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iTeos Reports First Quarter 2022 Financial Results and Provides Business Update

On May 12, 2022 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of potentially differentiated immuno-oncology therapeutics for patients, reported financial results for the first quarter ended March 31, 2022 and provided recent corporate highlights (Press release, iTeos Therapeutics, MAY 12, 2022, View Source [SID1234614517]).

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"The iTeos team is off to a strong start of the year as we continue to execute on the robust clinical development plans for both of our differentiated clinical-stage immunotherapy programs, EOS-448, our FcγR-engaging anti-TIGIT antibody, and inupadenant, our adenosine A2A receptor antagonist," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Notably, the new data we shared at AACR (Free AACR Whitepaper) in April indicating a decrease of TIGIT-expressing cells in patient tumor biopsies has heightened our optimism for our program, as it showcases key evidence of target engagement within the tumor in patients who were treated with EOS-448 in a clinical trial. These data support the potential of our TIGIT program and encourage us to pursue an efficient and data-driven strategy that will guide future development activities. We look forward to advancing EOS-448 and inupadenant with a goal of bringing new and more effective treatment regimens for advanced cancers."

Program Highlights

EOS-448/GSK4428859A: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through multifaceted mechanisms.

The company presented preclinical and clinical analyses supporting the multifaceted mechanism of action of EOS-448, including data on pharmacodynamics within the tumor microenvironment, as part of a late-breaking poster at the AACR (Free AACR Whitepaper) Annual Meeting in April. Data highlights are as follows:
Cell-based assays demonstrated the higher potency of EOS-448 relative to competitor anti-TIGIT monoclonal antibodies and provided the basis for its selection as a therapeutic candidate.
A decrease in TIGIT+ Tregs and potentially exhausted CD8 T cells in peripheral blood of patients with advanced cancers following treatment with EOS-448 provide evidence of target engagement and of the multifaceted mechanisms of action for EOS-448.
Treatment of patients with EOS-448 resulted in a decrease of TIGIT-expressing cells in the tumor, making EOS-448 the first anti-TIGIT antibody to demonstrate target engagement in human tumors.
Preclinical analyses of different anti-TIGIT antibody isotypes in combination with an anti-PD1 antibody in a murine cancer model highlighted the importance of FcyR engagement in the anti-tumor activity of TIGIT antibodies.

In collaboration with GSK, iTeos is planning multiple combination studies to evaluate EOS-448 as a potential next-generation immuno-oncology agent. We are continuously evaluating both internal and emerging data in the field to determine the optimal development pathways:

Enrollment is ongoing in a Phase 1b clinical trial in patients with non-small cell lung cancer (NSCLC) assessing the doublet of GSK’s anti-PD-1 (Jemperli (dostarlimab-gxly)) with EOS-448.
iTeos is evaluating the doublets of pembrolizumab with EOS-448 and inupadenant with EOS-448 in patients with solid tumors in an ongoing Phase 1/2 trial.
Plans to initiate Phase 1b trials with novel triplets are on track, including:
Jemperli with EOS-448 and inupadenant in patients with advanced solid tumors
EOS-448 with Jemperli and GSK’s investigational anti-CD96 antibody in patients with NSCLC
Enrollment is underway in a clinical trial evaluating EOS-448 as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in patients with multiple myeloma.
iTeos is working together with GSK to evaluate how best to proceed with additional clinical development of EOS-448 in light of the recent release regarding the Roche SKYSCRAPER-01 study.
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment.

iTeos is initiating a randomized Phase 2 trial mid-year in metastatic non-small cell lung cancer (mNSCLC) to evaluate the combination of inupadenant with chemotherapy compared to standard of care. A description of this trial will be presented in a Trial in Progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Enrollment is ongoing in a Phase 2a trial evaluating inupadenant in combination with pembrolizumab in PD-1 resistant melanoma.
iTeos has begun enrolling patients for the biomarker cohort of IO-001, the ongoing Phase 1b/2a trial, which evaluates inupadenant as a monotherapy in patients with solid tumors selected for high biomarker expression in four cohorts: NSCLC, endometrial cancer, head and neck squamous cell carcinoma and other solid tumors.

