On March 17, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or "the Company"), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported its financial and operational results, and provided an update for the fourth quarter and year ended December 31, 2021 (Press release, IMV, MAR 17, 2022, View Source [SID1234610225]).

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"2022 is off to a promising start, following the accomplishments across our pipeline in 2021," said Andrew Hall, Chief Executive Officer of IMV. "Our lead compound, MVP-S, has now shown defined clinical benefit across multiple cancers, in both hematological and solid tumors. We also extended our cash runway into the second quarter of 2023 through equity and non-dilutive debt."

"A top priority for the year ahead is to move MVP-S forward on the path toward registration based on the strength of the data observed across several indications to date. In parallel, we continue to look for opportunities to leverage our DPX delivery platform through business development activities," continued Mr. Hall. "Our technology is a highly versatile platform that uniquely mimics the natural flow of antigens to instruct a specific and persistent immune response. The DPX delivery platform has broad potential to generate value in immuno-oncology and eventually other therapeutic areas."

Clinical Programs with Maveropepimut-S (MVP-S)

VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

In January 2022, the Company announced that the first patient was dosed in VITALIZE Phase 2B clinical trial, advancing IMV’s lead compound, MVP-S on the path to a registration trial. This trial is designed to further evaluate the clinical benefit of MVP-S in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with r/r DLBCL.

IMV aims to further validate the strong therapeutic potential previously seen in PD-L1 positive patients who were administered a combination regimen of pembrolizumab, MVP-S and cyclophosphamide (CPA) in its SPiReL Phase 2 study. Eleven clinical sites are now activated in the US and Canada. The Company is currently activating more sites in North America, Europe, Asia and Australia to accelerate enrollment. Early data review from the initial patient group is expected in summer 2022.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

In December 2021, IMV announced the completion of enrollment in its Phase 2 basket trial in collaboration with Merck. This trial’s objectives were to identify and select the best solid tumor opportunities for the combination of MVP-S with Merck’s anti PD-1 checkpoint inhibitor Keytruda and CPA. Topline data from the metastatic bladder cohort were particularly promising. Clinical benefit (measured as complete responses, partial responses, and stable disease by standard RECIST criteria) was observed in advanced, metastatic bladder cancer patients, including in patients who had received prior immune checkpoint inhibitor therapy.

Data observed in this cohort of the trial will be presented at a late-breaking oral symposium at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2022.

Presentation Number: CT035

Session Date and Time: Tuesday Apr. 12, 2022, 2:30 p.m. – 4:30 p.m. CST

AVALON Phase 2B Trial in Platinum-Resistant Ovarian Cancer.

The Company is preparing to initiate AVALON, Phase 2B, single arm trial evaluating MVP-S and intermittent low-dose CPA in subjects with platinum-resistant ovarian cancer. The goal of this trial is to further evaluate the data observed in our Phase 2 DeCidE trial. The AVALON design was informed by results from the DeCidE study, completed in 2021. Among patients with advanced and recurrent ovarian cancer receiving MVP-S and intermittent, low-dose CPA, nearly half survived to 2 years. Treatment-related adverse events (AEs) were mostly Grade 1 and Grade 2 and tolerable. Translational analyses from DeCidE (presented at the SITC (Free SITC Whitepaper) annual meeting and ESMO (Free ESMO Whitepaper)-IO congress in 2021) implicated roles for both T and B cells in the sustained, anti-tumor immune response induced by MVP-S. Site selection and activation are ongoing, and the first patient is expected to be dosed in H2 2022.

Phase 1B Trial in HR+/HER2- Breast Cancer

In November 2021, enrollment was initiated in the Phase 1B trial of MVP-S in hormone receptor positive/HER2-negative (HR+/HER2-) breast cancer. For the first time, MVP-S is being evaluated in a neoadjuvant setting with an aromatase inhibitor. Across the three arms of this study, MVP-S will be evaluated in 18 subjects with resectable, non-metastatic HR+/HER2- breast cancer. This investigator-initiated phase 1B clinical study is being conducted at the Providence Cancer Institute in Oregon. Early data are expected to be presented in late 2022.

