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CASI Pharmaceuticals Announces Second Quarter 2021 Financial Results

On August 12, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the second quarter of 2021 (Press release, CASI Pharmaceuticals, AUG 12, 2021, View Source [SID1234586454]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are pleased to report $7.1 million EVOMELA revenues for the quarter. Based on the current trend, we are revising our guidance for full-year 2021 revenue growth to exceed 80% over 2020. We are proud of our commercial franchise execution for EVOMELA and have expanded to over 100 FTEs on the commercial and marketing teams. In addition to the continued EVOMELA revenue growth, we achieved dosing of first patient of CID-103 in our Phase 1 clinical trial for relapse or refectory multiple myeloma. CID-103 has previously shown encouraging preclinical efficacy, a favorable preclinical safety profile, and greater antibody-dependence cellular cytotoxicity activity over other anti-CD38 mAbs, and we are hopeful this will translate into patient benefit."

Dr. He continued, "We are thrilled with the progress we continue to see throughout our hematology oncology pipeline. Our partner, Juventas, has completed CNCT19’s (CD19 CAR-T) Phase 1 studies of B-ALL and B-NHL in China. The Phase 2 B-NHL and B-ALL registration studies of CNCT19 are currently enrolling in China. Additionally, BioInvent recently announced that the China National Intellectual Property Administration (CNIPA) has issued a notice of allowance, informing the company that a patent application relating to the anti-FcγRllB antibody BI-1206 is expected to be granted. Together with BioInvent we plan to continue to develop BI-1206 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in Greater China."

Second Quarter 2021 Financial Results

Revenues consist of product sales of EVOMELA that launched during August 2019. Revenue was $7.1 million for the three months ended June 30, 2021 compared to $2.6 million for the three months ended June 30, 2020. Revenues increased by 173% in the second quarter of 2021 as compared to same quarter in 2020 due to the continued growth in EVOMELA sales.

Costs of revenues were $2.9 million for the three months ended June 30, 2021, compared to $2.5 million for the three months ended June 30, 2020, which includes royalty payment of $1.4 million and $0.5 million for the same period. Costs of revenues excluding royalty were $1.5 million and $2.0 million for the three months ended June 30, 2021, and 2020. Costs of revenues, excluding royalty as a percentage of revenues, decreased significantly in the three months ended June 30, 2021, compared within the three months ended June 30, 2020, due to the new alternate manufacturer now in place, resulting in a considerable decrease in the unit cost of inventories of EVOMELA.

General and administrative expenses for the three months ended June 30, 2021 were $5.4 million, compared with $4.1 million for the three months ended June 30, 2020.

Selling and marketing expenses for the three months ended June 30, 2021 were $3.4 million, compared with $1.6 million for the three months ended June 30, 2020. The increase in selling and marketing expenses was due to expansion of sales team in China in 2021.

Acquired in-process R&D expenses for the three months ended June 30, 2021 was $1.06 million, compared to $0 million for the three months ended June 30, 2020. In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment and accrued €250,000 ($305,000) payment under the terms of the agreement.

Net loss for the three months ended June 30, 2021 was $6.7 million compared to $8.5 million for the three months ended June 30, 2020 due to significant revenue increase. As of June 30, 2021, CASI had cash and cash equivalents of $60.4 million compared to $57.1 million as of December 31, 2020.
Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, can be found at www.casipharmaceuticals.com.

Conference Call

The Company will host a conference call reviewing the second quarter highlights today at 8:00 a.m. ET. The conference call can be accessed by dialing (833) 420-0382 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5639775. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

This call will be recorded and available for replay by dialing (800) 859-2056 (U.S.) or (404) 537-3406 (international) and enter 5639775 to access the replay.

Molecular Templates, Inc. Reports Second Quarter 2021 Financial Results

On August 12, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the second quarter of 2021 (Press release, Molecular Templates, AUG 12, 2021, View Source [SID1234586453]).

"We continue to make progress on advancing our wholly owned pipeline of next-generation ETBs and our existing partnerships. We reached an important milestone recently with initiation of clinical development of MT-6402 (targeting PD-L1 via dual mechanisms) which is the first of our third generation ETBs to enter the clinic," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "With regard to TAK-169, we are now looking forward to continuing clinical development, having assumed full rights to this asset from Takeda. We expect the second half of 2021 to be busy, with clinical data anticipated on MT-5111, TAK-169, and MT-6402 as well as further progress on our earlier stage programs."

