16 Candels

December 11, 2024

DENVER, Colo., Dec 11, 2024 (247marketnews.com)- Candel Therapeutics (NASDAQ: CADL), Siyata Mobile (NASDAQ: SYTA), SEALSQ Corp (NASDAQ: LAES), NewGen (NASDAQ: NIVF), Rigetti Computing (NASDAQ: RGTI), and AMPLITECH GROUP (NASDAQ: AMPG)

Candel Therapeutics (NASDAQ: CADL) looks like it could challenge its 52-week high of $14.30, after announcing results from a multicenter phase 3 clinical trial evaluating CAN-2409 viral immunotherapy in localized prostate cancer patients, conducted under a Special Protocol Assessment (SPA) with the FDA, which achieved primary endpoint by demonstrating statistically significant and clinically meaningful benefit when combined with radiation therapy for intermediate-to-high risk, localized prostate cancer.

The localized prostate cancer addressable market for CAN-2409 is potentially worth over $10 billion, just in the United States alone, as over 100,000 men are diagnosed with localized prostate cancer every year, and over 50,000 men currently receive radiotherapy.

Glen Gejerman, M.D., MBA, Co-Director of Urologic Oncology at Hackensack Meridian Health, and one of the principal investigators of the study, stated, “The improvement observed in disease-free survival in this phase 3 clinical trial is clinically meaningful. We have not seen significant advances in this indication in decades. CAN-2409 has demonstrated the potential to significantly improve long-term outcomes without adding substantial toxicity to standard of care radiation.

“If approved, this approach has the potential to transform the treatment paradigm in prostate cancer, offering patients with localized disease an effective treatment option that may reduce the risk of disease recurrence.”

Candel’s President and Chief Executive Officer, Paul Peter Tak, M.D., Ph.D., commented, “We are thrilled to report the phase 3 results for CAN-2409 in intermediate-to-high risk, localized prostate cancer. This study validates previous observations of CAN-2409 activity seen in difficult-to-treat solid tumors, often resistant to immunotherapy, and confirms our previous observation of synergies with radiation therapy in models of prostate cancer. Importantly, this study was conducted under a Special Protocol Assessment (SPA) agreed with the U.S. Food and Drug Administration (FDA), on key aspects of study design, meaning that safety and efficacy data generated from the study could be sufficient for the Company to seek regulatory approval for CAN-2409 in this indication. We look forward to working with the FDA, as a next step, to seek approval to bring CAN-2409 to patients in the U.S., and advance our broad viral immunotherapy pipeline across other large oncology indications of high unmet need.”

Candel doesn’t look like it’s hitting $16 today, but it may on the upcoming announcements.

Siyata Mobile (NASDAQ: SYTA) is positioned to squeeze and this morning it announced it will be relocating its current 4G and next generation 5G PTT handset manufacturing operations from China to the United States in 2025.

Marc Seelenfreund , Siyata’s CEO, stated, “We began working on a manufacturing relocation plan earlier this year and are proud to announce today that we expect to begin manufacturing operations in the U.S. in the first quarter of 2025. This is an important strategic move that we believe will open up additional sales opportunities globally, particularly in the U.S., and help us to further scale our business. Users of our devices, especially governmental agencies and first responders, value America manufactured products, but just as important, this move will enable us to shorten delivery lead times and operate within a stronger logistics infrastructure. We are very excited to be making this move and believe it is an important milestone for Siyata.”

SEALSQ Corp (NASDAQ: LAES) stated that it is solidifying its Application Specific Integrated Circuit (ASIC) developments in partnership with IC’ALPS to address growing demand in the segment.

Lucille Engels, COO of IC’ALPS, commented, “This collaboration was a true partnership, with each team bringing its own expertise and approach. Drawing on our experience, we adapted our methods to meet SEALSQ’s rigorous security standards. This partnership underlines our commitment to supporting our customers in the development of their products.”

Jean Pierre Enguent, SEALSQ’s CTO, added, “The collaboration between IC’ALPS and SEALSQ exemplifies the dynamic and innovative spirit of the French semiconductor ecosystem. This partnership showcases how mid-sized high-tech companies can unite their expertise to fast-track the development of cutting-edge products that not only meet market demands, but rival the capabilities of larger corporations. By combining agility with innovation, we are setting a benchmark for excellence in the competitive global semiconductor industry”.

NewGen (NASDAQ: NIVF) entered into a binding term sheet concerning the previously announced proposed reverse merger with healthcare company European Wellness Investment Holdings Limited (“EWIHL”), which is reportedly for $452 million at $3.20 per NewGen share

Siu Wing Fung Alfred, NewGen’s Founder, Chairman, and CEO, said, “We are pleased to announce this significant milestone in our discussions with EWIHL, which represents a substantial evolution from our initial non-binding term sheet in April. While we previously explored various alternatives, our ongoing engagement with EWIHL has consistently shown the strongest strategic alignment and potential for value creation. The signing of this binding term sheet demonstrates the progress we’ve made in our negotiations and provides us with a clear path to definitive agreements. The proposed transaction structure reflects our mutual commitment to creating a stronger combined entity at a valuation that we believe represents fair value for both parties. EWIHL’s profitability positions us well for future success, and we have already secured the required equity line of credit to support this transaction.

“We see substantial synergistic opportunities ahead. EWIHL’s advanced healthcare products complement our fertility treatments, while their extensive distribution network and healthcare facilities offer significant cross-selling opportunities for our services. Beyond these operational factors, EWIHL’s valuation metrics are also very positive, and we believe the combined entity created from our business combination would be profitable and compare favorably to our industry peers in terms of EPS. From a capital markets perspective, the increased scale and market capitalization of the combined company will enhance our trading liquidity and visibility in the capital markets, supporting our continued listing on Nasdaq’s Global Market tier. We have been formally granted a hearing to appeal the previously announced delisting notice, which stays any further action by Nasdaq pending the hearing process. We are pursuing multiple strategic options to maintain our listing status, including the option to transfer to the Nasdaq Capital Market and our recently secured funding arrangements. Importantly, these funding mechanisms are designed to strengthen our financial position and address our listing compliance requirements. Looking ahead, we are confident that this combination with EWIHL will create significant value for our shareholders while strengthening our ability to serve patients. We look forward to working with EWIHL to complete this transaction and begin realizing the full potential of our combined capabilities.”

Mobot alerted Rigetti Computing (NASDAQ: RGTI) in October at $0.926 and it traded as high as $7.96 this morning, on the heels of yesterday’s news that it successfully applied AI to automate the calibration of a quantum computer with Quantum Machines.

MoBot alerted AMPLITECH GROUP (NASDAQ: AMPG) yesterday morning at $1.00 and it traded over $2.00 this morning, but it’s pulled back, so look to see if it regroups for another run.

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