PONTE VEDRA, Fla., Feb. 8, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, today announced the appointment of Jeff Cole to the newly created position of Chief Operating Officer. In this role, Mr. Cole will be responsible for the Company’s manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.
Mr. Cole brings over 25 years of experience in global pharmaceutical manufacturing and commercial operations, finance, and corporate development to the Company. This includes senior executive roles at both private and publicly-traded companies such as Espero BioPharma, Valeant Pharmaceuticals International (now Bausch Health Companies), and Legacy Pharmaceuticals. Mr. Cole co-founded Espero, a biopharmaceutical company focusing on the late-stage development and commercialization of medicines to treat cardiovascular diseases, and served as Board Director, President, and Chief Financial Officer where he was responsible for the company’s supply chain, commercialization, and multiple licensing and M&A transactions.
“Jeff is an extremely accomplished pharmaceutical operations executive with a deep understanding of product development, manufacturing, and commercialization. His experience will serve Cadrenal well as we advance our tecarfarin clinical program and evaluate partnering opportunities,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.
While at Valeant, Mr. Cole held roles of increasing responsibility, including as General Manager, Vice President of Corporate Development, and Chief Financial Officer of North America, where revenue more than tripled during his tenure. As General Manager at Valeant, Mr. Cole managed a division of U.S. prescription and OTC products across multiple therapeutic areas with responsibility for product development, supply, and commercial operations. Prior to the pharmaceutical industry, Mr. Cole served as Principal in the Financial Management Consulting practice at PricewaterhouseCoopers.
“I am excited to be joining the team at Cadrenal at a pivotal time when demand is increasing for a new anticoagulation therapy to address the unmet needs for patients with left ventricular assist devices (LVADs), antiphospholipid syndrome (APS), and those with end-stage kidney disease (ESKD) and atrial fibrillation (AFib),” added Jeff Cole. “I look forward to leveraging my experience to advance tecarfarin to the market and help those underserved patient groups.”
Mr. Cole holds an MBA with honors from the University of Michigan and a BS in accounting from the University of Southern California.
ABOUT CADRENAL THERAPEUTICS, INC.
Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.
Safe Harbor Statement
Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the Mr. Cole’s experience serving the Company well as it advances its tecarfarin clinical program and evaluates partnering opportunities and leveraging Mr. Cole’s experience to advance tecarfarin to the market and help underserved patient groups. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the expected contribution from Mr. Cole and the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics: Matthew Szot, CFO 858-337-0766 press@cadrenal.com
Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 CVKD@lythampartners.com
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.
New Publication Shows Multiple Activities of THIO In SCLC. MAIA announced the publication of an article in the peer-reviewed journal Nature Communications that discusses the dual mechanism of action and effects of THIO in small cell lung cancer (SCLC). This is another tumor type in which THIO has been shown to have direct killing effects on cancer cells and activation the cGAS-STING signaling pathway that leads to an immune response. We see this as consistent with previous data confirming THIO benefits.
MAIA Is Developing THIO For Both Major Lung Cancers. Out of all lung cancer cases, non-small cell lung cancer (NSCLC) comprises about 87% while small cell (SCLC) comprises about 13%. Although less common than NSCLC, SCLC is highly aggressive and highly metastatic. SCLC cells have high telomerase activity that enables their high proliferation rate and immortality. MAIA has received Orphan drug designation from the FDA for SCLC, while the Phase 2 THIO-101 trial is testing THIO in NSCLC.
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THIO treatment leads to profound activation of innate and adaptive anti-tumor responses
THIO depletes cancer initiating cells (CICs) and thus diminishes tumor initiation and metastasis-forming potential in various in vivo models
THIO previously awarded orphan drug designation (ODD) by FDA for small cell lung cancer (SCLC) treatment
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the publication of extensive work describing preclinical studies for lead candidate THIO in small cell lung cancer (SCLC) in the peer-reviewed scientific journal Nature Communications. The reported findings from the research, conducted in collaboration with the University of Texas Southwestern (UTSW) scientists, led by corresponding author Dr. Esra Akbay, demonstrate the immune-enhancing, metastasis-reducing effects of MAIA’s telomere-targeting agent THIO (6TdG) in several well-characterized in vitro and in vivo models of SCLC.
