On August 14, 2024 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported financial results for the three and nine months ended June 30, 2024 and provided a corporate update (Press release, Sonnet BioTherapeutics, AUG 14, 2024, View Source [SID1234645929]).

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"We continue to be encouraged with the data generated by our lead program SON-1010. While preliminary, demonstrating evidence of clinical benefit at 4 months in 35% of evaluable patients in both of our ongoing studies of SON-1010 represents a significant opportunity to help patients with PROC and address an indication in desperate need of innovative therapies," commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "Additionally, we are actively working to identify a partner to help advance our SON-080 program through the next phases of development and potentially address a significant unmet need in diabetic peripheral neuropathy."

Recent Highlights

● Reported encouraging data from Phase 1b/2a clinical trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) that support advancement into Phase 2 study;
● Announced the exercise of warrants for $3.4 million in gross proceeds;
● Announced the generation and in vitro characterization of two novel drug candidates, SON-1411 (IL18-FHAB-IL12) and SON-1400 (IL18-FHAB), each containing a modified version of recombinant human interleukin-18 (IL-18);
● Presented the SB221 study of SON-1010 (recombinant human Interleukin-12 linked to Sonnet’s fully-human albumin binding domain or IL12-FHAB) dosed in combination with atezolizumab (Tecentriq) in a ‘Trial in Progress’ poster at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2024; and
● Announced updated clinical data for SON-1010 as monotherapy or combined with atezolizumab, an anti-PD-L1 antibody, along with an increase in the dose-escalation target.

Patent Update

● On June 11, 2024, the U.S. Patent and Trademark Office (USPTO) granted patent No. 12,006,361, titled, "Albumin Binding Domain Fusion Proteins," covering composition of matter for product candidate SON-1210, the Company’s proprietary, bifunctional version of human Interleukins 12 (IL-12) and 15 (IL-15), configured using Sonnet’s Fully Human Albumin Binding (FHAB) platform. The granted patent is a Continuation of Patent No. 11,028,166 issued in June 2021.

"We remain committed to strengthening the intellectual property portfolio for our FHAB enabling technology platform and are pleased to further expand our patent estate in this key territory for Sonnet with this granted U.S. patent for SON-1210, our dual-targeting cytokine. We believe that including SON-1210 in our unique platform may create a next generation cancer treatment that can enhance patients’ own immune systems to fight cancer. We look forward to identifying a development pathway through a collaboration for the continued advancement of SON-1210 and offering patients with cancer a much needed therapeutic option," added Pankaj Mohan, Ph.D., Founder and CEO of Sonnet.

Lead Clinical Programs Update

SON-1010: Targeted Immune Activation Cancer Therapy, Turning ‘Cold’ Tumors ‘Hot’ Initially Targeting Solid Tumors and Platinum-Resistant Ovarian Cancer (PROC)

Phase 1 Trial (SB101 Trial): Solid Tumors (Monotherapy)

This first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and is being conducted at several sites across the United States.

For more information about the SB101 clinical trial, visit clinicaltrials.gov and reference identifier NCT05352750.

Phase 1b/2a Trial (SB221 Trial): PROC (Combo with Atezolizumab)

The second trial is a global Phase 1b/2a multicenter, dose-escalation and randomized proof-of-concept study to assess the safety, tolerability, PK, PD, and efficacy of SON-1010 administered subcutaneously (SC) in combination with atezolizumab given intravenously (IV).

For more information about the SB221 clinical trial, visit clinicaltrials.gov and reference identifier NCT05756907.

SON-1010 Program Highlights:

● PK data reveals about 10-fold extended half-life for SON-1010 compared with rhIL-12 and suggests tumor targeting by the FHAB.
● Dose-related IFNγ response.
● The SB101 trial and the SB221 trial have collectively enrolled 61 subjects, with 8 of 23 patients (35%) with cancer suggesting clinical benefit of SON-1010 (Stable Disease at 4 months).
● Patients have received up to 25 cycles of SON-1010 as monotherapy and up to 10 cycles of SON-1010 with atezolizumab (Tecentriq) without dose-limiting toxicity at any dose level.
● Toxicity is minimized in both trials with the use of a ‘desensitizing’ first dose that takes advantage of the known tachyphylaxis with rhIL-12, which allows higher maintenance doses and potential improvements in efficacy.
● Favorable safety profile.

