On August 12, 2021 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported program updates and financial results for the second quarter ended June 30, 2021 (Press release, Poseida Therapeutics, AUG 12, 2021, View Source [SID1234586451]).

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"We made significant progress in the second quarter of 2021, advancing our science and operational capabilities and setting the stage to deliver on multiple key milestones," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "We are excited for the second half of the year when we plan to generate and report additional data on P-PSMA-101, our first solid tumor CAR-T; file two INDs for our fully allogeneic CAR-T programs, P-BCMA-ALLO1 for multiple myeloma, and P-MUC1C-ALLO1 for multiple solid tumor indications; update on our BCMA franchise later in the year and advance our in vivo gene therapy pipeline."

Poseida Therapeutics reported program updates and financial results for the second quarter ended June 30, 2021.

Program Updates
BCMA Programs
P-BCMA-101 is an autologous CAR-T product candidate currently in an ongoing Phase 1 dose expansion trial and Phase 2 trial in development for the treatment of relapsed/refractory multiple myeloma. Phase 1 dose expansion enrollment continues and the Company expects to provide an update on this program later in 2021.

P-BCMA-ALLO1, the Company’s first allogeneic CAR-T product candidate, is in development for the treatment of relapsed/refractory multiple myeloma. The program is proceeding as planned with an IND filing and initiation of a Phase 1 clinical trial on track for the third quarter of 2021.

PSMA Program
P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate-resistant prostate cancer (mCRPC) currently in an ongoing Phase 1 dose escalation trial, with an additional update on the program expected later in the third quarter of 2021.

MUC1-C Program
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in preclinical development with the potential to treat a wide range of solid tumors, including breast and ovarian cancers. P-MUC1C-ALLO1 is proceeding as planned, with an anticipated IND filing and initiation of Phase 1 clinical trial by the end of 2021.

Liver-Directed Gene Therapy Program
P-OTC-101 is the Company’s first liver-directed gene therapy program for the in vivo treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene, a condition characterized by high unmet medical need. The Company is currently evaluating whether to modify the P-OTC-101 program to move to the fully non-viral nanoparticle delivery system, which could shift timelines. The Company will update expected timing on program advancement once that evaluation is complete.

Other Operational Updates and Upcoming Events

Addition of Cynthia Collins to Board of Directors
In July, the Company announced the appointment of biotechnology industry veteran Cynthia Collins to its Board of Directors, a recognized leader in cell and gene therapies with broad expertise in gene engineering, oncology and hematology.

Ms. Collins most recently served as the CEO of Editas Medicine, Inc., previously having served as the CEO of Human Longevity, Inc.; the CEO/GM of the Cell Therapy and Lab Business of General Electric’s Healthcare Life Sciences; and the CEO of Clarient Diagnostics, Inc. Ms. Collins received a B.S. degree in Microbiology from the University of Illinois, Urbana and an MBA from The University of Chicago Booth School of Business. She is a member of the board of directors at DermTech, Inc., Certara, Inc., Biocare Medical, LLC, and Triumvira Immunologics, Inc., and previously served on the board for the ARM Foundation for Cell and Gene Medicine and Alliance for Regenerative Medicine.

Interim Update on Data from Phase 1 P-PSMA-101 Clinical Trial to be Presented at CAR-TCR Summit
The Company plans to provide an update from the Phase 1 P-PSMA-101 clinical trial to be presented by CEO, Eric Ostertag, at the 6th Annual CAR-TCR Summit virtual meeting at 10:00 am ET on August 31, 2021, entitled, "P-PSMA-101 is a High-Tscm Autologous CAR-T Targeting PSMA Producing Exceptionally Deep and Durable Responses in Castration-Resistant Metastatic Prostate Cancer."

Financial Results for the Second Quarter 2021
Research and Development Expenses
Research and development expenses were $36.0 million for the second quarter ended June 30, 2021, compared to $25.2 million for the same period in 2020. For the six months ended June 30, 2021, research and development expenses were $65.1 million, compared to $48.6 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount, external costs related to our preclinical programs and clinical stage programs, including the ongoing enrollment and manufacturing associated with our P-BCMA-101 and P-PSMA-101 clinical trials, and internal costs related to facilities development.