“This publication highlights a rather unique dual mechanism of action for THIO as a first-in-clinic telomere-targeted anticancer agent for potential treatment of SCLC,” said Sergei M. Gryaznov, PhD., MAIA’s Chief Scientific Officer. “In addition to the direct and potent cancer cell depletion activity, the observed specific interferons stimulation, immune responses-enhancement, and metastasis-reducing effects of THIO provide solid scientific foundation for further advancement of this compound in clinical development.”
A prominent characteristic of lung cancer small cells is their reliance on telomerase activity, a key enzyme essential for the continuous proliferation of SCLC. While 85-90% of all human cancers are telomerase positive, SCLCs are nearly all telomerase positive1, suggesting that telomerase targeting may be an effective strategy in the treatment of SCLC.
Key findings in the published paper include:
Human and mouse SCLC lines are sensitive to THIO (6TdG) treatment in vitro and in vivo
THIO decreases cancer initiating cells and diminishes tumor initiation potential in vitro and in vivo
Low doses of THIO are effective in treating metastatic mouse SCLC tumors
THIO activates type-I interferon pathway through cGAS-STING signaling
THIO is highly effective in combination with ionizing radiation treatment regiments
“With few, if any, effective treatments for small cell lung cancer, there is a widespread need for innovative therapeutic strategies. The positive outcomes reported in our publication show THIO’s potential as a new therapeutic approach,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO already holds Orphan Drug Designation for SCLC, underscoring the FDA’s recognition of THIO’s potential to improve outcomes for this highly lethal disease. With the positive preclinical and clinical data we have obtained to date for THIO, we have entered the Phase 2 planning stage for a clinical trial of THIO in SCLC along with two other cancers.”
Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.
About the Publication
Nature Communications, volume 15, article number: 672 (2024), “A telomere-targeting drug depletes cancer initiating cells and promotes anti-tumor immunity in small cell lung cancer,” published 22 January 2024. Co-author disclosures included in manuscript.
About Small Cell Lung Cancer
Small cell lung cancer (SCLC) accounts for 13% of lung cancers. As the deadliest of all lung cancers, SCLC is one of the leading causes of cancer-related mortality in United States with 30,000 deaths annually. It is less common than non-small cell lung cancer (NSCLC), but is more aggressive and rapidly spreads (metastasizes) throughout the body.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleoside 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei activating both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
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.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
_________________________________ 1 Hiyama, K. et al. Telomerase activity in small-cell and non-small-cell lung cancers. J Natl Cancer Inst 87, 895-902, doi:10.1093/jnci/87.12.895 (1995).
Second Quarter of Fiscal Year 2024 – Consolidated Earnings Highlights
Revenue of $405.4 million
Net income of $19.4 million
Adjusted EBITDA* of $67.4 million
Raising Fiscal Year 2024 Guidance Ranges:
Revenue expected in a range of $1.23 billion to $1.3 billion vs prior range of $1.05 billion to $1.2 billion
Net loss expected in a range of $45 million to $22 million vs prior range of $50 million to $22 million
Adjusted EBITDA* expected in a range of $90 million to $105 million vs prior range of $80 million to $105 million
Second Quarter of Fiscal Year 2024 – Segment Highlights
Senior
Revenue of $247.5 million
Adjusted EBITDA* of $78.7 million
Approved Medicare Advantage policies of 234,576
Healthcare Services
Revenue of $111.7 million
Adjusted EBITDA* of $3.0 million
Over 62,000 SelectRx members
Life
Revenue of $37.4 million
Adjusted EBITDA* of $4.6 million
Auto & Home
Revenue of $10.5 million
Adjusted EBITDA* of $4.7 million
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) reported consolidated revenue for the second quarter of fiscal year 2024 of $405.4 million, compared to consolidated revenue for the second quarter of fiscal year 2023 of $319.2 million. Consolidated net income for the second quarter of fiscal year 2024 was $19.4 million, compared to consolidated net income for the second quarter of fiscal year 2023 of $22.5 million. Finally, consolidated Adjusted EBITDA* for the second quarter of fiscal year 2024 was $67.4 million, compared to consolidated Adjusted EBITDA* for the second quarter of fiscal year 2023 of $63.6 million.
