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Proactive - Interviews for investors

Candel Therapeutics shares positive survival data for investigational immunotherapy in NSCLC

Candel Therapeutics CEO Dr. Paul Peter Tak joined Steve Darling from Proactive to announce final survival data from a Phase 2a clinical trial evaluating the company’s investigational immunotherapy in patients with stage III/IV non-small cell lung cancer (NSCLC) who had an inadequate response to immune checkpoint inhibitor (ICI) treatment. The study reported a median overall survival (mOS) of 24.5 months in 46 evaluable patients who received two courses of the investigational therapy. In a subset of patients who had progressive disease at baseline despite ICI treatment, mOS was 21.5 months. Historically, similar patients receiving standard-of-care chemotherapy have had mOS between 9.8 and 11.8 months, with published studies rarely exceeding 12 months. With a median follow-up of 32.4 months, the data demonstrated long-term survival benefits, with 37% of patients who had progressive disease despite ICI therapy still alive two years after treatment. Based on these positive results, Candel Therapeutics will continue advancing the development program, including preparations for a potential registrational trial in patients with non-squamous histology NSCLC. The U.S. Food and Drug Administration (FDA) has previously granted Fast Track Designation for the investigational therapy in combination with an antiviral agent and ICI therapy for patients with stage III/IV NSCLC who are resistant to first-line PD-(L)1 inhibitors and do not have activating molecular driver mutations or have progressed on targeted therapy. These findings support the therapy’s potential as a new treatment option for NSCLC patients with limited alternatives. #proactiveinvestors #candeltherapeuticsinc #nasdaq #cadl #CancerTreatment #ViralTherapy #ProstateCancer #PancreaticCancer #Glioblastoma #PaulPeterTak #ClinicalTrials #BiotechNews #Immunotherapy #Oncology #CancerResearch

Proactive - Interviews for investors

EBR Systems nears FDA approval for CRT pacemaker

EBR Systems Inc Senior Vice President Andrew Shute talked with Proactive at the AIM maSmall and Midcap Conference about the company’s upcoming FDA decision for its leadless CRT pacemaker system. The device is designed to treat heart failure and represents the only leadless option in a market currently dominated by three players—with no direct competitor. Shute said, “We've developed the world's only leadless pacemaker to treat heart failure. And we're on track to receive FDA approval within the next two and a half weeks.”* The product already holds FDA Breakthrough Device designation, and has shown strong clinical results, including a 16.4% reduction in left ventricular end systolic volume—well above the target goal of 9.3%. Shute outlined the company's go-to-market plan, emphasizing that reimbursement is expected to begin from October 1st under the NTAP and TPT schemes, enabling an ASP of USD 45,000. The company only needs to sell around 2,200 units annually to reach USD 100 million in revenue. “We’ve got no direct competition,” he said. He also highlighted the successful completion of the FDA’s pre-approval inspection with no observations—an uncommon achievement in the medical device industry. The device, supported by data published in JAMA Cardiology, was also featured at the Heart Rhythm Society meeting in 2023. During the interim, the US commercial team will establish purchasing agreements, prepare technology committee engagements, and begin physician training for a limited market release. #EBRSystems #MedicalDevices #HeartFailureTreatment #LeadlessPacemaker #CardiacTech #FDAApproval #CRTDevice #InvestingInHealthcare #BreakthroughDevice #MedTechInnovation #JAMACardiology #HeartRhythmSociety

Proactive - Interviews for investors

Southern Cross Gold reveals Sunday Creek scale

Southern Cross Gold Consolidated CEO Michael Hudson talked with Proactive at the AIM's Small and Midcap Conference about the company’s focus on gold and antimony exploration in Victoria, Australia, particularly at the Sundae Creek project. Hudson outlined the scale and significance of the discovery, describing it as “one of the most exciting gold discoveries globally… a rare tier one multi-million ounce high grade discovery.” The company is advancing exploration rapidly, with six drill rigs currently operating and plans to expand to eight. Hudson said the company has completed around 70km of drilling and estimates an exploration target of 2.2 to 3.2 million ounces gold equivalent, grading between 8.5 to 10.6 grams per tonne – all within just 5% of the identified trend. Antimony also plays a key role. Hudson explained that China and Russia dominate the global market and recent export bans have highlighted supply vulnerabilities: “You don't have a defense industry without it. And the Western world really doesn't have it. We've got it.” Hudson also reflected on the company’s recent inclusion in the All Ordinaries Index, following the merger of Canadian and Australian entities. He said it marks the first index entry for Southern Cross Gold Consolidated and is “a reflection on a business that's less than three years old.” #SouthernCrossGold #SundayCreek #GoldExploration #Antimony #ASX #MiningStocks #JuniorMiners #ResourceInvesting #MichaelHudson #AllOrdinaries #GoldAndAntimony #AustralianMining

Proactive - Interviews for investors

Saunders expands defense & fuel infrastructure work

Saunders International Ltd Managing Director and CEO Mark Benson talked with Proactive at the AIM's Small and Midcap Conference about the company’s strong momentum, recent project wins and the strategic expansion into defense and infrastructure sectors. Benson highlighted Saunders’ transformation from a tank constructor to a multi-disciplined, end-to-end engineering and construction provider. “We’ve diversified and become a multi-disciplined business… Now some of the projects we can do end-to-end,” he said, referencing the company’s work on the **Western Sydney Airport**, where it completed all elements from fuel tank construction to apron pipeline delivery. He also noted Saunders’ acquisition strategy as a driver of growth, enabling delivery of complex infrastructure through internal capabilities. Notable acquisitions include piping, civil infrastructure, and automation companies, helping the company expand its offering and grow organically and through M&A. Benson discussed the company’s extensive work in the defense sector, including the **Larrakeyah Defense Precinct** in Darwin, where Saunders handled the complete marine diesel infrastructure — from delivery to ship fueling — a capability he said sets the company apart. “Typically it’s done through 3 to 6 contractors. Now we can do that end to end.” The company now sees a $2.3 billion pipeline of directly addressable opportunities, with up to $4.8 billion in total defense-related fuel infrastructure upgrades anticipated across the next decade. Saunders is actively tendering for $580 million of that. Benson said Saunders’ unique value in defense projects includes not just technical delivery but risk reduction for government clients. “In defense, it’s not all about price. Sometimes price evaluation is only 30%. It’s about de-risking the project for the Commonwealth.” Visit Proactive’s YouTube channel for more company interviews, and don’t forget to like the video, subscribe to the channel, and turn on notific

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