Tag: healthcare

Release – Eledon Pharmaceuticals Reports Preliminary Second Quarter 2024 Operating Results

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on ELDN

Presented updated data on 13 participants from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation

80 participants (two-thirds of projected recruitment) enrolled in Phase 2 BESTOW trial

Completed an oversubscribed $50 million private placement; Company expects sufficient liquidity through December 2025

IRVINE, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported recent business highlights for its second quarter 2024.

“We have entered the second half of the year with a strong balance sheet following our oversubscribed $50 million private placement and we are highly encouraged by the progress and reception from the transplant community for our Phase 2 BESTOW trial, which remains on track to complete enrollment by the end of this year,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking at this progress and the data we presented in June, we continue to believe that tegoprubart has the potential to displace calcineurin inhibitors, the current standard of care, as a first-line immunosuppression agent for patients undergoing kidney transplant.”

Second Quarter 2024 and Recent Corporate Developments

  • Enrolled the 80th participant in July 2024 in the ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of organ rejection in kidney transplantation.
  • Presented updated data at the American Transplant Congress (ATC) in June 2024 from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 13 participants demonstrated that tegoprubart was generally safe and well tolerated, with an overall mean estimated glomerular filtration rate (eGFR) of all reported time points after day 30 post-transplant of 70.5 mL/min/1.73m2. Two participants completed over 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one-year post-transplant.
  • Completed an oversubscribed private placement financing for total gross proceeds of $50.0 million, before deducting any offering related expenses.

Anticipated Upcoming Milestones

  • End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • Mid-2025: Report updated interim clinical data from the ongoing Phase 1b and long-term safety and efficacy extension studies of tegoprubart in kidney transplantation.

Financial Results

In the course of preparing the Company’s financial statements as of and for the three and six months ended June 30, 2024, the Company, in consultation with Crowe LLP, the Company’s independent registered public accounting firm, determined that a reclassification was necessary with respect to the Company’s reporting and recording of the fair value of certain common stock warrants and pre-funded warrants associated with the Company’s Securities Purchase Agreement dated as of April 28, 2023 (and the potential second and third closings thereof), resulting in a reclassification of these warrants as liabilities on the Company’s balance sheet, on a mark-to-market basis.

The Company expects to restate its audited consolidated financial statements that appeared in its Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2024, as amended on April 26, 2024, and its unaudited condensed consolidated financial statements that appeared in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2024 (together, the “Impacted Reports”). As previously disclosed on the Company’s Form 12b-25 Notification of Late Filing filed with the SEC today, the Company also expects to delay the filing of its Form 10-Q for the three and six months ended June 30, 2024 in light of the time and resources needed to prepare a complete and accurate Form 10-Q in light of the restatement process . See also the Company’s Current Report on Form 8-K filed today for additional information.

This accounting reclassification is non-cash and is not expected to have an economic impact on the Company’s operations or on the Company’s cash, cash equivalents and short-term investments, or cash runway.

Eledon ended the second quarter with approximately $83.6 million in cash and cash equivalents, which includes the $50.0 million received in the private placement financing transaction during the second quarter.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (CD40L), a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40L biology to conduct preclinical and clinical studies in allogeneic kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about enrollment in our clinical trials, the development and future success of product candidates, the company’s capital resources and ability to finance operations through December 2025, our filing of amendments to the Impacted Reports and our Form 10-Q for the three and six months ended June 30, 2024, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the completion of our financial closing procedures; final adjustments; completion of the review by our independent registered public accounting firm; the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Qs, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – Cocrystal Pharma Reports Second Quarter 2024 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on COCP

  • Expects to report topline results in 2025 from Phase 2a influenza A human challenge study with oral CC-42344, including initial indication of virology
  • In vitro testing shows CC-42344 inhibits the avian influenza A (H5N1) PB2 protein recently identified in U.S. dairy cows
  • Expects to report topline results in late 2024 or early 2025 from Phase 1 study with oral CDI-988, the first potential pan-coronavirus/pan-norovirus oral antiviral
  • Plans to initiate Phase 1 study in 2025 with inhaled CC-42344, a potential influenza treatment and post-exposure prophylactic

BOTHELL, Wash., Aug. 14, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and six months ended June 30, 2024, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“We are rapidly approaching major inflection points in our clinical programs,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “In the coming months we expect to report topline results from our Phase 2a study with PB2 inhibitor CC-42344 including an initial indication of virology in humans infected with the influenza A virus. Our plan is to file an Investigational New Drug (IND) application in 2025 to conduct our next study in the U.S. We further validated CC-42344’s broad-spectrum activity through in vitro testing demonstrating it inhibits the new, highly pathogenic avian flu PB2 protein identified as infecting U.S. dairy cows. We also are preparing to initiate a Phase 1 study in healthy volunteers as the first clinical step in evaluating inhaled CC-42344 as a potential prophylactic and therapeutic for influenza A.

“Preparations are underway to begin the multiple-ascending dose portion of the first-in-human study with our pan-norovirus/pan-coronavirus oral protease inhibitor CDI-988, following favorable safety and tolerability data from the single-ascending dose (SAD) portion of this study,” said Dr. Lee. “We expect to report topline results from the full study in late 2024 or early 2025.”

“I’m pleased to report that through our cost-efficient business model, we expect our cash to be sufficient to advance our planned development programs through the coming 12 months,” said James Martin, CFO and co-CEO of Cocrystal.

Antiviral Product Pipeline Overview

We apply our proprietary structure-based drug discovery platform technology for developing broad-spectrum antivirals that inhibit viral replication. By designing and selecting antiviral drug candidates that target the highly conserved regions of the viral enzymes, we seek to develop drugs that are effective against the virus and mutations of the virus, and also have reduced off-target interactions that may cause undesirable side effects. Our drug discovery process differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes.

