Tag: Biotech

GC Oncology’s $380M IPO Kickstarts 2024 Biotech Market

Posted on by slightbourne@noblecapitalmarkets.com

The New Year has kicked off with a bang in biotech, as CG Oncology has completed the first initial public offering in the space for 2024. The cancer-focused biotech raised a whopping $380 million in its IPO on the Nasdaq, sailing past its initial target range of $181 million.

CG Oncology priced its shares at $19 apiece, above the $16-18 range it had set ahead of the IPO. The impressive deal is being viewed by many analysts and investors as a positive indicator that the biotech IPO market is rebounding in 2024 after a relatively slow 2023.

The robust demand for CG Oncology stock reflects renewed optimism and openness to investing in early-stage biotech companies, especially those with innovative science and strong leadership teams.

CG Oncology is developing a novel oncolytic virus therapy known as cretostimogene grenadenorepvec for the treatment of non-muscle invasive bladder cancer. Oncolytic viruses represent an exciting new approach in cancer treatment, wherein specially engineered viruses are able to infect and destroy cancer cells directly while also stimulating anti-tumor immune responses.

Cretostimogene grenadenorepvec is an adenovirus that has been engineered to replicate selectively in bladder cancer cells and stimulate the immune system by expressing granulocyte-macrophage colony-stimulating factor (GM-CSF). Early stage clinical data have shown promising signs of efficacy.

The company plans to use the IPO proceeds to fund a Phase 3 clinical trial of its lead candidate as well as earlier stage pipeline programs. Success in the Phase 3 study could support regulatory approval and commercialization.

CG Oncology was founded in 2018 by a veteran team of biotech entrepreneurs and scientists. The company pursued a pre-IPO crossover financing round in 2022, enabling it to build momentum heading into its public debut.

The IPO success places CG Oncology in a strong position to advance its pipeline. With the influx of capital, the company will be able to aggressively pursue its clinical development plans without relying heavily on external partners.

Moreover, the validation and visibility provided by being a public company can potentially help CG Oncology forge productive collaborations and access additional funding in the future.

Looking ahead, the positive investor response to CG Oncology seems likely to pave the way for more biotech IPOs in 2024. A robust IPO market provides fuel for innovation and discoveries that can transform patient lives.

The biotech sector sputtered in 2022, with only around 20 IPOs completed versus more than 50 in 2021. However, sentiment appears to be shifting, perhaps signaling sunnier days ahead.

In addition to favorable market conditions, biotech companies pursuing IPOs seem to be taking valuable lessons from 2022 by tightening focus on fundamentals like drug efficacy and visibility on clinical milestones.

Other than CG Oncology, a host of biotechs have already filed with SEC intentions to go public in 2024, spanning exciting areas like gene therapy, neurology, and synthetic biology.

With fresh capital and investor enthusiasm, the next generation of biotech companies can pursue ambitious goals to develop innovative medicines. More early-stage companies may also gain the funding needed to initiate or advance clinical trials.

CG Oncology’s big IPO pop reflects the right combination of cutting-edge science, unmet medical need, and strong leadership. This formula will likely be replicated by other emerging biotech stars in the making.

In all, the successful CG Oncology IPO kicks off 2024 as a promising year for biotech funding, innovation, and progress against once intractable diseases. Investors and industry observers will be tracking the IPO market closely through the year for signs of sustained momentum. If the appetite for compelling biotech stories persists, it could drive a much-needed renaissance helping to unlock new medical frontiers.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference 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.

Goldman Sachs Throws Weight Behind Life Sciences’ Hottest Startups with $650M Fund

Posted on by slightbourne@noblecapitalmarkets.com

Goldman Sachs Asset Management (GSAM) has raised $650 million for its inaugural life sciences private equity fund, West Street Life Sciences I, reflecting the firm’s bullish outlook on the high-growth potential in the sector.

The fund exceeded its original fundraising target and ranks as one of the largest-ever first-time private life sciences growth funds. GSAM secured commitments from a diverse group of institutional, strategic, and high net worth investors, including meaningful capital from Goldman’s own employees.

“We are in a golden-era of innovation in the life sciences, where technological breakthroughs are creating new approaches to diagnosing and treating disease,” said Amit Sinha, head of GSAM’s Life Sciences Investing Group. “We believe the current environment provides an attractive opportunity for investing in the next generation of leading life sciences companies.”

GSAM’s entrance into life sciences PE highlights the wave of investor interest into the sector, as rapid scientific and technological advancements transform healthcare. The strategy will focus on high-growth investment opportunities in early to mid-stage therapeutic companies developing innovative drugs and treatments, as well as life sciences tools and diagnostics companies.

