On November 12, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported financial results for the third quarter ended Sept. 30, 2021 (Press release, Forma Therapeutics, NOV 12, 2021, View Source [SID1234595392]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the third quarter, we made significant progress pursuing our commitment not only to serving the needs of people living with sickle cell disease with our lead program, etavopivat, but also targeting prostate cancer with initial FT-7051 results, in addition to new olutasidenib clinical data accepted for presentation at ASH (Free ASH Whitepaper) next month," said Frank Lee, president and chief executive officer of Forma.

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

Enrollment in etavopivat open label extension completed. Full enrollment of 15 patients in the open label extension (OLE) was completed during the quarter. Patients in the OLE are being administered etavopivat 400 mg once daily for up to 12 weeks and assessed for hematologic and hemolytic response, and improvement in markers of red blood cell (RBC) health, including oxygenation and deformability, as well as systemic biomarkers of SCD.
CPB/p300 Program in Prostate Cancer:

Initial FT-7051 Phase 1 clinical trial results presented at NCI/AACR/EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). Preliminary results included data as of Sept. 1, 2021, from eight men enrolled in the trial. FT-7051 was administered in 28-day cycles, with 21 days of dosing followed by seven days of no dosing. The initial pharmacokinetic (PK) analysis of FT-7051 documented rapid absorption, with drug concentrations that approached the predicted efficacious dose based on estimates from preclinical animal models. Skin biopsies of the men participating in the study demonstrated a reduction in H3K27AC, a marker of activity in the CBP/p300 pathway. The majority of the treatment-emergent adverse events (TEAEs) were mild or moderate, at Grade 2 or lower, with no events leading to treatment discontinuation. The first evaluable patient completing more than 90 days of treatment demonstrated an ongoing response of >80% decline in prostate-specific antigen (PSA80) from baseline with stable disease.
Corporate

Upcoming investor conference participation. Forma will participate in the Jefferies London Healthcare Conference taking place Nov. 16-19. The pre-recorded presentation will be available Nov. 18 at 8:00am Greenwich Mean Time (GMT) in the "News & Investors" section of Forma’s website at www.FormaTherapeutics.com.
Investor briefing to discuss results presented at ASH (Free ASH Whitepaper). Forma will hold an investor briefing Dec. 13 at 8:00 am Eastern Time (ET). The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.
Upcoming Milestones

Updated Phase 1 OLE trial results for etavopivat in SCD to be presented at ASH (Free ASH Whitepaper) Dec. 11-14. Results to be presented will include 15 patients being administered etavopivat 400mg once daily for up to 12 weeks and assessed for hematologic and hemolytic response, and improvements in markers of RBC health including oxygenation and deformability, and systemic markers of SCD.
Patient enrollment continues in Phase 2/3 registrational trial, the Hibiscus Study. The Hibiscus study includes two co-primary end points (hemoglobin and vaso-occlusive crises) that support the traditional approval pathway. Based on ongoing feedback from the FDA, although accelerated approval is still an available regulatory pathway, Forma will need to provide additional information to support hemoglobin response as a surrogate endpoint eligible for accelerated approval for etavopivat. The company plans to continue to seek accelerated approval for etavopivat utilizing hemoglobin response rates as a surrogate endpoint by providing additional data to support that hemoglobin response rates predict for a clinical benefit.
Additional etavopivat trials to begin late 2021/1H:22. Forma plans to initiate a Phase 2 trial in transfusion dependent SCD and both transfusion dependent and independent thalassemia prior to the end of the year, and a pediatric SCD trial beginning in the first half of 2022.
Olutasidenib results in R/R AML to be presented at ASH (Free ASH Whitepaper) Dec. 11-14. Results from the Phase 2 trial will show the impact of the combination of olutasidenib and azacitidine on rates of remission and transfusion independence in patients with mutant isocitrate dehydrogenase 1 (mIDH1) AML. Analyses of safety and efficacy will be presented at the ASH (Free ASH Whitepaper) annual meeting.
Additional FT-7051 clinical results in mCRPC to be presented in 2022. Men with mCRPC continue to be enrolled in the dose escalation portion of the Phase 1 trial. Forma plans to present updated results from the trial at a scientific conference in mid-2022.
Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma’s, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 have impacted enrollment of clinical trials or and the ability to access sites participating in clinical trials.
Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $531.8 million as of Sept. 30, 2021, as compared to $645.6 million as of Dec. 31, 2020. Current cash runway is projected through the third quarter of 2024.
Research and Development (R&D) Expenses: R&D expenses were $30.7 million for the quarter ended Sept. 30, 2021, compared to $24.8 million for the quarter ended Sept. 30, 2020. The increase was primarily attributable to an increase in research and development staff to support advancement of etavopivat and other programs, an increase in equity-based compensation, and increases in external predevelopment and preclinical programs, conduct of the Phase II/III etavopivat trial in SCD patients and study start-up costs related to a trial in thalassemia/transfusion dependence.
General and Administrative (G&A) Expenses: G&A expenses were $12.7 million for the quarter ended Sept. 30, 2021, compared to $7.5 million for the quarter ended Sept. 30, 2020. The increase was primarily attributable to equity-based compensation, costs due to executive and staff hiring, legal, consulting, and other professional fee expenses, and other related general and administrative costs.
Net Loss: Net loss was $43.3 million for the quarter ended Sept. 30, 2021, compared to net loss of $27.6 million for the quarter ended Sept. 30, 2020.
Forma will conduct a conference call and webcast Nov. 12 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss third quarter 2021 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 6662686.

