On November 10, 2022 QUE Oncology reported the results of its Phase II trial of Q-122, a novel non-hormonal oral therapy for the treatment of vasomotor symptoms (commonly known as hot flashes/flushes and night sweats) in women taking endocrine therapy for breast cancer, have been published in The Lancet (Press release, QUE Oncology, NOV 10, 2022, View Source [SID1234623861]).

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More than 75 per cent of breast cancers are hormone-sensitive, with endocrine therapy being the standard treatment option[1]. Endocrine therapy is recommended for 5-10 years after cancer treatment for those women that had hormone-sensitive breast cancer, to prevent disease recurrence. However, approximately 70 per cent of women taking endocrine therapy have vasomotor symptoms that contribute to over one third of women prematurely stopping this important therapy.

The Phase II study was a multicentre, randomised, double-blind, placebo-control trial involving 131 women taking endocrine therapy (tamoxifen or an aromatase inhibitor) following breast cancer.

Q-122 therapy significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, with associated improvement in quality of life, compared with placebo. Q-122 was well tolerated with no serious adverse effects. These results demonstrate the promise of Q-122 as a novel and differentiated, non-hormonal treatment of vasomotor symptoms for women with breast cancer taking endocrine therapy, and the potential for its use in post-menopausal women experiencing similar symptoms.

"Our research findings published in The Lancet demonstrate efficacy of Q-122 as a non-hormonal oral treatment for vasomotor symptoms in women taking oral adjuvant endocrine therapy after breast cancer, with no evidence of treatment side effects," explains Principal Investigator and Senior Author, Professor Susan Davis Director, of the Monash University Women’s Health Research Program.

"In addition to a reduction in flushes and sweats, women who received Q-122 in the study reported a significantly lower likelihood of their hot flushes and sweats interfering with their sleep, and social and leisure activities, compared with placebo. If Q-122 can provide relief from these symptoms, it holds great potential for reducing discontinuation of endocrine therapy, enabling ongoing protection against breast cancer recurrence. This is an extremely important potential benefit of Q-122 beyond symptom relief alone," Professor Davis added.

QUE Oncology was formed through a joint venture between Emory University in Atlanta and the University of Queensland (UQ) research commercialisation company, UniQuest. The company has been supported by leading life science investors, including the Brandon Capital-managed Brandon BioCatalyst and Uniseed.

"It’s great to see extremely positive results from QUE Oncology’s Phase II trials published in the world’s leading independent general medical journal. The research highlights the need for a therapy for patients undergoing endocrine therapy for breast cancer who are experiencing vasomotor symptoms, but also the broader potential for Q-122 beyond this patient group, including postmenopausal women, of which 70-80 per cent experience vasomotor symptoms," says Dr Chris Nave, Chairman of QUE Oncology and CEO of Brandon BioCatalyst.

The results of QUE Oncology’s Phase II study support the conduct of larger and longer studies of Q-122, with potential use extending to postmenopausal women who require an alternative to oestrogen therapy for vasomotor symptoms.

[1] Bell RJ, Fradkin P, Schwarz M, Davis SR. Understanding discontinuation of oral adjuvant endocrine therapy by women with hormone receptor positive invasive breast cancer nearly 4 years from diagnosis. Menopause. 2013 Jan;20(1):15-21

ENDS

Q-122 Phase 2 study:

Eligible participants were women, aged 18–70 years, taking a stable dose of tamoxifen or an aromatase inhibitor following breast cancer and experiencing at least 50 self-reported moderate to severe vasomotor symptoms per week.

Participants were randomly assigned (1:1) using an interactive web response system to oral Q-122 100 mg or identical placebo, twice daily for 28 days. Randomisation was stratified by BMI (≤30 kg/m² or >30 kg/m²) and use of any of a selective serotonin reuptake inhibitor, selective norepinephrine reuptake inhibitor, gabapentin, or pregabalin.

Between Oct 24, 2018, and Sept 9, 2020, 243 patients were screened, 131 of whom were randomly assigned and received treatment (Q-122 n=65 and placebo n=66).

Q-122 resulted in a significantly greater mean percentage change in msVMS-SS from baseline over 28 days of treatment compared with placebo (least squares mean: Q-122, –39% [95% CI –46 to –31] vs placebo –26% [–33 to –18]; p=0・018).
Treatment-emergent adverse events were generally mild to moderate and similar between the two groups (treatment-related treatment-emergent adverse events in 11 [17%] of 65 patients in the Q-122 group vs nine [14%] of 66 in the placebo group); zero patients in the Q-122 group and two (3%) patients in the placebo group had serious adverse events.

