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).
1

◦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.

On November 9, 2023 Celyad Oncology (Euronext: CYAD) (the "Company" or "Celyad Oncology"), a biotechnology company focused on innovative technologies for chimeric antigen receptor (CAR) T-cell therapies, reported its financial results for the third quarter of 2023 and provides an update on recent business developments (Press release, Celyad, NOV 9, 2023, View Source [SID1234637357]).

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" Celyad Oncology team is resolutely dedicated to harnessing our expertise, extensive know-how, and valuable intellectual property portfolio to address the existing challenges within CAR T-cell therapies. We are excited to report compelling data from our short hairpin RNA (shRNA)-based multiplexing platform, underscoring the remarkable versatility and adaptability of this technology. In addition, we are making significant progress with our multispecific CAR program, and we look forward to sharing an update at international conferences in the coming months. These achievements mark our commitment to advancing the frontiers of cellular immunotherapy and bringing innovative solutions to patients in need " commented Georges Rawadi, Chief Executive Officer of the Company.

Third quarter 2023 and recent corporate highlights:

On August 24, 2023, the Company announced that it has obtained commitments from Fortress, Tolefi and other longstanding existing shareholders to subscribe to a capital increase of up to €9.8 million in 2 tranches:
A first tranche of 2.0 million was disbursed in the context of authorized capital as of September 4, 2023; and
A second tranche to be subscribed by Fortress is subject to the approval by the extraordinary shareholders’ meeting. Following this private placement, the Company believes that its existing cash and cash equivalents should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the second quarter of 2025.
Celyad Oncology has relocated from September 25, 2023 into a new research facility which fits better its current needs after the strategic shift. The Company remains headquartered at the Axis Parc, Mont-Saint-Guibert, Belgium but with its new business location at Dumont 9.
Operational highlights

shRNA multiplexing platform:
Data validating our microRNA (miRNA)-based multiplex shRNA approach, which allows to down-regulate several genes simultaneously, were presented at the 4th International Conference on Lymphocyte Engineering (ICLE) in Munich (September 12-14) and at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in San Diego (November 1-5) and posters are available on the company’s website, at View Source;
With our approach we proved the feasibility of the simultaneous knock-down of 4 co-inhibitory receptors (PD-1, LAG-3, TIM-3 and CD95) to decrease the expression of exhaustion markers at the surface of CAR T-cells and the feasibility of this approach to improve allogeneic CAR T-cell viability by allowing evasion from graft-versus-host disease (GvHD), host-versus-graft (HvG) reaction and CD95L-induced autophagy.
The results detailing the technical aspects of the development of this platform and showcasing the easiness, efficiency, and tunability of this technology to knock-down up to four target genes simultaneously have been published in Molecular Therapy – Nucleic Acids as of September 20.
NKG2D-based CAR T-cells:
We have developed different CD19/NKG2DL, BCMA/NKG2DL and PSMA/NKG2DL multi-specific CAR T-cells, utilizing both tandem constructs – that encompass the extracellular domain of the natural NKG2D receptor fused to a scFv targeting CD19, BCMA or PSMA, or dual constructs – that co-express the NKG2D-based CAR with an anti-CD19, anti-BCMA or anti-PSMA CAR, respectively;
Our data provides the proof-of-concept that NKG2DL are valuable targets in a multispecific CAR approach;
Specifically, we showed that CD19/NKG2DL multispecific CAR T-cells, and in particular dual receptors, are highly effective in vitro against CD19+ and CD19- cell lines and against CD19+ primary B-cell acute lymphoblastic leukemia (B-ALL) cells. In vivo, CD19/NKG2DL tandem CAR T-cells outperforms dual CAR T-cells in controlling tumor growth in an aggressive B-ALL relapse model.
In vitro data generated with BCMA/NKG2DL and PSMA/NKG2DL multispecific CAR T-cells further validate this approach and its application in other hematological and solid indications.
Preliminary data were presented at the 4th ICLE conference in Munich (September 12-14) and at the 38th SITC (Free SITC Whitepaper) meeting in San Diego (November 1-5) and posters are available on the company’s website, at View Source.
Financial highlights – Third quarter 2023 financial review

As of September 30, 2023, the Company had cash and cash equivalents of €2.3 million. Net cash burn during the third quarter of 2023 amounted to €2.7 million, in line with expectations.