Influenza Programs
Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

  • Oral CC-42344 for the treatment of pandemic and seasonal Influenza A infections
    • Our novel PB2 inhibitor CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In March 2022 we initiated enrollment in a randomized, double-blind, dose-escalating Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of oral CC-42344 in healthy adults.
    • In July 2022 we reported PK results from the SAD portion of the study that support once-daily dosing.
    • In December 2022 we reported favorable safety and tolerability results from the oral CC-42344 Phase 1 study.
    • In April 2023 we received authorization from United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for an oral CC-42344 Phase 2a human challenge study.
    • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects.
    • In March 2024 we received feedback from the FDA on a Pre-IND package improving clarity on clinical study design, drug manufacturing and nonclinical studies necessary to file a Phase 2b study design.
    • In May 2024 we completed enrollment in the Phase 2a human challenge study.
    • In June 2024 we reported that in vitro testing showed CC-42344 inhibited the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein that was identified as infecting U.S. dairy cows.
    • We expect to report topline results from the Phase 2a human challenge study in 2024 and to plan to file an IND application in 2025 to conduct a late-stage study in the U.S.
  • Inhaled CC-42344 for the treatment of pandemic and seasonal Influenza A infections
    • GLP toxicology study is underway with inhaled CC-42344 as a potential therapeutic and post-exposure prophylaxis for influenza A. CC-42344 has exhibited superior pulmonary exposure in preclinical studies.
    • We expect to begin a Phase 1 study with inhaled CC-42344 in Australia in 2025.
  • Influenza A/B Program
    • Preclinical lead development of novel influenza replication inhibitors is underway.

Norovirus Program
Norovirus is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 50,000 child deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion. By targeting viral replication, we believe it is possible to develop an effective treatment and/or short-term prophylactic for closed environments for all genogroups of norovirus.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of norovirus and coronavirus infections
    • Our novel broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential oral treatment for noroviruses and coronaviruses.
    • CDI-988 has shown pan-viral activity against multiple norovirus strains, including the genogroup II, genotype 4 (GII.4) norovirus strain that is responsible for major norovirus outbreaks.
    • In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and PK of oral CDI-988 in healthy volunteers.
    • In August 2023 we announced our selection of CDI-988 as our lead for the oral treatment for norovirus, in addition to coronavirus.
    • In September 2023 we began dosing subjects in a first-in-human study in healthy volunteers in Australia with oral CDI-988.
    • In July 2024 we reported favorable safety and tolerability results from the SAD cohorts in the Phase 1 study.
    • We expect to report topline results from the CDI-988 Phase 1 study in late 2024 or early 2025.

COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. The global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031.

  • Oral pan-viral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
    • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
    • In September 2023 we dosed the first subject in our dual norovirus/coronavirus oral CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
    • In July 2024 we reported favorable safety and tolerability results from the SAD cohorts in the Phase 1 study.
    • We expect to report topline results from the CDI-988 Phase 1 study in late 2024 or early 2025.

Second Quarter Financial Results

Research and development (R&D) expenses for the second quarter of 2024 were $4.3 million, compared with $2.8 million for the second quarter of 2023. The increase was primarily due to CC-42344 entering into a Phase 2a clinical study and norovirus and coronavirus candidate CDI-988 entering into a Phase 1 clinical study. General and administrative (G&A) expenses for the second quarter of 2024 were $1.1 million, compared with $1.5 million for the second quarter of 2023, with the decrease mainly due to lower legal expenses.

The net loss for the second quarter of 2024 was $5.3 million, or $0.54 per share, compared with a net loss for the second quarter of 2023 of $4.2 million, or $0.41 per share.

Six Month Financial Results

R&D expenses for the first six months of 2024 were $7.3 million, compared with $6.7 million for the first six months of 2023. G&A expenses for the first six months of 2024 were $2.3 million, compared with $2.7 million for the first six months of 2023.

The net loss for the first six months of 2024 was $9.3 million, or $0.91, per share, compared with a net loss for the first six months of 2023 of $9.4 million, or $1.03 per share.

Cocrystal reported unrestricted cash as of June 30, 2024 of $18.1 million, compared with $26.4 million as of December 31, 2023. Net cash used in operating activities for the first six months of 2024 was $8.2 million, compared with $8.7 million for the first six months of 2023. The Company had working capital of $17.0 million and 10.2 million common shares outstanding as of June 30, 2024.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including preparation, commencement and advancement of clinical studies for certain product candidates in 2024 and 2025, the viability and efficacy of potential treatments for diseases our product candidates are designed to treat, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, and the expected sufficiency of our cash balance to advance our programs and fund our planned operations. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the high interest rates in response to inflation, uncertainty in the financial markets, the possibility of a recession, and geopolitical conflict in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions on our ability to proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

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Release – Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on UNCY

– On Track to Submit OLC New Drug Application (NDA) by End of August 2024 –

LOS ALTOS, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended June 30, 2024, and provided a business update.

“Achieving successful results from our oxylanthanum carbonate (OLC) pivotal trial was a significant milestone for the company and brings us one step closer to becoming a commercial organization,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Importantly, the trial confirmed tolerability of OLC in patients with hyperphosphatemia on dialysis which is the final data component needed to support submission of a New Drug Application (NDA) to the FDA utilizing the 505(b)(2) regulatory pathway. In addition, we were able to achieve phosphate control in 90% of patients at the end of their titration. Our recent pharmacokinetic analysis of samples from the pivotal study revealed that the systemic exposure of our drug is minimal and, as expected, the serum lanthanum levels are similar to that seen with Fosrenol®. With this data, we believe that we have completed all the necessary requirements from this pivotal clinical trial to fulfill the FDA’s requests. We remain on track to submit our NDA by the end of this month, and we maintain a high degree of confidence in the potential for OLC to be a best-in-class commercial product, if approved.”

“In July 2024 we were granted a new patent for UNI-494 by the USPTO which is an important component of our development strategy to target patients with acute kidney injury (AKI), a serious condition resulting from a sudden loss of kidney function. We have completed enrollment in the UNI-494 Phase 1 dose-ranging study and expect to report results in the third quarter of this year. With assets targeting both chronic and acute kidney conditions, we remain steadfastly focused on improving treatment options and overall quality of life for patients living with renal diseases,” concluded Dr. Gupta.

