Tag: healthcare

Kestra Medical Technologies Prices Upsized IPO at $17 Per Share

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Kestra Medical Technologies has priced its upsized initial public offering (IPO) of 11,882,352 common shares at $17.00 per share, aiming to raise approximately $202 million.
– Shares are set to begin trading on the Nasdaq Global Select Market on March 6, 2025, under the ticker symbol “KMTS.”
– Kestra specializes in wearable medical devices and digital healthcare solutions, particularly for cardiovascular disease monitoring and intervention.

Kestra Medical Technologies, a Kirkland, Washington-based company specializing in wearable medical devices and digital healthcare solutions, has announced the pricing of its upsized initial public offering (IPO). The company is offering 11,882,352 common shares at a public offering price of $17.00 per share, with gross proceeds expected to be approximately $202 million, excluding any exercise of the underwriters’ option to purchase additional shares. This option allows underwriters a 30-day period to acquire up to 1,782,352 additional common shares at the IPO price, less underwriting discounts and commissions.

Trading of Kestra’s common shares is scheduled to commence on March 6, 2025, on the Nasdaq Global Select Market under the ticker symbol “KMTS.” The closing of the offering is anticipated to occur on March 7, 2025, contingent upon the fulfillment of customary closing conditions.

The IPO is being led by prominent financial institutions, with BofA Securities, Goldman Sachs & Co. LLC, and Piper Sandler acting as lead bookrunners. Wells Fargo Securities and Stifel are serving as bookrunners, while Wolfe | Nomura Alliance is participating as co-manager for the offering.

Kestra Medical Technologies is a commercial-stage company focused on transforming patient outcomes in cardiovascular disease through intuitive, intelligent, and connected monitoring and therapeutic intervention technologies. Their flagship product, the ASSURE® Wearable Cardioverter Defibrillator (WCD) system, is designed to provide automatic detection and defibrillation for ventricular arrhythmias, offering a modern approach to sudden cardiac arrest protection. The ASSURE system integrates with the Kestra CareStation™ remote patient data platform, enabling configurable notifications for clinical events and trending of physiological and device data at any time.

The company’s decision to go public comes amid increasing demand for wearable medical technology, particularly in the cardiovascular sector. As heart disease remains one of the leading causes of death globally, there is a growing market for advanced monitoring and intervention solutions. Kestra’s innovative approach to real-time monitoring and emergency response through connected devices positions it as a competitive player in this expanding industry. The funds raised through the IPO will likely support further research and development, product expansion, and potential strategic partnerships to enhance its market presence.

Investors will be closely watching the stock’s performance following its debut on the Nasdaq. Given the strong interest in digital healthcare and the increasing adoption of wearable medical devices, Kestra’s IPO could attract significant attention from both institutional and retail investors. The success of this offering could also signal broader investor confidence in the future of digital health solutions, particularly those that leverage artificial intelligence and real-time data tracking to improve patient outcomes.

Ocugen (OCGN) – Ocugen Reports FY2024 With Progress Toward “3 BLA Filings In 3 Years”

Posted on by cpereira@noblefcm.com


Thursday, March 06, 2025

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Clinical Progress Expected To Lead To Filings For Three Product Approvals. Ocugen reported a 4Q24 loss of $13.9 million or $(0.05) per share and FY2024 loss of $54.1 million or $(0.20) per share. The company made significant progress in its clinical trials during the quarter and since the start of FY2025. It has also received regulatory designations that accelerate product approval. The company had $58.5 million in cash on December 31, sufficient to fund operations through 1Q26.

Clinical Trial Advances Point To Three BLAs In 3 Years. Ocugen has made significant progress with three products for three diseases that lead to vision loss. The three ongoing trials are Phase 3 for OCU400, the Phase 2/3 for OCU410ST in Stargardt disease, and the Phase 1/2 trial for GA. These trials are on schedule for filing applications for approval in 2026, 2027, and 2028 respectively. OCU400 and OCU410ST have Orphan Drug designations that can accelerate approval, while GA is a large market of over 10 million patients in the US alone.


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Cadrenal Therapeutics (CVKD) – Development Agreement With Abbott Brings Another Tecarfarin Indication To Clinical Trials

Posted on by cpereira@noblefcm.com


Wednesday, March 05, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Cadrenal and Abbott Announce The LVAD Collaboration We’ve Been Waiting For. Cadrenal announced a development agreement with Abbott (ABT, Not Rated) to develop Tecarfarin in patients with Abbott’s HeartMate3 LVAD (left ventricle assist device). Under the agreement, Abbott will support Cadrenal’s pivotal TECH-VLAD (TECarfarin Anticoagulation and Hemocompatibility with Left Ventricular Assist Devices) trial in its design, site selection, recruitment, and its HeartMate3 experience.

