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]).

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"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.

On August 9, 2021 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended June 30, 2021 and provided a corporate update (Press release, Athersys, AUG 9, 2021, View Source [SID1234586126]).

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"We are happy about the positive topline results for the ONE-BRIDGE ARDS study in Japan reported by Healios last week," stated Mr. William (B.J.) Lehmann, Jr., Interim Chief Executive Officer of Athersys. "The results are consistent with results from our previous MUST-ARDS trial in the United States and the United Kingdom and provide further support for the potential therapeutic benefit for ARDS patients treated with MultiStem cell therapy."

"Additionally, we were pleased to announce new agreements with Healios to improve our collaboration as the MultiStem therapy approaches commercialization following potential regulatory approvals in Japan," added Mr. Lehmann. "Healios will take on greater responsibility and investment with respect to product supply in Japan, which we will continue to support, while we deepen our focus on advanced manufacturing technologies and higher volume manufacturing. In addition, by expanding the scope of the license in Japan, we have created opportunities for both parties to realize additional returns on their investments in this innovative therapy."

Highlights of the second quarter of 2021 and recent events include:

Partner HEALIOS K.K. (Healios) announced positive topline data from its ONE-BRIDGE clinical trial in Japan evaluating the safety and efficacy of MultiStem cell therapy (HLCM051; invimestrocel) in patients with pneumonia-induced and COVID-induced acute respiratory distress syndrome (ARDS);
Expanded our partnership with Healios to optimize and better align the collaboration structure to drive the commercial success and therapeutic reach for MultiStem therapy in Japan;
Published in Scientific Reports important new data about the relevance of MultiStem’s mechanism of action in critical care applications – specifically, the role of these cells in promoting regulatory T cell (Treg) differentiation and proliferation and modulation of immune response;
Advanced our large-scale bioreactor manufacturing platform and initiated efforts to establish GMP production capacity including necessary supply chain and support capabilities;
Continued to build an experienced, world-class team with important hires in regulatory, supply chain, and operations, including the addition of Mr. James Glover as Senior Vice President of Commercial Manufacturing;
Recognized net loss of $22.6 million, or $0.10 net loss per share, for the quarter ended June 30, 2021; and
Ended the second quarter with $56.7 million of cash and cash equivalents.
"We continue to advance our clinical programs with a priority focus on our MASTERS-2 ischemic stroke trial and on the establishment of core capabilities and partnerships necessary for driving commercial success following approval. With important read-outs ahead of us, including Healios’ TREASURE stroke study and our MASTERS-2 study, we are planning and preparing for success," concluded Mr. Lehmann.

Second Quarter Results

There were no revenues for the three months ended June 30, 2021 compared to $0.1 million for the three months ended June 30, 2020. Our collaboration revenues currently fluctuate from period to period based on the delivery of goods and services under our arrangement with Healios.

Research and development expenses increased to $17.7 million for the three months ended June 30, 2021 from $13.8 million for the comparable period in 2020. The $3.9 million increase is associated with increases in clinical trial and manufacturing process development costs of $2.6 million, personnel costs of $0.8 million, facilities costs of $0.3 million and other costs of $0.2 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

General and administrative expenses decreased slightly to $4.2 million for the three months ended June 30, 2021 from $4.4 million in the comparable period in 2020. The $0.2 million decrease was primarily related to decreased stock compensation expense.

Net loss for the second quarter of 2021 was $22.6 million compared to a net loss of $18.4 million in the second quarter of 2020. The difference primarily results from the above variances.

During the six months ended June 30, 2021, net cash used in operating activities was $37.2 million compared to $24.9 million in the six months ended June 30, 2020. At June 30, 2021, we had $56.7 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.

Conference Call

Members of the management will host a conference call today to review the results as follows:

We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive the toll-free number, a direct entry passcode and a registrant ID.

A replay of the event will be available on the webcast link at www.athersys.com under the investors’ section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 PM Eastern Time on August 16, 2021, by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 5972392.

On August 9, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported second quarter 2021 financial results and provided a business update (Press release, Rubius Therapeutics, AUG 9, 2021, View Source [SID1234586142]).

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"During the quarter, we continued to make excellent progress in advancing our fully owned oncology pipeline," said Pablo J. Cagnoni, M.D., President and Chief Executive Officer. "Given the favorable emerging safety profile and promising initial clinical activity reported for RTX-240, we initiated a combination Phase 1 arm with pembrolizumab with the goal of providing benefit to patients with cancers that have relapsed or are refractory after treatment with anti-PD-1 or PD-L1 antibodies."