Clinical Programs with IMV’s Second DPX-based Product Candidate, DPX-SurMAGE

IMV initiated a Phase 1 clinical trial evaluating both MVP-S and DPX-SurMAGE, in patients with non-muscle invasive bladder cancer (NMIBC) in early 2022. Preliminary data are expected by the end of 2022.

Research and Development Day Held on February 24

IMV hosted a "Research and Development Day" for the investment community via webcast on February 24, 2022. The event featured a presentation by Michael Kalos, Ph.D., member of IMV’s Board of Directors and internationally recognized pioneer in T cell therapy and immunotherapy. During the presentation, Dr. Kalos gave an overview of the differentiated capabilities of IMV’s DPX delivery technology. IMV’s Chief Scientific Officer, Dr. Jeremy Graff, further detailed the unique mechanism of action of the DPX platform, its differentiation from first generation cancer vaccine efforts and data from the lead DPX product, MVP-S, which provide the clinical and pre-clinical proof of concept for DPX-based immune instruction. A replay of the event can be found here.

Selected Upcoming Milestones

Maveropepimut-S (MVP-S):

April 2022: Present detailed top line data on the bladder cancer cohort from the basket trial at a late-breaking oral presentation at the annual AACR (Free AACR Whitepaper) meeting.
Summer 2022: Provide clinical update on the open-label Phase 2B VITALIZE r/r DLBCL trial.
H2 2022: Initiate enrollment in AVALON open-label Phase 2B Avalon platinum-resistant ovarian cancer trial.
December 2022: Present first clinical and translational results update for the investigator-initiated breast cancer trial.
Q4 2022: Present preliminary Phase 1 data from the MVP-S and DPX-SurMAGE in non-muscle invasive bladder cancer (NMIBC).
Corporate Updates

Andrew Hall Appointed as Chief Executive Officer (CEO)

The company’s Board of Directors appointed Andrew Hall to the role of Chief Executive Officer and Director of the Board, effective January 1, 2022.

Kabir Mody, M.D. Appointed as Medical Director

Dr. Kabir Mody joined IMV earlier this year as Medical Director. Dr. Mody brings experience in clinical oncology from the Mayo Clinic where he most recently served as vice chair to the Division of Hematology/Oncology and as Associate Professor of Medicine.

Anthony Atala, M.D. Joined as Clinical Advisor

Anthony Atala, M.D., is an American bioengineer, urologist, and pediatric surgeon. Dr. Atala is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine, and the W. Boyce Professor and Chair of the Department of Urology at Wake Forest University. His work focuses on growing human cells, tissues and organs. Fifteen applications of technologies developed in Dr. Atala’s laboratory have been used clinically in patients. Dr. Atala has led or served on several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, and the National Cancer Institute’s Advisory Board.

Overview of Full Year 2021 Financial Results

As of December 31, 2021, the Company had cash and cash equivalents of $38.6 million, compared to $36.3 million as of December 31, 2020. The increase in cash primarily reflects proceeds from the $25 million public offering completed on July 20th, $15 million in proceeds from the first tranche of the Horizon Venture Debt Facility and $2.3 million in proceeds raised from the October 2020 At-The-Market (ATM) offering, offset by cash used for operations and the repayment of a debt facility. Based on its current operating plan, IMV expects its current cash position will be sufficient to fund operations into the second quarter of 2023.

Research and development expenses were $23 million for the year ended December 31, 2021, compared with $19.9 million for the year ended December 31, 2020. This increase of $3.2 million was mainly due to a rise in expenses related to the manufacturing and development costs for MVP-S, start-up costs for the DLBCL phase 2B trial, and personnel costs due to an increase in headcount. The increase was offset in part by a decline in DPX-COVID-19 development costs due to program deprioritization as part of a strategic realignment and the completion of the ovarian trial.