Key Highlights

  • Reported positive topline data from the pivotal clinical trial of OLC with regard to both safety and tolerability endpoints. The study established promising tolerability of OLC at clinically effective doses in chronic kidney disease (CKD) patients on hemodialysis. In terms of tolerability, OLC had a low rate of discontinuation due to adverse events (AEs) with only 5/86 patients (6%) discontinuing from the Study. The primary endpoint was defined as the rate of discontinuations due to treatment-related AEs leading to discontinuation in the maintenance period. In the UNI-OLC-201 trial, the discontinuation rate was 1.4%, as there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population (n=71). In the full Safety Population (n=86), a total of 3 patients discontinued due to treatment-related AEs, a rate of 3.5%. There were no treatment-related serious adverse events (SAEs).
  • Announced initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. In the survey, OLC consistently outperformed the other phosphate binders in all categories: 79% of patients preferred OLC while 18% preferred their prior therapy, 98% of patients said that OLC was easy to take compared to 55% for their prior therapy, 89% of patients said they were satisfied with OLC while 49% were satisfied with their prior therapy.
  • Enrollment in the UNI-494 Phase 1 study is complete, and the Company expects to present the data in Q3 2024.
  • Granted a patent on UNI-494 to treat AKI by the United States Patent and Trademark Office (USPTO). The patent, valid until 2040, secures protection of a method of treating a disease or a condition selected from AKI or contrast induced nephropathy by administering the UNI-494 compound.
  • Included in the Russell Microcap® Index effective July 1, 2024. Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes.
  • Delivered multiple presentations on OLC and UNI-494 at the 61st European Renal Association (ERA) Congress including two oral presentations and trial-in-progress posters on OLC and UNI-494. An oral presentation demonstrated a significant reduction in urinary phosphate excretion for OLC compared to vehicle treated animals. A second oral presentation evaluated the in vivo efficacy of UNI-494 and showed that a single oral dose of UNI-494 significantly reduced important kidney functional markers.
  • Presented two posters related to OLC at the National Kidney Foundation (NKF) Spring Clinical Meeting. Importantly, it was demonstrated that OLC is bioequivalent to lanthanum carbonate from the Phase 1, single-center, randomized 1:1, open-label, controlled, 2-way crossover study. In addition, a poster presentation on the findings of a survey of 100 renal dieticians concluded that strategies that reduce pill burden and increase ease of use for patients are needed. This poster was among the top-rated submissions to the Meeting.

Financial Results for the Quarter Ended June 30, 2024

Research and Development (R&D) expenses were $4.9 million for the three months ended June 30, 2024, compared to $2.3 million for the three months ended June 30, 2023. The increase in research and development expenses was primarily due to increased drug development costs.

General and Administrative (G&A) expenses were $2.5 million for the three months ended June 30, 2024, compared to $2.1 million for the three months ended June 30, 2023. The increase was primarily due to increased non-cash stock compensation costs.

Other Income (Expense) was $17.3 million for the three months ended June 30, 2024 compared to $0.5 million in the three months ended June 30, 2023, due primarily to a decrease in the fair value of our warrant liability.

Net income attributable to common stockholders for the three months ended June 30, 2024 was $3.0 million, and basic earnings per share was $0.08. On a diluted basis, we reported a loss per share for the same period of $0.15. The net income for the three-month period ended June 30, 2024 was attributable to a decrease in the fair value of our warrant liability. For the three months ended June 30, 2023, we reported a net loss of $4.4 million, and basic loss per share of $0.29. On a diluted basis, we reported a loss per share for the same period of $0.29.

As of June 30, 2024, cash and cash equivalents totaled $41.8 million. The Company believes that it has sufficient resources to fund planned operations into 2026.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Fosrenol® is a registered trademark of Shire International Licensing BV.

Investor Contact:

ir@unicycive.com
(650) 900-5470

SOURCE: Unicycive Therapeutics, Inc.

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Release – Schwazze Announces Second Quarter 2024 Financial Results

Posted on by dburczyk@noblecapitalmarkets.com

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Growth and Restructuring Initiatives Lead to Quarter-over-Quarter Growth Across all Key Financial Metrics in Q2

Schwazze Management to Host Conference Call Today at 5:00 p.m. Eastern Time

DENVER, Aug. 13, 2024 (GLOBE NEWSWIRE) — Medicine Man Technologies, Inc., operating as Schwazze, (OTC: SHWZ) (Cboe CA: SHWZ) (“Schwazze” or the “Company”), today announced financial and operational results for the second quarter ended June 30, 2024.

“We made solid progress on our growth and optimization initiatives in Q2 and generated sequential quarterly growth across all key financial metrics while advancing our retail strategy,” said Forrest Hoffmaster, Interim CEO of Schwazze. “During the quarter, we continued to deepen our customer understanding, sharpen our pricing and promotional strategy, enhance the in-store experience, and improve our assortment and in-stock positions. These efforts drove increased store traffic and market share expansion in both Colorado and New Mexico. In our wholesale business, we generated our second consecutive period of quarter-over-quarter growth in both states with penetration growth and catalog expansion while improving wholesale margins.”

“To drive growth in the competitive Colorado environment, we continued to elevate the retail experience and loyalty offerings to improve customer acquisition and retention. As a result, we outpaced the market on a year-over-year basis and generated 6% growth in a market that declined 11% during the same period. As part of our restructuring initiative, we shuttered our non-plant touching wholesale operation in Denver and eliminated three underperforming stores that no longer met our high-margin expectations. We continue to evaluate our asset base to ensure we’re running as efficiently as possible while maximizing output.”

“In New Mexico, state cannabis sales were up 7% across a store base that was 20% higher year-over-year in Q2. The state’s regulatory body continued to increase its enforcement, helping lead to a reduction in net new store openings, which we anticipate will flip from positive to negative in the back half of the year. Our consistent efforts to optimize our pricing and promotional strategy, expand assortment with high-quality flower, and deliver an enhanced customer experience is generating momentum. In the second quarter, we grew revenue 9% sequentially compared to the state’s 2%, demonstrating the effectiveness of our operating playbook to compete in challenging environments.”

“Looking ahead, we will continue to refine our retail strategy while further driving operating efficiencies across our retail, cultivation, and manufacturing assets. Our recent debt restructuring provides us with the financial flexibility to execute our strategic growth initiatives in Colorado and New Mexico. Over the past year, our consistent efforts to optimize operations have established a solid foundation, positioning us for continued growth and stronger levels of profitability in the second half of 2024.”