SON-1010 Upcoming Milestones

● Phase 1: Solid Tumors (Monotherapy)

○ 2H 2024: Safety Data
○ 1H 2025: Topline Efficacy Data

● Phase 1b/2a: PROC (Combo with Atezolizumab)

○ 2H 2024: Additional Safety Data
○ 2H 2025: RP2D & Topline Efficacy Data

SON-080: Low dose of rhIL-6 for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN)

Phase 1b/2a Trial (SB211 Trial): Chemotherapy Induced Peripheral Neuropathy (CIPN)

The SB211 study is a double-blind, randomized, controlled trial of SON-080 conducted at two sites in Australia in patients with persistent CIPN using a new proprietary version of recombinant human Interleukin-6 (rhIL-6) that builds upon previous work with atexakin alfa. The goal of the Phase 1b portion of the SB211 study was to confirm safety and tolerability before continued development in Phase 2. As previously announced in March 2024, a data and safety monitoring board reviewed the unblinded safety and tolerability of SON-080 in the first nine patients and concluded that the symptoms were tolerable in the initial patients and the study could proceed to Phase 2.

Phase 1b Data Highlights:

● SON-080 demonstrated to be well-tolerated at both 20 µg and 60 µg/dose, which was about 10-fold lower than the maximum tolerated dose (MTD) for IL-6 that was established in previous clinical evaluations.
● Pain and quality of life survey results suggest the potential for rapid improvement of peripheral neuropathy symptoms and post-dosing durability with both doses, compared to placebo controls.

For more information about the SB211 study, visit clinicaltrials.gov and reference identifier NCT05435742.

SON-080 Upcoming Milestones

● Seeking partnership to support initiation of a Phase 2 clinical trial in DPN, a mechanistically synergistic and larger, high-value indication with unmet medical need.

Summary of Financial Results for the Third Quarter 2024

As of June 30, 2024, Sonnet had $3.6 million cash on hand, which the Company believes is sufficient to fund operations into November 2024.

Research and development expenses were $1.7 million for the three months ended June 30, 2024, compared to $2.4 million for the three months ended June 30, 2023. The decrease of $0.7 million was primarily due to cost saving initiatives, as the Company is managing expenses for liquidity purposes and is tightening its focus on the research and development projects it has assessed to have the greatest near-term potential. In addition to transitioning product development activities to cost advantaged locations such as India and Australia, the Company has reduced expenditures on tertiary programs and suspended antiviral development related to SON-1010, as well as programs related to SON-080 and SON-1210 while it seeks potential partnering opportunities.

General and administrative expenses were $1.8 million for the three months ended June 30, 2024, compared to $1.5 million for the three months ended June 30, 2023. The increase of $0.3 million related primarily to costs incurred in connection with the May 2024 ChEF Purchase Agreement entered into with Chardan Capital Markets LLC and an increase in legal and professional expenses and franchise taxes, partially offset by a decrease in consulting expenses related to licensing.

On August 13, 2024 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the second quarter ended June 30, 2024, and provided a business update (Press release, Bolt Biotherapeutics, AUG 13, 2024, View Source [SID1234645792]).

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"During the second quarter, we continued to make significant progress across our two programs, BDC-3042 and BDC-4182, following our strategic pipeline prioritization in May," said Willie Quinn, Chief Executive Officer. "For our lead program BDC-3042, we completed the safety evaluation period for cohort 5 with no dose-limiting toxicities. BDC-3042 continues to be well tolerated to date, and we are now enrolling patients into cohort 6. We will be presenting a poster on BDC-4182, our claudin 18.2-targeting BoltbodyTM ISAC, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, and we look forward to sharing more data on this program in November. I’m proud that the team has not missed a beat working through our strategic pipeline prioritization and restructuring. Our strong cash position allows us to move these programs through early clinical development and provides us with cash runway through mid-2026."

