On March 21, 2022 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported business highlights and financial results for the fourth quarter and full year 2021 (Press release, Caribou Biosciences, MAR 21, 2022, View Source [SID1234610472]).

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"2021 was a year of tremendous accomplishment for Caribou as we completed our successful IPO, advanced our pipeline of allogeneic CAR-T and CAR-NK cell therapies, including the initiation of the ANTLER Phase 1 clinical trial for our lead program CB-010, and expanded our leadership team," said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. "These achievements put us in a great position to execute on our 2022 plans to present initial data from the ANTLER clinical trial for CB-010 at a medical meeting; submit an IND for CB-011, our second allogeneic CAR-T cell program; and share target selection for CB-020, our first genome-edited CAR-NK cell therapy. We believe our chRDNA genome-editing platform has superior specificity and has the potential to be applied across a broad number of therapeutic applications, in oncology and beyond."

Recent Business Highlights

Pipeline

•Caribou continues to enroll patients in ANTLER, a Phase 1 clinical trial of CB-010 in adults with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010 is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) technology to insert a CD19-specific CAR into the TRAC gene and knock out PD-1 to boost the persistence of antitumor activity. More information can be found at www.clinicaltrials.gov (NCT04637763).
•Caribou is conducting IND-enabling studies to support a planned IND application submission in 2022 for CB-011 in patients with relapsed or refractory multiple myeloma (r/r MM). CB-011 is an allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology to insert a BCMA-specific CAR into the TRAC gene and armor the cells with an immune cloaking strategy that includes a knockout of the endogenous B2M gene and site-specific insertion of a B2M–HLA-E fusion transgene into the B2M gene.

Expanded leadership team

•In January 2022, Caribou appointed Syed Rizvi, M.D., as chief medical officer. Dr. Rizvi has more than two decades of experience in all stages of drug development, from clinical strategy and execution through regulatory submissions to support approval and commercialization of several cancer treatments, including three approved autologous CAR-T cell therapies ABECMA, BREYANZI, and CARVYKTITM. Prior to joining Caribou, Dr. Rizvi served as chief medical officer of Chimeric Therapeutics and worked for Legend Biotech, Celgene Corporation (now Bristol Myers Squibb), Novartis, Merck, and Genta, Inc. Since the beginning of 2021, Caribou has welcomed three new members of the executive leadership team. In addition to Dr. Rizvi, Ruhi Khan joined as chief business officer, and Jason O’Byrne joined as chief financial officer.
•In January 2022, Zili An, M.D., joined Caribou as Vice President of Pharmacology. He brings over 20 years of drug development experience in multiple cancer therapeutic modalities, including CAR-T cell therapies.
•During 2021, Caribou expanded its board of directors, which currently includes Andrew Guggenhime (board chair), Scott Braunstein, M.D., Rachel Haurwitz, Ph.D., Dara Richardson-Heron, M.D., Natalie Sacks, M.D., Nancy Whiting, Pharm.D., and Ran Zheng. Caribou’s directors bring significant and broad expertise in strategy, drug development, operations, and patient need.
•In 2021, two new members joined the Caribou’s scientific advisory board, Katy Rezvani, M.D., Ph.D., and Christopher Sturgeon, Ph.D., both of whom bring significant expertise in the development and role of natural killer (NK) cells in mediating immunity against hematologic and solid tumors.

Anticipated Milestones for 2022 and Beyond

•CB-010: Caribou expects to present initial data from its ongoing ANTLER Phase 1 trial for CB-010, an anti-CD19 CAR-T cell therapy, in adults with r/r B-NHL at a medical meeting in 2022.
•CB-011: Caribou expects to submit an IND application for CB-011, an anti-BCMA CAR-T cell therapy, in r/r MM in 2022.
•CB-020: Caribou expects to announce target selection for CB-020, an iPSC-derived CAR-NK cell therapy in 2022. Additionally, Caribou expects to disclose multiple armoring strategies under development for its CAR-NK platform in 2022.
•CB-012: Caribou expects to submit an IND application for CB-012, an anti-CD371 CAR-T cell therapy for r/r AML, in 2023.