LVAD Patients Have An Unmet Need For A New Anticoagulant. While Direct Oral Anticoagulation Drug (DOAC) category has been highly successful, there are several populations where they are not effective or have safety risks. Patients with LVAD devices can only use warfarin, a drug that has variable efficacy with several drawbacks, including a requirement for frequent patient monitoring. LVAD patients have less effective anticoagulation and remain at high risk for coagulation events (bleeding, stroke, myocardial infarct). 


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Ocugen (OCGN) – OCU410 and OCU410ST Receive ATMP Classification In Europe

Posted on by cpereira@noblefcm.com


Tuesday, March 04, 2025

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Ocugen Now Has Three Products With ATMP Designation. Two Ocugen products, OCU410 and OCU410ST, received Advanced Therapy Medicinal Product (ATMP) designation from the European Medicines Agency Committee for Advanced Therapies (EMA-CAT). These join OCU400, which received this designation for retinitis pigmentosa (RP) in February 2025. The designation is similar to the Breakthrough Therapy designation from the FDA, allowing increased interactions with the regulators and accelerating regulatory review.

OCU410 Has Completed Phase 2 Dosing In GA. The Phase 2 portion of the ArMaDa (pronounced ‘Armada”) trial has completed enrollment for OCU410 in geographic atrophy (GA), a lesion that results from advancing dry Age-related Macular Degeneration (dry AMD). The study has enrolled 51 patients randomized into a high dose arm, medium dose arm, or control. The completion of the dosing phase was ahead of our expected time frame, keeping the company on schedule to conduct Phase 3 in 2026 and potentially file for regulatory approval in 2028.


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GoHealth (GOCO) – Delivers a Robust Annual Enrollment Period

Posted on by slightbourne@noblecapitalmarkets.com


Friday, February 28, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Strong Q4. The company delivered impressive Q4 results driven by strong market dynamics during the Medicare Advantage Annual Enrollment Period (AEP). Quarterly revenue of $389.1 million was 16% stronger than our estimate of $336.0 million, and adj. EBITDA of $117.8 million exceeded our estimate of $80.4 million by 47%.

Improved efficiency. Average agent handle time was down roughly 9% from the prior year period and direct operating cost per policy submission was down 27% to $501. We believe these improvements are attributable to the company’s agent training and technology tool enhancements. Moreover, we believe the company’s focus on increasing productivity per agent could drive additional margin improvement over time.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Eli Lilly Acquires Organovo’s FXR Program in Strategic Expansion

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Eli Lilly (LLY) is acquiring Organovo’s (ONVO) FXR program, including lead drug candidate FXR314, for further development.
– Organovo will receive an upfront payment along with milestone-based regulatory and commercial payouts.
– ONVO stock surged over 200% following the announcement.

In a significant move for the biotechnology sector, Organovo Holdings, Inc. (Nasdaq: ONVO) announced the sale of its FXR program, including its lead candidate FXR314, to pharmaceutical giant Eli Lilly and Company (NYSE: LLY). The acquisition, disclosed on Tuesday, marks a pivotal moment for Organovo as it aligns its proprietary 3D human tissue technology with a global leader in drug development.

The FXR program, focused on inflammatory bowel disease (IBD), is a major step toward advancing novel treatment approaches. Organovo’s Executive Chairman, Keith Murphy, expressed confidence in Lilly’s ability to further develop FXR314, highlighting the company’s world-class expertise and commitment to patient care.

Under the agreement, Organovo will receive an upfront cash payment, with additional milestone payments contingent on regulatory approvals and commercial success. While the specific financial terms remain undisclosed, the market’s response has been overwhelmingly positive.

Following the announcement, ONVO shares skyrocketed by over 200%, reflecting investor optimism about the deal’s potential impact. Lilly’s stock also saw a modest gain of 2.32% as the acquisition strengthens its pipeline in the IBD treatment space.

For Organovo, this transaction reinforces its ability to leverage its cutting-edge 3D tissue technology for drug development partnerships. The company, known for pioneering bioprinting innovations, has been positioning itself as a key player in personalized medicine and regenerative therapies.

For Eli Lilly, the acquisition aligns with its broader strategy of expanding its immunology portfolio. FXR314’s development complements Lilly’s existing research efforts in inflammatory diseases, further cementing its position as a leader in next-generation therapeutics.

With FXR314 now under Lilly’s stewardship, the biotech industry will closely monitor its progression into Phase 2 trials. If successful, the drug could represent a breakthrough in IBD treatment, addressing a significant unmet medical need.

As Organovo pivots towards future innovation, and Lilly integrates this promising asset into its pipeline, investors and analysts alike will be watching closely to gauge the long-term benefits of this high-profile acquisition.