On November 10, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has presented posters from preclinical studies of four pipeline assets, ATG-031, ATG-101, ATG-018, and ATG-027 at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (SITC 2022), taking place on November 8-12, in Boston, Massachusetts (the United States), via in person/virtual attendance (Press release, Antengene, NOV 10, 2022, View Source [SID1234623860]). As the world’s largest and most anticipated academic gathering in the field of immuno-oncology, the SITC (Free SITC Whitepaper) Annual Meeting is designed to promote scientific exchanges and cooperation for improving treatment outcomes for cancer patients.

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"We are very pleased to share this segment of our early stage portfolio with the oncology community. This year’s presentations highlight the breadth of Antengene’s internal research capabilities, evidenced by agents based on different modalities, including small molecules, monoclonal antibodies and bi-specific antibodies," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "These programs have shown promising data across a range of cell-based assays to confirm target affinity, appropriate in vitro cell and immune activation and strong in vivo anti-tumor activity, with differentiated performance compared to bench-mark compounds, as well as our growing expertise in the identification and validation of biomarkers and companion diagnostics to guide and support clinical development."

Oral Presentation

ATG-031 (anti-CD24 monoclonal antibody)

Title: ATG-031, a first-in-class anti-CD24 antibody, showed potent preclinical anti-tumor efficacy by blocking "don’t-eat-me" signal

Abstract#: 482

By overexpressing anti-phagocytic surface proteins, often known as"don’t eat me" signals, cancer cells can evade macrophage-mediated elimination. CD24, a GPI-anchored, highly glycosylated surface protein interacting with Siglec-10 on innate immune cells, was reported to be a novel "don’t eat me" protein. CD24 is over-expressed in multiple tumor types. And unlike CD47, another well-known "don’t eat me" target, CD24 is not expressed on human red blood cells (hRBC). ATG-031 is a first-in-class, humanized anti-CD24 antibody. ATG-031 potently binds to CD24-postive tumor cells, while showed no binding with hRBC. ATG-031 blocks the interaction between CD24 and Siglec-10 and inducesd potent macrophage-dependent tumor cell phagocytosis. Upon phagocytosis, M2 macrophages start to release M1-like cytokines suggesting a repolarization from M2 macrophages to M1 macrophages. ATG-031 significantly inhibited in vivo tumor growth and demonstrated synergism with immune checkpoint inhibitor (ICI) and chemotherapies. ATG-031 was well tolerated in preclinical toxicity studies in non-human primates. Also, a companion diagnostic antibody has been developed by Antengene as a patient selection tool.

In conclusion, these findings support further evaluation of ATG-031 in mono or combination therapy settings for patients with solid tumors or hematologic cancers. The Company intends to file an IND for ATG-031 in H1:2023.

Poster Presentations

ATG-101 (PD-L1/4-1BB bispecific antibody)

Title: ATG-101, a tetravalent PD-L1×4-1BB BsAb, demonstrates potent in vivo anti-tumor efficacy in Immune Checkpoint Inhibitor (ICI)-resistant or refractory mouse tumor models

Abstract#: 1150

ATG-101’s anti-"ICI-resistant or refractory tumors" activity was assessed in both in vitro and in vivo models. In the presence of PD-L1 positive cells, ATG-101 enhanced the IL2 and INF-γ production by the terminally exhausted T cells and progenitor exhausted T cells. The in vivo efficacy of ATG-101 was tested in 4-1BB humanized mouse bearing syngeneic B16F10 (Melanoma), EL4 (Lymphoma) or Pan02 (Pancreatic) tumors, all of which have been suggested to be ICI-resistant. ATG-101 was well tolerated and significantly inhibited tumor growth compared with control group. Furthermore, ATG-101 induced growth inhibition or regression in MC38 tumors that had progressed on atezolizumab, revealing a significant survival advantage over atezolizumab or the control group. TIL analysis suggested that ATG-101 increases the infiltration, proliferation and activation of CD8+ T cells, the infiltration of natural killer T cells and the CD8+/Treg ratio in TILs.

In conclusion, by cross linking 4-1BB with PD-L1, ATG-101 has the potential to activate exhausted T-cells and overcome ICI resistance. As the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia, ATG-101 is currently being evaluated in a Phase I study in Australia, China, and the U.S.