General and Administrative Expenses
General and administrative expenses were $8.9 million for the second quarter ended June 30, 2021, compared to $4.2 million for the same period in 2020. General and administrative expenses were $17.2 million for the six months ended June 30, 2021, compared to $9.1 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, headcount and professional fees associated with operating as a publicly traded company.

Net Loss
Net loss was $45.7 million and $84.0 million for the three and six months ended June 30, 2021, respectively, and $30.4 million and $59.2 million for the three and six months ended June 30, 2020, respectively.

Cash Position
As of June 30, 2021, cash, cash equivalents and short-term investments were $237.3 million.

On August 12, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported financial results for the three and six months ended June 30, 2021 and provided a business update (Press release, Aprea, AUG 12, 2021, View Source [SID1234586450]).

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Business Operations Update:

The Company is conducting, supporting, and planning multiple clinical trials of eprenetapopt (APR-246) and APR-548. On August 4, 2021, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in our myeloid malignancy programs.

There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in our myeloid malignancy programs, which includes the MDS, AML and post-transplant maintenance trials, all of which have completed enrollment. Patients who are benefiting from treatment can continue to receive study treatment. As part of the partial clinical hold, no additional patients should be enrolled to these clinical trials until the partial clinical hold is resolved, The Company intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial clinical hold as soon as possible.

On August 11, 2021, the FDA placed a clinical hold on the Company’s clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. There is one CLL patient currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab. This patient may continue to receive study treatment as long as the patient is deriving clinical benefit. No additional patients can be enrolled until the clinical hold is resolved. The Company intends to work closely with the FDA to address the specific questions raised, and seek to resolve the clinical hold as soon as possible.

The Company’s current clinical trials are as follows:

