On November 9, 2023 Exscientia plc (Nasdaq: EXAI) reported that recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the third quarter of 2023, are summarised below (Press release, Exscientia, NOV 9, 2023, View Source [SID1234637362]). Exscientia will host a conference call Thursday, November 9 at 1:30 p.m. GMT / 8:30 a.m. EST.

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"At Exscientia, we are laser-focused on building an engine that designs and develops high impact medicines that have the potential to transform patients’ lives," said Professor Andrew Hopkins FRS FMedSci, founder and Chief Executive Officer of Exscientia. "We are continuing to build out a highly-differentiated internal oncology pipeline, particularly with clinical and IND-enabling stage programmes targeting CDK7 and LSD1. In addition, our partnerships are steadily progressing, including our recently announced first milestone with Sanofi and a new collaboration with Merck KGaA, Darmstadt, Germany. These advancements, paired with our commitment to technological capabilities, such as automation and ex vivo patient tissue analysis, solidify Exscientia’s leadership in AI-enabled drug design and development."

Recent Highlights

Internal pipeline
●ELUCIDATE, the adaptive Phase 1/2 trial studying GTAEXS617 (‘617), Exscientia and partner GT Apeiron’s potential best-in-class CDK7 inhibitor, continues to enrol patients with advanced solid tumours including head and neck cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, colorectal cancer and ovarian cancer
●The Company announced in October 2023 that it is prioritising the advancement of its LSD1 inhibitor, EXS74539 (‘539), towards the clinic, with IND submission expected in 1Q 2024 and commencement of a first-in-human healthy volunteer trial anticipated in 1H 2024 in the United States
○Exscientia presented new preclinical data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, demonstrating that ‘539 induces differentiation of primary human acute myeloid leukaemia (AML) samples ex vivo, highlighting potential activity of ‘539 in AML
○The Company also presented data supporting ‘539’s combinatorial potential with standard of care AML treatments
●EXS73565 (‘565), the Company’s MALT1 inhibitor, continues to progress through IND/CTA-enabling studies and the Company expects to provide further updates in 1H 2024
○Exscientia presented preclinical data for ‘565 at ESMO (Free ESMO Whitepaper) 2023, highlighting ‘565’s competitive differentiation and potential toxicity benefits through a low predicted risk of hyperbilirubinaemia

Partnered programmes
●In September 2023, Exscientia announced a new collaboration with Merck KGaA, Darmstadt, Germany focused on the discovery of novel small molecule drug candidates across oncology and immunology using Exscientia’s AI-driven precision drug design and discovery capabilities
○Three potential first-in-class or best-in-class targets have been identified as the initial focus of the partnership
○Exscientia will receive $20 million upfront and is eligible for discovery, development, regulatory and sales-based milestone payments
●In September 2023, Exscientia achieved the first milestone in its collaboration with Sanofi
○$4 million milestone payment represents first of up to $343 million in milestone payments per programme
○First target identified in immunology & inflammation (I&I) is one of up to 15 oncology and immunology targets
●EXS4318 (‘4318), a PKC-theta inhibitor designed by Exscientia and in-licensed by Bristol-Myers Squibb, is continuing in a Phase 1 study
●Two programmes designed by Exscientia for Sumitomo Pharma, DSP-0038 (5-HT1A agonist/5-HT2A antagonist) and DSP-2342 (dual 5-HT2A/5-HT7 antagonist), are also continuing in Phase 1 studies
●As part of the company’s pipeline prioritisation, Exscientia refined its internal and partnered discovery pipelines to focus investment on programmes that Exscientia and its partners believe are differentiated and that have the highest potential impact
○In October 2023, the Company announced that it had discontinued internal development of its A2A receptor antagonist, EXS21546, and is winding down the Phase 1/2 clinical trial of ‘546 for the treatment of relapsed/refractory renal cell carcinoma and NSCLC

○The Company ended its collaboration with EQRx following EQRx’s announced acquisition by Revolution Medicines. Exscientia retained the exclusive rights to the intellectual property from all collaboration projects
○The Company and Bristol Myers Squibb (BMS) mutually determined not to proceed with development of certain projects and prioritise others within the BMS collaboration
○Work is progressing on multiple projects with Sanofi, BMS and Merck KGaA, Darmstadt, Germany