Recent Highlights and Anticipated Milestones
•Advanced to cohort 6 in the Phase 1 study of BDC-3042 in patients with advanced cancers. BDC-3042 is a proprietary agonist antibody that targets Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable triple-negative breast cancer (TNBC), colorectal cancer, clear cell renal cell carcinoma, head and neck cancer, non-small cell lung cancer (NSCLC), ovarian cancer, or melanoma.
•Preparing BDC-4182 to start clinical trials in 2025. BDC-4182 is a next-generation BoltbodyTM ISAC clinical candidate targeting claudin 18.2, a novel, clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models. A poster on BDC-4182 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, which will take place from November 6-10, 2024, in Houston, Texas.

•Collaborations with Genmab and Toray continue to progress. The Company continues to work with its collaborators to discover and develop ISACs for the treatment of cancer. Recent developments with Genmab supported the extension of the original initial research phase of the collaboration.
•Cash, cash equivalents, and marketable securities were $97.5 million as of June 30, 2024. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Second Quarter 2024 Financial Results

•Collaboration Revenue – Collaboration revenue was $1.3 million for the quarter ended June 30, 2024, compared to $1.4 million for the same quarter in 2023. Revenue in the comparative periods was generated from services performed under R&D collaborations as we fulfill our performance obligations.

•Research and Development (R&D) Expenses – R&D expenses were $15.4 million for the quarter ended June 30, 2024, compared to $15.6 million for the same quarter in 2023.

•General and Administrative (G&A) Expenses – G&A expenses were $4.9 million for the quarter ended June 30, 2024, compared to $5.6 million for the same quarter in 2023. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily due to a decrease in bonus expense as a result of the restructuring plan.

•Restructuring Charges – Restructuring charges were $3.6 million for the quarter ended June 30, 2024, consisting of $2.9 million of one-time termination benefits such as severance costs and related benefits and $0.7 million of non-cash stock-based compensation expense as a result of the restructuring plan. There were no restructuring charges in the quarter ended June 30, 2023.

•Loss from Operations – Loss from operations was $22.6 million for the quarter ended June 30, 2024, compared to $19.8 million for the same quarter in 2023.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On August 13, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported financial results for the second quarter of 2024 and provided a business update (Press release, Mural Oncology, AUG 13, 2024, View Source [SID1234645815]).

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"We’ve seen resurgent interest across the industry in cytokines as powerful tools to fight cancer and Mural is in a unique position to deliver promising drug candidates that have the potential to overcome the limitations of prior approaches," said Caroline Loew, Ph.D., Chief Executive Officer of Mural Oncology. "Since becoming an independent company late last year, we’ve rapidly worked to shape and grow a nimble organization focused on delivering meaningful new immunotherapy treatments to cancer patients. We believe each of our programs is engineered with a differentiated approach that we hope will play out significantly in the clinic starting early next year."

Recent Corporate Highlights and Upcoming Milestones

Mural appointed George Golumbeski, Ph.D., to its board of directors in July. Dr. Golumbeski currently serves as a partner at DROIA Ventures, a specialist biotech investment firm focused on therapeutics for oncology and genetic disease. Prior to DROIA, he served as President and Head of Corporate Development for GRAIL and Executive Vice President of Business Development for Celgene. He has nearly 30 years of extensive experience with strategic collaborations, M&A, in-licensing, out-licensing, and alliance management.
Mural’s late-stage clinical trials of nemvaleukin alfa continue to progress toward readouts in the first half of 2025. The company is focused on two foundational indications for nemvaleukin, where the majority of patients do not have any currently approved therapies.

