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

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Program Updates
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CAN-2409 – Pancreatic Cancer

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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).

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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.

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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.

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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.

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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.

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

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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.
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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
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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.
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As of the April 1, 2024 data cut-off date, CAN-2409 treatment in NSCLC continued to exhibit a favorable safety and tolerability profile.
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CAN-3110 – Recurrent High-Grade Glioma
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Received orphan drug designation from the FDA for CAN-3110 for the treatment of rHGG.
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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.
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enLIGHTEN Discovery Platform
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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.
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Corporate Updates

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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.

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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

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Updated phase 1b data (Arm C) for CAN-3110 in rHGG expected in H2 2024.
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Phase 2b topline data for CAN-2409 in low-to-intermediate-risk, localized, non-metastatic prostate cancer expected in Q4 2024.
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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 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported it has entered into definitive agreement for the purchase and sale of 2,000,000 shares of its American Depository Shares and Pre-Funded Warrants at an offering price of $1 per share in a registered direct offering and an additional 2,000,000 cash exercise only Series G warrants with an exercise price of £0.78 with a single investor (Press release, TC Biopharm, AUG 13, 2024, View Source [SID1234645833]).

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The gross proceeds to the Company from the offering are expected to be $2.0 million.

The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing operating expenses and working capital. A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the offering, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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 Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported a business update and provides financial results for the quarter ended June 30, 2024 (Press release, Panbela Therapeutics, AUG 13, 2024, View Source [SID1234645818]). As previously announced, management is hosting an earnings call today at 4:30 p.m. ET.

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Q2 2024 and Recent Highlights:

Clinical

• Phase 3 ASPIRE clinical trial received favorable third independent safety review: DSMB recommended continuation without modification.
• Completed Oral Presentation at Digestive Disease Week (DDW): Evaluation of the Safety and Efficacy of Eflornithine (Difluoromethylornithine, DFMO) in Patients with Gastric Premalignant Conditions in the High Incidence Areas of Latin American.
• Provided revised timing for the interim data analysis for its ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis is now expected in Q1 2025 due to a lower-than-anticipated event rate, which suggests the potential for improved survival outcomes for patients in the trial. Financial / Business
• Gained eligibility for quotation of common stock on the OTCQB.
• Issuance of a New Patent in the US and Canada for Claims of a Fixed Dose Combination of Eflornithine and Sulindac.

Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela, commented:

"In the second quarter, we continued to make significant progress in our clinical programs and corporate initiatives. Our Phase III ASPIRE clinical trial received a favorable third independent safety review, with the Data and Safety Monitoring Board (DSMB) recommending continuation without modification. We were also honored to have an oral presentation at Digestive Disease Week (DDW), where we evaluated the safety and efficacy of eflornithine (difluoromethylornithine, DFMO) in patients with gastric premalignant conditions in high incidence areas of Latin America. Furthermore, we recently announced revised timing for the interim data analysis of our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC).

Due to a lower-than-anticipated event rate, which suggests the potential for improved survival outcomes for patients in the trial, the analysis is now expected in Q1 2025. This is a testament to the potential of our lead candidate, ivospemin, and its ability to make a meaningful difference in the lives of patients with mPDAC. As we move forward, Panbela remains committed to advancing our clinical programs, exploring new indications, and creating value for our stockholders. With several key milestones on the horizon, including the highly anticipated overall survival interim analysis in our Phase III ASPIRE Trial, we are excited about the future and the potential impact our therapies can have on patients in need."

Second Quarter ended June 30, 2024 Financial Results General and administrative expenses were approximately $1.1 million in the quarter, compared to $1.6 million in the same period last year. The decrease is due primarily to reduced legal and compensation expense. Research and development expenses were approximately $7.0 million, compared to $4.2 million in the same period last year. This increase is primarily due to significant growth in the number of active sites and enrollment in project ASPIRE. Net loss in the quarter was approximately $7.1 million, or $1.47 per diluted share, compared to a net loss of $5.8 million, or $159.15 per diluted share, in the same period last year. This increased loss is due to the incremental research and development expenses. Total cash was $59,000 as of June 30, 2024. Total current assets were $0.8 million and current liabilities were $16.8 million as of the same date.