ATG-018 (ATR small molecule inhibitor)

Title: Discovery of blood pharmacodynamic biomarkers for ATR inhibitors

Abstract#: 76

Antengene presented the results of studies to identify validated PD biomarkers based on Antengene ATR’s inhibitor, ATG-018. To demonstrate this, Antengene first evaluated gene expression changes induced by ATG-018 on human peripheral blood mononuclear cells (PBMCs) by assessing PBMCs from three donor samples treated with different concentrations of ATG-018. NanoString technology was used to develop a high throughput gene expression profile at the transcriptome level. This work was validated by treating wild type mice with ATG-018 to define the expression of PD markers in plasma using Meso Scale Discovery’s technology. Through these studies, results showed that ATG-018 inhibited the expression of a set of chemokine genes (CCL2, CCL3/1 and CCL4) and that they could be detected in unmanipulated blood samples.

In conclusion, the expression of three chemokine genes that were inhibited by ATG-018 could have potential as clinically-relevant peripheral blood PD biomarkers to guide the development of ATG-018 and other ATR inhibitors in the clinic.

ATG-027 (B7H3/PD-L1 bispecific antibody)

Title: ATG-027, a first-in-class B7-H3/PD-L1 bispecific antibody, shows potent T cell activation capability and in vivo anti-tumor efficacy

Abstract#: 1397

ATG-027 is a B7-H3/PD-L1 bispecific antibody which enables key immune effects including immune checkpoint blocking, antibody-dependent cytotoxicity (ADCC) andand antibody-dependent cellular phagocytosis (ADCP). In the poster, results were presented from in vitro studies to evaluate the immune function and in vivo studies to assess the anti-tumor efficacy of ATG-027 using mice bearing syngeneic colorectal cancer cells overexpressing human B7-H3. Results showed that ATG-027 binds to B7-H3 and PD-L1 expressing cells with high affinity. ATG-027 demonstrated higher ADCC and ADCP activity compared with anti-PD-L1 and anti-B7-H3 parental antibodies. Interestingly, in a Mixed Lymphocyte Reaction (MLR) experiment to assess the T cell activation, ATG-027 and the B7-H3 parental antibody induced robust IL-2 and IFNγ production, indicating T cell activating function of tested antibodies. Besides, ATG-027 can potently block PD1/PD-L1 interaction. At in vivo studies, ATG-027 demonstrated superior anti-tumor activity compared to individual parental antibodies and induced tumor shrinkage or complete regression.

In conclusion, ATG-027’s dual functionality, from binding both B7-H3 and PD-L1, shows promising anti-tumor efficacy in preclinical models by enabling T-cell activation and powerful immune properties, ADCC and ADCP.

On November 10, 2022 Harbour BioMed (the "Company", HKEX: 02142) reported that Nona Biosciences, a subsidiary wholly owned by the Company, had entered into a license and collaboration agreement with ModernaTX, Inc. (NASDAQ: MRNA), a global biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines. The strategic collaboration will focus on discovering and developing nucleic acid-based immunotherapies for select oncology targets using the Company’s proprietary heavy chain only antibody discovery platform (HCAb) (Press release, Harbour BioMed, NOV 10, 2022, View Source [SID1234623859]).

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Upon the execution of the agreement and subject to terms and conditions thereof, Moderna will be granted an exclusive sub-licensable license to exploit a panel of sequences against multiple targets, derived from the Company’s HCAb platform, to develop products using nucleic acids. Moderna will assume full responsibility for all upcoming development, manufacturing, regulatory, and commercialization activities. Moderna would also be granted an option to obtain an exclusive sub-licensable license to exploit sequences against additional targets. Pursuant to the agreement, Nona Biosciences shall receive an upfront payment, and potential milestone payments based on pending achievement of certain regulatory, development, and sales milestones, and tiered royalties.

"We are very pleased and proud to collaborate with Moderna, a pioneering industry leader in the field of mRNA technology," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "This agreement marks a significant milestone in the Company’s business development, validating the potential of the Company’s technology platforms and innovation capabilities. Following a series of business achievements delivered on a global basis, we will continue to open up our technology platforms and talent and experience to innovators to empower global biotherapeutic innovation."