General and administrative expenses were $16 million for the year ended December 31, 2021, compared with $11.3 million for the year ended December 31, 2020. This increase was largely attributable to salaries and non-cash stock-based compensation related to planned hiring and executive leadership changes, an increase for the Company’s insurance premium, an increase in professional fees, as well as an increase in board directors’ compensation.

The net loss and comprehensive loss of $36.7 million ($0.49 per share) for the year ended December 31, 2021, was $10.5 million higher than the net loss and comprehensive loss for the year ended December 31, 2020.

On March 16, 2022, the number of issued and outstanding Common Shares was 82,221,363 and a total of 19,642,549 shares are reserved for the issuance of outstanding stock options, warrants and deferred share units.

The Company’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2021 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as on the Company’s website at www.imv-inc.com

Conference Call and Webcast Information

Management will hold a conference call and webcast on Thursday, March 17, 2022, at 8:00 a.m. EST to discuss the company’s 2021 fourth quarter and fiscal year-end financial and operational results.

Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5049587

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On March 17, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported the upcoming oral presentation of the discovery and initial clinical utility of a novel signature that identifies patients with head and neck squamous cell carcinoma (HNSCC) that may benefit from treatment beyond typical surgical resection (Press release, GeneCentric Therapeutics, MAR 17, 2022, View Source [SID1234610259]). The presentation will be made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, one of the world’s largest and long-standing scientific gatherings in the field of cancer research, which is being held in New Orleans, Louisiana, April 8-13, 2022. The results to be presented are from an ongoing collaboration with Jose P. Zevallos, MD, MPH, at the Washington University School of Medicine in St. Louis and Neil Hayes, MD, MPH, at the University of Tennessee Health Science Center’s Center for Cancer Research to discover and develop new prognostic and/or predictive signatures and related tests to aid in the selection of treatments for HNSCC.

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Multiple independent retrospective datasets were utilized as part of the initial signature discovery, including those providing for its initial clinical utility. Oral cavity HNSCC patients with lymph node-negative disease, who are typically treated with surgical resection without additional radiation and/or chemotherapy, were identified as mesenchymal or non-mesenchymal based upon the novel RNA-based signature. For the nearly one-quarter who were mesenchymal, survival was 2.4-fold worse compared to the remaining non-mesenchymal patients. A future diagnostic test, based upon this signature and related clinical findings, potentially may be used to ‘upstage’ patients typically receiving only surgical reduction to become candidates for the addition of radiation and/or chemotherapy.

"I am excited to present our initial findings from this important collaboration with my colleagues at Washington University School of Medicine and GeneCentric evaluating molecular subtypes for head and neck cancer," said Neil Hayes, MD, MPH, GeneCentric co-founder and Director of the University of Tennessee Health Science Center’s Center for Cancer Research. "In this study, our new RNA-based signature identified a significant population of patients who typically only undergo surgical resection based upon their lymph node status but have poor prognosis, making them likely candidates for additional treatment options such as radiation and/or chemotherapy."

Full results from the initial molecular analysis and clinical utility from this study, as well as potential future applications, will be presented at the conference. Further demonstration of clinical utility is ongoing, as well as initial test development discussions with several commercial reference laboratories.

Details regarding the presentation are provided below and will be available following the meeting at View Source

Title: Prognostic and predictive applications from mesenchymal gene expression subtype analysis for early-stage, HPV(-) head and neck squamous cell carcinoma
First Author: Neil Hayes, MD, MPH, Department of Medical Oncology, University of Tennessee Health Science Center’s Center for Cancer Research, Memphis, Tennessee
Abstract Number: 2142
Session: Session MS.CL11.02 – Biomarkers 2
Date: April 11, 2022
Time: 3:20-3:35 PM CST

About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers worldwide, and in the United States it is estimated that there were approximately 66,000 new cases and 14,00 deaths in 2021. The 5-year overall survival for Stage I-II and III-IV HNSCC is approximately 70-90% and 40-60%, respectively. Oral cavity HNSCC is the most common head and neck cancer, accounting for one-third of cases with a majority HPV-negative and associated with tobacco use. While the treatment of HNSCC depends on multiple tumor and patient-related factors, the three main treatments are surgical resection, radiation therapy and chemotherapy. Patients with early-stage lymph node-negative tumors are generally treated with surgical resection, but treatment for those with more advanced lymph node-positive tumors often includes radiation and/or chemotherapy.