Technology updates
●In September 2023, Exscientia presented data on its automated kinase design method, which is able to deliver potent kinase hits on certain targets from AlphaFold structures. Learnings from prior successful projects were encoded and automated to develop this tool. The Company expects to apply it at scale across future projects
●Exscientia’s automation facility recently opened and the Company has begun moving select biological assays and chemical synthesis to the facility. Productivity in the automated laboratory will ramp up through 2024, with meaningful impact on data and efficiency expected in 2025

Precision medicine
●EXCYTE-1, the first multi-centre trial evaluating the potential of Exscientia’s functional precision medicine platform in a solid tumour indication continues to progress in ovarian cancer
●Exscientia’s collaboration with Charité – Universitätsmedizin Berlin in haematological cancers is ongoing, which is utilising cloud-based AI to analyse samples imaged onsite at Charité

Investor Call and Webcast Information
Exscientia will host a conference call on Thursday, November 9 at 1:30 p.m. GMT / 8:30 a.m. EST.
A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialling +1 (888) 330 3292 (U.S.), +44 203 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.

Third Quarter and First Nine Months 2023 Financial Results
For the convenience of the reader, the company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.2214, which was the noon buying rate of the Federal Reserve Bank of New York on September 29, 2023.

Revenue: Revenue for the three and nine months ended September 30, 2023 was $10.8 million and $21.6 million respectively, compared to $7.7 million and $24.9 million for the three and nine months ended September 30, 2022. The increase in revenue quarter over quarter was primarily due to $8.38 million in revenue recognised from the projects that Exscientia and BMS mutually determined not to proceed with further development of under the BMS collaboration.

Research and development expenses: R&D expenses for the three and nine months ended September 30, 2023 were $39.8 million and $120.9 million respectively, as compared to $44.9 million and $113.9 million for the same period ended September 30, 2022. The current quarter over quarter decrease in research and development expenses was due to pipeline prioritisation activities and cost savings from operational efficiencies, including achieving faster cycle times and lower outsourcing costs.

General and administrative expenses: G&A expenses for the three and nine months ended September 30, 2023, were $13.6 million and $41.1 million respectively, or 22% of total operating expenses. For the three and nine months ended September 30, 2023, G&A expenses increased by $1.0 million and $4.2 million compared to the three and nine months ended September 30, 2022, primarily associated with the growth of the business being offset by automation and cost efficiency measures.

Cash inflows: For the first nine months of 2023, Exscientia received $3.5 million in cash inflows from its collaborations as compared to $117.3 million during the first nine months of 2022, when the upfront payment for the Sanofi collaboration was received.

Net operating cash flow and cash balance: For the first nine months ended September 30, 2023, net operating cash outflows were $145.1 million, in comparison to net operating cash outflows of $16.5 million for the nine months ended September 30, 2022. Cash, cash equivalents and short term bank deposits as of September 30, 2023 were $447.8 million, as compared to $617.8 million as of December 31, 2022 using the September 30, 2023 constant currency rate. With its pipeline prioritisation strategy, the Company expects to maintain a cash runway well into 2026.
●Includes constant currency mark-to-market foreign exchange impact of 1% based on a slight strengthening of pounds sterling for the nine months through September 30, 2023
●During the third quarter of 2023, Exscientia recognised net foreign exchange gain of $4.0 million
●The Company holds its deposits in both GBP and USD, intended to match expected operational cash needs in order to limit the impact of exchange rate fluctuations

On November 9, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended September 30, 2023, and provided business updates (Press release, Erasca, NOV 9, 2023, View Source [SID1234637361]).

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"In 2023, we have continued to make exciting progress across our pipeline," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "In August, we dosed the first patient with naporafenib (pan-RAF inhibitor) in combination with trametinib in our SEACRAFT-1 Phase 1b trial in patients with RAS Q61X tissue agnostic solid tumors. We identified promising activity in our HERKULES-3 signal-seeking study of ERAS-007 (ERK inhibitor) in combination with encorafenib and cetuximab (EC) in EC-naïve patients with BRAF-mutated (BRAFm) colorectal cancer (CRC) using a flexible BID-QW dosing regimen, reinforcing ERAS-007’s potential as a backbone of combination therapy. Our robust balance sheet and cash runway into the second half of 2025 position us well to report on multiple near-term readouts from our ongoing clinical programs."