Upcoming Meetings

•American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting – April 10, 2022, presentation of preclinical data from Caribou’s CB-011 program
•Cell & Gene Meeting on the Med – April 20-22, 2022, corporate overview
•Allogeneic Cell Therapies Summit – May 9-12, 2022, Caribou scientists will provide an overview of the company’s T cell programs

Fourth Quarter and Full Year 2021 Financial Results

Cash, cash equivalents, and marketable securities: Caribou had $413.5 million in cash, cash equivalents, and marketable securities as of December 31, 2021, which included $321.0 million in aggregate net proceeds from the company’s IPO completed in July and August 2021. Additional funding during 2021 came from the Series C financing completed in March 2021 and an upfront payment from Caribou’s collaboration and license agreement with AbbVie in February 2021.

Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $2.6 million for the three months ended December 31, 2021 and $9.6 million for the full year 2021, compared to $1.0 million and $12.4 million, respectively, for the same periods in 2020. The decrease for the year ended December 31, 2021, was primarily due to revenue recognized in 2020 pursuant to an exclusive license agreement between Caribou and a private company, partially offset by an increase in revenue recognized in 2021 pursuant to the AbbVie agreement.

R&D expenses: Research and development expenses were $15.1 million for the three months ended December 31, 2021, and $52.3 million for the full year 2021, compared to $12.0 million and $34.4 million, respectively, for the same periods in 2020. The increase for the year ended December 31, 2021, was primarily due to costs associated with clinical trial and preclinical study activities, personnel-related expenses attributable to increased headcount, and facilities expenses, partially offset by a decrease in expenses related to licenses and sublicensing revenues.

G&A expenses: General and administrative expenses were $7.9 million for the three months ended December 31, 2021, and $24.3 million for the full year 2021, compared to $4.2 million and $14.1 million, respectively, for the same periods in 2020. The increase for the year ended December 31, 2021, was primarily due to personnel-related expenses attributable to increased headcount, legal and accounting services associated with operating as a public company, and facilities and other expenses.

Other income (expense): The company recorded other income of $2.2 million for the three months ended December 31, 2021, and $0.4 million for the full year 2021.

Net loss: For the three months and year ended December 31, 2021, net loss was $18.5 million and $66.9 million, respectively, compared to $14.7 million and $34.3 million, respectively, for the same periods in 2020.

About Caribou’s Novel Next-Generation CRISPR Platform

CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Type II and Type V CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems occasionally edit unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed chRDNAs (pronounced "chardonnays"), RNA-DNA hybrid guides that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies.

On March 21, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Stifel 2022 CNS Days virtual conference at 3:30 p.m. Eastern Time on Monday, March 28, 2022 (Press release, Neurocrine Biosciences, MAR 21, 2022, View Source [SID1234610471]). Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On March 21, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the discontinuation of ORIC-101 and also reported financial results and operational updates for the quarter and year ended December 31, 2021 (Press release, ORIC Pharmaceuticals, MAR 21, 2022, View Source [SID1234610470]). The company conducted planned interim analyses of two Phase 1b studies and concluded that ORIC-101 did not demonstrate sufficient clinical activity to warrant further development.

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"We are disappointed in the outcome of the ORIC-101 studies in combination with nab-paclitaxel in various solid tumors and in combination with enzalutamide in metastatic prostate cancer, two late-line patient populations for whom limited treatment options exist today. We believe both studies were well designed, allowing us to thoroughly and efficiently answer an important clinical question. With this decision to discontinue ORIC-101 development, we would like to thank the investigators, site staff, the ORIC team, and most importantly, patients and families who participated in the trials," said Pratik S. Multani, MD, chief medical officer.

"We’ve always been committed to rapid, data driven decision making and allocating resources efficiently and prudently," said Jacob M. Chacko, MD, chief executive officer, "We intentionally built a diverse pipeline of differentiated programs, which includes our Phase 1b single agent trials for ORIC-533, our orally bioavailable CD73 inhibitor, ORIC-114, our brain penetrant EGFR/HER2 inhibitor, and ORIC-944, our embryonic ectoderm development (EED) inhibitor. We expect to report initial data from each study in the first half of 2023. As a result of the ORIC-101 discontinuation, we project our cash runway to extend into the second half of 2024, well beyond the planned initial data disclosures from these three clinical programs."

Fourth Quarter 2021 and Other Recent Highlights

ORIC-101: Glucocorticoid Receptor Antagonist

Based on interim analyses from the two Phase 1b studies, ORIC-101 did not demonstrate sufficient clinical activity and, therefore, the company has discontinued further development.