Preclinical programs: As part of the company’s ongoing commitment to advancing differentiated programs from discovery into the clinic, iTeos is focused on research programs for novel targets that address pathways of immunosuppression, including its candidate targeting a new mechanism in the adenosine pathway which is under evaluation in Investigational New Drug-enabling studies.

Upcoming Events

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL from June 3-7, 2022
Abstract Title: Randomized phase 2 study evaluating efficacy and safety of inupadenant in combination with chemotherapy in adults with metastatic non–small cell lung cancer (mNSCLC) who progressed on immunotherapy.
Date and Time: June 6, 2022, 9:00 a.m. EDT
Session Title: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: TPS9158

First Quarter 2022 Financial Results

Cash Position: The company’s cash and cash equivalent position was $824.0 million as of March 31, 2022, as compared to $321.4 million as of March 31, 2021. Cash balance provides the company runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $21.1 million for the quarter ended March 31, 2022, as compared to $11.6 million for the same quarter of 2021. The increase was primarily due to an increase in activities related to EOS-448 and inupadenant clinical trials along with increased spending related to the company’s preclinical programs.
General and Administrative (G&A) Expenses: G&A expenses were $10.6 million for the quarter, as compared to $7.0 million for the same quarter of 2021. The increase was primarily due to increased headcount, professional fees, including professional fees attributed to SEC reporting, SOX compliance and consulting costs related to iTeos’ corporate structure in Belgium.
Net Income/Loss: Net income attributable to common shareholders was $69.6 million, or net income of $1.96 per basic share and $1.82 per diluted share, for the quarter ended March 31, 2022, as compared to a net loss of $13.5 million, or a net loss of $0.39 per basic and diluted share, for the first quarter of 2021.

ERYTECH Provides Business and Financial Update for the First Quarter of 2022

On May 12, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business and financial update at the end of March 2022 (Press release, ERYtech Pharma, MAY 12, 2022, View Source [SID1234614514]).

"With the sale of our U.S. manufacturing facility to Catalent and the planned long-term supply agreement with Catalent, we managed to secure our potential long-term manufacturing needs in the United States while significantly extending our cash runway," said Gil Beyen, Chief Executive Officer of ERYTECH. "This brings us in a good position for the ongoing review of strategic options for the company, while we continue to focus on seeking an approval in the United States for our lead product candidate eryaspase (GRASPA) for the treatment of acute lymphoblastic leukemia patients who experienced hypersensitivities to pegylated asparaginase."

Business Highlights of the first quarter and April 2022

▪U.S. cell therapy manufacturing facility sold to Catalent for a total consideration of USD 44.5 million

Under the terms of an asset purchase agreement between ERYTECH and Catalent (the "APA"), Catalent acquired ERYTECH’s state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for a total consideration of $44.5 million. ERYTECH’s staff at the site of approximately 40 people have been offered Catalent’s employment.

The parties also agreed on the terms of a long-term supply agreement, under which Catalent will manufacture ERYTECH’s lead product candidate eryaspase (GRASPA) for clinical and commercial supply in the United States.

The Princeton facility is a 30,900 square foot modern manufacturing facility, designed with the flexibility to expand to support various cell therapy production requirements and capacities. Catalent intends to expand the Princeton site and leverage the experienced staff previously employed by ERYTECH to manufacture a broader portfolio of cell therapies. ERYTECH retained its manufacturing site in Lyon, France and its expertise and capabilities in manufacturing process science to continue innovating in cell therapy manufacturing.