ARTISTRY-7 is a potentially registrational, phase 3 clinical trial evaluating nemvaleukin in combination with pembrolizumab compared to investigators’ choice of chemotherapy in patients with platinum-resistant ovarian cancer. Patient enrollment in this trial is now complete. Mural continues to expect to report interim overall survival (OS) results based on approximately 75% of events in the first quarter of 2025. The company anticipates reporting final OS results in the second quarter of 2026.
Mural expects to report top-line data results from cohort 2 of ARTISTRY-6 in the first half of 2025. This is a potentially registrational, phase 2 clinical trial evaluating nemvaleukin as a monotherapy in patients with mucosal melanoma.
Mural is also evaluating a less-frequent intravenous (LFIV) dose of nemvaleukin in patients with cutaneous melanoma in cohort 3 (monotherapy) and cohort 4 (combination therapy) in ARTISTRY-6. The company expects preliminary data readouts in the monotherapy cohort in the first half of 2025, and in the combination cohort with pembrolizumab in the second half of 2025.
In June, Mural presented data from ARTISTRY-3, an evaluation of the LFIV dosing of nemvaleukin, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. This data from ARTISTRY-3 informed the LFIV dose currently being used in cohort 3 and cohort 4 of ARTISTY-6. In the ARTISTRY-3 trial, the company evaluated escalating LFIV infusions, all of which were generally well tolerated. The safety profile in all dosing schedules evaluated was consistent with nemvaleukin’s known mechanism of action, and no dose limiting toxicities were observed. Although administering higher doses per cycle than in previous trials evaluating nemvaleukin, no new safety signals were identified. The desired pharmacodynamic (PD) effects were also seen across all evaluated doses. Expansion of antitumor CD8+ T cells and natural killer (NK) cells was observed concurrent with minimal expansion of immunosuppressive regulatory T cells (Tregs).

Mural’s preclinical interleukin-18 (IL-18) and IL-12 programs remain on track, with nominations for both development candidates expected this year.

Mural’s enhanced IL-18 is engineered to deliver a more sustained immune response for cancer treatment. Native IL-18 is a potent immune-stimulating cytokine, but its efficacy is blunted by IL-18 binding protein (IL-18BP), a high affinity decoy receptor that binds with and neutralizes IL-18, thereby rendering it ineffective. Native IL-18 is also limited by its short half-life. Mural’s IL-18 variant contains mutations that eliminate binding to IL-18BP while minimally impacting the native IL-18 structure. The company has also fused IL-18 to protein scaffolds to extend the half-life and increase IL-18’s exposure. Together, Mural believes these have demonstrated a more durable immunological effect in preclinical studies.
The company’s enhanced IL-12 is engineered to leverage native IL-12’s anti-tumor potency while mitigating its hallmark toxicity. Native IL-12 is a highly potent pro-inflammatory cytokine, but because of its very narrow therapeutic index, it can also be incredibly toxic with systemic exposure. Mural’s IL-12 variant splits the molecule into two inactive monomers, and these individual subunits are then separately fused to antibody fragments and sequentially injected, which deliver and concentrate IL-12 specifically in the tumor microenvironment with the goal of limiting systemic exposure. In preclinical studies, Mural believes its engineered IL-12 achieved the desired reduction in serum while maintaining tumor concentrations providing the potential to reduce systemic toxicities.
Financial Results for the Quarter Ended June 30, 2024

Cash Position: As of June 30, 2024, cash, cash equivalents, and marketable securities were $204.7 million.
R&D Expenses: Research and development expenses were $27.5 million for the second quarter of 2024 compared to $42.5 million for the second quarter of 2023. The decrease in R&D expenses was primarily due to different team composition compared to the personnel allocated to us by Alkermes, our former parent, prior to the separation, as well as decreased spend on the ARTISTRY-1 and ARTISTRY-2 trials as activities related to these trials wound down in 2023 and decreased spend on the ARTISTRY-7 trial due to the timing of patient enrollment.
G&A Expenses: General and administrative expenses were $6.7 million for the second quarter of 2024 compared to $4.7 million for the second quarter of 2023. The increase in expenses was primarily due to costs associated with operating as a standalone company after the separation. This includes employee-related expenses and professional fees.
Net Loss: Net loss was $31.6 million for the second quarter of 2024 compared to $50.2 million for the second quarter of 2023.
Financial Guidance

The company reaffirms guidance that its cash, cash equivalents, and marketable securities are expected to fund its operations into the fourth quarter of 2025.
As noted previously, management forecasts lower operating expenses in 2025 versus 2024 due to the timing of clinical trial expenses.
About Nemvaleukin
Nemvaleukin alfa (nemvaleukin) is a novel, engineered cytokine designed to leverage antitumor effects of the IL-2 pathway while mitigating the hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in two potentially registrational late-stage trials.