About HCAb

HCAb’s patented technology generates novel "heavy chain only" antibodies, which are about half the size of a typical IgG. These antibodies carry IgG-like PK properties and Fc-domain functions without the need for additional engineering or humanization. Lack of light chain also minimizes the issue of light chain mispairing and heterodimerization. These characteristics enable the development of products with attributes not achievable by conventional antibody platforms. In addition, HCAb-derived multiple novel therapeutic antibody modalities, including single-domain antibodies, bi-, and multi-specifics, antibody-drug conjugates, CAR-Ts, or VH domain-derived diagnostic or therapeutic products, are also achievable using this platform.

On November 10, 2022 Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the third quarter, ended September 30, 2022 (Press release, Monte Rosa Therapeutics, NOV 10, 2022, View Source [SID1234623832]).

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"Throughout 2022, we have made important strides in advancing our QuEENTM platform and our portfolio of MGDs derived from it, including our GSPT1 degrader MRT-2359. The FDA’s clearance of our first investigational new drug application, along with the recent initiation of patient dosing of MRT-2359 in our clinical trial in MYC-driven tumors, serve as strong validation of our platform, the quality of our team and the level of innovation we are bringing to the field," said Markus Warmuth, M.D., CEO of Monte Rosa. "We are continually progressing toward our goal of discovering and developing MGDs into a new generation of precision medicines for patients who currently have no real alternatives. With a strong cash position and investor support, we are well positioned to continue to execute on our first clinical program, as well as advance additional discovery programs through lead optimization."

THIRD QUARTER 2022 & RECENT HIGHLIGHTS

Received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2 clinical trial for MRT‑2359, a potent, selective and orally bioavailable GSPT1-directed MGD

Recently initiated patient dosing with MRT-2359, evaluating the treatment of MYC-driven solid tumors, including lung cancer

Advanced VAV1 degrader program into lead optimization; VAV1 plays a key role in T-cell and B-cell development and activation and is a highly validated target for multiple autoimmune diseases, as well as several types of lymphoma

Continued progress of CDK2 and NEK7 programs toward development candidate nominations

Entered into collaboration with Professor Sereina Riniker, Ph.D., (ETH Zürich) to integrate molecular dynamics into Monte Rosa’s AI/ML engine for target identification and virtual screening

Gave multiple presentations at the 5th Annual Targeted Protein Degradation Summit in October in Boston, which included new and updated preclinical data supporting development of MRT-2359 in MYC-driven lung cancer, and novel AI applications for the discovery of MGDs
img106802192_0.jpg

Presented overview of development of MRT-2359 as a GSPT1-directed MGD to target MYC-driven malignancies at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Oct. 28 in Barcelona, Spain

UPCOMING INVESTOR EVENTS

Monte Rosa will be participating in the following upcoming investor conferences:

Jefferies 13th Annual Global Healthcare Conference, Nov. 15-17, London

Piper Sandler 34th Annual Healthcare Conference, Nov. 29-Dec. 1, New York

41st Annual J.P. Morgan Health Care Conference, Jan. 9-12, 2023, San Francisco

THIRD QUARTER 2022 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2022 were $21.3 million, compared to $15.1 million for the third quarter of 2021. These increases were due to the expansion of R&D activities, including the advancement of MRT-2359 toward clinical development and the development of the company’s QuEEN platform and its preclinical programs, as well as increased headcount and laboratory-related expenses due to the company’s continued growth as an R&D organization. R&D expenses for the third quarter of 2022 included non-cash stock-based compensation of $1.7 million and non-cash lease expense of $1.5 million due to a rent holiday on the company’s Harrison Avenue facility lease. The same period in 2021 included non-cash stock-based compensation expense of $1.1 million.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2022 were $7.0 million, compared to $4.8 million for the third quarter of 2021. The increase in G&A expenses was a result of additional expenses incurred in support of the company’s growth and operations as a public company. G&A expenses included non-cash stock-based compensation of $1.5 million for the third quarter of 2022, compared to $1.0 million for the same period in 2021.

Net Loss: Net loss for the third quarter of 2022 was $27.3 million, compared to $19.8 million for the third quarter of 2021.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash and marketable securities as of September 30, 2022, were $277.4 million, compared to cash, cash equivalents and restricted cash of $299.5 million as of June 30, 2022. The decrease is primarily related to cash used to fund operations of $20.6 million and cash used for fixed assets of $1.4 million, partially off-set by proceeds from the exercise of stock options of $0.1 million. The company expects that its cash and cash equivalents will be sufficient to fund planned operations and capital expenditures into late 2024.

On November 10, 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 third quarter ended September 30, 2022 (Press release, Century Therapeutics, NOV 10, 2022, View Source [SID1234623831]).