Recent Highlights

  • In July 2024, Schwazze extended the maturities of its original $15.0 million Altmore, LLC Loan Agreement and its $17.0 million Reynold Greenleaf & Associates LLC Promissory Note to November 2025 (both previously due in February 2025) in a step toward addressing future debt obligations.
  • Announced the grand opening of a medical and recreational dispensary in June under the R. Greenleaf banner in Bernalillo, New Mexico, increasing the Company’s retail footprint to 35 stores across the state.
  • Closed the Company’s Colorado distribution center and shuttered its non-plant touching wholesale operations, The Big Tomato, in Colorado to concentrate on core business operations.
  • Closed three underperforming Colorado dispensaries and streamlined the Company’s corporate office support structure to strengthen its retail forward strategy.
  • Increased wholesale penetration during the quarter to approximately 34% and 35% of total doors in Colorado and New Mexico, respectively.
  • Expanded wholesale catalog in New Mexico with the launch of Lowell Farms pre-rolls.
  • Generated 28% sequential wholesale unit growth in New Mexico with Wana gummies.

1 Adjusted EBITDA is a non-GAAP measure as defined by the SEC, and represents earnings before interest, taxes, depreciation, and amortization, adjusted for other income, non-cash share-based compensation, one-time transaction related expenses, or other non-operating costs. The Company uses Adjusted EBITDA as it believes it better explains the results of its core business. See “ADJUSTED EBITDA RECONCILIATION (NON-GAAP)” section herein for an explanation and reconciliations of non-GAAP measure used throughout this release.

Second Quarter 2024 Financial Results

Total revenue in the second quarter of 2024 increased 2% to $43.2 million compared to $42.4 million for the same quarter last year. The increase was primarily due to growth from new stores compared to the prior year period, partially offset by lower wholesale revenue and continued pricing pressure from the proliferation of new licenses in New Mexico.

Gross profit for the second quarter of 2024 was $19.0 million or 44.0% of total revenue, compared to $23.0 million or 54.4% of total revenue for the same quarter last year. The decrease in gross margin was primarily driven by the aforementioned pricing pressure and greater mix of third-party purchasing in New Mexico to broaden assortment in the state, as well as higher medical sales mix in Colorado.

Operating expenses for the second quarter of 2024 were $21.8 million compared to $18.1 million for the same quarter last year. The increase was primarily driven by four-wall SG&A costs associated with five additional stores in Colorado and New Mexico, as well as non-recurring professional service fees related to prior period workpaper review stemming from work required to comply with SEC based on their Order against BF Borgers.

Loss from operations for the second quarter of 2024 was $2.7 million compared to income from operations of $5.0 million in the same quarter last year. Net loss was $13.9 million for the second quarter of 2024 compared to $6.6 million for the same quarter last year.

Adjusted EBITDA for the second quarter of 2024 was $9.0 million compared to $13.8 million for the same quarter last year. The decrease in Adjusted EBITDA was primarily driven by lower gross margin and higher operating expenses.

As of June 30, 2024, cash and cash equivalents were $12.3 million compared to $19.2 million on December 31, 2023. Total debt as of June 30, 2024, was $163.4 million compared to $156.8 million on December 31, 2023.

Conference Call

The Company will conduct a conference call today, August 13, 2024, at 5:00 p.m. Eastern time to discuss its results for the second quarter ended June 30, 2024.

Schwazze management will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.

Date: Tuesday, August 13, 2024
Time: 5:00 p.m. Eastern time
Toll-free dial-in: (844) 825-9789
International dial-in: (412) 317-5180
Conference ID: 10191294
Webcast: SHWZ Q2 2024 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (844) 512-2921
International replay number: (412) 317-6671
Replay ID: 10191294

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

About Schwazze

Schwazze (OTC: SHWZ) (Cboe CA: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to explore taking its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit https://schwazze.com/.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include financial outlooks; any projections of net sales, earnings, or other financial items; any statements of the strategies, plans and objectives of our management team for future operations; expectations in connection with the Company’s previously announced business plans; any statements regarding future economic conditions or performance; and statements regarding the intent, belief or current expectations of our management team. Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. We have based our forward-looking statements on management’s current expectations and assumptions about future events and trends affecting our business and industry. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Therefore, forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Investor Relations Contact
Sean Mansouri, CFA or Aaron D’Souza
Elevate IR
(720) 330-2829
ir@schwazze.com

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GoHealth, Inc. (GOCO) – Is there a Tailwind in the Forecast?

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 09, 2024

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.

Q2 results below estimates. The company reported Q2 revenue and adj. EBITDA of $105.9 million and a loss of $12.3 million, respectively, below our estimates. Our revenue and adj. EBITDA estimates were $144.0 million and a loss of $6.3 million, respectively.

Preparing for AEP. The company has been testing Plan Fit Save, an initiative whereby it is compensated by health plan carriers for improving customer retention when GoHealth recommends consumers to keep their existing plans. We believe the combination Plan Fit Save, as well as the prospect for disruption to health plan benefits in the upcoming Annual Enrollment Period, could set the company up for a strong finish to the year.


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Release – Ocugen, Inc. Announces FDA Approval of Expanded Access Program for Patients with Retinitis Pigmentosa

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on OCGN

MALVERN, Pa., Aug. 05, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it has received notification from FDA to begin its expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candidate.

“Each clinical milestone achieved by OCU400 brings us closer to providing a potential one-time treatment for life to patients living with RP,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “With positive Phase 1/2 study data and an ongoing Phase 3 liMeliGhT (pronounced “limelight”) clinical trial, we now plan to work with clinicians, patients, and the RP community to provide access to OCU400 for eligible patients through our EAP. The EAP strengthens our commitment to serving RP patients—300,000 in the U.S. and Europe and 1.6 million globally.”

EAP allows patients who have unmet medical needs with serious or life-threatening conditions to access treatments outside of a clinical trial that are not yet approved by the FDA.

The OCU400 EAP is available for patients with early, intermediate to advanced RP with at least minimal retinal preservation who may benefit from the mechanism of action of OCU400 prior to approval of the Biologics License Application (BLA). Ocugen is actively dosing patients in the Phase 3 liMeliGhT clinical trial.

“RP patients with mutations in multiple genes currently have no therapeutic options. As a retinal surgeon, I am encouraged by the therapeutic potential of OCU400 to provide long-term benefit,” said Lejla Vajzovic, MD, FASRS, Director, Duke Surgical Vitreoretinal Fellowship Program, Associate Professor of Ophthalmology with Tenure, Adult and Pediatric Vitreoretinal Surgery and Disease, Duke University Eye Center, and Retina Scientific Advisory Board Chair of Ocugen. “The OCU400 EAP gives RP patients access to this novel modifier gene therapy outside of the ongoing Phase 3 study.”

