinical pipeline, including the latest data for several of our key programs.
PRGN-3005 UltraCAR-T

PRGN-3005 UltraCAR-T is a first-in-class investigational therapy under evaluation in a Phase 1/1b clinical trial for the treatment of patients with advanced, recurrent platinum resistant ovarian cancer. Study subjects receive the PRGN-3005 infusion either via intraperitoneal (IP) (Arm A) or intravenous (IV) (Arm B) infusion.
Preliminary Phase 1 data previously reported from the two lowest dose levels of the IP arm showed a favorable safety profile with no dose-limiting toxicities (DLTs), neurotoxicity or cytokine release syndromes (CRS); encouraging expansion and persistence without lymphodepletion; and clinical activity as evidenced by regression in total target tumor burden.
The dose escalation phase of both the IP and IV arms of the trial is ongoing concurrently. Enrollment in dose level 4 of the IP arm and dose level 3 of the IV arm is ongoing.
The Company anticipates the presentation of interim data from the Phase 1 trial in the fourth quarter of 2021.
PRGN-3006 UltraCAR-T

PRGN-3006 UltraCAR-T is a first-in-class investigational therapy under evaluation in a Phase 1/1b clinical trial for the treatment of patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS). Study subjects receive the PRGN-3006 infusion either without prior lymphodepletion (Cohort 1) or following lymphodepleting chemotherapy (Cohort 2). PRGN-3006 UltraCAR-T has been granted Orphan Drug Designation in patients with AML by the US FDA.
Preliminary Phase 1 data previously reported for the two lowest dose levels in Cohort 1 and the lowest dose level in Cohort 2 showed a favorable safety profile with no DLTs or neurotoxicity; encouraging expansion and persistence of PRGN-3006 UltraCAR-T in both cohorts; and clinical activity as evidenced by reduction in AML tumor blast levels. One of the patients treated with PRGN-3006 at the lowest dose level with lymphodepletion (Cohort 1), with approximately nine million UltraCAR-T cells, achieved complete remission with incomplete hematologic recovery (CRi) per European Leukemia Net (ELN) criteria and subsequently received allogeneic hematopoietic stem cell transplant (HSCT).
The dose escalation phase of both the lymphodepletion and non-lymphodepletion cohorts of the Phase 1 trial is ongoing concurrently. Enrollment in dose level 4 of the non-lymphodepletion cohort and dose level 3 of the lymphodepletion cohort is ongoing.
The Company anticipates the presentation of interim data from the Phase 1 trial in the fourth quarter of 2021.
PRGN-2009 AdenoVerse Immunotherapy

PRGN-2009 is a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform that has been designed to activate the immune system to recognize and target HPV-positive solid tumors. PRGN-2009 is currently under evaluation in a Phase 1/2 clinical trial as a monotherapy or in combination with bintrafusp alfa (M7824) in patients with HPV-associated cancers. The trial is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).
Preliminary Phase 1 data previously reported for the monotherapy arm of the Phase 1 trial showed that the treatment was well-tolerated with no DLTs. Furthermore, preliminary correlative analysis from the patients treated at the lowest dose in the monotherapy arm showed an increase in HPV-specific T-cell response in 100% (3 of 3) of patients and an increase in the magnitude of immune response with repeated PRGN-2009 administrations.
As previously announced, enrollment in the Phase 1 monotherapy dose escalation arm is complete, with all patients (n=6) receiving multiple doses of PRGN-2009, as many as thirteen doses to date. Subsequently, the monotherapy arm of the Phase 2 trial, which evaluates PRGN-2009 as neoadjuvant therapy for newly diagnosed oropharyngeal or sinonasal squamous cell cancer patients as a first line treatment was initiated. Enrollment in the Phase 2 monotherapy arm is ongoing with four patients enrolled to date. Enrollment in the Phase 1 combination arm is also ongoing with six patients enrolled to date.
A trial-in-progress update on the PRGN-2009 study was provided at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 annual meeting as a poster presentation by Charalampos S. Floudas, MD, DMSc, MS, Assistant Research Physician, Genitourinary Malignancies Branch at the Center for Cancer Research at the NCI.
The Company anticipates the presentation of interim Phase 1 data in the fourth quarter of 2021.
PRGN-2012 AdenoVerse Immunotherapy

PRGN-2012 is a first-in-class, investigational OTS AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with HPV 6 or HPV 11 for treatment of recurrent respiratory papillomatosis (RRP). A Phase 1 clinical trial of PRGN-2012 in adult patients with RRP is ongoing. The Phase 1 trial is designed to follow 3+3 dose escalation of PRGN-2012 as an adjuvant immunotherapy following standard-of-care surgical removal of visible papillomas. Patients receive up to four injections of PRGN-2012. The study is designed to enroll 3 to 6 subjects at each dose level followed by an expansion cohort with 12 patients treated at the maximum tolerated dose. The trial is being conducted under a CRADA with the NCI. PRGN-2012 has been granted Orphan Drug Designation in patients with RRP by the US FDA.
In January 2021,the Company announced US FDA clearance of the IND to initiate the PRGN-2012 Phase 1 trial.
In March 2021, the first patient was dosed and, subsequently, enrollment was completed in the 3+3 dose escalation portion of the Phase 1 trial. Enrollment then was initiated and the first patient dosed in the expansion cohort of the Phase 1 study at the maximum study dose, exceeding the Company’s goal this year.
AG019 ActoBiotics