On March 17, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, reported the planned upgrade of its Research and Development laboratory facility for formulations intended to treat cancers (Press release, Vivesto, MAR 17, 2022, View Source [SID1234611840]).

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The laboratory facilities, in Uppsala, Sweden, are being upgraded to provide greater capacity to handle these formulations which include new formulations of Cantrixil and formulations using Oasmia’s proprietary drug delivery platform.

Oasmia acquired the global development and commercialization rights for Cantrixil from Kazia Therapeutics, an Australian oncology-focused biotechnology company in March 2021. Following the publication of positive Phase I results, Oasmia is now preparing for the initiation of a Phase II trial of an intraperitoneal formulation of Cantrixil in advanced ovarian cancer. Oasmia will, among other things, be developing a preclinical intravenous formulation of Cantrixil which will be developed at the new facility in Uppsala.

Kai Wilkinson PhD., Chief Technical Officer of Oasmia, commented "With this new laboratory facility, we will be expanding our capabilities to provide novel developments and formulations. Not only will we be able to formulate new compounds for further clinical testing, but we will also be able to handle more advanced synthesis work, if required."

On March 17, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported full access to its Personalized Cancer Monitoring (PCMTM) platform to help detect minimal or molecular residual disease (MRD) in patients with solid tumors (Press release, Invitae, MAR 17, 2022, View Source [SID1234610226]). Invitae PCM uses a novel set of personalized assays based on a patient’s tumor to detect circulating tumor DNA (ctDNA) in blood, offering the ability to perform risk stratification, response assessment to treatment and detection of cancer recurrence, based on recent studies.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Relapse risk stratification is a clinical need for many patients undergoing treatment for solid tumors and is best served by up-to-date molecular tools to complement and improve upon the standard of care methods for recurrence detection," said Robert Nussbaum, M.D., chief medical officer, Invitae. "The PCM platform complements current monitoring methods, and has the ability to determine a cancer therapy’s effectiveness earlier than those methods for many patients, allowing clinicians the opportunity to refine treatment options."

Over the past several years, research from Invitae and the greater scientific community, including the TRACERx study led by Professor Charles Swanton at the Francis Crick Institute and University College London (UCL), and funded by Cancer Research UK, has shown that MRD monitoring can reliably identify lung cancer patients at high risk of relapse, detect post-surgical recurrence often earlier than standard imaging, assess therapy response, and potentially act as a surrogate for clinical trial endpoints. With these capabilities, MRD monitoring promises to shorten clinical trials and accelerate the development of potentially life-saving new drugs. Invitae PCM is a pan-cancer, tumor-informed liquid biopsy assay, co-developed with the TRACERx consortium, that uses a next generation sequencing (NGS) to analyze ctDNA in a patient’s plasma.

"MRD is an important biomarker in the adjuvant and surveillance period," said Professor Charles Swanton, MBPhD, FRCP, FMedSci, FRS, FAACR, at the Francis Crick Institute and UCL Cancer Institute and Chief Clinician of Cancer Research UK. "As we’ve seen in the TRACERx study, PCM provides prognostic information, can aid in cases of radiographic ambiguity, and demonstrates high clinical sensitivity and specificity."

Liquid biopsy tests have been available for therapy selection, but to identify MRD at an earlier stage than conventional methods before patients clinically relapse, the technology must be sensitive enough to detect ctDNA at very low levels. Additionally, an MRD test with high specificity is also needed to reduce the likelihood of false positive results. The PCM test utilizes advanced technologies to arrive at high levels of sensitivity and specificity, detecting tumor DNA at very low levels of concentrations in peripheral blood. Validation studies demonstrate greater than 99.9% sensitivity in detecting ctDNA at a 0.008% variant allele frequency.