“We are pleased to make OCU400 available to patients beyond our Phase 3 liMeliGhT clinical trial through this EAP,” said Dr. Huma Qamar, Ocugen’s Chief Medical Officer. “We are excited to expand our enrollment to include patients representing a diverse array of RP gene mutations. This program reflects our ongoing commitment to develop a safe and effective therapy for RP patients who may not have other treatment options.”

Ocugen previously announced that OCU400 has received orphan drug and Regenerative Medicine Advanced Therapy (RMAT) designations from FDA and that the European Medicines Agency (EMA) accepted the U.S.-based trial for submission of a Marketing Authorization Application (MAA). With the dosing of patients in the Phase 3 clinical trial program underway, OCU400 remains on track for targeted BLA and MAA approval in 2026.

About OCU400 EAP
The OCU400 EAP is a U.S.-only protocol for (1) eligible adult RP patients, 18 years and older, with early, intermediate to advanced disease with at least minimal retinal preservation, (2) patients who participated in the OCU400 Phase 1/2 study and who qualify for dosing in the contralateral eye, (3) patients who failed to meet inclusion criteria in the Phase 1/2 trial and ongoing Phase 3 liMeliGhT clinical trial who could benefit from OCU400, and (4) RP patients who can benefit from the mechanism of action of OCU400 prior to BLA approval.

Additional information on the OCU400 EAP will be available on www.clinicaltrials.gov.

About OCU400 Phase 3 (liMeliGhT) for RP
The Phase 3 liMeliGhT clinical trial, with a duration of one year, will have a sample size of 150 participants. One arm will include 75 participants with RHO gene mutations, and the other arm will include 75 participants who have mutations in other genes. Within each arm, participants will be randomized 2:1 to the treatment group (2.5 x1010 vector genomes/eye of OCU400) and untreated control group, respectively. Patients eight years of age and older with early to late-stage RP are being recruited to participate in the liMeliGhT study.

About OCU400
OCU400 is the Company’s modifier gene therapy product based on a nuclear hormone receptor (NHR) gene called NR2E3. This gene regulates diverse physiological functions within the retina, such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival. Retinal cells in RP patients have a dysfunctional gene network, and OCU400 resets this network to reestablish a healthy cellular homeostasis—which has the potential to improve vision in patients with RP.

About Modifier Gene Therapy
Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP, Leber congenital amaurosis (LCA) and Stargardt disease, as well as multifactorial diseases like dry age-related macular degeneration (dAMD). Our modifier gene therapy platform is based on the use of NHRs, master gene regulators, which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently, Ocugen has three modifier gene therapy programs in the clinic: OCU400, OCU410, and OCU410ST. In addition to the OCU400 Phase 3 liMeliGhT clinical trial, the OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA) secondary to dAMD and the OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease are currently underway. GA affects approximately two to three million people in the U.S. and EU combined and Stargardt disease affects nearly 100,000 people in the U.S. and EU combined.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Corporate Communications
Tiffany.Hamilton@ocugen.com

Release – Schwazze Sets Second Quarter 2024 Conference Call for August 13, 2024 at 5:00 P.M. ET

Posted on by dburczyk@noblecapitalmarkets.com

Research News and Market Data on SHWZ

DENVER, July 30, 2024 (GLOBE NEWSWIRE) — Medicine Man Technologies, Inc., operating as Schwazze, (OTC: SHWZ) (Cboe CA: SHWZ) (“Schwazze” or the “Company”), will host a conference call on Tuesday, August 13, 2024 at 5:00 p.m. Eastern time to discuss its financial and operational results for the second quarter ended June 30, 2024. The Company’s results will be reported in a press release prior to the call.

The Schwazze management team will host the conference call, followed by a question-and-answer period. Interested parties may submit questions to the Company prior to the call by emailing ir@schwazze.com.

Date: Tuesday, August 13, 2024
Time: 5:00 p.m. Eastern time
Toll-free dial-in: (844) 825-9789
International dial-in: (412) 317-5180
Conference ID: 10191294
Webcast: SHWZ Q2 2024 Earnings Call

The conference call will also be broadcast live and available for replay on the investor relations section of the Company’s website at https://ir.schwazze.com.

Toll-free replay number: (844) 512-2921
International replay number: (412) 317-6671
Replay ID: 10191294

If you have any difficulty registering or connecting with the conference call, please contact Elevate IR at (720) 330-2829.

About Schwazze

Schwazze (OTC: SHWZ) (Cboe CA: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale.

Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit http://www.schwazze.com/.

Investor Relations Contact

Sean Mansouri, CFA or Aaron D’Souza
Elevate IR
(720) 330-2829
ir@schwazze.com

AI Revolution in Healthcare: Simplify Healthcare Acquires Virtical.ai

Posted on by slightbourne@noblecapitalmarkets.com

In a groundbreaking move, Simplify Healthcare has announced its acquisition of Virtical.ai, setting the stage for a dramatic transformation in health insurance technology. This strategic merger, revealed on June 24, 2024, combines Simplify Healthcare’s established SaaS platform with Virtical.ai’s advanced artificial intelligence capabilities, promising to revolutionize how health insurance providers operate in an increasingly complex market.

The timing of this acquisition is particularly significant as the healthcare industry grapples with mounting pressures to personalize services, streamline operations, and navigate intricate regulatory landscapes. By integrating Virtical.ai’s AI prowess into its Simplify Health Cloud™ platform, Simplify Healthcare aims to empower health insurance companies (Payers) with sophisticated tools to address these challenges effectively.

At the core of this acquisition lies the transformative potential of AI-driven solutions. Virtical.ai’s technology, which has been trained on an extensive database of health plan-specific documents, excels in data extraction and comparison. This capability enables Payers to offer highly personalized plans and benefits to both employer and individual segments, potentially revolutionizing the way health insurance is customized to meet individual needs.

Simplify Healthcare’s leadership team has expressed enthusiasm about the merger’s potential to reshape the industry. They emphasize the ability of AI models to process complex documents such as Statements of Benefits and Coverage (SBCs) and Machine Readable Files (MRFs), highlighting the potential for significant advancements in plan comparison, selection, and price transparency.

The acquisition also addresses critical challenges in network management. Virtical.ai’s platform can identify gaps in Payer networks by analyzing provider and member locations. This feature allows Payers to strategically promote their network coverage strengths and address deficiencies, ensuring members have access to suitable providers within their area. Moreover, the ability to benchmark negotiated provider rates against competitors offers Payers valuable insights for rate-setting and targeted marketing initiatives.