Chief Executive Officer Tim Danker stated, “The second quarter marked SelectQuote’s eighth consecutive quarter of performance ahead of expectations, and we remain confident that our strategy to prioritize predictable and cash efficient growth will continue to generate value for both our customers and shareholders. We are also pleased with our progress on operating cash flow and now anticipate that SelectQuote will approach positive free cash flow in fiscal 2024.”
“SelectQuote drove strong results throughout the annual enrollment period for Medicare Advantage where our Senior business grew revenues by double digits, and our second quarter Adjusted EBITDA margin of 32% remains attractive. These strong Senior operating results were a function of higher tenured agent productivity and solid policyholder persistency, which we expect to benefit SelectQuote in the open enrollment period as well.”
“Additionally, Healthcare Services, and our SelectRx business specifically, drove substantial growth in excess of our original forecast. As of the end of the second quarter, SelectRx members have surpassed 62,000, which is in excess of our original expectation for the full year. More importantly, the business was again Adjusted EBITDA profitable.”
Mr. Danker continued, “We are pleased to increase our fiscal year 2024 outlook based on the strength of both businesses year-to-date.”
Segment Results
We currently report on four segments: 1) Senior, 2) Healthcare Services, 3) Life, and 4) Auto & Home. The performance measures of the segments include total revenue, Adjusted EBITDA,* and Adjusted EBITDA Margin.* Costs of revenue, cost of goods sold-pharmacy revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses that are directly attributable to a segment are reported within the applicable segment. Indirect costs of revenue, marketing and advertising, selling, general, and administrative, and technical development operating expenses are allocated to each segment based on varying metrics such as headcount. Adjusted EBITDA is calculated as total revenue for the applicable segment less direct and allocated costs of revenue, cost of goods sold, marketing and advertising, technical development, and selling, general, and administrative operating costs and expenses, excluding depreciation and amortization expense; gain or loss on disposal of property, equipment, and software; share-based compensation expense; and non-recurring expenses such as severance payments and transaction costs.
Combined Senior and Healthcare Services – Consumer Per Unit Economics
The opportunity to leverage our existing database and distribution model to improve access to healthcare services for our consumers has created a need for us to review our key metrics related to our per unit economics. As we think about the revenue and expenses for Healthcare Services, we note that they are derived from the marketing acquisition costs associated with the sale of an MA or MS policy, some of which costs are allocated directly to Healthcare Services, and therefore determined that our per unit economics measure should include components from both Senior and Healthcare Services. See details of revenue and expense items included in the calculation below.
Combined Senior and Healthcare Services consumer per unit economics represents total MA and MS commissions; other product commissions; other revenues, including revenues from Healthcare Services; and operating expenses associated with Senior and Healthcare Services, each shown per number of approved MA and MS policies over a given time period. Management assesses the business on a per-unit basis to help ensure that the revenue opportunity associated with a successful policy sale is attractive relative to the marketing acquisition cost. Because not all acquired leads result in a successful policy sale, all per-policy metrics are based on approved policies, which is the measure that triggers revenue recognition.
The MA and MS commission per MA/MS policy represents the LTV for policies sold in the period. Other commission per MA/MS policy represents the LTV for other products sold in the period, including DVH prescription drug plan, and other products, which management views as additional commission revenue on our agents’ core function of MA/MS policy sales. Pharmacy revenue per MA/MS policy represents revenue from SelectRx, and other revenue per MA/MS policy represents revenue from Population Health, production bonuses, marketing development funds, lead generation revenue, and adjustments from the Company’s reassessment of its cohorts’ transaction prices. Total operating expenses per MA/MS policy represents all of the operating expenses within Senior and Healthcare Services. The revenue to customer acquisition cost (“CAC”) multiple represents total revenue as a multiple of total marketing acquisition costs, which represents the direct costs of acquiring leads. These costs are included in marketing and advertising expense within the total operating expenses per MA/MS policy.
The following table shows combined Senior and Healthcare Services consumer per unit economics for the periods presented. Based on the seasonality of Senior and the fluctuations between quarters, we believe that the most relevant view of per unit economics is on a rolling 12-month basis. All per MA/MS policy metrics below are based on the sum of approved MA/MS policies, as both products have similar commission profiles.