Specifically, the fund will target several key themes that GSAM believes will drive significant growth, including precision medicine, genetic medicine, cell therapy, immunotherapy, synthetic biology, and artificial intelligence. By leveraging GSAM’s global platform and Advisory Board of seasoned life sciences experts, the fund aims to identify the most promising companies in these emerging areas.

The Life Sciences Investing Group at the helm of managing the fund was established in 2021 and is led by Amit Sinha. The team brings decades of combined experience investing in life sciences and will tap into GSAM’s broader resources and expertise to source deals and create value.

According to Marc Nachmann, global head of Asset & Wealth Management at Goldman Sachs, “Life sciences represents one of the most exciting areas in the private investing landscape, with advances in technology transforming healthcare at an unprecedented pace. We have a long history of partnering with companies in this space and look forward to bringing the full resources of Goldman Sachs to world-class management teams who are driving progress in the industry.”

The new fund has already made 5 investments totaling approximately $90 million into high-potential life sciences startups. The deals include companies using precision medicine, immunotherapy, and artificial intelligence to develop new therapies in oncology, neurology, rare diseases, and other areas.

One portfolio company, MOMA Therapeutics, is pioneering novel therapeutics targeting mitochondrial diseases, which lack effective treatments. Another investment, Nested Therapeutics, is developing a new modality of antibody therapeutics focused on hard-to-drug intracellular protein targets.

Overall, the launch of West Street Life Sciences I demonstrates Goldman Sachs’ confidence in the booming life sciences sector and its commitment to funding innovation. With its deep expertise, global resources, and strategic focus on cutting-edge healthcare technologies, GSAM is positioning itself to capitalize on the most promising opportunities. The new fund is a bellwether for the growing intersection of finance, biotech, and next-gen medicine.

Take a moment to take a look at emerging biotech companies by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Release – GeoVax Announces Issuance of Malaria Vaccine Patent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Patent Covers Multiple Component Vaccine for Both Prevention and Treatment

Atlanta, GA, January 3, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11,857,611 to GeoVax, pursuant to the Company’s patent application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”

The claims granted by the patent generally cover compositions comprising GeoVax’s modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.

David Dodd, GeoVax President and CEO, commented, “During 2023, there were the first cases of locally transmitted malaria reported in the United States in 20 years, with cases reported in Florida, Maryland and Texas. Worldwide, there are over 600,000 deaths annually attributed to malaria. This patent represents a potentially significant advance against a most critical deadly threat worldwide. While our focus and priority is to support our clinical-stage programs, we also remain strongly committed to improving public health worldwide and developing vaccines against global public health threats, such as malaria, as a part of our long-term vision for the company.”

According to data from the World Health Organization, globally, malaria causes 227 million infections and 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. Most of these vaccines are based on individual proteins that induce immune responses targeting only one stage of the malaria parasite’s life cycle. GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.

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. 

Company Contact:             Investor Relations Contact:             Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Biotech Dealmaking Heats Up as Private Capital Charges Back In

Posted on by slightbourne@noblecapitalmarkets.com

A wave of multibillion dollar buyouts has swept the beaten-down biotech sector in recent months, marking a potential turning point for an industry hammered throughout 2022 – 2023.

With valuations of public companies still depressed, flush private investors have stepped up acquisitions of promising drug developers to bolster pipelines for the long-term. And in a bullish sign for the strategic direction of the space, therapeutics targeting high unmet needs and novel modalities remain key areas of focus amid dealmaking.

As macro gloom recedes, the renewed embrace of biotech M&A highlights a pivot back toward the innovation-driven spending required to sustain growth post-pandemic.

BMS Kicks Off Buying Spree With $13.2B Turning Point Deal

Bristol Myers Squibb fired the starting gun on big-ticket biopharma deals in October, announcing a $5.8 billion purchase of Mirati Therapeutics (MRTX). The buyout delivered a 122% premium in order to land Mirati’s promising portfolio of precision cancer medicines.

Market observers viewed the unsolicited, $58 per share bid as a credible benchmark of intrinsic value vigilantly researched by a strategic acquirer. Immediately in the deal aftermath, similar development-stage oncology names rallied sharply as traders priced in new takeout probabilities.

In fact, suitors moved swiftly to capitalize on improved biotech sentiment, with Horizon Therapeutics agreeing to a $26.4 billion around the same time. The transaction marked 2023’s largest healthcare buyout, further reinforcing peak valuations remain attainable for commercial-stage rare disease names.