"We are excited about PCM availability globally, as this is an evolving area where we have invested over the last year and we believe has the potential to give patients the information needed to understand their recurrence risk to fight and beat the disease," said Sean George, Ph.D., co-founder and CEO of Invitae.

Each assay is custom designed to detect a patient’s unique tumor signature, allowing for personalized results to guide treatment decisions. Invitae PCM requires both blood and tumor tissue samples from the patient to conduct tumor-normal whole exome sequencing (WES). Based on the results, Invitae’s proprietary algorithm selects 18-50 tumor-specific variants to include on the patient’s custom-designed ctDNA panel. This range of variants allows for a balance of highly sensitive and specific MRD detection in cancers that have lower or higher mutational burdens.

If an MRD-positive result is obtained at any point in a cancer patient’s journey, the clinician and patient can discuss the implications of the result and the most appropriate treatment or clinical trial options. "This molecular knowledge impacts cancer patients throughout their cancer journey, making this a mainstay in precision oncology," said George.

Invitae is actively expanding the research portfolio globally to continue to gather data on PCM clinical utility as well as MRD-guided studies. Invitae anticipates multiple publications this year across its PCM studies in lung, breast, head and neck, and GI tumors as well as several prospective studies kicking off in the first half of the year. These prospective studies include a pan-tumor study (MARIA) and several studies in breast and GI cancers, including ARTEMIS, a study examining Invitae’s PCM offering specifically for patients with pancreatic cancer. The study will be conducted in partnership with a high profile institution near Tokyo, the National Cancer Center Hospital East, Kashiwa, Chiba, Japan. Sample collection will begin in Q2 2022.

On March 17, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the fourth quarter and full-year ending December 31, 2021 (Press release, In8bio, MAR 17, 2022, View Source [SID1234610260]). In addition, the Company provided an overview of recent corporate developments.

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"Our leading clinical programs, INB-100 in leukemia and INB-200 in newly diagnosed GBM, are advancing and generating promising early clinical results," said William Ho, Chief Executive Officer and co-founder of IN8bio. "We are encouraged by these data and hopeful that these trends will translate to real long-term benefits for cancer patients in terms of durable remissions and increased time with respect to survival. We look forward to providing clinical updates and announcing exciting new preclinical programs throughout this year."

Business Highlights & Updates

In October 2021, IN8bio announced the peer-reviewed publication of preclinical results that provide the foundational support for the Phase 1 trial of its DeltEx Drug Resistant Immunotherapy (DRI) in newly diagnosed GBM. This work, published in Scientific Reports, a Nature Portfolio journal, focused on the use of gamma-delta T cells genetically engineered to be chemotherapy resistant through the addition of a gene encoding the O6-Methylguanine-DNA Methyltransferase (MGMT) protein. Concurrent dosing of DRI cells with temozolomide (TMZ) chemotherapy resulted in 80% long-term survivors and complete eradication of tumor in a patient-derived xenograft model of classical primary high-grade gliomas.
In November 2021, IN8bio presented preclinical data on the potential for their DeltEx DRI in combination with poly (ADP-ribose) polymerase (PARP) inhibitors in solid tumors at the 36th Annual Meeting of the Society for Immunotherapy Conference (SITC; Poster 158). The research, conducted in collaboration with the laboratory of Dr. Anita Hjelmeland, at the University of Alabama at Birmingham (UAB), demonstrated that gamma-delta T cell therapy could be enhanced through therapeutic combinations that drive increased mRNA expression of immune markers (NKG2DL) by as much as 2,800%.
In November 2021, IN8bio appointed Trishna Goswami, M.D., as Chief Medical Officer. Dr. Goswami has extensive experience managing the clinical development and regulatory approval of oncology product candidates, including those for both solid and hematologic tumors.
In December 2021, IN8bio promoted Kate Rochlin, Ph.D., to Chief Operating Officer. Dr. Rochlin had previously served as the Company’s Vice President, Operations and Innovation.
In December 2021, IN8io provided an update from the ongoing Phase 1 clinical trial of its allogeneic gamma-delta T cell therapy, INB-100, in leukemia patients undergoing HSCT. Of the three patients treated, all remain in morphologic remission with durable responses of greater than 1.5 years observed in two patients. The third patient remains in remission for six months as of December 2021.
In January 2022, IN8bio provided a clinical update from the Phase 1 clinical trial of its genetically modified gamma-delta T cell therapy candidate in newly diagnosed GBM. In the single ascending dose cohort 1 (n=3), all three patients showed no dose limiting toxicities (DLTs), cytokine release syndrome, or neurotoxicity and showed a manageable safety profile. Cohort 2, which received three repeat doses of DeltEx DRI gamma-delta T cells, includes one patient who has received all three doses without any DLTs or significant drug related adverse events. Of the four patients treated as of the last clinical update on January 6, 2022, all have exceeded their expected progression-free survival interval based on age and MGMT status and with encouraging trends in overall survival.
Upcoming Milestones and Events