▪Path to BLA in hypersensitive ALL, based on results of NOPHO-sponsored Phase 2 trial

The NOPHO trial evaluated the safety and pharmacological profile of eryaspase in acute lymphoblastic leukemia (ALL) patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy. In December 2020, positive trial results were presented at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

◦The Company pursues its interactions with the U.S. Food and Drug Administration (FDA) regarding a potential regulatory approval in this indication based on the NOPHO-sponsored trial. A pre-BLA meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021 after which the Company confirmed its intention to submit a BLA, subject to successful completion of remaining activities.

The BLA application is now almost completed, and the Company is planning for submission once the FDA has finalized its review of the remaining information requests.

▪rESPECT, Phase 1 investigator-sponsored trial (IST) in first-line pancreatic cancer

rESPECT is a Phase 1 trial, sponsored by the Georgetown Lombardi Comprehensive Cancer Center, evaluating the safety of eryaspase in combination with mFOLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer in approximately 18 patients.

◦Interim data, presented at ASCO (Free ASCO Whitepaper) GI in January 2022, confirmed the acceptable safety profile in the trial and showed encouraging clinical activity. Out of the twelve patients enrolled, ten patients have been evaluated for response. They all achieved disease control; five patients had an objective response and five achieved stable disease.

The trial will continue enrolling up to approximately 18 patients. Reporting of data is expected in the third quarter of 2022.

▪ERYCEVTM, novel red blood cell vesiculation technology

ERYTECH presented its red blood cell vesiculation technology at the 24th Meeting of the European Red Cell Society (ERCS) in April 2022.

◦RBC-derived extracellular vesicles are formed naturally during senescence and storage of mature RBCs and are a potentially attractive drug delivery system. Vesiculation of RBCs that have already been loaded with active therapeutic compounds utilizing the ERYCAPS process, entails the potential of producing cargo-loaded RBC-derived extracellular vesicles for the development of novel therapeutic approaches.

▪Process to review strategic options and partnering alternatives

As announced on October 25th 2021, the Company has appointed a specialized advisor to evaluate its strategic and partnering options. After the transaction with Catalent, the Company continues to evaluate further strategic options to leverage its ERYCAPS platform with complementary assets and/or a broader corporate transaction.

Q1 2022 Financial Results

▪Key financial figures for the first quarter of 2022 compared with the same period of the previous year are summarized below:

▪Net loss for the first quarter of 2022 was €11.9 million, stable year-over-year, with a €0.7 million improvement (-5.5%) in operating loss and a €0.7 million decline in net financial income. The €0.7 million improvement in operating loss was attributable to the €2.4 million decrease in preclinical and clinical development expenses, offset in part by the €0.9 million decrease in other income from R&D tax credits, both reflecting the decrease in the Company’s clinical development activities, while general and administrative expenses increased by €0.8 million, mostly related to legal and due diligence expenses for partnering activities.

▪As of March 31, 2022, ERYTECH had cash and cash equivalents totaling €25.1 million (approximately $27.9 million), compared with €33.7 million as of December 31, 2021. The €8.6 million decrease in cash position during the first three months of 2022 was the result of a €10.7 million net cash utilization in operating activities and investing activities and €1.8 million generated in financing activities, including €2.3 million in pre-payment of a portion of the expected 2021 R&D tax credit, while the variation of the U.S. dollar against the euro led to a €0.3 million positive currency exchange impact.

▪The Company has not drawn any new tranche on the convertible note facility (OCABSA) since August 2021 and as of September 2021, there were no outstanding and unconverted notes. The company does not plan to draw any further OCABSA tranche until the expiration of the financing facility in June 2022.

▪The Company believes that its current cash position, including the $44.5 million gross proceeds received upon closing of the transaction with Catalent in April 2022, can fund its current development programs and planned operating expenses to mid-2024.