"Bolstered by the promising clinical activity and safety reported as part of the initial data results in March 2021, and no dose-limiting toxicities observed to date, we are continuing to explore the dose and schedule in new cohorts in the Phase 1 arm of single-agent RTX-240 in advanced solid tumors," said Christina Coughlin, M.D., Ph.D., Chief Medical Officer. "We plan to present a comprehensive clinical data set from the trial, including data from the new cohorts and longer follow up for all patients."

Second Quarter 2021 and Recent Highlights

Strengthened Leadership Team

Dannielle Appelhans was appointed chief operating officer. She will oversee corporate strategy and technical operations. Dannielle brings significant experience in building organizations as they evolve from early- to late-stage development, with a particular focus on clinical and commercial manufacturing and scaling supply chains.

Single-Agent RTX-240 Phase 1/2 Clinical Trial for Advanced Solid Tumors

During the second quarter, two additional cohorts were added to explore the dose of RTX-240 with a more frequent schedule of administration in the Phase 1 single-agent arm in solid tumors. Enrollment in these cohorts continues.
The changes in dose and schedule are supported by initial clinical activity, safety data and no dose-limiting toxicities observed to date along with additional emerging data from dose escalation in the Phase 1 study.
The Company currently plans to present comprehensive results from this study at the end of 2021 or during the first quarter of 2022.
The Company presented preliminary safety and efficacy data from RTX-240 Phase 1/2 clinical trial for advanced solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting on April 10, 2021.
The initial safety (n=16) and efficacy (n=15) findings, based on RECIST v1.1., with a data cutoff of February 28, 2021, demonstrated favorable emerging safety results across dose levels with no treatment-related Grade 3/4 adverse events or dose-limiting toxicities.
Single-agent activity was demonstrated with two partial responses (1 confirmed and 1 unconfirmed) and six patients with stable disease.
RTX-240 stimulated innate and adaptive immunity as demonstrated by the activation and expansion of NK or memory CD8+ T cells in all patients, with 9/16 patients showing activation and expansion in both cell types.
Additionally, trafficking data was separately reported as part of the initial data readout on March 15, 2021, which noted that immune cell trafficking of activated NK and T cells into the tumor microenvironment (TME) was observed in two solid tumor biopsies and one acute myeloid leukemia (AML) biopsy.
Phase 1 Arm in Ongoing Phase 1/2 RTX-240 Clinical Trial in Combination with KEYTRUDA (pembrolizumab) for Advanced Solid Tumors

The first patient was dosed with RTX-240 in combination with pembrolizumab for the treatment of patients with relapsed/refractory or locally advanced solid tumors in June 2021.
To be eligible for the trial, patients must have disease that is relapsed or refractory to an anti-PD-1 or PD-L1 therapy. The study continues to enroll additional patients.
With its mechanism of action as a broad immune agonist, RTX-240 may have synergy with immune checkpoint inhibition and potentially overcome resistance to PD-1 inhibition.
Preliminary data from single-agent RTX-240 Phase 1 study reported in March 2021, showed early evidence of favorable immune-permissive changes in the TME, including increased expression of PD-L1 and/or increased ratio of M1/M2 macrophages after treatment with RTX-240 in three out of four patient biopsies, suggesting single-agent RTX-240 is able to induce changes in the TME that have been associated with response to checkpoint inhibition.
Phase 1 Arm in Ongoing Phase 1/2 RTX-240 Clinical Trial in Relapsed/Refractory (R/R) Acute Myeloid Leukemia

RTX-240 is currently being evaluated as a single-agent in a Phase 1 arm of the ongoing Phase 1/2 clinical trial of RTX-240 in patients with R/R AML.
Based on the initial clinical and pharmacodynamic data observed in the single-agent solid tumor Phase 1 arm, the Company implemented a more frequent dose administration schedule and added an additional cohort in the R/R AML arm of the trial.
Dosing has been completed in the first four dose cohorts and enrollment in an additional dose cohort is expected to begin in the third quarter of 2021.
Given the mechanism of RTX-240 in activating and expanding NK and T cells and its preliminary favorable safety profile seen to date, RTX-240 could potentially provide benefit as a maintenance therapy for AML patients in remission following chemotherapy or stem cell transplantation.
RTX-321 Artificial Antigen-Presenting Cell (aAPC) Development Program for Human Papillomavirus (HPV) 16-Positive Cancers

Enrollment continues in the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers, including cervical, head & neck cancers, and anal cancer.