Research and Development (R&D) Highlights

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Dosed First Patient in SEACRAFT-1 Phase 1b Trial for Naporafenib: In August 2023, Erasca dosed the first patient in the SEACRAFT-1 Phase 1b trial evaluating naporafenib (pan-RAF inhibitor) in combination with trametinib (MEK inhibitor, MEKINIST) in patients with RAS Q61X tissue agnostic solid tumors.

Key Upcoming Milestones

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SEACRAFT-1: Phase 1b trial for naporafenib (pan-RAF inhibitor) plus trametinib in patients with RAS Q61X tissue agnostic solid tumors
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Initial Phase 1b combination data expected between the second and fourth quarters of 2024
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SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRAS-mutated melanoma
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Dosing of the first patient expected in the first half of 2024
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HERKULES-3: Phase 1b trial for ERAS-007 (ERK inhibitor) plus encorafenib (BRAFTOVI) + cetuximab (ERBITUX) (EC) in EC-naïve patients with BRAFm CRC
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Phase 1b combination expansion data in patients with BRAFm CRC expected between the second half of 2023 and the first half of 2024
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FLAGSHP-1: Phase 1b trial for ERAS-601 (SHP2 inhibitor) in patients with advanced solid tumors
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Phase 1b combination expansion data in relevant patient populations, including patients with human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC), expected in the first half of 2024
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THUNDERBBOLT-1: Phase 1 trial for ERAS-801 (central nervous system (CNS)-penetrant EGFR inhibitor) in patients with recurrent glioblastoma (GBM)
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Initial Phase 1 monotherapy dose escalation data in patients with recurrent GBM expected in the second half of 2023

Third Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $343.6 million as of September 30, 2023, compared to $435.6 million as of December 31, 2022. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $25.2 million for the quarter ended September 30, 2023, compared to $28.2 million for the quarter ended September 30, 2022. The decrease was primarily driven by decreases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities, and outsourced services and consulting fees, as a result of pipeline prioritization, partially offset by increases in personnel costs, including stock-based compensation expense.

General and Administrative (G&A) Expenses: G&A expenses were $9.4 million for the quarter ended September 30, 2023, compared to $8.8 million for the quarter ended September 30, 2022. The increase was primarily driven by personnel costs, including stock-based compensation expense, partially offset by decreases in legal and accounting fees.

Net Loss: Net loss was $30.4 million, or $(0.20) per basic and diluted share, for the quarter ended September 30, 2023, compared to $35.5 million, or $(0.29) per basic and diluted share, for the quarter ended September 30, 2022.

On November 9, 2023 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Chemomab, NOV 9, 2023, View Source [SID1234637360]).

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"Chemomab made excellent progress during the third quarter," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "Our focus on successfully completing our CM-101 Phase 2 trial in primary sclerosing cholangitis (PSC) is fueling rapid progress, as robust patient interest is enabling us to advance towards completion of the enrollment stage of the trial. We expect to provide more detail on projected trial completion and reporting timelines early in the new year."

Dr. Mor added, "During the quarter we also participated in activities to raise awareness about PSC and the high unmet need for effective PSC therapies. We were an active participant in and supporter of the annual conference of the leading U.S. patient advocacy organization, which was complemented by our work with PSC advocates in Europe and Israel. We also continued to work closely with PSC key opinion leaders who are coordinating efforts to advance the evolving regulatory environment for PSC therapies, with the goal of incorporating new knowledge and improved technologies into regulatory decision-making. We expect that our ongoing collaborations with opinion leaders and patient groups will help us move expeditiously towards a Phase 3 registrational trial in PSC, if our current Phase 2 trial is successful."

"We are also continuing our campaign to educate the scientific and medical communities about CCL24 and CM-101. We have an oral presentation and multiple posters at both the 2023 AASLD Liver Meeting in Boston and the 2023 ACR Convergence conference in San Diego next week. Our continued success in achieving oral and poster presentations at top medical conferences highlights the scientific relevance of our CM-101 programs."

"We are continuing to manage our resources prudently and expect our quarterly cash burn to continue to decrease in 2024. We reiterate our prior guidance that we believe we have adequate financial resources to both achieve our significant Phase 2 PSC topline data milestone and take us through the end of next year. We view the upcoming PSC milestone as a major catalyst for Chemomab. If successful, we expect the trial results to provide us a range of options for advancing CM-101 in PSC and other indications."