Company Highlights and Upcoming Milestones

Corporate

On August 4, 2021, MTEM assumed full rights to TAK-169 from its former co-development partner, Takeda, including full control of TAK-169 clinical development.
On April 5, 2021, MTEM announced the decision to discontinue development of MT-3724, MTEM’s only first-generation ETB. MTEM will focus on the clinical development of next-generation ETBs MT-5111, TAK-169, and MT-6402, as well as advancing next-generation preclinical ETB candidates against targets including CTLA-4, CD20, SLAMF-7, CD45, TROP2 and TIGIT.
MTEM had three presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which took place virtually from April 10-15, 2021:
MT-5111 (interim Phase 1 data as of December 2020), abstract CT130, titled "Phase 1 study of the novel immunotoxin MT-5111 in patients with HER-2+tumors."
MT-6402 (preclinical data), abstract 1628, titled "Engineered toxin bodies targeting PD-L1 to alter tumor immunophenotypes and deliver broad antigenic diversity and patient coverage."
CTLA-4 ETB (preclinical data), abstract 1627, titled "Preclinical characterization of a novel CTLA-4-targeted ETB for direct Treg depletion."
MTEM provided a corporate update and participated in 1-on-1 investor meetings at the Ladenburg Thalmann 2021 Healthcare Conference, which took place July 13-14, 2021.
MT-5111 (HER2 ETB)

The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment. Details of the study were presented at AACR (Free AACR Whitepaper) in April.
The HER2-positive breast cancer expansion cohort is planned to begin in 3Q21 at a dose of 10 mcg/kg (anticipated to be a therapeutic dose level), pending adequate safety data. Dose escalation will continue to determine the recommended Phase 2 dose while the breast cancer expansion cohort collects efficacy and safety data.
Additional data from both the dose escalation portion of the study and the metastatic breast cancer dose expansion cohort are expected in 4Q21.
TAK-169 (CD38 ETB)

On August 4, 2021, MTEM assumed full rights to TAK-169 from its former co-development partner, Takeda, including full control of TAK-169 clinical development, per the terms of the terminated collaboration agreement with Takeda. MTEM will continue conducting the ongoing Phase 1 study for TAK-169 in relapsed/refractory multiple myeloma. This study, which started dosing in February 2020, had a temporary pause in the activation of new study sites and new patient enrollment (along with most of Takeda’s other early-stage studies) due to COVID-19 and was re-initiated in 4Q20.
As previously disclosed, Takeda had enrolled and treated four subjects in the Phase 1 study. Pharmacodynamic activity was noted in the subjects, all treated at the starting dose of 50 mcg/kg. Clearance of natural killer (NK) cells in peripheral blood was observed in all subjects with a maximal reduction of peripheral NK cells of 56%, 85%, 88%, and 92%, respectively, after the first dose. The subject with 56% reduction in NK cells exhibited a low percentage of CD38+ NK cells. These values appear comparable to the reported maximal peripheral NK clearance seen with CD38-targeting antibodies at receptor-saturating doses. The geometric mean of Cmax in these four subjects appears lower than the predicted EC50 observed in patient-derived ex vivo cell-kill assays but above in vitro EC50 values in multiple myeloma cell-lines.
MTEM expects to provide an update on the Phase 1 study in 4Q21.
MT-6402 (PD-L1 ETB with antigen seeding)

In July 2021, MTEM dosed its first subject in a Phase 1 study of MT-6402. MT-6402 is the first of MTEM’s 3rd generation ETBs to enter the clinic. MT-6402 was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the PD-L1 antibodies.
The Phase 1 study is a multi-center, open-label, dose escalation and dose expansion trial in the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment. The starting dose is 16 mcg/kg.
Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.
MTEM expects to provide an update on the Phase 1 study in 4Q21.
Research

MTEM expects to initiate a Phase 1 study for an ETB targeting CTLA-4 in 2022.
Several other wholly owned ETB candidates are in preclinical development against targets including CD20, SLAMF-7, CD45, TROP2, and TIGIT.
In 2021, MTEM expects to present preclinical data on ETB candidates at medical and scientific conferences.
Financial Results

The net loss attributable to common shareholders for the second quarter of 2021 was $15.6 million, or $0.28 per basic and diluted share. This compares with a net loss attributable to common shareholders of $31.2 million, or $0.68 per basic and diluted share, for the same period in 2020.

Revenues for the second quarter of 2021 were $15.1 million, compared to $6.9 million for the same period in 2020. Revenues for the second quarter of 2021 were comprised of revenues from collaborative research and development agreements with Takeda, Vertex and Bristol Myers Squibb. Total research and development expenses for the second quarter of 2021 were $21.1 million, compared with $30.4 million for the same period in 2020. Total general and administrative expenses for the second quarter of 2021 were $8.9 million, compared with $6.4 million for the same period in 2020.

As of June 30, 2021, MTEM’s cash and investments totaled $200.7 million. MTEM’s current cash and investments are expected to fund operations into the second half of 2023.

Poseida Therapeutics Reports Program Updates and Financial Results for the Second Quarter of 2021

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]).

"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.

Aprea Therapeutics Reports Second Quarter 2021 Financial Results and Provides Update on Business Operations

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]).

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.

SELLAS Life Sciences Reports Second Quarter 2021 Financial Results and Provides Business Update

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]).

"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].