On August 14, 2024 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that the first participant has been successfully dosed in the first-inhuman Phase I trial of IMP761 (Press release, Immutep, AUG 13, 2024, View Source [SID1234645831]). This first-in-class agonist LAG-3 antibody is designed to restore balance to the immune system by enhancing the "brake" function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases.

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The single and multiple ascending dose, placebo-controlled, double-blind Phase I study is being conducted by the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands, specializing in cutting-edge early-stage clinical drug research. The study aims to enrol 49 healthy volunteers, to assess safety, pharmacokinetics (PK) and pharmacodynamics (PD).

CHDR will implement its unique keyhole limpet haemocyanin (KLH) challenge model allowing for the evaluation of IMP761’s pharmacodynamic activity at the earliest stages of clinical development. Immutep anticipates the first safety data from the Phase I study to be available before end of the year with assessment of PK/PD relationships to follow in the first half of CY2025.

The immune checkpoint LAG-3 has been identified as a promising target for agonist LAG-3 immunotherapy to treat rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, among other autoimmune diseases.1,2,3 In preclinical studies, IMP761 has led to a large decrease in inflammatory cytokines and demonstrated its effectiveness in suppressing antigen-specific T cell–mediated immune responses.

About IMP761

IMP761, a first-in-class immunosuppressive LAG-3 agonist antibody, has the potential to address the root cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites and restoring balance to the immune system. As published in the Journal of Immunology, encouraging pre-clinical in vivo and in vitro studies show IMP761 inhibits peptide-induced T cell proliferation, activation of human primary T cells, and an antigen-specific delayed-type hypersensitivity (DTH) reaction. Additional preclinical data in oligoarticular juvenile idiopathic arthritis (o-JIA) published in Pediatric Research details how IMP761 led to a decrease in a broad spectrum of effector cytokines in just 48 hours. This study also showed children with o-JIA have a skewed LAG-3 metabolism and suggested they can benefit from agonistic LAG-3 activity.

On August 13, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported financial results for the second quarter ended June 30, 2024, and provided a corporate update (Press release, Candel Therapeutics, AUG 13, 2024, View Source [SID1234645793]).

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"The second quarter of 2024 represented a pivotal period for Candel, characterized by robust clinical advancements and key regulatory successes, that further validate our innovative approach to cancer immunotherapy," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Our encouraging overall survival phase 2 data for CAN-2409 highlights the potential of our lead candidate to address a significant unmet need for non-small cell lung cancer patients, who are non-responsive to immune checkpoint inhibitor treatment, and for patients with borderline resectable pancreatic cancer. In addition, the FDA granting orphan drug designation for

CAN-3110 in recurrent high-grade glioma underscores the promise of this first-in-class, novel asset developed for difficult-to-treat cancers."

Dr. Tak continued, "Our inclusion in the Russell 3000 Index also marks a significant milestone in Candel’s growth and offers an opportunity to increase our recognition within the investment community. These achievements, coupled with a successful R&D event at ASCO (Free ASCO Whitepaper), have set a strong foundation as we approach several key readouts in the latter half of 2024."

Second Quarter 2024 & Recent Highlights

•Program Updates
oCAN-2409 – Pancreatic Cancer

▪In early April, announced positive updated survival data from the phase 2 randomized controlled clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, in borderline resectable pancreatic ductal adenocarcinoma (PDAC).

▪Data showed notable improvements in estimated median overall survival (mOS) of 28.8 months after experimental treatment with CAN-2409 versus 12.5 months in control group.

▪At 24 months, survival rate was 71.4% in CAN-2409 treated patients after chemoradiation and prior to surgery versus 16.7% in the control group. At 36 months, estimated survival was 47.6% in the CAN-2409 group after chemoradiation and prior to surgery versus 16.7% in the control group.