AG019 ActoBiotics is a first-in-class, orally administered, investigational therapy designed to address the underlying cause of Type 1 diabetes (T1D) and is currently under evaluation in a Phase 1b/2a clinical trial for the treatment of early-onset T1D. The study is assessing safety and tolerability of AG019 administered as monotherapy or in combination with teplizumab.
Enrollment and dosing is complete in the Phase 1b and Phase 2a portions of the study.
Positive topline data from the AG019 Phase 1b/2a clinical trial were reported at the Federation of Clinical Immunology Societies (FOCIS) 2021 Virtual Annual Meeting by Kevan Herold, MD, CNH Long Professor of Immunobiology and of Medicine (Endocrinology) at the Yale School of Medicine, meeting the Company’s goal to present AG019 Phase 1b/2a data this year. The primary endpoints of safety and tolerability for the Phase 1b AG019 monotherapy and the Phase 2a AG019 combination therapy were met. No serious adverse events (SAEs) were reported. AG019, as a monotherapy and in combination with teplizumab, showed stabilization or increase of C-peptide levels, a biomarker for T1D disease progression, and induced antigen-specific tolerance in conjunction with the reduction of disease-specific T cell responses. Results indicated the potential of the oral AG019 monotherapy to preserve insulin production in recent-onset T1D through its capacity to reduce autoreactive T cells and increase the frequency of memory Tregs to induce antigen-specific immune modulation.
Additional data from the AG019 Phase 1b/2a clinical trial will be presented on October 1, 2021 at 12:00 PM CET as an oral presentation at the European Association for the Study of Diabetes (EASD) 57th Annual Meeting. The abstract entitled, "AG019 ActoBiotics as monotherapy or in association with teplizumab in recent-onset type 1 diabetes was safe and demonstrated encouraging metabolic and immunological effects" will be presented by Chantal Mathieu, MD, PhD, Professor of Medicine at the Katholieke Universiteit Leuven, Belgium.
A clinical trial assessing the efficacy of prolonged treatment of oral AG019 is planned.
Second Quarter and First Half 2021 Financial Highlights

Net cash used in operating activities of $24.2 million during the six months ended June 30, 2021 compared to $41.5 million during the six months ended June 30, 2020;
Cash, cash equivalents, short-term and long-term investments totaled $200.4 million as of June 30, 2021; and
Total revenues of $33.6 million and $58.1 million during the three and six months ended June 30, 2021, respectively, compared to $30.4 million and $60.3 million during the three and six months ended June 30, 2020, respectively.
Second Quarter 2021 Financial Results Compared to Prior Year Period
Research and development expenses increased $4.2 million, or 44%, over the quarter ended June 30, 2020. Contract research organization costs and lab supplies increased $3.8 million with the advancement of the Company’s clinical and preclinical programs. Selling, general and administrative ("SG&A") expenses increased $2.1 million, or 12%. The majority of the SG&A increase was due to an increase in professional fees. Net loss from continuing operations was $20.1 million, or $(0.10) per basic share, of which $8.2 million was for non-cash charges in 2021 compared to net loss from continuing operations of $15.7 million, or $(0.10) per basic share, of which $8.7 million was for non-cash charges in 2020.

Total revenues increased $3.2 million, or 10%, over the quarter ended June 30, 2020. Collaboration and licensing revenues decreased $4.0 million primarily due to a decrease in the recognition of previously deferred revenue in the current period resulting from fewer services being performed pursuant to the Company’s collaboration agreements. Product and service revenues generated by Trans Ova and Exemplar increased $7.2 million primarily due to higher customer demand for Trans Ova’s products and services as a result of stronger beef and dairy industries in the current year and a change in pricing structure with certain customers, as well as increased services provided by Exemplar to new and existing customers. Gross margin on products and services improved as a result of the increased revenues, the change in pricing structure for certain customers, and operational efficiencies that have been gained through reductions in workforce and improved inventory management.

First Half 2021 Financial Results Compared to Prior Year Period
Research and development expenses increased $3.4 million, or 16%, over the six months ended June 30, 2020. Contract research organization costs and lab supplies increased $3.8 million with the advancement of the Company’s clinical and preclinical programs. SG&A expenses were comparable period over period due to offsetting changes. Salaries, benefits, and other personnel costs decreased $1.6 million in 2021 primarily due to a reduced headcount as the Company scaled down its corporate functions to support a more streamlined organization and reduced stock compensation costs for previously granted awards that became fully vested in early 2021. These decreases were partially offset by an increase in professional fees. Net loss from continuing operations was $41.9 million, or $(0.21) per basic share, of which $17.9 million was for non-cash charges in 2021 compared to net loss from continuing operations of $36.6 million, or $(0.23) per basic share, of which $16.4 million was for non-cash charges in 2020.

Total revenues decreased $2.2 million, or 4%, from the six months ended June 30, 2020. Collaboration and licensing revenues decreased $14.7 million as the Company accelerated the recognition of previously deferred revenue in the prior period upon the mutual termination of one of its collaboration agreements in February 2020. Product and service revenues generated by Trans Ova and Exemplar increased $12.6 million primarily due to higher customer demand for Trans Ova’s products and services as a result of stronger beef and dairy industries in the current year and a change in pricing structure with certain customers, as well as increased services provided by Exemplar to new and existing customers. Gross margin on products and services improved as a result of the increased revenues, the change in pricing structure for certain customers, and operational efficiencies that have been gained through reductions in workforce and improved inventory management.