The live webcast will be available in the "News & Investors" section of Forma’s website www.formatherapeutics.com.

On November 12, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported two ePoster presentations of preclinical data on its Amphiphile (AMP) platform in combination with TCR-T and CAR-T therapies, respectively, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting taking place in Washington D.C. and virtually November 10-14, 2021 (Press release, Elicio Therapeutics, NOV 12, 2021, https://elicio.com/2021/11/elicio-therapeutics-presents-preclinical-data-on-amp-tcr-t-and-car-t-combination-therapies-at-the-2021-society-for-immunotherapy-of-cancer-annual-meeting/ [SID1234595391]). The ePosters are available on the SITC (Free SITC Whitepaper) website starting November 12, 2021, at 7 a.m. ET., and accessible here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"These preclinical datasets demonstrate the broad potential of our AMP platform and build on previous data validating our AMP boosting approach to enhance already established TCR-T and CAR-T cell therapies. By successfully targeting the lymph nodes, AMP-boosting can enhance both adoptively transferred and endogenous T cell responses to activate potent, functional and durable immunity against tumors," said Peter DeMuth, Ph.D., Vice President of Research at Elicio Therapeutics. "We are excited to continue building on these data to enable clinical translation including through our collaboration with the Moffitt Cancer Center, where we are evaluating AMP-boosting of CD19 CAR-T therapies to promote durable CAR-T responses to tumors. With many patients failing to enter remission with CAR-T therapy alone or relapsing due to poor CAR-T persistence, this could be the boost that immunotherapy needs."

Data Presentation Details:

Title: Lymph Node Targeted Boosting with Cognate Amphiphile-Peptide Vaccines Enhances TCR-T Cell Therapy to Eradicate Solid Tumors

Abstract Number: 157

AMP boosting significantly enhanced TCR-T cell anti-tumor response and led to durable cures of solid tumors in an established, syngeneic tumor model.
AMP boosting delivers cognate peptides and adjuvant to lymph nodes, which induces dendritic cell (DC) activation and provides in vivo activation of tumor-specific TCR-T cells to amplify anti-tumor potency of adoptively transferred cells.
AMP-peptide pulsed autologous human DCs enhanced the function of clinically relevant human KRAS-specific TCR-T cells in vitro.
These studies provide direct rationale and evidence for the combination of AMP boosting with TCR-T cell therapies to augment clinical responses.
Title: Amphiphile-Peptide Boosting with FMC63-binding Surrogate Peptide Mimotopes Induces Activation and Potent Effector Function in CAR-T Cells Targeting CD19

Abstract Number: 552

The AMP platform can potentially be utilized as a mechanism to expand and functionally enhance CAR-T cells in vivo targeting blood and solid tumors.
AMP-peptides (AMPlifiers) effectively accumulate in lymph nodes and decorate lymph node resident antigen-presenting cells (APCs) as well as boost CAR-T activation and expansion in vivo.
Phage display screening enables AMPlifier discovery and validation for CAR scFv domains such as FMC63, the CD19 specific domain used in marketed CD19 CAR-T products.
In vitro, CD19 AMPlifiers induce phenotypic activation, cytotoxic and effector function in cognate CD19 CAR-T cells with 28z or BBz signaling domains.
About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph-node specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.