Scaling Up to Compete in Gene Therapy

Gene therapy remains one especially alluring area for dealmaking despite lofty price tags. These ultra-rare disease medicines come with cure potential that commands premium sales and reimbursement pricing power.

Recognizing the imperative to bulk up gene therapy capabilities, Pfizer ponied up $5.4 billion to reinforce its genetic medicines pipeline through the acquisition of French outfit Vivet Therapeutics. The move added Vivet’s promising gene therapy for Wilson disease, along with manufacturing strengths across multiple delivery mechanisms.

And gene editing pioneer Sangamo Therapeutics is selling off its cell therapy assets to Sanofi for $700 million as it refocuses efforts around in vivo gene insertion. The deal hands Sanofi disruptive cell therapy technology utilizing precisely engineered zinc fingers to correct disease-causing mutations.

Analysts say more buyouts centered on next-gen platforms are likely on the horizon as drug developers vie for leadership in areas forecast to reshape therapeutic spaces.

Take a look at more biotechnology companies by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Private Capital Eagerly Steps in to Back Innovation

Beyond M&A from strategic acquirers, private equity firms have swooped in to capitalize on depressed biotech valuations. The robust dry powder levels built up during the boom years leave private investors eager to allocate while achieving advantageous cost bases.

Among notable deals, Angel Pond Capital teamed up with life science investor OrbiMed to take gene therapy biotech Generate Biomedicines private for $478 million. The transaction represented a 130% premium to ensure locking up Generate’s base editing technologies believed to be capable of correcting over 75% of known point mutations.

In cybersecurity and enterprise software, sponsor-led take privates had utterly dominated deal flow in 2022. But order books are now once again filling up with biotech buyouts from special purpose acquisition vehicles, highlighting a normalization in deal dynamics after last year’s freeze-out from rate-sensitive private market valuations.

Market Recovery Taking Shape

The fresh upswing in biotech M&A follows a wave of dip buying from some the world’s largest asset managers in shares of industry leaders like Vertex Pharmaceuticals and Regeneron Pharmaceuticals. Warren Buffett’s Berkshire Hathaway has been particularly aggressive stepping in to purchase stakes in key biopharma bluechips.

Meanwhile, the fund-raising backdrop continues improving for earlier stage biotechs as well after deal activity all but shuttered for much of 2023. Multiple debt offerings and venture rounds have successfully priced in recent months, ensuring the all-important continuity of innovation cycling.

With fundamentals stabilizing and access to capital normalizing, the environment for biopharma dealmaking has markedly improved. Expect the momentum to carry through 2024 as drug developers position through M&A for the next, post-pandemic leg higher while private capital readily supports compelling technologies at discounted prices. The long-term health of the biotech ecosystem depends on transactions advancing today’s high-potential assets, and the industry appears to have emerged from its lull ready to strike the necessary deals.

MustGrow Biologics Corp. (MGROF) – New Commercial Agreement with Bayer

Posted on by cpatches


Tuesday, December 12, 2023

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.

New Agreement. MustGrow announced yesterday that the Company signed a collaboration agreement with Bayer AG covering soil applications of MustGrow’s mustard-based biocontrol technologies in Europe, Middle East, and Africa, excluding home and garden, turf, and ornamental applications. Bayer also has been granted a right-of-first-negotiation for a license to use MustGrow’s technologies for use in bananas in particular applications.

Details on the Agreement. Under the terms, MustGrow will be receiving an initial upfront payment as well as additional payments linked to the achievement of certain business milestones. Once the commencement of commercial sales has begun, MustGrow also will be entitled to fees from royalties and manufacturing sales. Bayer will be responsible for regulatory and market development work to commercialize MustGrow’s mustard-based biocontrol technologies.


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Release – MustGrow Biologics and Bayer Sign Commercial License Agreement for Biocontrol Technologies in Europe, Middle East and Africa

Posted on by cpatches
Research News and Market Data on MGROF
  • Bayer’s commercial license covers soil applications of MustGrow’s mustard-based biocontrol technologies in Europe, Middle East and Africa.
  • MustGrow to receive upfront license fees and milestone payments, royalties, and manufacturing sales linked to development and commercial achievements.

SASKATOON, Canada, December 11, 2023 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (“MustGrow”) is pleased to announce the signing of a collaboration agreement (the “Agreement”) with Bayer AG (BAYN) (“Bayer”) covering soil applications of MustGrow’s mustard-based biocontrol technologies in Europe, Middle East and Africa, excluding home and garden, turf and ornamental applications.

