On August 13, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported an update on its Orano Support SAS partnership in the radiopharmaceuticals field, on behalf of Orano SAS ("Orano"), a world-renowned multinational nuclear company, headquartered in France (Press release, Defence Therapeutics, AUG 13, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-collaboration-agreement-with-orano-to-develop-the-next-generation-of-targeted-radio-immunotherapy-for-cancer-advances [SID1234645803]).

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Defence is developing in collaboration with Orano Support SAS, a novel Radio-Immuno-Conjugate ("RIC"), which includes an antibody to deliver the radioactivity specifically to cancer cells, a chelating agent linked to the radionuclide and specific Defence’s Accum variants, resulting in increasing the efficacy to treat cancers. The objective of this project is to develop the next generation of RIC exploiting the therapeutic dependency of Auger electron ("AE") emitter elements in closer proximity to nuclear DNA when combined with Defence’s Accum technology to induce its nuclear accumulation. AE emitters are very promising radionuclides for RIC development because of their very short pathlength radiation energy deposition, which decreases radiotoxicity on healthy tissues.

The Accum moiety can overcome major limitations of RIC e.g. endosomal sequestration and poor nuclear accumulation, by destroying endosome membrane without affecting the plasma membrane nor mAbs specificity and by forcing the nuclear re-localization of the RIC. Defence has developed a multitude of Accum variants with different biochemical properties and activities such as hydrophobicity and cytotoxicity.

Presently, no cancer treatment uses this type of radionuclides in RIC formulation due to the lack of efficacy induced by their endosomal entrapment and their dependency to be close to nuclear DNA. Defence’s objective is to efficiently treat cancers with the potential of opening a new cancer therapy market based on a very promising radiotherapeutics implicating AE emitter radionuclides.

Defence has completed the conceptualization of the Accum variant peptides and secure their production/manufacturing. Defence has showed and patented that some Accum variants can be conjugated to an antibody or an antibody-conjugate to deliver it inside the nucleus. Defence is also pleased to have secured the in vitro and in vivo preclinical studies to be performed by the radiopharmaceuticals scientific team at the Canadian Nuclear Laboratories.

On August 13, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported financial results for the second quarter ended June 30, 2024, and provided an update on its corporate activities and product pipeline (Press release, Cidara Therapeutics, AUG 13, 2024, View Source [SID1234645802]).

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"We continue to focus on our Cloudbreak DFC platform with the advancement of CD388 and other programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our Phase 2b study to evaluate the efficacy and safety of CD388, a long-acting drug candidate that provides season-long, universal protection from influenza, is on track to start in the fall of 2024 during the Northern Hemisphere influenza season with 4,000 subjects to be enrolled in the United States and 1,000 subjects to be enrolled in the United Kingdom. We believe that CD388 has important advantages over vaccines to provide long-term protection against both seasonal and pandemic strains of influenza with a single dose per flu season."

Recent Corporate Highlights

Reacquired exclusive global development and commercial rights to CD388: In April 2024, Cidara entered into a definitive agreement with J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B (Janssen License Agreement). Cidara is finalizing the protocol for a Phase 2b clinical trial, which the Company intends to initiate in the fall of 2024 during the Northern Hemisphere influenza season.
Closed $240.0 million private placement: In April 2024 and in conjunction with the reacquisition of CD388, Cidara closed a definitive agreement for the sale of preferred stock in a $240.0 million private placement (Private Placement) led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund and Canaan Partners. The proceeds from the Private Placement were used to fund the upfront payment of $85.0 million under the agreement with Janssen and the remainder of the gross proceeds of $155.0 million are expected to provide runway beyond topline data from CD388’s planned Phase 2b trial.
Divested rezafungin to its former licensee, Mundipharma: In April 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited (Napp), a member of the international network of Mundipharma independent associated companies (Mundipharma), for the divestiture of rezafungin (Purchase Agreement). Cidara estimates that it will achieve approximately $128.0 million in cost savings over the patent life of rezafungin. On July 18, 2024, Cidara received a notice of satisfaction from Mundipharma that it had completed the required performance obligations under a transition services agreement and, accordingly, the $11.1 million development milestone advance previously made to Cidara, and reimbursable to Mundipharma, was forgiven by Mundipharma.
IND Clearance for CBO421: Cidara received investigational new drug application (IND) clearance for CBO421 in July 2024.
Second Quarter 2024 Financial Results