The dose expansion portion of the Phase 1b clinical trial of ORIC-101 in combination with enzalutamide enrolled 28 patients at the recommended phase 2 dose (RP2D) with metastatic prostate cancer progressing on enzalutamide. The RP2D was well tolerated with a safety profile consistent with previously reported results. ORIC-101 in combination with enzalutamide did not translate into a meaningful clinical benefit, with a median progression-free survival (PFS) in the target patient population of 3.7 months.

The dose expansion portion of the Phase 1b clinical trial of ORIC-101 in combination with nab-paclitaxel enrolled 61 patients at the RP2D across four cohorts: pancreatic ductal adenocarcinoma (PDAC), ovarian cancer, triple negative breast cancer (TNBC), and other advanced solid tumors. The RP2D was well tolerated with a safety profile consistent with previously reported results. There were no objective responses in the PDAC cohort (n=21) and there was one confirmed partial response in the ovarian cancer cohort (n=13). There was no meaningful clinical benefit based on median PFS across all cohorts (PDAC: 1.9 months, and ovarian cancer: 2.2 months).

ORIC-533: CD73 Inhibitor
ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73 and has demonstrated more potent adenosine inhibition in preclinical studies compared to an antibody approach and other small molecule inhibitors of the adenosine pathway.

Ex vivo human data supporting the therapeutic potential of single agent ORIC-533 in multiple myeloma were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
Single agent activity in an autologous bone marrow mononuclear assay system from multiple myeloma patients showed CD73 inhibition compared favorably to approved therapies for the treatment of multiple myeloma, including lenalidomide, bortezomib and daratumumab.
A Phase 1b trial with ORIC-533 as a single agent in multiple myeloma is enrolling patients and initial data are expected to be reported in the first half of 2023.

ORIC-114: EGFR/HER2 Inhibitor
ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations.

Compelling brain exposure and antitumor activity of ORIC-114 in preclinical studies of HER2-positive breast cancer were presented at AACR (Free AACR Whitepaper)-NCI-EORTC.
Head-to-head data in an EGFR exon 20 NSCLC xenograft model were disclosed demonstrating good tolerability and improved efficacy, including a 90% complete response rate, with ORIC-114 versus multiple clinical stage exon 20 inhibitors.
The Clinical Trial Application (CTA) for ORIC-114 was filed in the fourth quarter of 2021 and was cleared by the regulatory authorities of the Republic of Korea in the first quarter of 2022.
A Phase 1b trial with ORIC-114 as a single agent has been initiated and will enroll patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and will allow patients with CNS metastases that are either treated or untreated but asymptomatic. The company expects to report initial Phase 1b data from this trial in the first half of 2023.
ORIC-944: PRC2 Inhibitor
ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies.

The IND for ORIC-944 was cleared by the FDA in the fourth quarter of 2021.
A Phase 1b trial with ORIC-944 as a single agent will enroll patients with metastatic prostate cancer. The company expects to report initial Phase 1b data from this trial in the first half of 2023.
PLK4 Inhibitor Program
In March, the company announced a small molecule therapeutic program intended to address a mechanism of innate resistance found in a subset of breast cancers, specifically a synthetic lethal interaction of polo-like kinase 4 (PLK4) inhibition in tumors bearing a TRIM37 DNA amplification. Breast cancer models as well as other tumor models with this TRIM37 amplification have a key tumor dependency on PLK4 and our therapeutic approach is to selectively inhibit this enzyme.

Corporate
In November 2021, the company appointed Angie You, PhD, to its board of directors. Dr. You was most recently CEO of Amunix Pharmaceuticals, which was acquired by Sanofi, and brings broad experience spanning venture capital, business development and public company leadership roles.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533: Initial Phase 1b data in 1H 2023
ORIC-114: Initial Phase 1b data in 1H 2023
ORIC-944: Initial Phase 1b data in 1H 2023
Fourth Quarter and Full year 2021 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $280.4 million as of December 31, 2021, and with the discontinuation of ORIC-101, the company expects its cash runway to be extended into the second half of 2024.

R&D Expenses: Research and development (R&D) expenses were $16.7 million for the three months ended December 31, 2021, compared to $12.1 million for the three months ended December 31, 2020, an increase of $4.6 million. For the year ended December 31, 2021, R&D expenses were $56.9 million compared to $35.9 million for the same period of 2020, an increase of $20.9 million. The increases for the 2021 periods were primarily driven by an increase in external expenses related to the advancement of ORIC-101, ORIC-533 and our other product candidates, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.7 million and $2.9 million for the three and twelve months ended December 31, 2021, as compared to the same periods in 2020, respectively.

