On May 16, 2022 RadNet, Inc., (NASDAQ: RDNT) reported that it has received FDA clearances for its DeepHeatlh Saige-DX mammography and Quantib Prostate 2.0 MRI artificial intelligence ("AI") algorithms (Press release, RadNet, MAY 16, 2022, View Source [SID1234614705]).

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Saige-DX: AI Mammography Diagnostic Software

Saige-Dx, a more advanced successor to our FDA approved Saige-Q worklist triage software, is a cancer detection tool that enables radiologists to more effectively detect the presence or absence of breast cancer with the use of artificial intelligence. DeepHealth’s powerful new AI technology automatically identifies suspicious lesions in mammograms and assigns a suspicion level to each finding and to the entire case. It helps detect and diagnose breast cancer earlier while reducing unnecessary recalls.

"In our study to support FDA clearance, all 18 radiologists who participated exhibited improved performance when using Saige-Dx, resulting in the largest increase in performance across all mammography AI products on the market to date. The improved performance was reflected in both an increase in the percentage of the cancers detected and a lower false positive rate when using Saige-Dx," said Bill Lotter, Ph.D., CTO, and co-founder of DeepHealth.

"Saige-Dx is built on our advanced deep-learning algorithms. Our highly accurate AI, as is described in a Nature Medicine article last year, showed the ability to find cancer one to two years earlier than fellowship-trained breast imaging radiologists. The approval of Saige-Dx represents another step forward in advancing cancer care. The feedback from physicians who have worked with our software tools is overwhelmingly positive, making them more accurate and efficient at interpreting mammography images," said Gregory Sorensen, M.D., CEO, and co-founder of DeepHealth.

Quantib Prostate 2.0: An AI Powered Solution for Prostate MRI Reading and Reporting

Quantib Prostate is an AI-based software solution that advances the MRI prostate reporting workflow and is accessible directly from the radiologist’s reading station. The solution comes with a suite of tools to improve reporting quality and speed, including AI-based segmentations and volumetry, PSA density calculation, precise registration and movement correction, one-click segmentation of lesion candidates, PI-RADS scoring support, and standardized reporting to facilitate easy and comprehensive communication of results. FDA 510k special clearance has been given for a major upgrade to the solution (from release 1.3) that now includes fully automatic prostate zone segmentation (in addition to prostate gland segmentation) and automated initiation of localization of lesions on the PI-RADS sector map.

"We are delighted to present this update of Quantib Prostate, including a selection of new features that our customers requested over the past few months. We seek to continuously improve our software to support radiologists and urologists in the best way possible, and we deliver updated solutions to our customers as quickly as possible," said Arthur Post Uiterweer, CEO of Quantib.

Dr. Howard Berger, President and Chief Executive Officer of RadNet, said, "We are very proud that two of our subsidiaries, DeepHealth and Quantib, have received FDA clearance for their flagship products. Artificial intelligence will have a transforming impact on radiology and cancer care, and we are committed to delivering those advances to patients and healthcare providers. These recent approvals will help us drive improved patient outcomes while lowering costs. The Biden administration, through its Cancer Moonshot program, is committed to significantly reducing the mortality rates from cancer in the coming decades. We believe that these AI tools will play an important role in the early detection and diagnosis of cancer, resulting in improved survival rates and better patient outcomes."

On May 16, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported its financial results for the first quarter 2022 and provided a business update (Press release, AIM ImmunoTech, MAY 16, 2022, View Source [SID1234614582]).

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"The first quarter was marked by the rollout of important clinical data across our pipeline which gives us added confidence in the potential of Ampligen as an important treatment in high-value indications," commented Thomas Equels, Chief Executive Officer of AIM. "We published clinical efficacy data in our three lead indications, pancreatic, ovarian and triple negative breast cancers in a prestigious peer-reviewed journal and/or at leading oncology scientific congresses. These data were consistent with prior clinical data seen with Ampligen and we believe validate our conviction of its potential in these difficult to treat cancers, including data indicating potentially important effects in combination with checkpoint inhibitors. We remain committed to continue working with preeminent scientific institutions to advance our rich oncology pipeline towards commercialization that we believe will drive the execution of clinical, regulatory and operational catalysts that have the potential to build shareholder value in the near and long-term."