Total revenue per MA/MS policy increased 37% for the twelve months ended December 31, 2023, compared to the twelve months ended December 31, 2022, primarily due to the increase in pharmacy revenue. Total operating expenses per MA/MS policy increased 23% for the twelve months ended December 31, 2023, compared to the twelve months ended December 31, 2022, driven by a 100% increase in operating expenses related to SelectRx due to the growth of the business, offset by a 3% decrease in other operating expenses driven by a decrease in marketing and advertising costs for the second half of fiscal year 2023 compared to the second half of fiscal year 2022.
*See “Non-GAAP Financial Measures” below.
Earnings Conference Call
SelectQuote, Inc. will host a conference call with the investment community today, Wednesday, February 7, 2024, beginning at 8:30 a.m. ET. To register for this conference call, please use this link: https://www.netroadshow.com/events/login?show=3bad4d79&confId=59966. After registering, a confirmation will be sent via email, including dial-in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call we suggest registering at least 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx.
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures intended to supplement, not substitute for, comparable GAAP measures. To supplement our financial statements presented in accordance with GAAP and to provide investors with additional information regarding our GAAP financial results, we have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin, which are non-GAAP financial measures. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similarly titled measures presented by other companies. We define Adjusted EBITDA as income (loss) before interest expense, income tax expense (benefit), depreciation and amortization, and certain add-backs for non-cash or non-recurring expenses, including restructuring and share-based compensation expenses. The most directly comparable GAAP measure is net income (loss). We define Adjusted EBITDA Margin as Adjusted EBITDA divided by revenue. The most directly comparable GAAP measure is net income margin. We monitor and have presented in this release Adjusted EBITDA and Adjusted EBITDA Margin because they are key measures used by our management and Board of Directors to understand and evaluate our operating performance, to establish budgets and to develop operational goals for managing our business. In particular, we believe that excluding the impact of these expenses in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our core operating performance.
We believe that these non-GAAP financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude in the calculations of these non-GAAP financial measures. Accordingly, we believe these financial measures provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects. Reconciliations of the differences between the non-GAAP financial measures included herein and their most directly comparable GAAP financial measures are set forth below beginning on page 12.
Forward Looking Statements
This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.
There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: the impacts of the COVID-19 pandemic and any other public health events, our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, including exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants and meet our scheduled repayment obligations under out debt arrangement; our ability to access to additional capital on acceptable terms; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) provides solutions that help consumers protect their most valuable assets: their families, health, and property. The company pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads.
With an ecosystem offering high touchpoints for consumers across insurance, medicare, pharmacy, and value-based care, the company now has four core business lines: SelectQuote Senior, SelectQuote Healthcare Services, SelectQuote Life, and SelectQuote Auto and Home. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, and Population Health which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
Joe Gomes, 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.
Another Approval. Oregon is the newest state to approve TerraSante for product sales, as management announced receipt of The State of Oregon Agriculture Fertilizer Registration Certificate for its product. The Company’s organic compliance certification from the USDA National Organic Program will apply to the product sales.
Expansion of Revenue. The Oregon approval provides MustGrow with another agriculture-rich state, with the state recording $5.0 billion in agriculture production on 16 million acres of farmland in 2021, which generated 13% of the states’ GDP. With the sales & marketing commercialization strategy in conjunction with BioAg Product Strategies in place for the 2024 planting season, we believe adding Oregon provides another positive to top-line revenue growth for the Company.
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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.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Initial Phase 2 Data Announced. GeoVax announced positive initial findings from its Phase 2 clinical trial testing GM04S1 as a booster vaccine in patients who had previously been vaccinated with an mRNA vaccine from Pfizer or Moderna. This includes the initial safety and immune response measured 30 days after patients received the vaccine.
GM-04S1 Is Designed As A Successor To Current Vaccines. GM04S1 is an MVA-based SARS-CoV-2 vaccine designed to stimulate immunity against two viral proteins, the spike (S) and nucleocapsid (N). Prior testing showed both antibody and T-cell responses against conserved regions of the virus that are less likely to mutate and protect against future variant strains. Stimulation of both the antibody and cellular arms of the immune systems could provide long-term immunity and durability of the response.