G&A Expenses: General and administrative (G&A) expenses were $6.1 million for the three months ended December 31, 2021, compared to $4.3 million for the three months ended December 31, 2020, an increase of $1.8 million. For the year ended December 31, 2021, G&A expenses were $22.0 million compared to $13.4 million for the same period in 2020, an increase of $8.6 million. These increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.1 million and $4.6 million for the three and twelve months ended December 31, 2021, as compared to the same periods in 2020, respectively, and higher costs related to operating as a public company.
Webcast and Conference Call

ORIC will host a conference call and webcast today at 5:00 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 8637367. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

On March 21, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, reported that the companies have signed a large-scale manufacturing agreement for the main drug intermediate in the supply of clinical material for its investigational drug candidate, Cantrixil (Press release, Oasmia, MAR 21, 2022, View Source [SID1234610469]).

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Cantrixil, an intraperitoneally administered drug in development for the treatment of late-stage ovarian cancer, was licensed by Oasmia from the Australian pharmaceutical company Kazia in 2021, having successfully completed a Phase I trial. Ovarian cancer is one of the most aggressive cancers and is difficult to treat in advanced stages. The Phase I study of Cantrixil demonstrated the potential for it to provide prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy. Oasmia is now preparing for the initiation of a Phase II trial of Cantrixil in advanced ovarian cancer.

Under the terms of the agreement, Lonza will provide kilogram-scale synthesis, purification, and stability testing of Cantrixil, and deliver cGMP batches of drug substance for clinical supply. Oasmia will leverage Lonza’s extensive experience and expertise in manufacturing highly-potent API (HPAPI). The drug substance will be manufactured at Lonza’s recently expanded production facility at Nansha, China. The manufacturing is expected to begin later in March 2022.

Kai Wilkinson, Chief Technical Officer at Oasmia, commented: "We are excited to have partnered with Lonza, a global leader in drug manufacturing. The manufacture of Cantrixil is planned to be performed in three steps and this agreement is the first and most crucial step in us securing the clinical drug supply for its development."

Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, added: "Our team has extensive experience with supporting the development and manufacture of challenging molecules. We are looking forward to collaborating with Oasmia to advance this promising drug candidate in the clinic."

On March 21, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for 2021 and provided a business update (Press release, Diffusion Pharmaceuticals, MAR 21, 2022, View Source [SID1234610467]).

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Corporate Strategy and Events

Business and financial highlights during 2021 and 2022 year-to-date include:

Declared Lead Development Program: The Company announced its intent to develop its novel, oxygen enhancing therapeutic, Trans Sodium Crocetinate ("TSC"), as an adjunct to standard of care therapy for hypoxic solid tumors in November 2021 ("Hypoxic Solid Tumor Program").

Strengthened Balance Sheet: In February 2021, the Company raised approximately $34.5 million in gross proceeds through an up-sized, follow-on public offering of its common stock with proceeds to be used to fund research and development efforts for the TSC oxygenation trials ("Oxygenation Trials") and corporate expenses. As of December 31, 2021, the Company reported a total of $37.3 million in cash and cash equivalents. As of March 18, 2022, the Company expects cash resources to fund operations through 2023.

Board Updates: Jane Hollingsworth appointed as new Board Chair in June 2021. Diana Lanchoney, M.D., and Eric Francois also elected to the Company’s board of directors in June 2021.

"We are pleased with the progress we achieved in 2021. We executed our corporate, clinical, and regulatory strategies, accelerating development of our lead product candidate, TSC. The capital we raised in the first half of 2021 allowed us to design and execute critical clinical trials to assess TSC’s therapeutic potential in treating hypoxia-related conditions using three unique short-term experimental clinical models of oxygenation," said Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion.

Dr. Cobuzzi continued, "We believe the hard work demonstrated by our team in 2021 has laid a solid foundation for Diffusion’s success in 2022. The initiation of our Altitude and ILD-DLCO trials in the last quarter of 2021 represented a significant inflection point on the route to achieving the goal of demonstrating TSC’s potential to enhance the body’s ability to deliver oxygen to areas where it is needed most and potentially provide a novel treatment option for a variety of conditions complicated by hypoxia. Moreover, in late 2021 we announced our intent to design and execute a clinical program to support the use of TSC as an adjunct treatment of hypoxic solid tumors as the next step in our efforts to realize TSC’s potential. We believe targeting hypoxic solid tumors is appropriate for TSC given the significant unmet medical need, the compelling preclinical and clinical data accumulated to date, and the current, intravenous formulation of TSC. The team has been working closely with our advisors to design a Phase 2 study that we believe, if successful, will help patients and enhance shareholder value."