Revenue totaled $0.3 million and $1.3 million for the three and six months ended June 30, 2024, respectively, compared to $5.1 million and $11.3 million for the same periods in 2023, respectively. Revenue for the three and six months ended June 30, 2024 and 2023 related to research and development and clinical supply services provided to Janssen under the preexisting Janssen Collaboration Agreement. The Janssen Collaboration Agreement was terminated upon the effectiveness of the Janssen License Agreement on April 24, 2024.
Cash and cash equivalents totaled $164.4 million as of June 30, 2024, compared with $35.8 million as of December 31, 2023.
Acquired in-process research and development expenses were $84.9 million for the three and six months ended June 30, 2024 and related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement, on April 24, 2024, plus $0.4 million in direct transaction costs, offset by a settlement gain of $0.5 million to settle the preexisting Janssen Collaboration Agreement relationship.
Research and development expenses were $6.7 million and $12.6 million for the three and six months ended June 30, 2024, respectively, compared to $8.7 million and $18.4 million for the same periods in 2023, respectively. The decrease in research and development expenses for the three and six months ended June 30, 2024, compared to the three and six months ended June 30, 2023 is primarily due to lower nonclinical expenses associated with our Cloudbreak platform, offset by higher personnel costs supporting our Cloudbreak platform.
Selling, general and administrative (SG&A) expenses were $4.7 million and $8.3 million for the three and six months ended June 30, 2024, respectively, compared to $3.2 million and $6.8 million for the same period in 2023, respectively. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs.
On April 24, 2024, Cidara entered into the Purchase Agreement with Napp, pursuant to which we sold to Napp all of its rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations. Net income from discontinued operations for the three months ended June 30, 2024, was $3.0 million and net income from discontinued operations for the six months ended June 30, 2024 was $0.9 million, compared to net loss from discontinued operations of $7.5 million and net income from discontinued operations of $2.5 million for the same periods in 2023, respectively.
Net loss for the three and six months ended June 30, 2024 was $91.2 million and $101.5 million, respectively, compared to a net loss of $13.6 million and $10.6 million for the same periods in 2023, respectively.
During the three and six months ended June 30, 2024, Cidara did not sell shares of common stock pursuant to its at-the-market sales agreement.
As of June 30, 2024, Cidara had 4,568,991 shares of common stock outstanding, 240,000 shares of Series A Convertible Voting Preferred Stock outstanding, which are convertible into 16,800,000 shares of common stock, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock.
On July 18, 2024, the Company’s stockholders approved the issuance of up to 16,800,000 shares of common stock upon conversion of 240,000 shares of Series A Convertible Voting Preferred Stock issued in the Private Placement completed in April 2024. On July 19, 2024, the Company issued 2,469,250 shares of common stock upon automatic conversion of 35,275 shares of Series A Convertible Voting Preferred Stock. Cidara had 7,038,241 shares of common stock issued and outstanding immediately following this automatic conversion.

On August 13, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported financial results for the quarter ended June 30, 2024, and provided a corporate update (Press release, Cellectar Biosciences, AUG 13, 2024, View Source [SID1234645801]).

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"With our recent positive data announcement from the CLOVER WaM pivotal study evaluating iopofosine I 131 in Waldenstrom’s macroglobulinemia, we remain focused on filing our WM NDA in the fourth quarter of this year," said James Caruso, president and CEO of Cellectar. "We anticipate an accelerated six-month NDA review period and continue to prepare for a potential launch of iopofosine in 2025. We look forward to bringing this meaningful therapy to market and establishing iopofosine I 131 as the standard of care for the treatment of relapsed and refractory WM patients."

Second Quarter and Recent Corporate Highlights

· Announced final data exceeded the primary endpoint in the company’s CLOVER WaM pivotal study evaluating iopofosine I 131, a potential first-in-class, targeted radiotherapeutic candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients that received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors (BTKi’s). Data from the pivotal study demonstrated an 80% overall response rate (ORR), and a 56.4% major response rate (MRR) which exceeded the agreed-upon primary endpoint of a 20% MRR. The median number of prior lines of therapy was 4 (range, 2-14), with approximately 27% of patients’ refractory to all available therapies (BTKi, anti-CD20 antibody, chemotherapy), and 40% of patients dual-class refractory (BTKi and rituximab). Notably, comparable iopofosine I 131 ORRs were observed across all clinically challenging disease subgroups, including: MYD99-wt (81%; n=16), P53-mutated (80%; n=5), and clinical patient cohorts including post-BTKi (72%; n=39), as well as dual-class (59%; n=22), and triple-class (53%; n=15) refractory patients. Secondary endpoints of disease control rate (98.2%) and duration of response (DoR) presented evidence that iopofosine provided durable clinical benefit across all response categories. The median DoR in patients achieving major response and overall response were not reached as of the data cutoff, with 78% of major response patients and 72% of overall response patients remaining free from disease progression at 18 months, respectively.

· Announced a strategic partnership with City of Hope Cancer Center, one of the largest cancer research and treatment organizations in the United States, to evaluate iopofosine I 131 in mycosis fungoides, a rare form of non-Hodgkin’s lymphoma (NHL) that affects the skin and, in some patients, internal organs and blood. The investigator-sponsored trial will evaluate approximately 10 patients with initiation planned for late 2024 or early 2025.

Second Quarter 2024 Financial Highlights

· Cash and Cash Equivalents: As of June 30, 2024, the company had cash and cash equivalents of $25.9 million, compared to $9.6 million as of December 31, 2023. Net cash used in operating activities during the three months ended June 30, 2024, was approximately $14.1 million. The company believes its cash balance as of June 30, 2024, when combined with the $19.4 million raised in July, is adequate to fund its basic budgeted operations into the second quarter of 2025.

· Research and Development Expense: R&D expense for the three months ended June 30, 2024, was approximately $8.2 million, compared to approximately $6.3 million for the three months ended June 30, 2023. The overall increase in R&D was primarily a result of expenditures for the company’s WM pivotal trial, in addition to investments in product sourcing, manufacturing, and logistics infrastructure.

· General and Administrative Expense: G&A expense for the three months ended June 30, 2024, was $6.4 million, compared to $2.0 million for the same period in 2023. The increase in G&A was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon anticipated NDA approval, including the related marketing and personnel costs.

Conference Call & Webcast Details

Cellectar management will host a conference call for investors today, August 13, 2024, beginning at 8:30 am Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. The call will be available via webcast by clicking HERE or on the Events page of the company’s website.

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 [SID1234645800]).

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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
o
CAN-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.

o
CAN-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.
o
CAN-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.
o
enLIGHTEN 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

o
Hosted 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.

o
Announced 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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

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"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.