On May 12, 2022 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported financial results for the first quarter of 2022 (Press release, NexImmune, MAY 12, 2022, View Source [SID1234614529]).

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"This quarter, we have continued to execute on our clinical and corporate strategy, taking the necessary steps to achieve our upcoming catalysts for the remainder of this year," said Kristi Jones, Chief Executive Officer. "We remain on track to provide a clinical update for the NEXI-001 trial in AML during the second half of 2022, and to provide an update on the expansion cohort in the NEXI-002 trial in relapsed / refractory multiple myeloma. We also plan to file our first solid tumor IND application for HPV-associated malignancies in the near term. In parallel, we are advancing IND-enabling work for our AIM injectable modality and expect to provide updates on preclinical data for oncology and autoimmune indications throughout the second half of the year. With our new target discovery collaborations, we are well-positioned to leverage our modular AIM platform for efficient and rapid new product development. Overall, I am excited with our progress and focus on execution to deliver on upcoming catalysts."

First Quarter 2022 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

Robust immune responses with signs of clinical activity across all dose levels to date
NEXI-001 continues to be well tolerated across all dose levels administered to date, with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Due to the favorable emerging clinical profile, plans are underway to expand the addressable population with an additional study arm to include patients with haplo-identical donors
Enrollment continues, and updated clinical results are expected to be announced in the second half of 2022
NEXI-002

Expansion phase is ongoing
In this heavily pre-treated population, evidence of immune response and signals clinical activity have been observed. NEXI-002 continues to be well tolerated with no Grade ≥3 treatment-related adverse events, including infusion reactions, GVHD, CRS or neurotoxicity (ICANS), reported
Manufacturing achieved higher final cell count yield in recent products by adjusting prior treatment washout period, updating cell collection guidance and other process adjustments
Further clinical data from the Phase 1/2 trial are expected in the second half of 2022
NEXI-003

Preclinical data supporting the selection of multiple immunogenic antigen peptides commonly expressed on HPV-associated tumors and a cancer survival antigen was presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2021) in November 2021
Finalized antigen selection for NEXI-003 and manufactured nanoparticles for clinical trials
Investigational New Drug (IND) submission planned for the first half of 2022
Injectable AIM nanoparticle programs and other preclinical research

Advanced in vivo and preclinical work to support the development of AIM injectable nanoparticles as a therapeutic in oncology and autoimmune diseases
Advanced work with Yale University Professor Kevan Herold to evaluate AIM INJ nanoparticles for type 1 diabetes. A JDRF grant award will support the collaboration
Announced a strategic partnership with Zephyr AI in oncology for novel target discovery and validation to support target selection for potential future products candidates
Announced research collaboration with Rutgers, The State University of New Jersey, for neuroendocrine tumor checkpoint targets, which may have utility in other cancers
Announced research collaboration with NYU Langone Perlmutter Cancer Center for melanoma neo-antigen-specific CD8+ T cell expansion using the AIM platform technologies
Announced a preclinical research collaboration with Columbia University Irving Medical Center’s Herbert Irving Comprehensive Cancer Center focused on NexImmune’s AIM ACT in Columbia’s patient-derived organoid models of HPV-associated cancers
Business Updates

Announced the appointment of Kristi Jones as Chief Executive Officer and Member of the Board of Directors
Announced the promotion of Mathias Oelke, Ph.D. to Chief Scientific Officer
Announced the appointment of Dr. Leena Gandhi, Director of Dana-Farber’s Center for Cancer Therapeutic Innovation, to NexImmune’s Board of Directors
Announced the formation of the Autoimmune and Infectious Diseases Scientific Advisory Board
Continued to strengthen the management team with key appointments across the organization
Select 1Q 2022 Financial Highlights

Cash, cash equivalents and marketable securities for the Company as of March 31, 2022 were $65.0 million compared to $81.8 million for quarter ending December 31, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its operating and capital expenditure requirements into the second quarter of 2023.

Research and development expenses were $10.4 million in the first quarter of 2022, compared to $6.0 million for the same period in the prior year. The increase in R&D expenses was mainly attributable to costs for the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $4.6 million, compared to $4.1 million for the same period the prior year. The increase was due primarily to personnel-related expenses and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $15.0 million for the quarter, or a basic and diluted GAAP loss per share of $0.66. This compared to a net loss of $8.5 million, or a basic and diluted GAAP loss per share of $0.71, for the same period the prior year.

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.

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]).

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"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

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.

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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.

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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