In April, Panbela’s partner in Pediatric Neuroblastoma, US WorldMeds, provided a nondilutive payment of approximately $0.8 million in exchange for a reduction in the potential future milestone payments. In July, Panela secured a loan from this same partner for $1.5 million. Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of Cancer Prevention Pharmaceuticals, Inc., totaled approximately $4.3 million. The current portion of the notes payable plus accrued interest totaled approximately $1.1 million.

On August 13, 2024 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the second quarter 2024 (Press release, Grail, AUG 13, 2024, View Source [SID1234645834]).

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Revenue in the second quarter was $32.0 million, representing 43% growth year over year. Net loss for the quarter, which includes amortization and impairment of acquisition-related intangible items, was $(1.6) billion. Our gross loss was $(17.9) million. Non-GAAP adjusted gross profit was $16.0 million and Non-GAAP adjusted EBITDA was $(139.4) million.1

"GRAIL completed the separation from Illumina on June 24, 2024, and we are pleased to report our quarterly results for the first time as an independent public company. In the second quarter of 2024, GRAIL continued to deliver U.S. commercial growth, and as of June 30, we have sold more than 215,000 Galleri tests. We are focused on detecting cancer early, when it can be cured, and are committed to serving Galleri patients, providing support for ordering physicians, advancing our commercial and research partnerships, and building our clinical and real-world evidence base," said Bob Ragusa, Chief Executive Officer at GRAIL. "We have an unprecedented opportunity to establish a new standard of care by adding Galleri to existing single-cancer screenings, and to establish and maintain the market leading position in multi-cancer detection."

For the three months ended June 30, 2024, as compared to the three months ended July 2, 2023, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $32.0 million, an increase of $9.6 million or 43%.
Net loss: Net loss was $1.59 billion, an increase of $1.39 billion or 721%. Net loss includes goodwill and intangible impairment of $1.42 billion.
Gross loss: Gross loss was $(17.9) million, an improvement of $6.4 million or 26%.
Adjusted gross profit1: Adjusted gross profit was $16.0 million, an increase of $6.4 million or 66%.
Adjusted EBITDA1: Adjusted EBITDA was $(139.4) million, a decrease of $2.8 million or 2%.
Cash position: Cash and cash equivalents totaled $958.8 million as of June 30, 2024.
Recent business highlights include:

Commenced enrollment in the REACH study. The REACH study, also known as the Galleri-Medicare study, will enroll 50,000 individuals and allow for three annual screens to provide clinical validation and utility in the Medicare population, with a focus on health equity. Medicare beneficiaries are among those most at risk for cancer due to age and other risk factors, representing an important unmet need for early cancer detection.
Completed enrollment of more than 35,000 participants in the registrational PATHFINDER 2 study. The PATHFINDER 2 study is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in a population of individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.
Completed final study visits for the registrational NHS-Galleri trial. The NHS-Galleri trial is a prospective, randomized controlled clinical utility trial of over 140,000 participants between the ages of 50-77 at the time of enrollment, each of whom provided three annual blood samples to evaluate the implementation of Galleri alongside existing NHS standard of care screenings.
Strategic update:

Following a portfolio review, we are reducing our overall spend and focusing our resources on our core multi-cancer early detection ("MCED") priorities, including progress toward completion of our registrational studies and our premarket approval application submission.

As part of this restructure, we are reducing existing headcount and planned hires for 2024 by approximately 30% and substantially decreasing investment in product programs beyond Galleri. We are also reducing the size of our commercial organization, focusing our field-based activities on the most productive provider territories and streamlining investments in our enterprise business, which includes the Company’s employer and life insurance businesses. In addition, we are making reductions in general and administrative expense to reflect the focus on our MCED opportunity. We will continue to invest in our biopharmaceutical partnerships, and are committed to working with our partners to leverage GRAIL’s proprietary methylation technology in precision oncology applications.

We expect these cost reductions to extend our existing cash runway from the second half of 2026 into 2028. As a result, we anticipate reducing our burn in 2025 to $325 million. In 2024, we expect $27 million in savings, net of anticipated severance and benefits costs.

Conference Call and Webcast
A webcast and conference call will be held today, Aug. 13, 2024, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL’s website at investors.grail.com.

A replay of the webcast will be available on GRAIL’s website for 30 days.