Recent Highlights

Provided a summary of clinical data that support the potential of Ampligen with checkpoint blockade therapies (see AIM’s 4/21/22 press release).
Engaged world-renowned CRO, Amarex Clinical Research LLC to conduct upcoming Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270).
Presented data at the prestigious American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022:
Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver
Systemic Rintatolimod and Interferon-α2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells
Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer
Received notification from the U.S. Food and Drug Administration ("FDA") that the FDA’s Clinical Hold on AIM’s investigational new drug ("IND") application for a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270) has been lifted and the Company may proceed with the study.
Announced the publication of positive data from a single-center, named-patient program treating advanced and metastatic pancreatic cancer patients (see: Rintatolimod (Ampligen) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program)
Announced a contract for the strategic sale of its facility located in New Brunswick, New Jersey for a purchase price of $3.9 million.
Appointed biotech and finance industry veteran Robert Dickey IV as Chief Financial Officer, effective April 4, 2022.
Announced the publication of positive results from Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer.
Clinical Program Update

Ampligen (rintatolimod): dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system

Ampligen has demonstrated in the clinic a potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown therapeutic synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used in combination with checkpoint blockade therapies. The first detection of Ampligen’s synergistic potential with checkpoint blockade therapeutics was witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. Additionally, the Company now has data from two clinical studies – in advanced recurrent ovarian cancer and triple negative breast cancer – that indicate that the drug may have similar anti-tumor activity in humans. (See AIM’s 8-K financial filing on 6/14/21 regarding a patent in the Netherlands)

Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers. Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

Immuno-Therapy Targeting Multiple Cancers with High Unmet Need

Locally Advanced Pancreatic Cancer – Phase 2 study IND cleared by the U.S. Food and Drug Administration ("FDA"). Study will compare the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Approximately 90 subjects expected to be enrolled across up to 30 centers in the U.S. and Europe. Study is on track to commence in Q3 2022.
Advanced Recurrent Ovarian Cancer – Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. Phase 1 portion was completed. The Phase 2 portion of the study is planned to be conducted in the future. ClinicalTrials.gov: NCT02432378
Advanced Recurrent Ovarian Cancer – A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; numerous patients have commenced treatment. ClinicalTrials.gov: NCT03734692
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver was completed and met primary endpoint, evidenced by increased CD8a expression post-treatment (p=0.046); 19 patients were enrolled and 12 patients were evaluable. Data suggest that chemokine modulatory (CKM) regimen with Ampligen may be useful to enhance effectiveness of immunotherapies. Data from the Phase 2a study were presented in April 2022 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. ClinicalTrials.gov: NCT03403634
Stage 4 Metastatic Triple Negative Breast Cancer – a Phase 1 study of metastatic triple-negative breast cancer using CKM therapy, including Ampligen and pembrolizumab, successfully met its primary endpoint. Eight patients were enrolled and 6 patients were evaluable. Positive data from this proof-of-concept study indicate that short-term systemic CKM followed by pembrolizumab is well-tolerated and selectively enhances local cytotoxic T-lymphocyte (CTL) infiltration in the tumor microenvironment (TME). The data from the Phase 1 study was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in April 2022. ClinicalTrials.gov: NCT03599453
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. ClinicalTrials.gov: NCT03899987
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. This study is recruiting patients and is designed for up to 24 patients. ClinicalTrials.gov: NCT04081389
Refractory Melanoma – Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled. ClinicalTrials.gov: NCT04093323
Advanced Ovarian Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2 (COVID-19)

Previous animal studies yielded positive results utilizing Ampligen to treat Western Equine Encephalitis Virus, Ebola and SARS-CoV-1. The Company has also conducted laboratory experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company also plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.

Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler

The Company is currently sponsoring an expanded access program (EAP) for ME/CFS patients in the United States, and in 2021 AIM dosed its first "Long Hauler" patient with Ampligen in its post-COVID-19 "Long Hauler" portion of the active AMP-511 EAP in the United States. Patients receiving Ampligen in the ongoing AMP-511 EAP with Long Hauler/Post-COVID conditions (such as fatigue and cognitive function deficiency) have reported improvements after receiving Ampligen.