Take a moment to take a a look at Noble Capital Markets’ biotechnology Research Analyst Robert LeBoyer’s coverage list.

Unicycive Therapeutics (UNCY) – OLC Shows Synergy With Alternative Potassium Binder

Posted on by cpereira@noblefcm.com


Friday, February 21, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Pre-Clinical Study Shows Synergy With Tenapanor. Unicycive Therapeutics announced the results of an animal model study that tested its phosphate binder, OLC, or oxylanthanum carbonate, and tenapanor, a phosphate-control drug that works through a different mechanism than the phosphate binding drugs. The results showed OLC had a greater reduction than tenapanor, and the combination of both drugs given together had synergistic effects that were better than either drug given alone.

Study Design. Tenapanor (Xphozah, from Ardelyx) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor that works through paracellular absorption. It is used in patients that do not respond to phosphate binders or do not tolerate them. The study, “Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats,” was published in the American Nephrology Society’s journal Kidney360. It compared the two drugs against a control (delivery vehicle alone) in rats receiving a high phosphorus diet.


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Nutriband Inc. (NTRB) – Nutriband Extends Partnership Agreement To Include Post-Approval Financial Terms

Posted on by cpereira@noblefcm.com


Friday, February 14, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Previous Agreements Have Been Extended. Nutriband and its partner, Kindeva, have amended their development and commercialization agreement covering AVERSA Fentanyl, the abuse-deterrent transdermal fentanyl patch in development. The amendments include cost sharing and royalties on product sales. We see this as a sign that both parties are optimistic for the future of the product.

Agreement Provides For Development Cost Sharing and Royalty Payments. Nutriband and Kindeva first collaborated on a feasibility study to determine the efficacy of the AVERSA abuse-deterrent technology and its manufacturing requirements. The next agreement covered the development of manufacturing processes for commercial-scale production. The new revisions cover sharing of development costs and royalty payments on sales.


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MustGrow Biologics Corp. (MGROF) – Exclusive Distribution Agreement Signed

Posted on by cpereira@noblefcm.com


Wednesday, February 12, 2025

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Distribution. Yesterday, MustGrow announced the signing of a five-year exclusive distribution agreement with Adjuvants Plus Inc., in which MustGrow will distribute Adjuvants’ product line across Canada through NexusBioAg. In addition, MustGrow has a First Right of Refusal for the distribution of Adjuvants’ product line in the U.S. market.

Complementing Products. Four key products are being introduced by Adjuvants in the agreement, with a particular focus on EndoFine and EndoGuard. Adjuvants’ patented Clonostachys rosea, a fungus that provides plant health and protection benefits, is in both products, offering an abundance of advantages for various crops in North America, such as corn, soybeans, pulses, canola, and fruits and vegetables. In our view, products such as EndoFine and EndoGuard complement MustGrow’s product line, as both lines target similar crops while offering health and protection benefits.


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Eledon Pharmaceuticals (ELDN) – Tegoprubart Used In Pig Kidney Transplant Patient

Posted on by cpereira@noblefcm.com


Monday, February 10, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Tegoprubart Used For Immunosuppression In Another Transplantation Surgery. A transplant patient that received a genetically engineered pig kidney has been given tegoprubart as part of their drug regimen to prevent organ rejection. The genetically engineered pig kidney was produced by Eledon’s partner, eGenesis, with the surgery performed at Massachusetts General Hospital (MGH). We see the continued use of tegoprubart instead of tacrolimus, the standard of care, as a positive sign from the transplant community.

Tegoprubart Was Chosen Over Tacrolimus. Tegoprubart is an anti-CD40 ligand antibody that modulates the immune system and avoids the long-term toxic side effects of tacrolimus. It is currently in two human clinical trials for kidney transplantation and has been used in several recent xenotransplantation procedures. We see this choice as a sign that doctors see its clinical data as an improvement over tacrolimus.


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Zomedica Corp. (ZOM) – New TRUFORMA Assay Improves Diagnostic Offering

Posted on by cpereira@noblefcm.com


Friday, February 07, 2025

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Zomedica Launches New ACTH Assay For Equine PPID. Zomedica has launched an updated TRUFORMA assay for diagnosis of Equine PPID, Pituitary Pars Intermedia Dysfunction, an endocrine disorder in horses also known as Equine Cushing’s Disease. The new assay measures ACTH and one of its breakdown products, CLIP, then calculates a value that can be compared with established standard levels. The measures in this assay allow for better, faster diagnosis at the point-of-care.

PPID Is A Common Condition In Older Horses. An estimated 20% of the horses over 15 years of age are affected by PPID. Benign tumors or enlargement of the pituitary gland leads to overproduction of endocrine hormones and dysregulation of metabolism. ACTH is one of the hormones affected, causing a variety of symptoms that may lead to muscle wasting, thirst, urination, behavior, immune suppression, and metabolic changes. This affects the horse’s overall health, quality of life, and value to the owner.