Phase 3 Frontline MDS Trial — In June 2020, the Company completed full enrollment of 154 patients in a pivotal Phase 3 trial of eprenetapopt with azacitidine for frontline treatment of patients with TP53 mutant MDS. The pivotal Phase 3 trial is supported by data from two Phase 1b/2 investigator-initiated trials, one in the U.S. and one in France, testing eprenetapopt with azacitidine as frontline treatment in TP53 mutant MDS and AML patients. The data from the U.S. and French Phase 1b/2 trials were published in The Journal of Clinical Oncology in January 2021 and February 2021, respectively. In December 2020, the Company announced that its pivotal Phase 3 trial failed to meet its predefined primary endpoint of complete remission (CR) rate. Analysis of the primary endpoint at this data cut demonstrated a higher CR rate (53% more patients achieving a CR) in the experimental arm receiving eprenetapopt with azacitidine versus the control arm receiving azacitidine alone but did not reach statistical significance. Based on a thorough analysis of the current Phase 3 trial data and comparisons to the U.S. and French Phase 1b/2 trials the Company believes that despite similar types and frequency of adverse events observed in the Phase 3 experimental arm and the Phase 1b/2 trials, patients in the Phase 3 experimental arm experienced substantially more study treatment dose modifications compared to the experience in the U.S. and French Phase 1b/2 trials. The Company believes that dose modifications of eprenetapopt and azacitidine led to undertreatment in the Phase 3 experimental arm that negatively impacted efficacy, particularly the primary endpoint of CR rate. The Company continues to follow patients who remain on-study. Based on initial feedback from the FDA and the partial clinical hold on its myeloid malignancy programs, the Company believes that there is no registrational pathway for this Phase 3 trial.
Phase 2 MDS/AML Post-Transplant Trial – In July 2021, the Company announced positive results from a single-arm, open-label Phase 2 clinical trial evaluating eprenetapopt with azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and AML patients who have received an allogeneic stem cell transplant. The primary endpoint of the trial is the rate of relapse-free survival (RFS) at 12 months. In 33 patients enrolled in the trial, the RFS at one-year post-transplant was 58% and the median RFS was 12.1 months. The overall survival (OS) at 1-year post-transplant was 79% with a median OS at 19.3 months. Prior clinical trials evaluating post-transplant outcomes in TP53 mutant MDS and AML patients have a reported 1-year post-transplant RFS of ~30% and a median OS of ~5-8 months. As part of the Company’s plan to seek to resolve the partial clinical hold, the Company plans to share data with the FDA. The Company also expects to present data from the clinical trial at a future scientific or medical conference.
Phase 1/2 AML Trial – The Company is currently enrolling a Phase 1/2 clinical trial evaluating the safety, tolerability, and preliminary efficacy of eprenetapopt therapy in TP53 mutant AML patients. The lead-in portion of the trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in 12 patients receiving either regimen. Based on these results, the Company has expanded the trial to treat 33 additional frontline TP53 mutant AML patients with the combination of eprenetapopt, venetoclax and azacitidine. In June 2021, the Company announced that the regimen of eprenetapopt with venetoclax and azacitidine met the CR primary efficacy endpoint. In 30 patients who were evaluable for efficacy at the time of the analysis, the CR rate was 37% and the complete response rate was CR plus CR with incomplete hematologic recovery (CRi), CR/CRi, was 53%. The trial met the primary efficacy endpoint of CR, which is based on a Simon 2-stage design. As of that data cut, 11 patients remain on study treatment and continue to be followed for safety and efficacy. The Company plans to continue collecting data from this Phase 2 clinical trial and share data with the FDA as part of the Company’s effort to resolve the partial clinical hold. The Company also expects to present data from this clinical trial at a future scientific or medical conference.
Phase 1 NHL Trial – The Company is currently enrolling a Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing eprenetapopt with venetoclax and rituximab and eprenetapopt with acalabrutinib in order to further assess eprenetapopt in hematological malignancies. The first patient was enrolled in the first quarter of 2021. The Company intends to work with the FDA to address the specific questions raised, and seek to resolve the clinical hold as soon as possible.
Phase 1/2 Solid Tumor Trial – The Company is currently enrolling a Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy. The dose-escalation phase of the trial enrolled 6 patients with advanced solid tumors and no dose-limiting toxicities were observed. Based on these results, the Company is enrolling expansion cohorts for patients with advanced gastric, bladder and non-small cell lung cancers and has currently enrolled 26 patients across these expansion arms. A poster presentation for this trial was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting (abstract TPS3161).
APR-548 Phase 1 Trial — The Company’s second product candidate, APR-548, is a next-generation p53 reactivator that is being developed in an oral dosage form. The Company has planned a Phase 1 dose-escalation clinical trial evaluating the safety, tolerability, and preliminary efficacy of APR-548 with azacitidine in frontline and relapsed/refractory MDS patients. The Company anticipates the first patient to be enrolled in the second half of 2021.
Second Quarter Financial Results

Cash and cash equivalents: As of June 30, 2021, the Company had $69.8 million of cash and cash equivalents compared to $89.0 million of cash and cash equivalents as of December 31, 2020. The Company expects cash burn for the full year 2021 to be between $30.0 million $35.0 million. The Company believes its cash and cash equivalents as of June 30, 2021, will be sufficient to meet its current projected operating requirements into 2023.
Research and Development (R&D) expenses: R&D expenses were $6.7 million for the quarter ended June 30, 2021, compared to $10.7 million for the comparable period in 2020. The decrease in R&D expenses was primarily due to decreases in clinical trial costs for our pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS which completed enrollment in Q2 2020 and our Phase 2 post-transplant MDS/AML clinical trial. These decreases were partially offset by increases in clinical trial costs for our other ongoing clinical trials.
General and Administrative (G&A) expenses: G&A expenses were $3.4 million for the quarter ended June 30, 2021, compared to $3.8 million for the comparable period in 2020. The decrease in G&A expenses was primarily due to a decrease in pre-commercialization development activities.
Net loss: Net loss was $10.3 million, or $0.48 per share for the quarter ended June 30, 2021, compared to a net loss of $16.4 million, or $0.78 per share for the quarter ended June 30, 2020. The Company had 21,186,827 shares of common stock outstanding as of June 30, 2021.

On August 12, 2021 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported its financial results for the quarter ended June 30, 2021 and provided a business update (Press release, Sellas Life Sciences, AUG 12, 2021, View Source [SID1234586449]).