Under the terms of the Agreement, MustGrow will receive an initial upfront payment as well as additional payments linked to the achievement of certain business milestones. Upon the commencement of commercial sales, MustGrow will also be entitled to fees from royalties and manufacturing sales. Additionally, Bayer will be responsible for regulatory and market development work (the “Development Work“) in the respective field of use necessary to commercialize MustGrow’s mustard-based biocontrol technologies, including the development of the formulated product, conducting relevant regulatory data studies for regulatory submissions, filing regulatory submissions, registration with relevant regulatory authorities, and support, marketing, and commercial sales activities. MustGrow anticipates that the value of the upfront, milestone payments and Development Work could approximate USD $35 to $40 million over the next several years (not including additional fees from royalties and manufacturing sales).

“Biologicals are part of an exciting frontier that offers new solutions for the challenges that growers face across the world,” said Benoit Hartmann, Head of Biologics for Bayer. “We’re committed to working with leading innovators like MustGrow to accelerate the development of innovative biological solutions that provide safe, sustainable options for farmers and are looking forward to continuing our work together.”

Pursuant to the Agreement, Bayer has also been granted a right-of-first-negotiation for a license to use MustGrow’s mustard-based biocontrol technologies for use in bananas in particular applications, excluding postharvest applications. MustGrow expects to continue collaborating with Bayer to consider other potential applications of MustGrow’s mustard-based biocontrol technologies, including potentially testing in regions not currently covered by the Agreement.

Sustainable innovations and green technologies are necessary to ensure agricultural production continues to address food safety and security as well as soil health. MustGrow’s rapidly developing technologies are focused on sustainable, safe, and effective, organic plant-based crop protection technologies that harness the mustard seed’s natural defense mechanism to treat diseases, pests and weeds. MustGrow’s technology has shown consistent efficacy in multiple global regions, in multiple crops, in multiple applications, over multiple years. The Agreement between Bayer and MustGrow demonstrates the importance of innovation in sustainable technologies in agricultural regions around the world.

“MustGrow is thrilled to commercialize our technologies with Bayer in three important food producing regions. Through Bayer’s research, development and commercial teams we have seen a rapid  advancement in our product and market knowledge in the last two years,” remarked Corey Giasson, CEO of MustGrow. “Working with the leader in global crop science and sustainable agriculture is a tremendous opportunity for our organization to see our mustard plant-based technologies commercialized globally.”

About MustGrow

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 an 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 50.1 million basic common shares issued and outstanding and 55.0 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: MustGrow receiving upfront license fees and milestone payments, royalties, and manufacturing sales linked to development and commercial achievements; whether and if certain development and commercial achievements, that are a pre-condition to MustGrow receiving certain fees from royalties and manufacturing sales, will occur; the anticipated value of potential aggregate payments and development capital being USD $35 to $40 million; whether and how Bayer completes any regulatory and market development work; and MustGrow’s expectation to continue collaborating with Bayer to consider other potential applications of MustGrow’s mustard-based biocontrol technologies, including testing in regions not currently covered by the Agreement.

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.

© 2023 MustGrow Biologics Corp. All rights reserved.

Pfizer Weight Loss Pill Hits Snag in Mid-Stage Trial

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Pfizer suffered a setback this week in the high-stakes race to tap into the burgeoning multi-billion dollar weight loss drug market. The company announced it is halting development of the twice-daily formulation of its experimental obesity pill danuglipron after underwhelming mid-stage trial results.

While the drug induced significant weight loss in obese patients, it came at the cost of poor tolerability. Over half of participants dropped out of the phase 2 study due to adverse gastrointestinal side effects like nausea and diarrhea.

Nonetheless, Pfizer still intends to stay in the game with a once-daily version of danuglipron. The company aims to release fresh phase 2 data on the more competitive formulation in early 2024 before determining next steps.

For a drugmaker grappling with fading Covid-19 revenues, the news deals a tough blow to its strategy to offset declines through potential new blockbusters for obesity. Just last year, CEO Albert Bourla tagged the total addressable weight loss market at a whopping $90 billion.

But competition is cutthroat, with Novo Nordisk and Eli Lilly vying to convert millions from their injectable diabetes meds to an oral option. Their rival pills have already posted mid-teens percentage weight loss results that position them to potentially leapfrog Pfizer’s attempt.

Danuglipron Quick Facts

  • Twice-daily formulation now discontinued after 6.9% to 11.7% weight loss at 32 weeks
  • Well below 14-15% loss seen as competitive threshold
  • High rates of nausea, vomiting, diarrhea
  • Over 50% dropout rate

Key Takeaways for Investors
The disappointing data for danuglipron’s twice-daily pill underscores several investor concerns around Pfizer’s efforts to expand into weight loss medicines.