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Alumis and ACELYRIN Announce Definitive Merger Agreement in All-Stock Transaction

Posted on by cpatches
Key Points:
– Alumis and ACELYRIN have agreed to an all-stock merger, creating a well-capitalized biopharmaceutical company focused on advancing immunology treatments.
– The combined company will have approximately $737 million in cash and securities, supporting multiple clinical trial readouts and operations into 2027.
– Alumis will retain its name and leadership team, with an expanded board including two ACELYRIN members, and the merger is expected to close in Q2 2025.

Alumis Inc. (NASDAQ: ALMS) and ACELYRIN (NASDAQ: SLRN) have announced a definitive merger agreement, combining the two clinical-stage biopharmaceutical companies in an all-stock transaction aimed at advancing immunology treatments and optimizing clinical outcomes.

Strategic Rationale and Financial Position

The merger will create a strongly capitalized company with a combined cash, cash equivalents, and marketable securities position of approximately $737 million as of year-end 2024. This financial strength is expected to support the advancement of the companies’ combined pipeline through multiple key clinical data readouts and fund operating expenses and capital expenditures into 2027.

The combined company will leverage its track record in research and development and a proprietary data and analytics platform to drive innovation in immune-mediated diseases.

Martin Babler, President, CEO, and Chairman of Alumis, stated: “Through this combination with ACELYRIN, Alumis will have the financial flexibility and runway to advance an expanded late-stage pipeline, now including lonigutamab, and build commercial capabilities. Since completing our IPO, Alumis has operated with speed and rigor, and the multiple development milestones expected in 2025 and 2026, coupled with potential additional indications for ESK-001, represent exciting breakthroughs for our patients and value-driving opportunities for the combined company’s stockholders. As we move forward together, we will maintain financial discipline and a flexible capital allocation strategy with the goal of maximizing the value of our highly differentiated portfolio.”

Pipeline Highlights

  • Alumis’ ESK-001: A next-generation, allosteric TYK2 inhibitor, currently in Phase 3 ONWARD trials for moderate-to-severe plaque psoriasis (PsO) and Phase 2b LUMUS trials for systemic lupus erythematosus (SLE). Key Phase 2 52-week updates expected in 2025, with Phase 3 topline data in H1 2026.
  • Alumis’ A-005: A CNS-penetrant allosteric TYK2 inhibitor, targeting neuroinflammatory and neurodegenerative diseases like multiple sclerosis (MS) and Parkinson’s Disease. A Phase 2 trial is set to begin in H2 2025.
  • ACELYRIN’s Lonigutamab: A subcutaneous anti-IGF-1R therapy with best-in-class potential for thyroid eye disease (TED), currently under Phase 2 evaluation.

Transaction Terms & Leadership Structure

  • Exchange Ratio: ACELYRIN stockholders will receive 0.4274 shares of Alumis common stock for each ACELYRIN share owned.
  • Ownership Breakdown: 55% Alumis stockholders, 45% ACELYRIN stockholders post-transaction.
  • Leadership: The combined company will operate under the Alumis name and be led by Alumis’ executive team, strengthened by key ACELYRIN professionals and medical experts.
  • Board Expansion: The board will grow to nine members, including two from ACELYRIN.
  • Closing Timeline: The transaction is expected to close in Q2 2025, subject to regulatory and shareholder approvals.

This merger brings together two companies dedicated to transforming immunology treatments, strengthening their pipeline, and delivering long-term value to patients and investors alike.

MAIA Biotechnology (MAIA) – THIO-101 Interim Update Shows Increasing Survival

Posted on by cpereira@noblefcm.com


Wednesday, February 05, 2025

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

MAIA Provides Phase 2 Interim Data Update In NSCLC. The Phase 2 THIO-101 trial is testing the combination of THIO with cemiplimab (Libtayo), a PD-1 checkpoint inhibitor from Regeneron, in patients with advanced non-small lung cancer (NSCLC). Median overall survival was 16.9 months, compared with expected survival of 5.8 months. Importantly, the lower limit of the statistical confidence intervals for the trial shows a 99% chance of surviving 10.8 months, a statistically significant result.

Combination Uses Two Mechanisms Of Action. The THIO-101 trial combines the killing effects from THIO with the PD-1 inhibition from cemiplimab. THIO uses its telomere targeting to damage cancer cell DNA, causing cell death. This also stimulates an immune response in the tumor through the cGAS/STING pathway and T-cell responses. Cemiplimab provides a second mechanism, allowing the immune cells to recognize and kill the cancer cells.


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