▪No new safety signals were observed, providing further support that multiple injections of CAN-2409 have been generally well-tolerated to date, with no dose-limiting toxicities and no cases of pancreatitis reported.

▪Analysis of resected tumors showed the formation of dense aggregates of immune cells, including CD8+, cytotoxic tumor infiltrating lymphocytes and dendritic cells, within the tumor microenvironment after CAN-2409 administration, confirming the activation of a robust antitumoral immune response.

▪Received orphan drug designation from the FDA for CAN-2409 for the treatment of pancreatic cancer.

oCAN-2409 – Non-Small Cell Lung Cancer

▪Presented topline overall survival data from the phase 2 clinical trial of CAN-2409 plus valacyclovir in combination with continued immune checkpoint inhibitor (ICI) therapy in patients with stage III/IV NSCLC inadequately responding to ICI therapy at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.
▪Data showed mOS of 20.6 months in patients with progressive disease despite ICI treatment compared to published results of less than 12 months with SoC docetaxel-based chemotherapy in similar patient populations.1
▪CAN-2409 treatment resulted in activation of the systemic immune response after two administrations of CAN-2409, including increased numbers of circulating cytotoxic and memory T cells associated with subsequent prolonged survival.
▪As of the April 1, 2024 data cut-off date, CAN-2409 treatment in NSCLC continued to exhibit a favorable safety and tolerability profile.
oCAN-3110 – Recurrent High-Grade Glioma
▪Received orphan drug designation from the FDA for CAN-3110 for the treatment of rHGG.
▪Presented a Trial-in-Progress poster at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting on the ongoing phase 1b clinical trial exploring multiple doses of CAN-3110 in patients with rHGG.
oenLIGHTEN Discovery Platform
▪Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting unveiling the second candidate from the enLIGHTEN Discovery Platform, a first-in-class multimodal immunotherapy candidate to induce tertiary lymphoid structures (TLS), being developed as a novel therapeutic for solid tumors.
•Corporate Updates

oHosted successful NSCLC Research and Development panel during the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, featuring prominent scientific and medical thought leaders discussing the topline overall survival data from the phase 2 clinical trial of CAN-2409 in NSCLC.

oAnnounced inclusion in the Russell 3000 Index, effective July 1, 2024, as part of FTSE Russell’s annual reconstitution of its U.S. equity indexes.
Anticipated Milestones

•Updated phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024.
•Phase 2b topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024.
•Phase 3 topline disease-free survival data for CAN-2409 in localized intermediate/high-risk prostate cancer expected in Q4 2024.
Financial Results for Second Quarter Ended June 30, 2024

Research and Development Expenses: Research and development expenses were $5.0 million for the second quarter of 2024 compared to $5.9 million for the second quarter of 2023. The decrease was primarily due to lower clinical development costs driven by a reduction in regulatory, manufacturing and clinical trial costs for CAN-2409 programs and lower payroll-related expenses following the corporate restructuring in the fourth quarter of 2023. These decreases were partially offset by increased stock-based compensation expense. Research and development expenses included non-cash stock compensation expense of $1.3 million for the second quarter of 2024 compared to $0.3 million for the second quarter of 2023.

General and Administrative Expenses: General and administrative expenses were $3.6 million for both the second quarter of 2024 and the second quarter of 2023. There was a small decrease, primarily due to lower insurance costs and recruiting costs. These decreases were partially offset by increased professional and consulting fees. General and administrative expenses included non-cash stock compensation expense of $0.6 million for the second quarter of 2024 compared to $0.4 million for the second quarter of 2023.

Net Loss: Net loss for the second quarter of 2024 was $22.2 million, compared to a net loss of $9.6 million for the second quarter of 2023, and included other expense, net of $13.7 million and $35,000, respectively, primarily due to the change in the fair value of the Company’s warrant liability.

Cash Position: Cash and cash equivalents, as of June 30, 2024, were $21.5 million, as compared to $35.4 million as of December 31, 2023. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents will be sufficient to fund its current operating plan into the first quarter of 2025.