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"We were pleased to report in June updated clinical data for our two earlier stage studies of GPS in combination with PD-1 inhibitors – the combination of GPS with nivolumab (Opdivo) in MPM patients and GPS with pembrolizumab (Keytruda) in advanced ovarian cancer patients. We will continue our analyses as we collect more data over the remainder of the year," said Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS. "We also activated additional clinical sites and continued to enroll patients in the United States and Europe for our Phase 3 REGAL study of GPS in AML patients, and expect to activate additional sites in the European Union (EU) as well as other countries outside of the EU throughout the remainder of 2021."

"Also, we note recently published data in the journal Bone Marrow Transplantation regarding the outcomes of AML patients, including those who undergo transplant, which clearly shows that there continues to be a large unmet need in the treatment of AML even among those who successfully receive a transplant but harbor minimal residual disease. In our completed Phase 2 study of AML patients who achieved first remission (CR1), overall survival for patients treated with GPS was 48.5 months from time of enrollment. The retrospective analysis of the pooled outcomes for AML patients who underwent a transplant in the article published in Bone Marrow Transplantation indicates that the median overall survival from the time of transplant is approximately 26 months. Given the results of our studies in AML CR1 patients, we believe that there is strong scientific rationale for consideration of a study in the post-transplantation setting," concluded Dr. Stergiou.

Pipeline Updates:

Galinpepimut-S (GPS)

In June 2021, a peer-reviewed article was published in the journal Bone Marrow Transplantation which included a comprehensive retrospective analysis of survival outcomes in 4,280 AML patients treated in more than 450 blood and marrow transplant centers worldwide between 2007 and 2015. The analysis demonstrates the high unmet medical need to extend survival in AML patients. The published analysis shows that even among patients eligible to receive a bone marrow transplant, considered to be the only potential curative therapy in AML, less than half of the patients are alive five years after initial diagnosis. The analysis highlights the importance of the presence of minimal residual disease, or MRD, with patients who harbored MRD at the time of transplant having only 34%-37% probability of surviving five years. In the Company’s completed Phase 2 study of AML patients who achieved first remission (CR1), overall survival (OS) for patients treated with GPS was 48.5 months from the time of enrollment in the study (67.6 months from initial AML diagnosis). The retrospective analysis of the pooled outcomes for AML patients who underwent a transplant in the article published in Bone Marrow Transplantation indicates that the median OS from the time of transplant is approximately 26 months.

In June 2021, the Company reported encouraging updated clinical data from the Phase I open-label investigator-sponsored clinical trial of GPS in combination with the anti-PD-1 therapy nivolumab (Opdivo) in patients with MPM, who harbor relapsed or refractory disease after having received frontline standard of care multimodality therapy. For the four evaluable patients, all of whom had the epithelioid and/or sarcomatoid variant and have received and progressed with, or are refractory to, frontline pemetrexed-based chemotherapy, the average OS was 35.3 weeks with a median OS of 35.4 weeks at a median follow-up of 35.4 weeks. Overall survival for relapsed/refractory patients receiving standard of care (pemetrexed, a chemotherapy) is approximately 28 weeks. Average progression-free survival (PFS) was 8.8 weeks with a median PFS of seven weeks at a median follow-up of 35.4 weeks. The safety profile of the GPS-nivolumab combination was similar to that seen with nivolumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site, which was consistent with previous clinical studies of GPS.

In June, the Company reported updated clinical data and immune response profiles from the basket study of GPS in combination with the anti-PD-1 therapy pembrolizumab (Keytruda) for treating WT1+ advanced ovarian cancer. Of the 11 evaluable patients, 66.7% were refractory to or had failed their second-line therapies and 33.3% had failed third-line or later therapy and all patients were resistant to the standard of care platinum-based therapy. Overall survival for patients receiving standard of care platinum-based therapy is approximately nine to 12 months. The median OS among the patients in this trial is not yet known as all patients remained alive at the time of analysis, which exceeds nine months. In an ad hoc analysis of the clinical outcomes for the cohort of 11 patients, the disease control rate, or DCR, which is the sum of overall response rate and rate of stable disease, was 63.6% with a median follow-up of 15.4 weeks. At the time of follow-up analysis, median PFS was 11.8 weeks. The safety profile of the GPS-pembrolizumab combination was similar to that seen with pembrolizumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site which was consistent with previous clinical studies of GPS.