Key News Flow and Milestones Expected Over the Next 12 Months

▪Targeted BLA submission of eryaspase in hypersensitive ALL (Q3 2022)
▪Results from the Phase 1 rESPECT trial of eryaspase in combination with mFOLFIRINOX in first-line pancreatic cancer (Q3 2022)
▪Data from the randomized Phase 2 TRYbeCA-2 trial of eryaspase in TNBC (Q3 2022)

First Quarter 2022 Conference Call Details

ERYTECH management will hold a conference call and webcast on Friday, May 13, 2022, at 8:30am ET / 2:30 pm CEST on the business highlights and financial results for the quarter ended March 31, 2022. Gil Beyen, CEO, Eric Soyer, CFO/COO, and Iman El-Hariry, CMO, will deliver a brief presentation, followed by a Q&A session.

The audio call is accessible via the below registering link: View Source (Conference ID: 9535729)

Once registered, participants will receive a unique access code and the call number details to join the teleconference.

The webcast can be followed live online via the link:
View Source

An archived replay of the call will be available for 7 days by dialing + 1 855 859 2056, Conference ID: 9535729#.

An archive of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com

ERYTECH plans on attending the following upcoming investor conferences:
▪H.C. Wainwright Global Investment Conference (Miami, USA) – May 23-26, 2022
▪Jefferies Global Healthcare Conference (New York, USA) – June 8-10, 2022
▪Spring Midcap Event (Paris, France) – June 23-24, 2022

Coherus Returns Rights for Avastin Biosimilar to Innovent

On May 12, 2022 Coherus Biosciences of Redwood City, CA, reported that returned the US rights to market an Innovent Avastin biosimilar to Innovent (Press release, Coherus Biosciences, MAY 12, 2022, View Source [SID1234614512]). Coherus announced the move in its Q1 earnings call with analysts, blaming the COVID-19 epidemic for slowing its development of the biosimilar. Coherus has signed several big deals to market China-developed drugs in North America, a major part of its business plan. However, during the first three months of 2022, it also dissolved a partnership with Junshi Biosciences for an Eylea (aflibercept) biosimilar.

Panbela Provides Business Update and Reports Q1 2022 Financial Results

On May 12, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported its financial results for the quarter ended March 31, 2022 (Press release, Panbela Therapeutics, MAY 12, 2022, View Source [SID1234614511]). Management is hosting an earnings call today at 4:30 p.m. ET.

The first quarter was marked by meaningful progress.

Q1 and Recent Highlights:

• Agreed to acquire Cancer Prevention Pharmaceuticals, Inc. (CPP). The combined entity would target an estimated $5 billion aggregated market opportunity upon closing.

• Hosted a virtual R&D Day on the company’s investigational drug, SBP-101, as a polyamine metabolism modulator in ovarian cancer.

• Poster presentation highlighting the results for SBP-101 as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2022. The work reflects the company’s ongoing collaboration with Johns Hopkins University School of Medicine.

• Initiated our ASPIRE trial-a global, randomized, double-blind, placebo controlled clinical trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel versus Gemcitabine, Nab-paclitaxel and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma.

• Announced a new development program in ovarian cancer expected to start in the first half 2022 as the result of positive preclinical data supporting the activity of SBP-101 in ovarian cancer cell lines.

• Poster presentation of abstract for SBP-101 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2022.

• Median overall survival of 12.53 months for the phase 1 first line metastatic pancreatic trial was reached shortly after the January poster presentation.

"Q1 and year to date have represented a transformational time of value creation for Panbela. During the quarter, we signed a definitive agreement to acquire CPP, presented ovarian cancer data at AACR (Free AACR Whitepaper) and initiated our global randomized trial in pancreatic cancer," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Through the pending acquisition and organic execution, Panbela is better positioned to be able to treat more patients, and drive shareholder value

Milestones:

We announced:

• The ASCO (Free ASCO Whitepaper) GI poster presentation in January, and

• The research day to review the ovarian cancer data and ovarian cancer treatment standards. Additionally in the first half, we anticipate:

• First patient enrolled in our ASPIRE trial as well as expansion outside the US.

• Satisfaction of conditions and closing of the CPP acquisition.

• Final data from our Phase I untreated metastatic pancreatic cancer study.