"Finally, I want to note that despite the major challenges confronting Israel, we do not expect an impact on our ongoing activities. Currently, our headquarters and R&D operations in Tel Aviv are fully operational and our clinical development and medical affairs teams based in the U.S. are functioning normally, as planned. We would like to thank our employees and our many colleagues around the globe who have offered us tremendous support during this difficult time for Israel."

Third Quarter 2023 Corporate Updates

Scientific Studies Accepted for Oral and Poster Presentations at 2023 AASLD The Liver Meeting and at ACR Convergence 2023
Studies authored and co-authored by Chemomab scientists were accepted for presentation at two major U.S. medical conferences in November, including an oral presentation on PSC and a scientific poster at the AASLD The Liver Meeting in Boston, as well as a poster presentation on the role of Chemomab’s CCL24 target in systemic sclerosis at the American College of Rheumatology Convergence 2023 conference in San Diego. Further details of the presentations will be released later this month.

Participated in Investor Conferences
Chemomab management recently participated in several investor conferences, including the 2023 Roth MKM Health Opportunities Conference and the 2023 H.C. Wainwright 25th Annual Global Investment Conference. During the quarter the Company was also proactive in reaching out to analysts and investors to educate them about Chemomab’s programs and our future plans.

Third Quarter 2023 Financial Highlights

Cash Position: Cash and cash equivalents were $21.4 million as of September 30, 2023, compared to $26.7 million for the quarter ended June 30, 2023. The Company currently expects its cash runway to last through year-end 2024.
Research and Development (R&D) Expenses: R&D expenses were $3.4 million for the third quarter ended September 30, 2023, compared to $5.4 million for the same quarter in 2022. The decrease in R&D expense year-over-year primarily reflects a decrease in manufacturing costs for clinical supplies, which was partly offset by increases in the company’s clinical program activities.
General and Administrative (G&A) Expenses: G&A expenses were $1.0 million for the third quarter ended September 30, 2023, compared to $2.9 million for the same quarter in 2022. The decrease was primarily due to a decrease in salaries and related benefits expenses as well as a decrease in non-cash share-based expenses.
Net Loss: Net loss was $4.1 million, or a net loss of approximately $0.017 per basic and diluted share, for the third quarter ended September 30, 2023, compared to a net loss of $8.1 million, or a net loss of approximately $0.035 per basic and diluted share, for the quarter ended September 30, 2022.
The weighted average number of Ordinary Shares outstanding, basic and diluted, for the quarter ended September 30, 2023, was 236,449,153 (equal to 11,822,458 American Depository Shares) compared to 228,773,418 Ordinary Shares (equal to 11,438,671 American Depository Shares) for the quarter ended September 30, 2022.

For further details on Chemomab’s financial results for the quarter ended September 30, 2023, refer to the Report of Foreign Private Issuer on Form 6-K, which was filed with the SEC on November 9, 2023.

On November 9, 2023 Avalo Therapeutics, Inc. (Nasdaq: AVTX), reported business updates and financial results for the third quarter of 2023 (Press release, Avalo Therapeutics, NOV 9, 2023, View Source [SID1234637359]).

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Dr. Garry Neil, Chief Executive Officer and Chairman of the Board remarked, "We made significant progress in the third quarter, highlighted by the full debt payoff and divestiture of the 800 series. Our strengthened balance sheet and focused pipeline underscores our unwavering commitment to execute our strategy to progress our promising immunology drug candidates and positions us to consider collaborations, pursue funding for research and development, and bring innovative treatments to market."

Dr. Neil continued, "I am excited to potentially kick off a randomized placebo-controlled trial of quisovalimab, our anti-LIGHT mAb, in patients with ulcerative colitis or another inflammatory indication, subject to funding. This drug candidate has previously shown strong target engagement in both acute and chronic inflammatory diseases, and I remain optimistic that it could transform the lives of patients with immunological diseases and address unmet medical needs. Additionally, we look forward to progressing AVTX-008, our BTLA agonist fusion protein with high-binding affinity and serum stability, to IND. Targeting BTLA represents a promising and increasingly recognized avenue for developing therapies that can effectively modulate the immune response in autoimmune diseases while minimizing the risk of systemic immunosuppression. We believe AVTX-008 is unique in this class because it is a fusion protein that utilizes the natural ligand thus avoiding potential problems with agonist mAbs. Finally, we continue to evaluate new opportunities to further augment our immunology pipeline."