Recent Ampligen Data Publications

Positive data from a single-center named patient program was published in March 2022. The manuscript titled, "Rintatolimod (Ampligen) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program1," was published in the peer-reviewed journal, Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer.
Positive results of a Phase 1/2 study of intraperitoneal chemo- immunotherapy in advanced recurrent ovarian cancer were published in January 2022. The manuscript titled, "Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity2" was published in the American Association for Cancer Research (AACR) (Free AACR Whitepaper) publication, Clinical Cancer Research.
Summary of Financial Highlights for First Quarter 2022

As of March 31, 2022, AIM reported cash and cash equivalents of $44.5 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through 2023.
Research and development expenses for the three months ended March 31, 2022 were $1.0 million, compared to $1.4 million for the same period in 2021.
General and administrative expenses were $2.1 million for the three months ended March 31, 2022 and 2021.
The net loss from operations for the three months March 31, 2022 was $3.8 million, or $0.08 per share, compared to $3.6 million, or $0.08 per share, for the three months ended March 31, 2021.
Please refer to the full 10-Q for complete details.

On May 16, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics targeting DNA damage response pathways reported that it has acquired Atrin Pharmaceuticals Inc. ("Atrin") and reported financial results for the three months ended March 31, 2022 (Press release, Aprea, MAY 16, 2022, View Source [SID1234614630]).

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Business Operations Update:

On May 16, 2022 Aprea completed the acquisition of Atrin, a privately held biotechnology company focused on the discovery and development of novel therapeutics targeting proteins in the DNA damage response, or DDR, pathway in oncology through synthetic lethality. The Company believes its cash and cash equivalents as of March 31, 2022 will be sufficient to meet its current projected operating requirements through the second half of 2023.

With the acquisition of the Atrin programs, Aprea intends to shift its primary focus to the ATR inhibitor ATRN-119, which will be studied as both a monotherapy and in combination with standard of care in Phase 1/2a clinical trials in solid tumor malignancies. In parallel with ATRN-119 development, Atrin initiated separate programs for a second-generation ATR inhibitor, ATRN-354, with potentially improved potency and pharmacokinetics, as well as for a potentially highly potent and selective WEE1 inhibitor – ATRN-W1051. These programs are expected to enter IND-enabling studies in 2022 and Aprea anticipates filing Investigational New Drug applications for these programs in 2023. Furthermore, with the acquisition of Atrin, Aprea obtained an active proprietary development platform to drive the identification of new oncology drug targets and biomarkers.

"Aprea has explored a range of strategic alternatives to maximize shareholder value and we believe the acquisition of Atrin represents an opportunity to create substantial value for Aprea shareholders," said Christian Schade, Chairman and Chief Executive Officer of Aprea. "The founders of Atrin are pioneers in the development of novel oncology compounds in the DNA damage pathway. We are excited to work with the Atrin team to begin clinical development of Atrin’s lead ATR program over the coming months, hasten the development of its differentiated WEE1 program, and support a robust platform to build a pipeline of novel inhibitors of the DDR pathway."

"We are excited to join forces with Aprea and expedite the clinical development of our lead programs and drug development platform," said Oren Gilad, Ph.D., the former Chief Executive Officer of Atrin. "Aprea’s knowledge of the p53 pathway in oncology is complimentary to Atrin’s in-house expertise in developing novel targets in the DNA damage response pathway. With supportive resources we look forward to moving our programs into clinical development to better understand the importance of our robust synthetic lethality platform."

Management and Organization

Christian Schade, our current Chairman and Chief Executive Officer will remain with Aprea along with Scott Coiante, our current Senior Vice President and Chief Financial Officer, and Greg Korbel will remain with Aprea, but will transition from his current role as Senior Vice President and Chief Business Officer to Senior Vice President and Chief Operating Officer. Our management team will be expanded with the appointment of Dr. Gilad, the former Chief Executive Officer of Atrin, who will be President of Aprea and Ze’ev Weiss, the former Chief Business Officer of Atrin, who will be the Chief Business Officer of Aprea. After the 2022 annual stockholder meeting of Aprea, Dr. Gilad will assume the role of Chief Executive Officer from Mr. Schade and Mr. Schade will continue as Executive Chairman of the Board of Directors.