The Company projects that its existing cash and cash equivalents should be sufficient to fund operating expenses and capital expenditure requirements into the first quarter of 2024.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2023 and 2024, the Company continues to project that its existing cash and cash equivalents will not be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date that this release is issued.

On August 24, 2023, the Company announced that it has obtained commitments from Fortress, Tolefi and other longstanding existing shareholders to subscribe to a capital increase of up to €9.8 million (whose €2.0 million related to the first tranche has been already proceeded as of September 4, 2023). Taking into account the Management’s assumptions regarding estimated cash-flows for the years 2023, 2024 and 2025, the Company believes that following the close of the second tranche subscribed by Fortress which is subject to approval by the extraordinary shareholders’ meeting, its existing cash and cash equivalents should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the second quarter of 2025.

Upcoming Anticipated Milestones

More data and evidence in the context of the multi-specific CAR platform and shRNA multiplexing approach will be shared in the first quarter of 2024, with the aim of a clinical evaluation of assets and initiation of clinical trials either by the Company and/or through strategic partnerships afterwards.
Upcoming Conferences

Celyad Oncology will attend the 7th CAR-TCR Europe summit in London, UK (February 27-29, 2024), the must-attend forum to brainstorm advanced in cell therapies and stay at the forefront of cell therapy innovations.

On November 9, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Candel Therapeutics, NOV 9, 2023, View Source [SID1234637356]).

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"Candel has made very significant progress with our viral immunotherapy platforms and oncology-focused pipeline," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "We are encouraged by the recent clinical and biomarker data for CAN-2409 in NSCLC and pancreatic cancer, and CAN-3110 in recurrent HGG. The quality of the science was recently validated by a publication in Nature. Our off-the-shelf investigational medicines are designed to elicit individualized, systemic anti-tumor immune responses and, to date, have shown promise for extended survival beyond historical rates, along with a generally favorable safety and tolerability profile. We observed markedly increased immune cell infiltration in immunosuppressive tumors and systemic immune activation after experimental treatment with both CAN-2409 and CAN-3110."

"We look forward to multiple anticipated data readouts in 2024, including topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC in Q2 2024, topline progression-free survival data from the randomized phase 2 study of CAN-2409 vs. active surveillance alone in early localized prostate cancer, and topline disease-free survival data from the randomized phase 3 clinical trial of CAN-2409 in intermediate to high risk localized prostate cancer in Q4 2024, in addition to the first data on multiple injections of CAN-3110 in recurrent HGG in the second half of 2024," Dr. Tak concluded.

Third Quarter 2023 & Recent Highlights

•
Program Updates:
o
CAN-2409 – Non-Small Cell Lung Cancer (NSCLC)
▪
Initial data from the phase 2 NSCLC clinical trial suggested promising extension of overall survival, consistent with an increased tail on the maturing survival curve in patients whose disease progressed despite receiving anti-PD(L)1 treatment (Cohort 2).
▪
Data showed 93% of patients with long survival (≥12 months) were low or negative for PD-(L)1 expression, which supports the potential of CAN-2409 to convert patients unresponsive to immune checkpoint inhibitor treatment into long-term survivors.
▪
Robust activation of the immune system and immunological correlations between early changes in key effector immune populations after CAN-2409 treatment and survival suggested the potential to use early biological readouts as predictors of clinical response.
o
CAN-3110 – Recurrent High-Grade Glioma (HGG)
▪
Nature published results from the phase 1 investigator-sponsored clinical trial of CAN-3110 in 41 patients with recurrent HGG.
▪
New findings demonstrated that the proposed dual mechanism of CAN-3110 to trigger potent oncolysis and immune activation may be further enhanced in the presence of pre-existing antibodies to HSV (herpes simplex virus)-1.Median overall survival (mOS) of 14.2 months was observed in the patients with antibodies to HSV-1 virus (66%), present either at baseline or developed after CAN-3110 treatment.