• Initiation of the ovarian cancer clinical program for SBP-101 mid-year.

In addition, during the second half of 2022, we expect to announce the opening of a neoadjuvant pancreatic cancer investigator initiated trial. Subject to closing the CPP transaction, we anticipate announcing additional milestones for 2022 that will reflect the increased flow of planned development activity and data.

First Quarter ended March 31, 2022 Financial Results

General and administrative expenses were $1.8 million in the first quarter of 2022, compared to $1.1 million in the first quarter of 2021. The change is due primarily to expenses, including legal and financial advisory fees, associated with the acquisition of CPP. Research and development expenses were $2.2 million in the first quarter of 2022, compared to $1.1 million in the first quarter of 2021. The change is due primarily to an increase in spending on our clinical studies as we launched the global ASPIRE clinical trial. Net loss in the first quarter of 2022 was $3.7 million, or $0.27 per diluted share, compared to a net loss of $2.3 million, or $0.23 per diluted share, in the first quarter of 2021.

Total cash was $7.4 million as of March 31, 2022. Total current assets were $7.9 million and current liabilities were $4.5 million as of the same date. Also at March 31, 2022, total noncurrent assets, consisting of cash deposits held by our contract research organization, were $3.2 million. The company had no debt as of March 31, 2022. Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

About: SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma, ovarian cancer and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.53 months, which is now final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source

IN8bio Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 12, 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 quarter ended March 31, 2022 (Press release, In8bio, MAY 12, 2022, View Source [SID1234614483]). In addition, the Company provided an overview of recent corporate developments.

"Our team continues to execute and advance our programs on multiple fronts despite these challenging times in biotech," said William Ho, CEO and co-founder of IN8bio. "Our Phase I clinical trials for both DeltEx gamma-delta product candidates, INB-200 in GBM and INB-100 in leukemia patients, continue to progress with encouraging early data. We added key clinical and regulatory expertise to our senior management team and we will be introducing our iPSC derived gamma-delta T cell platform at ASGCT (Free ASGCT Whitepaper) next week. The IN8bio team will continue to be disciplined with our capital and we will use our resources to continue to accelerate the growth and momentum in our Company."

Business Highlights & Updates

In January 2022, IN8bio provided a clinical update from the Phase 1 clinical trial of its genetically modified gamma-delta T cell therapy candidate, INB-200, in newly diagnosed GBM. In the single ascending dose cohort 1 (n=3), all three
patients showed no dose limiting toxicities (DLTs), no cytokine release syndrome (CRS) or neurotoxicity and demonstrated a manageable safety profile. Cohort 2, which will receive three repeat doses of INB-200, includes one patient who has already received all three doses without any DLTs or significant cell therapy related adverse events. All of the patients treated have exceeded their expected progression-free survival (PFS) interval based on age and MGMT status and exceeded median expected PFS of up to seven months with encouraging trends in overall survival.

IN8bio presented a clinical update from the ongoing Phase 1 clinical trial of INB-100, an allogeneic gamma-delta T cell therapeutic candidate in leukemia patients undergoing hematopoietic stem cell transplantation. All three patients treated remain in morphologic CR with durable remissions ranging from nine to 23 months through March 2022. We observed robust immune reconstitution in the patients including T cells, B cells and gamma-delta T cells. INB-100’s safety profile continues to be manageable with no DLTs, no grade 3 or greater graft vs. host disease (GvHD), no CRS and no neurotoxicity. The data were presented at the EBMT 48th Annual Meeting. These are encouraging results given up to 51% are expected to relapse within a year with standard of care treatment.