In conjunction with the transaction, the Aprea board was expanded to eight members. Immediately following the consummation of the transaction, the Aprea board will consist of, Dr. Gilad, Mike Grissinger, Rif Pamukcu, and Marc Duey, each of whom were members of the Atrin board who will join the Aprea board, and current Aprea Board members Christian Schade, Jack Henneman, Richard Peters and Bernd Seizinger. Christian Schade will remain the Executive Chairman of the Aprea Board for up to six months, and he would remain as Non-Executive Chairman thereafter. Aprea and Atrin have agreed to expand the Aprea board to nine members following Aprea’s 2022 annual stockholder meeting. The Aprea Board plans to fill the remaining vacancy after such meeting.

About the Transactions

The acquisition of Atrin was structured as a stock-for-stock transaction whereby all of Atrin’s outstanding equity interests were exchanged for a combination of shares of Aprea common stock and shares of Series A non-voting convertible preferred stock (the "Series A preferred stock"). Subject to Aprea stockholder approval, each share of Series A preferred stock will, at the option of the holder, convert into 10 shares of common stock, subject to certain beneficial ownership limitations set by each holder. On a pro forma basis and based upon the number of shares of Aprea common stock and preferred stock issued in the acquisition, holders of Aprea equity holders immediately prior to the acquisition will own approximately 41.2% of Aprea on an as-converted basis and former Atrin equity holders will own approximately 58.8% of Aprea on an as-converted basis immediately after these transactions. The acquisition was approved by the Board of Directors of Aprea and the Board of Directors and the requisite equity holders of Atrin. The closing of the transactions was not subject to the approval of Aprea stockholders.

In connection with acquisition of Atrin, each holder of Aprea common stock as of immediately before the closing of the transaction will be entitled to a non-transferrable contingent value right ("CVR"). Holders of the CVR will be entitled to receive certain payments from proceeds received by Aprea, if any, related to the disposition, if any, of its legacy p53 reactivator assets during the 2-year period following the closing of the transaction.

Wedbush PacGrow is serving as exclusive strategic advisor to Aprea, H.C. Wainwright & Co. is serving as exclusive strategic advisor to Atrin, Sidley Austin LLP is serving as legal counsel to Aprea, and DLA Piper LLP (US) is serving as legal counsel to Atrin.

Immediately after the completion of the acquisition, Aprea is expected to have pro forma cash on hand, before transaction-related expenses, of approximately $48 million (unaudited) and cash runway through the second half of 2023.

Additional details will be available in an updated corporate presentation that can be found in the investor section of the Aprea website at Link.

First Quarter Financial Results

Cash and cash equivalents: As of March 31, 2022, the Company had $47.6 million of cash and cash equivalents compared to $53.1 million of cash and cash equivalents as of December 31, 2021. The Company believes its cash and cash equivalents as of March 31, 2022 will be sufficient to meet its current projected operating requirements through the second half of 2023.
Research and Development (R&D) expenses: R&D expenses were $4.1 million for the quarter ended March 31, 2022, compared to $6.8 million for the comparable period in 2021. The decrease in R&D expenses was primarily due to decreases in clinical trial activity and related costs for (i) our pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS, (ii) our Phase 2 post-transplant MDS/AML clinical trial, (iii) our Phase 1 AML trial, (iv) our Phase 1/2 solid tumor trial and our Phase 1 dose-escalation trial of APR-548.
General and Administrative (G&A) expenses: G&A expenses were $4.0 million for the quarter ended March 31, 2022, compared to $3.4 million for the comparable period in 2021. The increase in G&A expenses was primarily due to increases in legal expense and non-cash stock-based compensation expense.
Net loss: Net loss was $7.9 million, or $0.36 per share for the quarter ended March 31, 2022, compared to a net loss of $9.7 million, or $0.46 per share for the quarter ended March 31, 2021. The Company had 21,974,302 shares of common stock outstanding as of March 31, 2022.
Conference Call and Webcast Details

Aprea will host a webcast on May 16, 2022 at 4:30pm EDT to discuss the acquisition. The webcast can be accessed under the "Events Calendar" in the Investors section of the Aprea website at Link

On May 16, 2022 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the first quarter ended March 31, 2022 (Press release, Celcuity, MAY 16, 2022, View Source [SID1234614647]).