In May 2021, the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application covering the use of GPS in combination with checkpoint inhibitor therapies for treatment of WT1-expressing cancers.
Corporate and Financial Highlights for the Second Quarter 2021:

In June 2021, the Company received a $1 million milestone payment from 3D Medicines Inc., its licensee for development and commercialization of GPS in the Greater China territory.

In June 2021, the Company was included in the Russell Microcap Index. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes.
Financial Results for the Second Quarter 2021:

Licensing revenue: Licensing revenue was $1.9 million for the second quarter of 2021 and $7.6 million for the first half of 2021 which consists of the recognition of revenue from the Company’s license agreement with 3D Medicines. The Company did not record any licensing revenue for the first half of 2020.

R&D Expenses: Research and development expenses for the second quarter of 2021 were $3.5 million, as compared to $2.3 million for the same period in 2020. Research and development expenses for the first half of 2021 were $7.7 million as compared to $4.1 million for the same period in 2020. The increase was primarily due to an increase in clinical trial expenses related to the Company’s Phase 3 REGAL clinical trial of GPS in AML patients and a ramp up of the manufacture of clinical trial materials and registration batches of GPS, a technology transfer to a new contract manufacturer, and clinical drug supply purchase costs in the EU in preparation for opening sites and enrolling patients in EU countries.

G&A Expenses: General and administrative expenses for the second quarter of 2021 were $2.8 million, as compared to $2.0 million for the same period in 2020. General and administrative expenses for the first half of 2021 were $6.4 million, as compared to $4.2 million for the same period in 2020. The increase was primarily due to amortization expense associated with the capitalized contract acquisition costs of the 3D Medicines license agreement as well as an increase in legal fees as compared to the same period in 2020 during which the majority of legal expenses were offset by a reimbursement credit.

Net Loss: Net loss attributable to common stockholders was $4.6 million for the second quarter of 2021, or a basic and diluted loss per share attributable to common stockholders of $0.30, as compared to a net loss attributable to common stockholders of $4.4 million for the same period in 2020, or a basic and diluted loss per share attributable to common stockholders of $0.66. Net loss attributable to common stockholders was $7.0 million for the first half of 2021, or a basic and diluted loss per share attributable to common stockholders of $0.47, as compared to a net loss attributable to common stockholders of $8.6 million for the same period in 2020, or a basic and diluted loss per share attributable to common stockholders of $1.32.

Cash Position: As of June 30, 2021, cash and cash equivalents totaled approximately $29.9 million.

Upcoming Investor Symposium

The Company will host a virtual investor symposium on its lead asset, GPS, on Tuesday, August 17, 2021, from 1:00 p.m. to 2:00 p.m. ET.

The event will focus on the Company’s clinical program for GPS, including additional details on its recently released clinical data, as well as the significant unmet need in AML, the indication being studied in the GPS Phase 3 REGAL study. SELLAS management will be joined by leading cancer researcher, M. Yair Levy, M.D., Director of Hematologic Malignancies at the Baylor University Medical Center, and member of the REGAL Steering Committee.

To attend the live video webcast, please register or email KCSA Strategic Communications at [email protected].

On August 12, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported financial results for the second quarter ended June 30, 2021 (Press release, Repare Therapeutics, AUG 12, 2021, View Source [SID1234586447]).

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"We are pleased to have dosed the first patient in our Phase 1b/2 ATTACC trial of our ATR inhibitor RP-3500 and additional new PARP inhibitor combinations in patients with molecularly selected cancers." said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We also look forward to disclosing initial results from the monotherapy arm of the Phase 1/2 clinical trial of our ATR inhibitor RP-3500 early in the fourth quarter of 2021."