Virtical.ai’s leadership shares the excitement about the merger’s potential impact. They highlight how their AI models, built on decades of industry experience, are positioned to drive membership growth and revenue when integrated with Simplify Healthcare’s enterprise SaaS platform.

The integration of Virtical.ai’s technology is expected to enhance several of Simplify Healthcare’s existing solutions, including Benefits1™, Provider1™, Service1™, Claims1™, and Experience1™. These enhancements promise to provide Payers with more precise solutions to complex challenges in delivering products, benefits, and provider data.

Simplify Healthcare’s strategic team underscores the acquisition’s importance in the face of market disruptions. They believe that combining their industry-leading platform with Virtical.ai’s innovative AI solutions in Health Plan Sales and Network Management will empower Payers to achieve growth despite facing disruptive market and regulatory forces.

This merger also reflects a broader industry trend towards leveraging AI and machine learning to improve efficiency and personalization. By utilizing both generative AI and machine learning algorithms on unstructured document content and structured data, the combined entity aims to deliver cutting-edge solutions to Payers navigating the complexities of AI integration.

As the healthcare landscape continues to evolve, this acquisition positions Simplify Healthcare at the forefront of the AI revolution in health insurance technology. The promise of more personalized health plans, optimized network coverage, and data-driven decision-making tools could significantly impact not only Payers but also brokers and, ultimately, healthcare consumers.

With this bold move, Simplify Healthcare and Virtical.ai are poised to play a pivotal role in shaping the future of health insurance in an increasingly digital and personalized world. Their combined expertise and technological capabilities have the potential to drive innovation, enhance efficiency, and improve the overall experience for all stakeholders in the health insurance ecosystem.

Take a moment to take a look at GoHealth Inc. (GOCO), a health insurance marketplace that leverages modern machine-learning algorithms and helps individuals find the best health insurance plan for their specific needs.

Quantum Leap: The Next Big Investment Opportunity in Healthcare?

Posted on by slightbourne@noblecapitalmarkets.com

Imagine a world where diseases are detected at the earliest stages, new life-saving drugs are developed in a fraction of the time, and medical resources are optimized to deliver the best possible care. This future may not be as far-fetched as it sounds, thanks to a revolutionary technology called quantum computing.

What is Quantum Computing?
Quantum computing is a mind-bending technology that harnesses the strange behavior of particles at the subatomic level. Unlike traditional computers that process information as binary bits (0s and 1s), quantum computers use quantum bits or qubits that can exist in multiple states simultaneously. This superposition phenomenon allows quantum computers to perform millions of calculations at once, making them exponentially more powerful than classical computers.

The Healthcare Revolution
While quantum computing may seem like something straight out of a science fiction movie, its potential applications in healthcare are very real and could transform the industry as we know it.

  1. Accelerating Drug Discovery
    One of the most promising applications of quantum computing is in the field of drug discovery. Finding new medicines is a painstakingly slow and expensive process, often taking decades and billions of dollars. Quantum computers can simulate complex molecular interactions at an unprecedented scale, allowing researchers to quickly identify promising drug candidates. This could dramatically shorten the drug development timeline, saving lives and billions of dollars.

Consider this: It takes an average of 10 years and $2.6 billion to develop a new drug from initial discovery to market approval. With quantum computing, pharmaceutical companies could potentially cut development times by years, significantly reducing costs and getting life-saving treatments to patients faster.

  1. Personalized Medicine
    We all have unique genetic makeups that influence our response to different treatments. Personalized medicine aims to tailor therapies to an individual’s genetic profile, but analyzing vast amounts of genomic data is a daunting task for classical computers. Quantum computers can process and identify patterns in complex genetic data, enabling truly personalized treatment plans that maximize efficacy and minimize side effects.

Imagine a future where your doctor can analyze your entire genome and prescribe a medication tailored specifically to your genetic makeup, minimizing the risk of adverse reactions or ineffective treatments. This level of precision could revolutionize healthcare, improving outcomes and reducing waste.

  1. Enhanced Medical Imaging
    Medical imaging techniques like MRI and CT scans generate massive amounts of data. Quantum computing can enhance image processing, improving clarity and resolution, enabling earlier detection of diseases like cancer. Early detection is key to successful treatment and could save countless lives.

With quantum-enhanced imaging, doctors could potentially identify tumors and other abnormalities at much earlier stages, significantly increasing the chances of successful treatment and survival.

  1. Optimized Healthcare Logistics
    Healthcare systems involve intricate logistics, from managing hospital resources to optimizing patient care. Quantum computing’s ability to solve complex optimization problems can help hospitals better manage staff, equipment, and patient flow, leading to improved efficiency and reduced costs.

By optimizing resource allocation and patient flow, quantum computing could help hospitals reduce wait times, improve patient experiences, and ultimately deliver better care at lower costs.

The Investment Opportunity
While quantum computing is still in its early stages, the potential payoffs in healthcare are staggering. Tech giants like IBM, Google, and startups like Rigetti Computing are investing heavily in quantum research. As the technology matures, we can expect to see a surge of investment opportunities in quantum computing companies and healthcare firms that leverage this technology.

Analysts estimate that quantum computing could create a $450 billion to $850 billion annual market by 2045, with healthcare being one of the prime beneficiaries. Early investors in this space could see massive returns as the technology takes off.

Of course, there are challenges to overcome, such as building stable, large-scale quantum computers and developing algorithms tailored for healthcare applications. However, the potential rewards are vast, both in terms of human lives saved and financial returns for savvy investors who recognize the transformative power of quantum computing in healthcare.

Quantum computing holds the promise to revolutionize healthcare by accelerating drug discovery, enabling personalized medicine, enhancing medical imaging, and optimizing resource management. While the technology is still in its early stages, the potential benefits for medicine are enormous. As we continue to explore and develop quantum computing, the future of healthcare looks brighter than ever, offering new hope for patients and medical professionals alike.

Novavax Soars on Major Sanofi Partnership, Opening New Doors for Biotech Investors

Posted on by slightbourne@noblecapitalmarkets.com

In a dramatic turn of events, shares of Novavax skyrocketed over 130% on Friday after the struggling vaccine maker announced a landmark deal with global pharmaceutical giant Sanofi. This multibillion-dollar agreement could prove to be a game-changer, not just for Novavax’s outlook, but for biotech investors evaluating the emerging opportunities across the vaccine technology landscape.