Peer-Reviewed Publications and Poster Presentations at Medical Conferences

In July 2021, the manuscript entitled "Anti-Tumor Effects of RTX-240: an Engineered Red Blood Cell Expressing 4-1BB Ligand and Interleukin-15" was published in the peer-reviewed journal Cancer Immunology, Immunotherapy, highlighting preclinical findings for RTX-240, which demonstrated that RTX-240 activates and expands CD8+ T cells and NK cells in vitro and in vivo generating potent anti-tumor activity in both a colorectal and melanoma model.
In May 2021, the manuscript entitled, "Engineered Red Blood Cells as an Off-the-Shelf Allogeneic Anti-Tumor Therapeutic" was published in the peer-reviewed journal Nature Communications highlighting preclinical findings for RTX-321, which demonstrated that the surrogate of RTX-321 induced a broad immune response, epitope spreading and memory formation in preclinical models.
Preliminary safety and efficacy data from RTX-240 Phase 1/2 Clinical Trial for advanced solid tumors was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting on April 10, 2021.
Near-Term Catalysts and Operational Objectives

Present additional clinical data from the RTX-240 solid tumor Phase 1 clinical trial at the end of 2021 or during the first quarter of 2022;
Select specific solid tumor types that will be pursued in the Phase 2 expansion cohort of RTX-240;
Report initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in relapsed/refractory AML;
Report initial Phase 1 clinical data from RTX-321 for the treatment of HPV 16-positive cancers by the first quarter of 2022; and
Submit an Investigational New Drug Application for RTX-224 by year-end.
Second Quarter Financial Results
Net loss for the second quarter of 2021 was $50.2 million or $0.56 per common share, compared to $37.9 million or $0.47 per common share in the second quarter of 2020.

In the second quarter of 2021, Rubius invested $36.1 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $26.1 million in the second quarter of 2020. This year-over-year increase was principally due to a $9.1 million increase in costs incurred for the Company’s lead cancer programs, including, RTX-240 and RTX-321, primarily CRO and internal manufacturing costs incurred in connection with both arms of its Phase 1/2 clinical trial of RTX-240 for the treatment of solid tumors and AML and for its Phase 1 clinical trial of RTX-321 for the treatment of HPV 16-positive cancers. Additionally, personnel-related costs increased $1.2 million for additions to headcount to support the Company’s expanded operations and stock-based compensation expense increased by $1.0 million. Increases in oncology program expenses, personnel-related costs and stock-based compensation expense were offset by a $1.5 million reduction in contract R&D, laboratory supplies and research materials driven primarily by a shift in research activities to support clinical programs.

General and administrative (G&A) expenses were $13.9 million during the second quarter of 2021, as compared to $11.6 million for the second quarter of 2020. The higher costs were driven by a $1.0 million increase in personnel-related costs to support rising headcount in the Company’s general and administrative function, including recruitment costs, as well as a $0.9 million increase in professional and consultant fees and facility-related expenses.

Six Month Financial Results
Net loss for the first six months of 2021 was $92.5 million or $1.08 per common share, compared to $86.3 million or $1.07 per common share in the first six months of 2020.

In the six months ended June 30, 2021, Rubius invested $63.7 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $62.3 million in the first six months of 2020. The year-over-year increase was driven primarily by a $10.9 million increase in costs incurred for the Company’s lead cancer programs. These costs were incurred for its Phase 1/2 clinical trial of RTX-240 for the treatment of solid tumors, including clinical CRO and internal manufacturing costs, as well as costs incurred for its Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers. This increase was partially offset by a $6.7 million reduction in rare disease program costs, following the deprioritization of the Company’s rare disease pipeline in March 2020. Additionally, platform development, early-stage research and other unallocated expenses decreased by $2.8 million due principally to reductions in contract R&D, laboratory supplies and research materials as research activities shifted to support clinical programs.

G&A expenses were $27.1 million during the first six months of 2021, as compared to $24.3 million for the same period in 2020. The higher costs were driven by a $1.0 million increase in personnel-related costs, including recruitment costs, as well as a $1.7 million increase in professional and consultant fees and facility-related expenses.

During the first six months of 2021, other income and expenses decreased by $1.9 million, from other income, net of $0.2 million during the first six months of 2020, to other expense, net of $1.7 million. The change was principally due to lower prevailing interest rates and an increase in outstanding debt following the final borrowing under the Company’s debt facility in June 2020.

Cash Position
As of June 30, 2021, cash, cash equivalents and investments were $298.2 million, compared to $176.3 million as of December 31, 2020. In connection with its underwritten public offering completed in March 2021, the Company received net proceeds of $187.2 million, after deducting underwriting discounts and commission and other offering costs. In addition, during the second quarter, the Company amended its debt facility, postponing principal payments, by two and a half years, until mid-2024.

On August 9, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the second quarter 2021 and financial and business update on Monday, August 16, 2021 (Press release, Protalix, AUG 9, 2021, View Source [SID1234586159]). The Company’s management will host a conference call to discuss the financial results and provide a business update on recent corporate and clinical developments at 8:30 a.m. Eastern Daylight Time (EDT).

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Conference Call Details:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13721687

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

Heron Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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