Corporate Updates:

•In September of 2023, Avalo paid off the remaining $14.3 million of its original $35 million debt owed to Horizon Technology Finance Corporation (Nasdaq: HRZN). As a result, Avalo’s obligations under the debt agreement were deemed satisfied.

•On October 27, 2023, Avalo completed the divestiture of its rights, title and interest in, assets relating to AVTX-801, AVTX-802 and AVTX-803 (collectively, the 800 Series) to AUG Therapeutics, LLC (AUG). The Company is entitled to up to $45 million of contingent milestone payments. The Company previously announced it entered into a purchase agreement with AUG to divest the 800 Series on September 12, 2023.

Program Updates:

•Quisovalimab (AVTX-002): Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases.
◦Quisovalimab has shown a rapid and sustained reduction of LIGHT levels, as well as a favorable safety and tolerability profile, in all indications studied including COVID-19 Acute Respiratory Distress Syndrome (ARDS), Crohn’s Disease and Non-Eosinophilic Asthma (NEA).
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◦Quisovalimab was statistically significant in reducing respiratory failure and mortality in patients hospitalized with COVID-19 ARDS in a randomized placebo-controlled trial. Quisovalimab also demonstrated positive trends in an open-label study in Crohn’s Disease.

◦A post-hoc analyses in the PEAK Trial showed a sub-population of NEA patients with baseline LIGHT levels over 125 pg/mL, which represented over 50% of patients, had an approximate 50% reduction in asthma-related events (AREs) for patients treated with quisovalimab compared to placebo.

◦Avalo is pursuing funding for the program and is considering a randomized placebo-controlled trial in patients with Ulcerative Colitis or other inflammatory conditions.

•AVTX-008: B and T Lymphocyte Attenuator (BTLA) agonist fusion protein targeting immune dysregulation disorders.
◦AVTX-008 is uniquely positioned as a fusion protein with high-binding affinity and serum stability. It utilizes the natural ligand thus it may avoid the potential problems with agonist mAbs.

◦Avalo previously identified a lead molecule, is evaluating several immune dysregulation disorders to pursue and plans to rapidly progress the asset to IND, subject to funding.

Third Quarter 2023 Financial Update:

Avalo had $10.2 million in cash and cash equivalents as of September 30, 2023. The Company fully eliminated its debt with principal payments of $21.2 million, inclusive of the full payoff of the remaining loan in September of 2023. The Company raised $46.2 million of net proceeds from equity financings in the nine months ended September 30, 2023.

Total operating expenses decreased $24.7 million for the nine months ended September 30, 2023 as compared to the same period in 2022. This decrease was primarily driven by decreases to both research and development expenses and selling, general and administrative as a result of cost savings initiatives implemented in the first quarter of 2022 and fewer research and development programs ongoing in the current year.

The net loss and net loss per share for the nine months ended September 30, 2023 was largely driven by operating expenses. The significant decrease in net loss for the nine months ended September 30, 2023 as compared to the prior year period was due to the $24.7 million decrease in operating expenses, partially offset by the $14.5 million of license revenue in the prior year that did not repeat. Net loss per share decreased as a result of the decrease in net loss and due to a significant increase in shares outstanding.

About quisovalimab (AVTX-002)

Quisovalimab is a fully human monoclonal antibody (mAb), directed against human LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes). There is increasing evidence that the dysregulation of the LIGHT-signaling network which includes LIGHT, its receptors HVEM and LTβR and the downstream checkpoint BTLA, is a disease-driving mechanism in autoimmune and inflammatory reactions in barrier organs. Therefore, we believe reducing LIGHT levels can moderate immune dysregulation in many acute and chronic inflammatory disorders. Quisovalimab previously demonstrated proof of concept in COVID-19 induced acute respiratory distress syndrome including reduction in mortality and respiratory failure, as well as a positive signal in patients with Crohn’s Disease.

About AVTX-008

AVTX-008 is a fully human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein in the IND-enabling stage. AVTX-008 is differentiated by having specific binding to BTLA, with no binding to LIGHT or CD160. AVTX-008 also has high-serum stability and solubility.