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"We are off to a strong start in 2022, which we expect will be a transformational year for Century as we transition into a clinical-stage organization," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "Looking ahead, we remain on track to submit our first IND application for our lead program, CNTY-101, mid-year, with the Phase 1 ELiPSE-1 trial for CNTY-101 in relapsed/refractory lymphoma expected to commence in the second half of 2022. We are continuing to invest in our comprehensive, next-generation iPSC-based cell therapy platform, and believe we are well positioned to advance multiple product candidates into the clinic over the next several years. We look forward to providing updates at scientific congresses this year and our upcoming virtual R&D Day next month"

Business Highlights & Upcoming Milestones

Earlier this month, the Company presented preclinical data at the 18th Annual PEGS Boston Conference & Exposition, on the discovery and optimization of CD22 VHH antibodies for CAR T cell therapy.
The Company plans to present preclinical data on MAD7, a novel CRISPR nuclease used to enable the genetic engineering of iPSC-derived NK and T cell product candidates, during a poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting being held May 16-19, 2022 in Washington, D.C. Full abstracts are currently available through the ASGCT (Free ASGCT Whitepaper) conference website.
Virtual research and development update to be held June 13, 2022, at 4:30 PM ET. Century’s management team will discuss CNTY-103 and progress on the next-generation platform. Dr Sheila Singh, Professor of Surgery and Biochemistry, Chief Pediatric Neurosurgeon at McMaster Children’s Hospital, the Division Head of Neurosurgery at Hamilton Health Sciences, and the inaugural Director of McMaster’s new Cancer Research Centre will discuss the current treatment paradigm in GBM.
The Company remains on track to initiate ELiPSE-1, its Phase 1 clinical trial to assess CNTY-101 in patients with relapsed/refractory CD19 positive aggressive lymphoma or indolent lymphoma after at least two prior lines of therapy, including patients who have received prior CAR-T cell therapy, in the second half of 2022 subject to U.S. Food and Drug Administration acceptance of its Investigational New Drug (IND) application, which is expected to be submitted in mid-2022.
The Company’s current Good Manufacturing Practice (cGMP) manufacturing facility in Branchburg, New Jersey is expected to be operational in 2022.
Century expects to submit an IND application for CNTY-103 in 2023. CNTY-103 is the Company’s first solid tumor candidate for glioblastoma.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $466.4 million as of March 31, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $86.8 million for the three months ended March 31, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $122.1M) compared to net cash used in operations of $22.2 million for the three months ended March 31, 2021.
Collaboration Revenue: Collaboration revenue was $1.1 million for the three months ended March 31, 2022, generated through the Company’s collaboration, option and license agreement with BMS.
Research and Development (R&D) expenses: R&D expenses were $21.2 million for the three months ended March 31, 2022, compared to $15.4 million for the same period in 2021. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s R&D capabilities, costs for pre-clinical studies, costs for laboratory supplies and facility costs.
General and Administrative (G&A) expenses: G&A expenses were $7.3 million for the three months ended March 31, 2022, compared to $2.7 million for the same period in 2021. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount, an increase in directors’ and officers’ insurance expense, and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company.
In-process research and development (IPR&D) expenses: One-time IPR&D expenses were $10.0 million for the three months ended March 31, 2022, in order to amend the FCDI agreement to gain access to the territory rights of Japan as a result of the Collaboration Agreement with BMS.
Net loss: Net loss was $37.5 million for the three months ended March 31, 2022, compared to $18.3 million for the same period in 2021.
Financial Guidance

The Company expects full year GAAP Operating Expenses to be between $155 million and $165 million including non-cash stock-based compensation expense of $10 million to $15 million.
The Company expects its cash, cash equivalents, and marketable securities will support operations into 2025.

On May 16, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it will report financial results for its fiscal fourth quarter and year ended March 31, 2022 on Thursday, June 16, 2022 (Press release, Beyond Air, MAY 16, 2022, View Source [SID1234614663]). The Company’s management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day.

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

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