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Novartis made a big move this week to expand its oncology portfolio, announcing plans to acquire German biotech MorphoSys in an all-cash deal valued at approximately $2.9 billion. The proposed acquisition continues Novartis’ strategy of striking deals and partnerships to enhance its drug development capabilities, especially in cancer.
Under the terms of the agreement, Novartis will pay $73 per share to purchase all outstanding ordinary shares of MorphoSys, representing a premium of 37% over the biotech’s closing price on February 3rd. The deal has been unanimously approved by MorphoSys’ board and is expected to close in the first half of 2024, pending regulatory and shareholder approval.
Driving Novartis’ interest is MorphoSys’ lead pipeline candidate pelabresib, an investigational BET inhibitor being studied for myelofibrosis. Myelofibrosis is a type of bone marrow cancer that disrupts the body’s normal production of blood cells.
Pelabresib is currently in the Phase 3 MANIFEST-2 trial in combination with Incyte’s Jakafi for first-line myelofibrosis patients. While the trial posted mixed results in November, Novartis believes the data support a regulatory submission in the second half of 2024. The pharma giant sees pelabresib as having potential to be a “practice changing” myelofibrosis treatment.
Beyond pelabresib, MorphoSys brings other early-stage oncology assets that could strengthen Novartis’ position in blood cancers. However, the crown jewel of MorphoSys’ portfolio – its approved non-Hodgkin’s lymphoma drug Monjuvi – is not included in the acquisition. Just before the Novartis deal was announced, MorphoSys sold the global rights to Monjuvi to Incyte for $1.5 billion.
Novartis has been actively hunting for new drug programs and technology platforms to replenish its pipeline as patents expire over the next decade on blockbuster brands like Cosentyx and Entresto. The patent cliff threatens over 50% of Novartis’ current sales.
In 2022, the pharma giant established a $1 billion fund to invest in startups focused on potentially transformational medicines. It has also been open to large M&A, as seen last year with the $20.7 billion purchase of gene therapy biotech The Medicines Company.
The MorphoSys deal reinforces Novartis’ commitment to growing its oncology division, which accounted for over 30% of total sales in 2023. Earlier this year, Novartis acquired the oncology biotech Calypso for $335 million upfront.
From an investor perspective, the MorphoSys acquisition provides Novartis with multiple shots on goal in blood cancers. If pelabresib hits, it could generate peak sales above $1 billion annually according to analysts. And with MorphoSys trading at multi-year lows, Novartis appears to have struck at an opportune time.
However, the mixed clinical data keeps pelabresib’s commercial prospects uncertain. And with most of MorphoSys’ value residing in the newly divested Monjuvi, it remains to be seen if Novartis overpaid. Investors reacted with caution on Tuesday, with Novartis shares falling 1% on news of the acquisition.
But with MorphoSys providing additional expertise in hematology R&D and a foothold in the German biotech scene, Novartis can justify the deal as a strategic move to reinforce oncology leadership. The pharma giant has the resources to continue its shopping spree, with around $9 billion in annual free cash flow.
If Novartis can successfully integrate MorphoSys’ personnel and drug candidates into its pipeline, while achieving cost synergies, the acquisition could pay dividends over time as new oncology drugs emerge. But executing large M&A successfully is always challenging, and investors will watch closely how Novartis leverages its new MorphoSys assets.
Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More
Atlanta, GA, February 6, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023.
The study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.
GEO-CM04S1 is a next-generation Covid-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of Covid-19. Vaccines of this format should not require frequent and repeated modification or updating. These latest findings lend support to previously published findings in cell transplant patients of the ability of GEO-CM04S1 to stimulate functional antibody responses against a broad array of evolving SARS-CoV-2 virus variants (Chiuppesi et al, Vaccines, Sept 2023).
Kelly McKee, Jr., MD, MPH, GeoVax Chief Medical Officer, stated, “There is a critical need to address the recognized shortcomings of currently approved SARS-CoV-2 vaccines. Annual (or even more frequent) vaccination in a seemingly never-ending race to keep pace with this rapidly evolving virus is an unsustainable strategy. GEO-CM04S1 continues to demonstrate the ability to elicit broadly reactive functional antibodies in conjunction with robust and durable T-cell responses, offering the prospect of a next-generation solution to address these shortcomings.”