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"We made steady progress this quarter with our next generation platform and robust portfolio of cell therapy product candidates, including FDA clearance of our first IND for CNTY-101 in relapsed/refractory B-cell malignancies," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We are focused on initiating the Phase 1 ELiPSE-1 trial to assess the potential of our Allo-EvasionTM edits, designed to prevent immunological rejection and enhance persistence of multiple dosing regimens of CNTY-101 with the aim to increase the proportion of patients that achieve durable responses. We look forward to sharing meaningful preclinical data updates at the SITC (Free SITC Whitepaper) meeting this week on both our iNK and gamma delta iT cell platforms, and to discussing our pipeline progress and our solid tumor strategy at our virtual Research and Development Day tomorrow."

"As we continue to realize efficiencies in our platform and synergies across our pipeline, we are updating our financial guidance for the year by reducing our expected GAAP Operating Expenses to $140 million and $145 for the full year ended 2022," said Michael Diem, Chief Business Officer, Century Therapeutics. "We will remain fiscally responsible as we continue to execute and deliver on our platforms, programs and key milestones, leaving us well positioned with cash runway into 2025."

Business Highlights

●Following notification from the U.S. Food and Drug Administration (FDA) that the Phase 1 ELiPSE-1 study of the Company’s first clinical product candidate, CNTY-101, may proceed, Century expects to initiate the trial imminently. The Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. All patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for three days. Schedule A of the trial includes a single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule B will evaluate a three-dose schedule per cycle of CNTY-101. Patients who demonstrate a clinical benefit are eligible for additional cycles of treatment with or without additional lymphodepletion pending FDA consent.

●In October 2022, the Company announced the appointment of Daphne Quimi and Timothy Walbert to its Board of Directors. Ms. Quimi is currently Chief Financial Officer of Amicus Therapeutics and brings operational experience in public accounting and financial reporting to Century. Mr. Walbert is currently Chairman, President, and Chief Executive Officer of Horizon Therapeutics, and brings expertise in product portfolio building and commercialization.

Subsequent Events and Upcoming Milestones

●Century plans to present preclinical data from its iPSC-based cell therapy platform in two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting today, November 10, 2022, and tomorrow, Friday, November 11, 2022. A copy of the presentations will be made available in the Posters section of Century’s website.

●The Company will host a virtual Research and Development (R&D) Day on Friday, November 11, 2022, from 8:00 AM to 9:30 AM ET. The R&D Day will feature presentations from the Company’s management team and Jonathan Rosenberg, M.D., Chief of the Genitourinary Oncology Service at the Memorial Sloan Kettering Cancer Center (MSKCC), Physician at Memorial Hospital at MSKCC, and Professor of Medicine at Weill Cornell Medical College. The event will focus on the Company’s gamma delta iT cell platform and solid tumor strategy and include a discussion of preclinical data to be presented at the SITC (Free SITC Whitepaper) Annual Meeting. For additional information on how to access the event, please visit the Events & Presentations section of Century’s website.

Third Quarter 2022 Financial Results

●Cash Position: Cash, cash equivalents, and investments were $395.3 million as of September 30, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $36.9 million for the nine months ended September 30, 2022 (which includes deferred revenue from the Bristol-Myers Squibb (BMS) collaboration of $118.5 million) compared to net cash used in operations of $64.7 million for the nine months ended September 30, 2021.

●Collaboration Revenue: Collaboration revenue was $2.2 million for the three months ended September 30, 2022, generated through the Company’s collaboration, option and license agreement with BMS.

●Research and Development (R&D) expenses: R&D expenses were $25.9 million for the three months ended September 30, 2022, compared to $19.5 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 offset by a decrease in collaboration expenses with FUJIFILM Cellular Dynamics, Inc. (FCDI) as the scope of work with FCDI has narrowed down to primarily manufacturing CNTY-101 clinical supply.

●General and Administrative (G&A) expenses: G&A expenses were $8.1 million for the three months ended September 30, 2022, compared to $6.3 million for the same period in 2021. The increase was primarily 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, and increased information technology and facility costs.

●Net loss: Net loss was $30.7 million for the three months ended September 30, 2022, compared to $26.0 million for the same period in 2021.

Financial Guidance

●The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $140 million and $145 million, including non-cash stock-based compensation expense of $10 million to $15 million.

●The Company expects its cash, cash equivalents, and investments will support operations into 2025.