Second Quarter 2021 Review and Operational Updates:

Announced dosing of first patient in Phase 1b/2 ATTACC clinical trial
In August 2021, the Company dosed the first patient in its Phase 1b/2 ATTACC clinical trial (NCT04972110) of RP-3500, a potent and selective oral small molecule inhibitor of Ataxia-Telangiectasia and Rad3-related protein kinase, or ATR, and PARP inhibitor combinations in patients with molecularly selected cancers.
The primary objectives of the Phase 1b portion of the trial include assessment of safety and tolerability and dose finding to establish a recommended Phase 2 dose ("RP2D") of RP-3500 in combination with ZEJULA (niraparib) or LYNPARZA (olaparib) in up to 48 patients (24 per combination) with advanced solid tumors harboring specific mutations in DNA damage response.
The Phase 2 portion of the trial is designed to include a dose expansion at the RP2D with a primary objective to determine the antitumor activity of RP-3500 in combination with niraparib or olaparib.
Initial results to be presented from the monotherapy arm of the Phase 1/2 TRESR clinical trial evaluating RP-3500 as a monotherapy and in combination with Pfizer’s PARP inhibitor, talazoparib, in patients with solid tumors
In July 2020, the Company began dosing in a Phase 1/2 clinical trial of RP-3500.
The Company has activated 12 clinical trial sites across North America and Europe.
The Company plans to disclose initial results from the monotherapy arm early in the fourth quarter of 2021.
Announced dosing of first patient in RP-6306 Phase 1 clinical trial
In April 2021, the Company dosed the first patient in its Phase 1 clinical trial of RP-6306.
The trial is expected to enroll approximately 60 patients with recurrent tumors characterized by genomic alterations predicted by the Company’s SNIPRx CRISPR-based platform to be sensitive to RP-6306.
The trial objectives include assessment of safety, tolerability, dose, and schedule (including the establishment of a recommended Phase 2 dose).
Progressed towards first druggable target option exercise in our Bristol Myers Squibb collaboration and license agreement
In July and August 2021, the Company received notification with respect to druggable targets from Bristol Myers Squibb, pursuant to the Bristol Meyers Squib collaboration and license agreement. Based on these notifications, we reclassified $6.2 million of non-current deferred revenue to current.
Second Quarter 2021 Financial Results:

Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of June 30, 2021 were $301.0 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $20.2 million and $36.7 million for the three and six-month periods ended June 30, 2021, respectively, as compared to $9.0 million and $17.6 million for the three and six-month periods ended June 30, 2020, respectively. The increase in R&D expenses for the three and nine-month periods were primarily due to increases in development costs related to the Company’s RP-3500 and RP-6306 programs, as well as increases in personnel related expenses, including stock-based compensation.
General and administrative (G&A) expenses: G&A expenses were $6.7 million and $12.0 million for the three and six-month periods ended June 30, 2021, respectively, as compared to $3.4 million and $5.6 million for the three and six-month periods ended June 30, 2020, respectively. The increase in G&A expenses for the three and six-month periods were due to personnel related costs, including stock-based compensation, and D&O insurance which increased as a result of the Company’s IPO in June 2020.
Net loss: Net loss was $26.3 million, or $0.71 per share and $47.7 million, or $1.29 per share, in the three and six-month periods ended June 30, 2021, respectively, and $11.8 million, or $2.45 per share and $24.4 million, or $7.56 per share, in the three and six-month periods ended June 30, 2020, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On August 12, 2021 Lyell Immunopharma, Inc. (Lyell), (Nasdaq: LYEL), a T cell reprogramming company dedicated to the mastery of T cells to cure patients with solid tumors, reported financial results for the second quarter and first six months of 2021 and provided business highlights (Press release, Lyell Immunopharma, AUG 12, 2021, View Source [SID1234586446]).

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"Lyell is steadily progressing our two T cell reprogramming platforms, Gen-R and Epi-R, to address what we believe are the primary barriers that limit consistent, reliable and curative responses to cell therapy in solid tumors," said Liz Homans, Chief Executive Officer of Lyell. "Over the past six months we have expanded our development and executive teams and achieved important operational advances that keep us on track to submit four INDs and begin generating clinical data in 2022. With the completion of our initial public offering in June, we have a strong capital position to execute our vision of curing patients with solid tumors."