Second half of 2022: Plan to file an investigational new drug (IND) application for a Phase 1b/2 clinical trial of INB-400 in GBM.

May 2022: plan to hold an investor event during the American Society of Gene + Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting.

2022: Plan to announce new preclinical programs and indications.
Recent and Expected Upcoming Scientific Presentations

European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2022 (virtual), March 2022: presenting preclinical data on novel gamma-delta CAR-T approaches for systemic delivery in solid tumors (Poster 23P).

48th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) (hybrid), Prague, Czech Republic, March 2022: presenting on INB-100 clinical status and correlative biology.

American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, New Orleans, April 2022: two presentations; (1) "Dual chlorotoxin and methylguanine-DNA methyltransferase (MGMT) gamma-delta T cells for drug resistant immunotherapy" (INB-300) and (2) "maintenance-phase temozolomide as a lymphodepletion platform for intracranial-adoptive gamma-delta T cell-based therapy in primary high-grade gliomas" (INB-200).

International Society for Cell & Gene Therapy (ISCT) 2022, San Francisco, May 2022.

ASGCT 25th Annual Meeting, Washington, D.C., May 2022: Presenting new programs along with an oral presentation by Lawrence Lamb, Ph.D., Off the Shelf Cell Therapies – Beyond T Cells (Education Session); The Next Generation of γδ T Cell-based Therapies.
Fourth Quarter and Full Year 2021 Financial Highlights

Cash position: As of December 31, 2021, the Company had cash of $37.0 million, compared to $18.0 million as of December 31, 2020. The increase in cash was primarily due to the initial public offering proceeds, net of cash used by the Company in operations to advance its programs and research and development.
Research & Development (R&D) expenses: R&D expenses were $2.7 million for the three months ended December 31, 2021, compared to $1.5 million for the comparable prior year period. R&D expenses were $7.3 million for the year ended December 31, 2021, compared to $5.4 million in the prior year. The increase in R&D expenses were primarily due to increased personnel-related costs, including salaries, benefits and stock-based compensation. In addition, for the year, the increase in R&D expenses were related to increased third-party clinical trial-related activities and contract manufacturing costs for the ongoing clinical trials.
General and administrative expenses: General and administrative expenses were $3.2 million for the three months ended December 31, 2021, compared to $0.8 million for the comparable prior year period. General and administrative expenses were $7.3 million for the year ended December 31, 2021, compared to $3.2 million in the prior year. The increase was primarily due to increased personnel costs, including salaries, benefits and stock-based compensation, increased legal expenses, facilities and costs associated with operating as public company.
Net loss: The Company reported a net loss of $5.9 million, or $0.44 per basic and diluted common share, for the three months ended December 31, 2021, compared to a net loss of $2.3 million and a net loss attributable to common stockholders of $3.0 million, or $0.82 per basic and diluted common share, for the comparable prior year period. For the full year, net loss was $14.7 million, or $1.47 per basic and diluted common share compared to a net loss of $8.6 million and a net loss attributable to common stockholders of $10.3 million, or $3.02 per basic and diluted common share, for the comparable prior year.