“We are thrilled by these data and our investigational vaccine designed to protect against severe disease caused by emerging variants of Covid-19,” said David Dodd, GeoVax Chairman and CEO. “These interim data reinforce our resolve to bring our expertise in the development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to providing further updates regarding the successful progress of the clinical development of GEO-CM04S1.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized Covid-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “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 and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. 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.
MustGrow has received The State of Oregon Agriculture approval to commence sales of TerraSanteTM, an organic biofertility product, in Oregon State.
MustGrow’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to this Registration.
Mustard-derived TerraSanteTMfocuses on soil microbiome health, nutrient/water use efficiencies, and plant yields.
SASKATOON, Saskatchewan, Canada, February 6, 2024 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of The State of Oregon Agriculture Fertilizer Registration Certificate for its mustard plant-based TerraSanteTM, an organic biofertility product. TerraSanteTM’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to TerraSanteTM product sales in Oregon State.
TerraSanteTM product sales may now commence in Oregon State, with a sales and marketing commercialization strategy already underway with BioAg Product Strategies for the 2024 planting season. In addition to Oregon State and recently-awarded Washington State, further state-level registrations are progressing in other key U.S. states.
In 2021, Oregon State recorded $5.0 billion USD in agriculture production on 16 million acres of farmland and contributed $2.6 billion USD in agriculture exports.(1) Agriculture plays a critical role in the state’s economy, generating 13% of the state’s gross product and $30 billion USD in wages.(1) Oregon farmers grow a wide variety of fruits and vegetables, including potatoes, tomatoes, strawberries, wine-making grapes, cherries, pears, and apples. Oregon farmers are regarded for their innovative commitment to sustainable agriculture with a rising trend toward organic and sustainable farming practices.(2) MustGrow believes its organic TerraSanteTM product will position Oregon farmers to meet increasing demand for organic, local, and healthy produce.
The MustGrow organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Bayer, Sumitomo Corporation, Janssen PMP, and NexusBioAg. These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.
TerraSanteTM for Soil and Ecological Health
MustGrow’s soil amendment and biofertility development programs focus on soil microbiome health, nutrient and water use efficiencies, and plant yields. Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.
As an organic biofertilizer in soluble mixable form, TerraSanteTM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.
MustGrow is an agriculture biotech company developing organic biocontrol and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Bayer, Janssen PMP (pharmaceutical division of Johnson & Johnson), Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions for applications in biocontrol to potentially replace harmful synthetic chemicals in preplant soil treatment and weed control, to postharvest disease control and food preservation. Bayer has a commercial agreement to develop and commercialize MustGrow’s biocontrol soil applications in Europe, Africa, and the Middle East. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its first registered and OMRI Listed® product, TerraSanteTM, in key U.S. states. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features. MustGrow has approximately 51.5 million basic common shares issued and outstanding and 54.2 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: the commencement of TerraSanteTM product sales in Oregon State; the progress of state-level registrations of TerraSanteTM products in other states; whether the TerraSanteTM product will position Oregon farmers to meet increasing demand for organic, local, and healthy produce; whether MustGrow’s organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide; whether MustGrow’s four partnered programs will continue to achieve performance milestones and expand globally in scope and investment; whether targeted micro-communities can increase plant vigor and yields, while reducing plant stress; and the potential for TerraSanteTM to improve crop nutrient uptake and, hence, overall crop performance. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
In a strategic move aimed at addressing the soaring demand for its revolutionary weight-loss drug, Wegovy, Novo Holdings, the parent company of Novo Nordisk, has disclosed plans to acquire contract drug maker Catalent for $11.5 billion in cash. This acquisition is poised to fortify Novo Nordisk’s production capabilities in response to the extraordinary demand for innovative weight loss and diabetes medications.
Novo Holdings will acquire Catalent for $11.5 billion in cash. As part of the deal, Novo Nordisk will purchase three Catalent fill-finish sites, bolstering the production of Wegovy and other crucial medications. The acquisition is strategically driven by the exceptional demand for Wegovy and Ozempic over the past year.