On November 12, 2021 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported financial results for the quarter ended September 30, 2021 (Press release, Elevation Oncology, NOV 12, 2021, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-third-quarter-2021-financial-results [SID1234595390]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The third quarter was marked by continued progress on our mission to bring purpose-built medicines to patients with genomically defined cancers," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "The CRESTONE Study is now open and enrolling patients in the US, Canada, and Australia. Our collaboration with Caris Life Sciences is revealing a series of potential programs targeting genomic fusions. Finally, I am also pleased to welcome Valerie Malyvanh Jansen, MD, PhD, as our first Chief Medical Officer."

"We are encouraged by the durable clinical benefit seen with seribantumab in the case study of a patient with metastatic pancreatic cancer harboring an NRG1 fusion that was presented at the Australasian Gastro-Intestinal Cancer Trials Group conference," said Dr. Jansen. "Separately, we expect to complete enrollment of the first 20 patients in Cohort 1 of CRESTONE in mid-2022. We also anticipate presenting initial clinical data at a major medical meeting in mid-2022, which will include results from approximately 10 patients from Cohort 1 with meaningful follow-up who have been treated with seribantumab at 3 grams weekly."

Recent Business Highlights

Seribantumab

Case study of a patient with pancreatic cancer treated with seribantumab under a compassionate use program highlighted a confirmed partial response and durable clinical benefit, representing the first clinical data presented on the use of seribantumab in a patient with a tumor harboring an NRG1 fusion. Treatment with seribantumab was included as part of a case series presentation at the Australasian Gastro-Intestinal Trials Group (AGITG) 2021 Annual Scientific Meeting in October. A patient with treatment-refractory metastatic pancreatic cancer who had their tumor genomically profiled through the Cancer Molecular Screening and Therapeutics (MoST) program, was found to harbor an NRG1 fusion, and subsequently received treatment with seribantumab through a compassionate use program provided by Elevation Oncology. As of the data cut-off for the presentation, treatment with seribantumab resulted in durable clinical benefit for over 9 months, an approximately 90% reduction in the cancer biomarker CA19-9, and an ongoing 3 month confirmed partial response per RECIST criteria with a maximum tumor reduction of over 50%.
Launched additional global clinical trial sites in CRESTONE. The Company recently launched new clinical trial sites in Canada and Australia. CRESTONE is now open and enrolling patients at approximately 30 clinical trial sites across three countries. Through the "just-in-time" clinical site model in partnership with Caris Life Sciences, Tempus, and US Oncology, there are over 400 available sites that can be activated within the CRESTONE study.
Corporate

Strengthened corporate leadership. During the third quarter, the company announced Valerie Malyvanh Jansen, MD, PhD, as the company’s first Chief Medical Officer. Dr. Jansen was promoted from her prior role as Vice President, Clinical Development.
Upcoming Milestones

Complete enrollment of the first 20 patients in Cohort 1 of the CRESTONE study in mid-2022
Present initial clinical data from approximately 10 patients from Cohort 1 of the CRESTONE study treated with seribantumab at 3 grams weekly at a major medical meeting in mid-2022
Third Quarter 2021 Financial Results

As of September 30, 2021, the Company had cash and cash equivalents totaling $155.2 million, which is expected to fund current operations into the second quarter of 2023.

Research and development expenses for the third quarter 2021 were $9.3 million, compared to $2.6 million for the third quarter 2020. The increase in R&D expense was primarily related to an increase in manufacturing and clinical trial expenses associated with the CRESTONE study.

General and administrative expenses for the third quarter 2021 were $3.0 million, compared to $0.5 million for the third quarter 2020. The increase in G&A expense was primarily related to personnel costs, professional services and consulting, and other administrative costs.

Net loss for the third quarter 2021 was $12.3 million, compared to $3.0 million for the third quarter 2020.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.

On November 12, 2021 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the third quarter ended September 30, 2021 and provided an update on recent business highlights (Press release, Cyteir Therapeutics, NOV 12, 2021, View Source [SID1234595389]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make significant progress in advancing the Phase 1/2 study of our lead program, CYT-0851, as we reached an important milestone with the identification of the Phase 2 dose," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "The Cyteir team is excited to continue with the next steps of CYT-0851 clinical development as we advance the drug into the Phase 2 expansion cohorts as a monotherapy and as we initiate Phase 1 combination therapy with standard chemotherapy, with the ultimate goal of bringing the drug to patients in need."