The centerpiece of the deal is a co-commercialization partnership for Novavax’s protein-based Covid-19 vaccine beginning in 2025. Sanofi, with its vast global reach and resources, will take the lead in marketing and distributing the shot in most major markets outside of regions where Novavax already has existing commercial agreements.

For Novavax, which has grappled with sluggish demand and manufacturing challenges for its Covid vaccine, gaining access to Sanofi’s commercial juggernaut could unlock vastly greater market penetration worldwide. As a relatively small biotech player, going it alone has proven tremendously difficult against the entrenched dominance of mRNA giants like Pfizer and Moderna.

Investors clearly perceive the blockbuster potential in marrying Novavax’s innovative vaccine technology with Sanofi’s large-scale commercial capabilities and existing healthcare footprint. Expanded patient access could drive significant upside for Novavax’s revenues and growth trajectory in the coming years, breathing new life into a company that was on the brink.

But the deal goes far beyond just commercializing Novavax’s existing Covid vaccine. In a strategic masterstroke, Sanofi also secured the rights to develop new combination vaccines using Novavax’s breakthrough Matrix-M adjuvant technology, along with its Covid shot as a foundational component.

This pipeline partnership opens up a world of lucrative new product opportunities spanning respiratory illnesses like influenza to other viral targets. With Sanofi’s vast resources and deep experience in vaccines, the French pharma leader could rapidly advance and widely commercialize groundbreaking combination shots powered by Novavax’s underlying technology platform.

From an investment perspective, the potential to create multiple new high-value assets from a proven backbone of innovative biotech is hugely compelling. Sanofi is putting over $1 billion on the table in upfront fees and milestone payments tied to development and commercial objectives. Novavax will also earn royalties on all future product sales utilizing its technology.

Crucially, this deal relieves immense financial pressure from Novavax’s shoulders. Just a few months ago, the company warned of “substantial doubt” about its ability to continue operating through a dwindling cash position. Now flush with fresh capital from Sanofi and newly monetized royalty streams, Novavax can comfortably lift its “going concern” status while funding its own vaccine pipeline initiatives.

Investors should see the partnership as transformative, clearing the dark clouds of existential risk that had been swirling over Novavax and positioning the biotech for long-term sustainability through diversified vaccine revenue channels.

But Novavax’s good fortune goes beyond just its own prospects. The validation of its unique Matrix-M adjuvant and protein-based vaccine technology by a pharma titan like Sanofi should resonate across the broader biotech landscape. Smaller innovators working on novel vaccine platforms or therapeutic approaches could see heightened investor interest and appetite for collaborations.

The deal underscores how big pharma incumbents remain hungry for cutting-edge technologies to refresh and future-proof their product pipelines. More acquisitions and mutually beneficial licensing deals could emerge as large players double down on biotech externally to fuel new innovation cycles.

For biotech venture investors scouting breakthrough opportunities and transformative technology platforms, the Novavax-Sanofi partnership should serve as an encouraging proof-of-concept. Companies advancing truly differentiated science with clear competitive advantages and value-driving datasets now have a highly visible pathway to lucrative partnerships, exits or harnessing corporate funding muscle to propel their own commercialization dreams.

In life sciences industries where innovation is the key to disruption, this high-profile deal should instill greater confidence around investing in upstart biotechs clearing novel clinical and technological hurdles. The prospects of future value realization and exit opportunities just got a welcome booster shot.

While Novavax finally resolved one existential crisis, it may have just birthed an exciting new era of opportunity across the biotech investment landscape.

New Eli Lilly-Amazon Deal Signals Emerging Opportunities in Direct-to-Consumer Pharmaceuticals

Posted on by slightbourne@noblecapitalmarkets.com

The newly announced partnership between pharmaceutical giant Eli Lilly and e-commerce behemoth Amazon to enable direct-to-consumer medication delivery is sending shockwaves through the biotech and healthcare sectors. The deal, which allows customers to receive select Eli Lilly prescription drugs like diabetes, migraine, and weight-loss treatments via Amazon’s online pharmacy, represents a major shift in how pharmaceutical companies get products into the hands of consumers

For emerging biotech and healthcare companies watching this space, the Eli Lilly-Amazon partnership illuminates massive growth opportunities in the burgeoning direct-to-consumer pharmaceutical market. Cutting out the middlemen of insurance providers and brick-and-mortar pharmacies enables pharma companies to get closer to patients and potentially earn higher margins.

Under the partnership revealed this week, patients can receive Eli Lilly medications prescribed through the LillyDirect online platform or by their regular doctor, with Amazon handling the fulfillment and two-day delivery logistics. Axios’ Jacob Gardner points out this allows Eli Lilly “to reach more patients directly and sidestep more traditional pharmaceutical sales constraints.”

The collaboration helps both industry titans accomplish key objectives. For Eli Lilly, it expands their direct-to-consumer reach at a pivotal time following the approval of blockbuster weight-loss drug Zepbound last November. Amazon, meanwhile, continues growing its healthcare presence following the acquisition of PillPack and launch of Amazon Pharmacy in 2020.

Executives at emerging biotech and pharmaceutical companies would be wise to study this latest deal’s blueprint. By partnering with logistics giants like Amazon, FedEx, or UPS on the shipping side or digital health platforms on the consumer-facing end, they could unlock highly lucrative direct-to-consumer sales channels.

Beyond cutting out middlemen that take a cut of sales, direct-to-consumer pharma models can foster stronger patient relationships, bolster brand loyalty, and provide a wealth of data and analytics on consumer behaviors. Those insights allow companies to precisely tailor marketing and pricing strategies to drive further growth.

From the investor perspective, directly delivering cutting-edge treatments straight to patient doorsteps holds massive upside potential. Drug developers can keep more of the profits by circumventing insurance providers. But investing in the right direct-to-consumer pharmaceutical plays requires careful due diligence.

Investors need to scrutinize logistics capabilities, consumer marketing and branding strengths, and data analytics competencies in evaluating these emerging opportunities. The biggest winners will have a clear advantage in one or more of those mission-critical areas.

The overarching theme is clear – by cutting out the tangle of middlemen in the traditional pharmaceutical ecosystem, innovative companies embracing the direct-to-consumer model could potentially earn higher revenues, margins, and valuations. The ripple effects of the Eli Lilly-Amazon deal are likely just beginning for the healthcare investing space.