On November 9, 2023 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, 2023 (Press release, Century Therapeutics, NOV 9, 2023, View Source [SID1234637358]).

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"The last several months have been marked by immense progress for Century, and we are thrilled to welcome Brent to the team as our new leader at this exciting period in the Company’s history," said Joe Jimenez, Chairman of the Board of Directors of Century. Greg Russotti, Interim Chief Executive Officer, Century Therapeutics added, "We continued to advance our Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas. Building on the exciting case study featured in our ASH (Free ASH Whitepaper) abstract earlier this month, we look forward to sharing additional data in December which we believe continue to support the potential for a multi-dosing strategy for CAR iNK enabled by Allo-Evasion."

Dr. Russotti added, "Furthermore, we were extremely excited to announce this morning that we have expanded our license agreements with our partners at FCDI. These expanded agreements provide us new and continued access to technology that we believe will aid in our mission to bring curative cell therapy products to patients in need, including patients with autoimmune and inflammatory diseases."

Business Highlights and Upcoming Milestones

· This morning, Century announced the appointment of Brent Pfeiffenberger, Pharm.D., MBA, as Chief Executive Officer and member of the Board of Directors, effective December 4, 2023. He brings to Century over 20 years of broad-ranging global leadership experience across the healthcare industry, most recently serving as Chief Operating Officer at Neogene Therapeutics. Also effective December 4, 2023, Greg Russotti, Ph.D., who has served as Century’s Interim Chief Executive Officer since April 2023, will assume the role of Chief Technology and Manufacturing Officer, an expanded role from his previous position as Chief Technology Officer.

· During a poster session at the upcoming ASH (Free ASH Whitepaper) Annual Meeting being held December 9-12 in San Diego, the Company will present initial data from the ongoing first-in-human Phase 1 ELiPSE-1 trial of CNTY-101 in relapsed/refractory CD19 positive B-cell lymphomas. As previously announced, preliminary clinical data from a case study featured in the recently published ASH (Free ASH Whitepaper) abstract shows a complete response maintained in a Dose Cohort 1 (100 million cell dose level) patient with high risk relapsed/refractory follicular lymphoma following completion of four 28-day cycles of CNTY-101, the two most recent of which did not include lymphodepletion. Updated data to be announced in December will include additional results from patients treated in Dose Cohort 1 as of a more recent cutoff date, as well as preliminary data from patients in Dose Cohort 2 (300 million cell dose level).

· This morning, Century and FUJI Cellular Dynamics (FCDI) announced that they have entered into a worldwide license agreement whereby FCDI will grant the Company non-exclusive licenses for certain patent rights and know-how related to cell differentiation and reprogramming for the development and commercialization of iPSC-derived therapies for the treatment of autoimmune and inflammatory diseases. The Company also shared that it expanded its existing 2018 license agreement with FCDI related to the development and commercialization of iPSC-derived cancer immunotherapeutics to also include inflammatory and autoimmune diseases.

Third Quarter 2023 Financial Results

· Cash Position: Cash, cash equivalents, and investments were $284.3 million as of September 30, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $61.8 million for the nine months ended September 30, 2022 compared to net cash provided by operations of $37.0 million for the nine months ended September 30, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $118.5 million).

· Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option, and license agreement with BMS was $0.1 million for the three months ended September 30, 2023 compared to $2.2 million for the same period in 2022. Revenue recognized under the collaboration agreement fluctuates based on the amount and timing of expenses incurred under the agreement.

· Research and Development (R&D) expenses: R&D expenses were $22.8 million for the three months ended September 30, 2023 compared to $25.9 million for the same period in 2022. The decrease in R&D expenses was primarily due to the Company’s 2023 reorganization and reprioritization of early-stage programs and discovery platforms as well as a decline in sponsored research activities.

· General and Administrative (G&A) expenses: G&A expenses were $9.0 million for the three months ended September 30, 2023, compared to $8.1 million for the same period in 2022. The increase was primarily due increases in stock-based compensation and recruiting fees.

· Net loss: Net loss was $32.7 million for the three months ended September 30, 2023, compared to $30.7 million for the same period in 2022.

Financial Guidance

· The Company expects full year GAAP Operating Expenses to be between $135 million and $145 million including non-cash stock-based compensation expense of $12 million to $17 million.

· The Company expects its cash, cash equivalents, and investments will support operations into 2026.