Recent Business Highlights

Achieved operational readiness of state-of-the-art manufacturing capabilities to produce cell products for multiple upcoming planned clinical trials. The LyFE Manufacturing Center integrates innovations that enable real-time monitoring and analysis of data and insights into the manufacturing processes. LyFE is operational and the Company has successfully completed engineering runs at scale to supply product for its upcoming planned clinical trials.

Expanded Board of Directors with industry and medical leaders Otis Brawley, M.D., Elizabeth Nabel, M.D. and Lynn Seely, M.D.
Dr. Brawley is a Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University and is a member of the board of directors of PDS Biotechnology Corporation. He was formerly the Chief Medical and Scientific Officer of American Cancer Society and director of the Georgia Cancer Center at Grady Memorial Hospital.

Dr. Nabel is Executive Vice President for Strategy at ModeX Therapeutics and a member of the board of directors of Moderna, Inc., Medtronic, and Accolade. She is the former President of Brigham Health, which includes Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital, and the Brigham and Women’s Physician Organization. Dr. Nabel was also a Professor of Medicine at Harvard Medical School.

Dr. Seely is a member of the board of directors of Blueprint Medicines, Corp. She previously served as President, Chief Executive Officer and member of the board of directors of Myovant Sciences and Senior Vice President and Chief Medical Officer of Medivation.

Further strengthened its balance sheet with net proceeds of $391.8 million from the sale of 25 million shares of common stock in the Company’s initial public offering, bringing cash, cash equivalents and marketable securities to $974.8 million as of June 30, 2021.
Second Quarter and First Six Months of 2021 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents and marketable securities were $974.8 million as of June 30, 2021, compared to $692.6 million as of December 31, 2020, an increase of $282.2 million. Lyell successfully completed its initial public offering in June 2021 in which it issued 25 million shares of common stock, at a price of $17.00 per share, for net proceeds of $391.8 million, after deducting underwriting discounts and commissions and offering expenses.
Research and Development (R&D) Expenses: R&D expenses, were $46.4 million and $88.0 million for the three and six months ended June 30, 2021, respectively, as compared to $97.2 million and $122.7 million for the three and six months ended June 30, 2020, respectively. The decrease in R&D expense for the three and six months ended June 30, 2021, compared to the same periods in the prior year was primarily due to a decrease in collaborations and licensing costs, offset by an increase in success payments expenses.
General and Administrative (G&A) Expenses: G&A expenses were $19.1 million and $35.9 million for the three and six months ended June 30, 2021, respectively, as compared to $9.6 million and $18.4 million for the three and six months ended June 30, 2020, respectively. The increase in G&A expense for the three and six months ended June 30, 2021 compared to the same periods in the prior year was primarily due to an increase in stock-based compensation expense.
Net Loss: Net loss was $62.6 million and $117.6 million for the three and six months ended June 30, 2021, respectively, as compared to $100.7 million and $129.9 million for the three and six months ended June 30, 2020, respectively.
Non-GAAP Measures

Non-GAAP R&D Expenses: Non-GAAP R&D Expenses were $32.1 million and $58.8 million for the three and six months ended June 30, 2021, respectively, as compared to $91.6 million and $113.0 million for the three and six months ended June 30, 2020, respectively. Non-GAAP R&D expenses excludes non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities.
Non-GAAP G&A Expenses: Non-GAAP G&A Expenses were $9.0 million and $17.9 million for the three and six months ended June 30, 2021, respectively, as compared to $7.3 million and $15.0 million for the three and six months ended June 30, 2020, respectively. Non-GAAP G&A expenses exclude non-cash stock-based compensation expense.
Non-GAAP Net Loss: Non-GAAP Net loss was $38.1 million and $70.4 million for the three and six months ended June 30, 2021, respectively, as compared to $92.9 million and $116.8 million for the three and six months ended June 30, 2020, respectively. Non-GAAP net loss excludes non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities.
A discussion of these non-GAAP financial measures, including reconciliations of GAAP to non-GAAP financial measures, is presented below under "Non-GAAP Financial Measures."