Novo anticipates that the deal will have a low single-digit percentage negative impact on operating profit growth in 2024 and 2025. The terms include the acquisition of all outstanding shares of Catalent for $63.50 per share in cash, representing a premium of 16.5% to the company’s last trading price. Novo will also assume Catalent’s debt, bringing the total enterprise value of the deal to $16.5 billion.
The acquisition is expected to gradually increase Novo’s filling capacity, with notable effects expected from 2026 onwards. The three fill-finish sites, located in Italy, Belgium, and Bloomington, Indiana, will play a crucial role in supporting Novo Nordisk’s expanding drug portfolio.
In the growing obesity drug market, Novo Nordisk faces competition from Eli Lilly’s Zepbound. Analysts estimate that the obesity drug market could reach $100 billion by the end of the decade, highlighting the immense potential for companies in this sector.
The acquisition aligns seamlessly with Novo Holdings’ strategy of investing in established life science companies with significant long-term potential. Catalent’s expertise in enabling pharmaceutical, biotech, and consumer health partners is in harmony with Novo Holdings’ commitment to improving health and sustainability.
The merger is anticipated to close by the end of calendar year 2024, subject to customary closing conditions, Catalent stockholder approval, and regulatory approvals. Catalent’s Board unanimously recommends that stockholders vote in favor of the merger, following an evaluation of value-maximizing alternatives.
Kasim Kutay, CEO of Novo Holdings, expressed excitement about the partnership with Catalent and emphasized their commitment to supporting Catalent’s growth and mission to develop products that enhance lives.
Novo Holdings’ acquisition of Catalent represents a strategic move to strengthen production capabilities and meet the escalating demand for transformative medications like Wegovy. As the merger progresses, it not only positions Novo Nordisk for continued success in the competitive pharmaceutical landscape but also aligns with Novo Holdings’ broader mission of investing in high-quality life sciences companies for the betterment of society and the planet. The industry will be closely watching the outcome of this significant acquisition, anticipating positive impacts on Novo Nordisk’s product development and market position.
Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More
The biotech sector is witnessing a dynamic start to the year 2024, with companies such as Alto Neuroscience (ANRO) and Fractyl Health (GUTS) surpassing expectations in their initial public offerings (IPOs).
Alto Neuroscience’s Upsized IPO
Alto Neuroscience today announced the pricing of its upsized IPO, offering 8,040,000 shares of common stock at $16.00 per share. The aggregate gross proceeds are estimated to be approximately $128.6 million. This figure exceeds Alto’s earlier projection of $89 million to $103 million, showcasing strong investor confidence. The shares, traded under the ticker symbol ANRO, are set to commence trading on the NYSE, with the offering expected to close on February 6.
The substantial funds raised will propel Alto’s research and development efforts, primarily supporting the advancement of its lead asset, ALTO-100. This oral small molecule inhibitor of BDNF is currently undergoing a Phase II study for major depressive disorder. Additionally, the IPO proceeds will contribute to the progress of Alto’s other depression asset, ALTO-300, and the Phase I PDE4 asset, ALTO-101, targeted at neurodegenerative and neuropsychiatric conditions.
Fractyl Health’s Successful Debut
In a parallel success story, Fractyl Health has announced the pricing of its IPO, offering 7,333,333 shares of common stock at $15.00 per share. The total gross proceeds amount to approximately $110.0 million, surpassing the initial expectation of $99 million. Fractyl Health, trading under the ticker symbol GUTS on the Nasdaq Global Market, is scheduled to debut on Friday, with the IPO closing on February 6.
The lead product candidate for Fractyl, named Revita, is an outpatient endoscopic procedural therapy utilizing hydrothermal ablation to remodel the dysfunctional duodenal lining and restore metabolic health. Revita is currently in a pivotal study for insulin-treated type 2 diabetes, with anticipated data release in the fourth quarter of 2024.
Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More
Positive Industry Trends
Alto Neuroscience and Fractyl Health’s successful IPOs follow in the footsteps of CG Oncology, which recently announced an upsized IPO of $380 million, and ArriVent Biopharma, following suit with its own $175 million offering. These developments underscore the current investor enthusiasm and optimism surrounding biotech companies, indicating a positive trajectory for the sector in 2024.