For investors willing to conduct thorough research and identify the pioneers, the emerging direct-to-consumer pharmaceutical market could birth the next generation of blockbuster biotech and healthcare companies.

Learn more about Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18 here.

Biden’s Scrutiny of Private Equity Healthcare Deals: A New Hurdle for Investors?

Posted on by slightbourne@noblecapitalmarkets.com

The healthcare industry has long been a fertile ground for private equity investments, with firms eagerly scooping up stakes in hospitals, physician practices, and ancillary service providers. However, a recent move by the Biden administration to scrutinize these deals more closely could signal turbulent times ahead for investors eyeing opportunities in the healthcare space.

In February 2024, the White House announced plans to establish an interagency taskforce dedicated to investigating the effects of private equity ownership on healthcare costs, quality, and workforce compensation. This move comes amid growing concerns from lawmakers and advocacy groups about the potential negative impacts of private equity firms’ profit-driven strategies on patient care and healthcare affordability.

The taskforce’s mandate is broad, encompassing a comprehensive examination of how private equity business models influence everything from staffing levels and worker wages to service availability and pricing dynamics across various healthcare sectors. While the specific policy implications remain uncertain, the heightened scrutiny alone could cast a cloud of uncertainty over future private equity healthcare deals, particularly smaller acquisitions of physician practices, nursing homes, and ancillary service providers.

For investors, this development represents a potential new hurdle in an already challenging regulatory landscape. Private equity firms have long been drawn to the healthcare sector due to its recession-resistant nature, steady cash flows, and the potential for operational improvements and consolidation plays. However, the increased regulatory oversight could make it more difficult for these firms to execute their traditional playbook of cost-cutting, leveraged buyouts, and aggressive growth strategies. Nathan Cali, Head of Healthcare Investment Banking at Noble Capital Markets said, “Certainly, government oversight never means more business to be done, and alternatively may result in fewer healthcare services, healthcare innovations and reduce opportunities for patients. Private equity typically fuels great innovation with the necessary growth funds to already thriving good businesses. Government regulations and oversight may reduce these types of activities.”

One area likely to face heightened scrutiny is the acquisition of physician practices by private equity firms. These deals have been a contentious issue, with critics arguing that private equity ownership can lead to higher healthcare costs, a focus on profitable procedures over patient needs, and potential conflicts of interest. If the taskforce recommends additional regulations or restrictions on such acquisitions, it could dampen private equity firms’ appetite for these investments, potentially limiting exit opportunities for investors.

Similarly, private equity ownership of nursing homes and long-term care facilities has been a subject of intense debate, with concerns over staffing levels, quality of care, and the diversion of resources towards profit maximization. Increased oversight in this sector could lead to stricter requirements for private equity firms, potentially impacting their ability to implement cost-cutting measures and limiting the financial returns on these investments.

Beyond the direct impact on private equity firms, the taskforce’s findings and recommendations could also have broader implications for the healthcare sector as a whole. If the investigation uncovers evidence of harmful practices or negative outcomes associated with private equity ownership, it could prompt lawmakers to pursue more comprehensive regulatory changes or industry-wide reforms.

Such changes could include enhanced transparency requirements, stricter oversight of billing practices, or even limitations on the types of healthcare entities that can be acquired by private equity firms. These measures could potentially level the playing field between private equity-owned and non-profit healthcare providers, but could also create additional compliance burdens and operational challenges for all industry participants.

For investors, navigating this shifting landscape will require a keen eye for regulatory risks and a deep understanding of the potential impacts on specific healthcare subsectors. While the taskforce’s ultimate recommendations remain uncertain, investors should be prepared for potential changes in valuations, deal structures, and exit strategies for private equity healthcare investments.

Noble Capital Markets’ Senior Research Analyst Robert Leboyer states, “The Administration’s provisions for Medicare price negotiations in the Inflation Reduction Act have added uncertainty to a high-risk business, causing reduction in the value of future drugs and discontinuation of some drugs in development. Small company valuations were reduced and many were unable to raise capital. Additional regulation for healthcare facilities would add administrative costs and reduce profitability, reducing the incentives and competition in providing the best care for patients.”

Additionally, investors may need to reassess their due diligence processes to scrutinize not only the financial and operational aspects of potential investments but also the potential regulatory and reputational risks associated with private equity ownership in the healthcare space.

Despite the challenges, the healthcare sector remains an attractive target for private equity firms due to its resilience, growth potential, and the ongoing need for operational efficiencies and consolidation. However, the Biden administration’s heightened scrutiny serves as a reminder that the pursuit of profits must be balanced against the broader societal impact and responsibilities inherent in the healthcare industry.

As the taskforce’s work unfolds, investors would be wise to closely monitor developments and adapt their strategies accordingly. Those who can navigate this new reality adeptly may find themselves well-positioned to capitalize on the enduring opportunities in the healthcare sector, while those who fail to adjust could face significant headwinds in a rapidly evolving regulatory and political landscape.

Healthcare Investment Ideas on Display at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

Posted on by cpatches

Get the Virtual Conference eBook

Watch the Presentation and Q&A Replays

  • Emerging Growth Public Healthcare Company Executive Presentations
  • Q&A Sessions Moderated by Noble’s Analysts and Bankers
  • Scheduled 1×1 Meetings with Qualified Investors

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Emerging Growth Virtual Healthcare Conference, taking place April 17th and 18th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the life sciences, healthcare, and medical device sectors.

Part of Noble’s Robust 2024 Events Calendar

The Emerging Growth Virtual Healthcare Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two more sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.

Check out the calendar of upcoming in-person non-deal roadshows here.

Sign up to receive more information on Noble’s other virtual conferences here.

What to Expect

The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analyst or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in the healthcare sector, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.

Why Your Company Should Present

Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.

Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.

The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.

Benefits for Investors

The emerging growth healthcare space may be poised for a breakout year.  The recent dislocation in the healthcare and biotech spaces has created compelling valuation profiles for many companies. Hear directly from the c-suite of the next innovators in this space and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.

How to Register

Limited presenting slots are available

Publicly traded companies in the healthcare space can submit their registration details here.

If you have any questions about presenting, please contact events@noblecapitalmarkets.com

Investor / Guest attendees can register here

Interested in becoming a sponsor of Noble’s virtual and in-person investor conferences?

Contact events@noblecapitalmarkets.com for sponsorship information.