▪
As of the data cut-off of April 20, 2023, data support the continued tolerability of a single injection of CAN-3110 in recurrent HGG with no dose-limiting toxicity and observed nearly doubling of the expected mOS in 50 patients (Arm A and B).
▪
The observed increase in diversity of the T-cell receptor repertoire associated with improved survival after a single injection, suggests that CAN-3110 can induce a broad and diverse immune response against HSV-1 and against the newly released tumor antigens.
▪
Arm C, supported by the Break Through Cancer Foundation, is currently evaluating the effects of repeat dosing of CAN-3110 (up to six injections over four months).
o
CAN-2409 – Pancreatic Cancer
▪
Positive overall survival and immunological biomarker data were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting for 2023, based on an interim analysis of the ongoing, randomized, phase 2 clinical trial of CAN-2409 plus prodrug together with SoC chemoradiation followed by resection for borderline resectable non-metastatic pancreatic ductal adenocarcinoma (PDAC) as of the August 21, 2023 data cutoff date.
▪
An estimated survival rate of 71.4% at 36 months was observed in patients who received 2 or 3 injections of CAN-2409 regimen together with SoC chemoradiation prior to surgery, versus only 16.7% estimated survival at 36 months with SoC chemoradiation prior to surgery.
▪
Patients whose cancer progressed showed an altered disease course after salvage chemotherapy with improved CA19-9 levels (biomarker of tumor burden) and ongoing survival. Similar responses were not observed in the control arm.
▪
Biomarker analysis demonstrated dense aggregates of immune cells that included CD8 positive granzyme B positive cytotoxic T cells, dendritic cells, and B cells in PDAC tissue resections obtained after CAN-2409 treatment, which confirmed activation of a robust antitumoral immune response.
o
enLIGHTEN Discovery Platform
▪
Presented the first experimental agent from the enLIGHTEN Discovery Platform, Alpha-201-macro1, during SITC (Free SITC Whitepaper). This new agent is an investigational viral immunotherapy that is designed to interfere with the CD47/ SIRPα pathway and activate innate immune surveillance. Results demonstrated monotherapy activity

following local administration in a preclinical model of breast cancer.
▪
Additional preclinical data presented at SITC (Free SITC Whitepaper) confirmed the capability of the enLIGHTEN Advanced Analytics suite to predict optimal gene payload combinations to arm viral vectors, that enable the design of potential combination therapeutics to overcome tumor resistance especially in cancers resistant to immune checkpoint inhibitor treatment.
Anticipated Milestones

•
Expect to report topline overall survival data on the phase 2 clinical trial of CAN-2409 plus valacyclovir combined with continued PD-(L)1 targeting agents in patients whose disease progresses despite receiving anti-PD-(L)1 treatment with late-stage NSCLC (Cohort 2) in Q2 2024.
•
Expect to report topline disease-free survival data on the fully enrolled, pivotal, placebo-controlled, randomized phase 3 clinical trial of CAN-2409 in combination with valacyclovir in localized intermediate/high-risk prostate cancer in Q4 2024.
•
Expect to report topline progression-free survival data on the fully enrolled, placebo-controlled, randomized phase 2 clinical trial of CAN-2409 in patients with low-to-intermediate-risk, localized, non-metastatic prostate cancer in Q4 2024.
•
Expect to report clinical and immunological biomarker data in patients with recurrent HGG enrolled into Arm C, evaluating repeat dosing regimen of CAN-3110 in 2H 2024.

Financial Results for the Quarter Ended September 30, 2023

Research and Development Service Revenue, related party: Research and development service revenue, related party, was $0 for the third quarter of 2023 compared to $31,000 for the third quarter of 2022, as the amortizable $1.0 million up-front license fee that Candel received in 2014 and 2015 from Ventagen LLC was fully recognized as of December 2022.

Research and Development Expenses: Research and development expenses were $5.8 million for the third quarter of 2023 compared to $5.4 million for the third quarter of 2022. The increase was primarily due to manufacturing and regulatory activities in support of the Company’s CAN-2409 programs. Research and development expenses included non-cash stock compensation expense of $0.3 million for both the third quarter of 2023 and the third quarter of 2022.

General and Administrative Expenses: General and administrative expenses were $3.0 million for the third quarter of 2023 compared to $3.5 million for the third quarter of 2022. The decrease was primarily due to lower professional service and consulting expenses, recruiting and insurance costs. General and administrative expenses included non-cash stock compensation expense of $0.4 million for both the third quarter of 2023 and the third quarter of 2022.

Net Loss: Net loss for the third quarter of 2023 was $8.4 million compared to a net loss of $8.7 million for the third quarter of 2022, and included net other income of $0.4 million and $0.2 million, respectively, primarily related to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents as of September 30, 2023 were $43.0 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the second quarter of 2024.