The robust performance of Alto Neuroscience and Fractyl Health in the IPO market exemplifies the strong start for the biotech sector in 2024. These successful offerings not only provide these companies with the necessary capital for their innovative projects but also reflect a broader trend of confidence and interest from investors in the biotech industry. As the year progresses, these companies and their groundbreaking initiatives will undoubtedly be closely watched by industry insiders and investors alike.
Health insurer Cigna announced Wednesday it is divesting its Medicare Advantage, Medicare Part D, and other Medicare operations to Health Care Service Corporation (HCSC) in a $3.7 billion cash deal.
Cigna said the sale will streamline its business to focus on growing its health services and benefits platforms. Proceeds will also fund share repurchases, with the transaction expected to be accretive to adjusted earnings per share in 2025.
Refocusing the Portfolio
The sale includes Cigna’s Medicare Advantage plans, Medicare Part D prescription drug plans, Cigna Supplemental Benefits, and the CareAllies health support services unit.
With HCSC taking over these businesses, Cigna can direct more investment and resources toward expanding its Evernorth health services division and Cigna Healthcare commercial health benefits segment.
Evernorth provides pharmacy benefits management, specialty pharmacy, and health technology solutions. Cigna Healthcare offers employer-sponsored group health plans as well as individual plans.
While Cigna sees Medicare as an attractive market, the segment required outsized focus and capital relative to its size within Cigna’s broader portfolio. The sale unlocks value and simplifies operations.
Gaining Scale and Capabilities
For HCSC, the transaction accelerates growth in Medicare, where the company has over 1 million members currently across 7 states. Adding Cigna’s Medicare customers and capabilities will expand HCSC’s geographic reach and enhance its product portfolio.
The businesses being acquired generated around $5.5 billion in 2022 revenues for Cigna. So the deal provides HCSC with meaningful membership and revenue growth in Medicare and immediate scale.
Cigna built a significant presence in Medicare through organic growth and acquisitions like HealthSpring in 2011. HCSC gains these customer relationships and infrastructure with the purchase.
Focusing on What Cigna Does Best
Cigna has been optimizing its portfolio under CEO David Cordani to concentrate on its core competencies. Last year, Cigna sold its international life, accident, and supplemental benefits businesses.
The Medicare sale continues this strategic focus on areas where Cigna has differentiated capabilities and growth opportunities. Evernorth provides unique pharmacy solutions and analytics. Cigna Healthcare leverages the company’s strong employer and health plan expertise.
The transaction value of $3.7 billion represents about 10 times Medicare Advantage customer revenue and 16 times Medicare Part D customer revenue. This appears a solid price for Cigna to unlock capital from non-core assets.
Financial Benefits Cigna expects the deal will be 5-10% accretive to adjusted EPS in 2025 once completed. The company reaffirmed its 2024 outlook and long-term 10-13% annual EPS growth target.
Proceeds from the divestiture will primarily fund share buybacks, representing an attractive return of capital for investors. Cigna previously had around $7.5 billion remaining on its buyback authorization.
The deal is expected to close in the first quarter of 2025 after securing necessary regulatory clearances. There is no financing condition, providing transaction certainty.
Overall, the sale highlights Cigna’s disciplined portfolio approach to drive shareholder value. Consolidating its focus while monetizing Medicare strengthens Cigna’s growth trajectory in targeted segments. For HCSC, the deal accelerates its diversification into a key government market.
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.
New Article Discusses Uses and Contraindicated Patient Groups. An article in the Journal of the American College of Cardiology titled “When Direct Oral Anticoagulants Should Not Be Standard Treatment: JACC State-of-the-Art Review” summarized indications where DOAC drugs are commonly used, indications where they should not be used, and indications where efficacy is uncertain. The paper identifies conditions that tecarfarin is being developed to treat and supports the need we see for the drug.
DOAC Drugs Are Not For All Patients. The Direct Oral Anticoagulants (DOAC) drugs are anticoagulants that act on one specific protein in the clotting cascade. The class includes Eliquis (apixaban), Xarelto (rivaroxaban), Savaysa (edoxaban), and Pradaxa (dabigatran). Although these are effective in many conditions, some clinical trials have shown adverse findings and conditions where they should not be used.
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