Third Quarter and Recent Developments Business Review and Operational Updates

CYT-0851

Cyteir completed the dose-escalation portion of its Phase 1/2 study of CYT-0851 up to the maximum feasible daily dose of 1200 mg and declared the maximum tolerated dose of 600mg per day. Dose limiting toxicities of fatigue, vomiting, dehydration, dry skin, stomatitis, myalgia, and acidosis were observed at daily doses of 600mg and above. All were grade 3 events and reversible with dose interruption.

With the dose escalation portion of the study complete, the Phase 2 dose has been identified as 400 mg per day. We continue to enroll patients at the 400mg per day dose and below, to obtain additional safety, pharmacokinetic, and biomarker data. Simultaneously, we are initiating Phase 2 expansion study into disease-specific cohorts and expect to begin enrolling patients in the first quarter of 2022. We are also initiating a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: rituximab plus bendamustine, gemcitabine and capecitabine, in both hematologic malignancies and solid tumors.

Pipeline

Investigational New Drug (IND)-enabling studies with CYT-1853 are ongoing and the Company expects to submit an IND application for CYT-1853 in 2022. Cyteir is also advancing preclinical studies on additional targets to nominate the next target from the Company’s DNA damage response platform.

Third Quarter Financial Results

Cash and cash equivalents: Cash and cash equivalents for the quarter ended September 30, 2021, were $199.8 million. The cash and cash equivalents total for the third quarter includes the $14.5 million in net proceeds raised from the partial exercise of the option to purchase additional shares of common stock by the underwriters of our IPO.

Research and development (R&D) expenses: R&D expenses were $8.2 million for the third quarter of 2021 versus $4.2 million for the same period in 2020. The year-over-year increase in R&D spending in the comparative periods was due primarily to increased R&D and clinical activity and increased headcount.

General and administrative (G&A) expenses: G&A expenses were $3.5 million for the third quarter of 2021 compared to $0.8 million for the same period in 2020. The year-over-year increase in G&A expenses in the comparative periods was primarily due to increased headcount, as well as increased professional fees and other administrative expenses associated with company growth and operating as a public company.

Net loss: Net loss was $11.7 million, or $0.33 per share in the third quarter of 2021 compared to $5.0 million, or $3.44 per share in the third quarter of 2020.

On November 12, 2021 Checkmate Pharmaceuticals, Inc. (Nasdaq: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported third quarter 2021 financial results and provided a business update (Press release, Checkmate Pharmaceuticals, NOV 12, 2021, View Source [SID1234595388]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited about the future of vidutolimod as a potential novel treatment for multiple tumor types, including melanoma and head and neck cancer. We continue to advance our clinical trials towards potential data readouts in 2022," said Alan Fuhrman, interim President and Chief Executive Officer of Checkmate.

Recent Business Updates

During The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, Dr. John Kirkwood from the University of Pittsburgh Medical Center presented a poster on the final clinical data from the Phase 1b study of vidutolimod in combination with pembrolizumab or as a monotherapy in patients with anti-PD-1 refractory melanoma.
Vidutolimod in combination with pembrolizumab led to an ORR of 23.5% by RECIST v1.1, a complete response rate of 7.1%, and a median duration of response of 25.2 months.
Vidutolimod monotherapy resulted in a 20.0% ORR by RECIST v1.1 and a median duration of response of 5.6 months.
The most frequent treatment-related adverse events were consistent with flu-like symptoms and injection site reactions and were most commonly Grade 1 or 2.
We appointed Alan Fuhrman, an experienced biotech executive and Checkmate board member, as interim President and CEO.
Ongoing patient recruitment activities and enrollment across our clinical trials evaluating vidutolimod, including:
A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma, supported by a clinical collaboration with Bristol Myers Squibb.
A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma, also supported by the clinical collaboration with Bristol Myers Squibb.
A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer.
Start-up activities underway for the planned expansion of the development program for vidutolimod in combination with cemiplimab in cutaneous squamous cell carcinoma and Merkel cell carcinoma, supported by a clinical collaboration with Regeneron.
Third Quarter 2021 Financial Results

Research and development expenses (R&D): R&D expenses for the three months ending September 30, 2021, were $11.4 million, compared to $6.7 million for the same period in the prior year. This increase reflects higher third-party CRO and manufacturing costs directly related to the vidutolimod clinical trials, in addition to higher personnel and operating expense for the planning and execution of the clinical trials.
General and administration expenses (G&A): G&A expenses for the three months ending September 30, 2021, were $3.6 million, compared to $3.2 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense incurred in connection with Checkmate operating as a publicly traded company.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $80.8 million as of September 30, 2021.