Clinical Trial Execution & Strategy

TCOM Trial: In March 2021, the Company completed enrollment and dosing of all participants in its Phase 1 trial of TSC utilizing a transcutaneous oxygen monitoring ("TCOM") device to evaluate the pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy, normal volunteers. As reported in June 2021, the topline results of the study showed TSC was safe and tolerable at all doses tested with no serious adverse events or dose-limiting toxicities. Furthermore, the Company announced that a positive trend in peripheral tissue oxygenation was observed among participants treated with TSC when compared to placebo-treated participants. This trend persisted through the one-hour, post-dosing measurement period. The Company believes the data from the TCOM Trial validate the thesis that TSC enhances oxygenation without causing hyperoxygenation. The data from the TCOM Trial have guided the design of the two additional Oxygenation Trials, as well as the design of the Hypoxic Solid Tumor Program.

Altitude Trial: In November 2021, Diffusion announced the dosing of the first participants in the Altitude Trial which was designed to evaluate the effects of TSC in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or "simulated altitude." Due to enrollment delays experienced during early 2022 related to the omicron variant wave of the COVID-19 pandemic, the Company now anticipates completing dosing in the second quarter of 2022 and topline results are expected to be reported within one to two months of study completion.

ILD-DLCO Trial: Subsequent to receiving Investigational New Drug application clearance from the U.S. Food and Drug Administration ("FDA") in the third quarter of 2021, the Company announced the dosing of the first patient in the Phase 2 ILD-DLCO Trial in December 2021. The ILD-DLCO Trial was designed to evaluate the effects of TSC on carbon monoxide uptake through the lungs ("DLCO") and into the bloodstream of interstitial lung disease ("ILD") patients. DLCO measurement is used in the study as a surrogate measure of oxygen transfer efficiency, or uptake, from the alveoli of the lungs through the plasma, and onto hemoglobin within red blood cells. The Company intends to evaluate the effect of TSC on lung function as measured by DLCO, as well as distance covered in a standard six-minute walk test. Due to enrollment delays experienced during early 2022 related to the omicron variant wave of the COVID-19 pandemic, the effect of the omicron variant on patients with pulmonary diseases such as ILD, and staffing issues at the facilities where the ILD-DLCO Trial is being conducted, the Company now anticipates dosing to be completed by the middle of 2022, with topline results reported within two months of study completion.

Hypoxic Solid Tumor Treatment: In November 2021, based on the available preclinical and clinical data and the significant unmet medical need, including the TCOM and COVID-19 Trial results, the Company announced its intent to focus its near-term efforts on evaluating TSC as an adjunct to standard of care in the treatment of hypoxic solid tumors as a first indication. Solid tumors, which comprise approximately 90% of all adult cancers, are often affected by hypoxia, leading to treatment resistance, metastasis, and worse prognoses. Following, among other things, analyses and discussions with the Company’s oncology-focused SAB members and other external advisors over the last several months, Diffusion believes they have the necessary data to support the design and initiation of an appropriate Phase 2 trial as the first study in the Hypoxic Solid Tumor Program. The Company intends to file the study protocol with the FDA and expects to commence the trial in the second half of 2022, subject to FDA feedback and the availability of clinical drug supply.

2021 Financial Results

Diffusion had cash and cash equivalents of $37.3 million as of December 31, 2021, compared with $18.5 million as of December 31, 2020. Net cash used in operating activities during 2021 was $14.5 million, compared with $13.6 million used during 2020.

Research and development expenses were $8.5 million for 2021, compared with $9.4 million for 2020. The decrease was primarily attributable to lower project spending due to the completion and/or wind-down of the Company’s clinical studies evaluating TSC in COVID-19, glioblastoma multiforme brain cancer, and stroke.

General and administrative expenses were $7.4 million for 2021, compared with $6.4 million for 2020. The increase was primarily driven by increased headcount resulting in higher compensation expense and other costs associated with the hiring of new employees, as well as an increase in expense related to consulting services.

In 2021, the Company also recognized a non-recurring $8.6 million non-cash impairment charge related to the write down of its DFN-529 IPR&D asset.