In April 2022, IN8bio announced the continued expansion of its clinical and regulatory teams with the appointments of Urvashi Patel, Ph.D., Vice President, Regulatory Affairs, and Stacey Bilinski, Vice President, Clinical Operations. They bring deep clinical and regulatory experience to the IN8bio team, from early to late-stage development across the biotechnology and pharmaceutical industry with more than 45 years of combined experience. Dr. Patel has provided regulatory guidance to biopharmaceutical companies, including WindMIL Therapeutics, Precision for Medicine, Janssen, Elan Pharmaceuticals and Genentech. Ms. Bilinski has initiated numerous first in-human and early-phase clinical development programs at biopharmaceutical companies, including Taiho Oncology, Onconova, Insmed, Amicus Therapeutics and Covance.

Upcoming Milestones and Events

In May 2022, IN8bio unveiled a new preclinical program focused on developing iPSC derived gamma-delta T cells to be presented at the ASGCT (Free ASGCT Whitepaper) Annual Meeting, which will be held from May 16-19, 2022. Scalable iPSC-based cellular manufacturing is designed to create for a uniform and renewable therapeutic product available "off-the-shelf" for patients. IN8bio will be holding an investor event via webcast at the conference to introduce the program to the investment community on May 17, 2022, at 6:00 p.m. EDT. A link to the webcast will be available on the Events & Presentations page of the Company’s website.

IN8bio plans to submit an investigational new drug (IND) application for a Phase 1b/2 clinical trial of INB-400 in GBM during the second half of 2022.

Expected Upcoming Presentations

ASGCT 25th Annual Meeting, Washington, D.C., May 2022: introducing a new program on "The Development of Off-the-Shelf" Manufacturing Strategies for iPSC-Based Gamma-Delta T Cells" along with an oral presentation by Dr. Lamb, "Off the Shelf Cell Therapies – Beyond T Cells (Education Session) and The Next Generation of γδ T Cell-based Therapies" by Dr. Lamb.

Advanced Therapies Congress Live, London, May 2022: presenting "New Directions in the Treatment of Solid Tumors with gdT Cells" by Dr. Lamb.

Cambridge Healthcare Immuno-Oncology Therapeutic Development,
London, May 2022: presenting "Genetically Modified gamma delta T cells in
combination with chemotherapy: now in the clinic" by Dr. Lamb

Cell Engager summit, Boston, May 2022: presenting "Gamma-Delta T-cells: Novel approaches to genetic engineering and cell-type specific therapeutic applications" by Dr. Rochlin.

H.C. Wainwright Global Investment Conference, May 2022: Mr. Ho will participate in a fireside chat on May 25, 2022, at 2 p.m. EDT.

American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 2022: presenting "Phase 1 study of drug-resistant immunotherapy (DRI) with gene-modified autologous γδ T cells in patients with newly diagnosed glioblastoma multiforme (GBM) receiving maintenance temozolomide (TMZ)" by Louis B. Nabors, M.D.

Jefferies Healthcare Conference, June 2022: Mr. Ho will present at 1:30 p.m. EDT on Wednesday, June 8, 2022.

First Quarter 2022 Financial Highlights

Cash position: As of March 31, 2022, the Company had cash of $32.1 million, compared to $37.0 million as of December 31, 2021. The decrease in cash was primarily due to cash used by the Company in research and development and continued operations to advance its programs.

Research and Development (R&D) expenses: R&D expenses were $2.4 million for the three months ended March 31, 2022, compared to $1.2 million for the comparable prior year period. The increase in R&D expenses were primarily due to (i) increased third-party clinical trial and IND-related activities, (ii) contract manufacturing costs for the ongoing INB-200 clinical trial and (iii) increased personnel-related costs, including salaries, benefits and stock-based compensation due to increased headcount.

General and administrative expenses: General and administrative expenses were $3.8 million for the three months ended March 31, 2022, compared to $1.1 million for the comparable prior year period. The increase was primarily
due to increased legal expenses, insurance costs and expenses associated with operating as a public company.

Net loss: The Company reported a net loss attributable to common stockholders of $6.1 million, or $0.33 per basic and diluted common share, for the three months ended March 31, 2022, compared to a net loss attributable to common stockholders of $3.1 million, or $0.82 per basic and diluted common share, for the comparable prior year period.