Uphill Battle Against Rivals
Novo Nordisk and Eli Lilly already dominate the obesity drug landscape with their injectable products Saxenda and Ozempic. Lilly’s oral candidate tirzepatide is showing roughly 15% weight loss over 72 weeks, clearing the competitive bar Pfizer failed to hit.

While the field is large enough for multiple winners, Pfizer faces substantial share challenges from these deeply entrenched rivals. Its best-case outcome may be carving off a small slice rather than market leadership.

Tolerability Issues Limiting
Danuglipron has now faltered twice in mid-stage studies due to side effects leading over half of volunteers to quit treatment. The once-daily route shows some promise, but gastrointestinal problems may hamper uptake if they persist. By comparison, tirzepatide posted a 21% dropout rate.

Uncertainty Remains High
With phase 3 trials still a distant prospect, the program faces a long road ahead fraught with risk. While danuglipron evinced significant weight-loss efficacy, real-world commercial success depends greatly on improving its poor tolerability profile.

Until then, uncertainty around Pfizer’s weight loss aspirations stays high. Expect sales projections to remain muted absent positive late-stage outcomes down the line. But rivals like Lilly and Novo aren’t standing still either, making danuglipron’s path ahead even trickier.

Apollo Medical Scales Medicaid Presence with Purchase of CFC

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare investor favorite Apollo Medical Holdings (NASDAQ: AMEH) is expanding its presence in value-based care arrangements through the acquisition of Community Family Care (CFC), a large independent physician association based in Los Angeles. The all-cash deal worth up to $202 million reflects ApolloMed’s strategy of targeting risk-bearing providers as a high-growth segment of the health biotech sector.

CFC manages care for over 200,000 members via its network of more than 350 primary care physicians and 500 specialists. The group has a strong presence in Medicaid, with a Restricted Knox Keene (RKK) license enabling it to take on full risk for this population in California. CFC also serves Medicare and commercial members under value-based contracts that incentivize providers to control costs and improve health outcomes.

For ApolloMed, acquiring CFC significantly boosts its portfolio of managed lives, particularly under global capitation arrangements that cover total cost of care. Additionally, CFC’s long track record of profitability in Medicaid provides ApolloMed with demonstrated capabilities to take on risk successfully in a population that is often challenging for providers.

The deal exemplifies a unique competitive edge for ApolloMed – its end-to-end platform spanning technology, management services, and risk contracting. CFC has utilized ApolloMed’s care enablement tools since 2020, allowing it to perform well under value-based care. Now, full acquisition enables tight integration and aligned incentives as CFC transitions to an ApolloMed care partner responsible for total cost and outcomes.

For 2023, CFC is expected to generate $190 million in revenue with $25 million in adjusted EBITDA, an impressive 13% margin for a risk-bearing provider group. ApolloMed has agreed to an acquisition price of up to $202 million, including $152 million in cash, $20 million in ApolloMed stock, and $30 million in potential milestone payments. The deal is anticipated to close in Q1 2024 after clearing regulatory reviews.

Rapid Growth in Value-Based Care

The acquisition comes at a time of rapid expansion in value-based care, where providers take on financial accountability for cost and quality of healthcare for a population of patients. Government and commercial payers are pushing providers into these arrangements to incentivize focus on preventative care and eliminating wasteful spending.

Analysts size the global market for value-based care at $3.1 billion by 2030, reflecting a blistering compound annual growth rate of 21.7% from 2022. In the United States, value-based care penetration is expected to reach 65% of healthcare payments by 2025.

ApolloMed is positioned at the forefront of this transformation with its integrated platform and focus on enabling providers, such as CFC, to take on risk successfully. The CFC deal adds a sizable value-based care presence to ApolloMed’s portfolio, demonstrating the appetite to aggressively scale its model with like-minded partners.

Targeting High-Growth Segments

The CFC acquisition also highlights ApolloMed’s focus on areas of healthcare with strong secular tailwinds: government programs and risk-based arrangements.

Medicaid represents a massive $650 billion total addressable market, and ApolloMed is specifically targeting expansion in California, which has among the most progressive Medicaid programs in supporting coordinated care models. CFC’s strong capabilities in the Medicaid population will be a key strategic asset.

Likewise, ApolloMed’s thesis of investing behind risk-bearing providers is underscored by CFC’s demonstrated ability to generate double-digit margins while managing patients under capitated contracts. As fee-for-service reimbursement models decline, providers capable of taking on risk will be increasingly valuable.

Wall Street’s View

ApolloMed has been a darling of growth investors, with shares up 270% over the past five years. Revenue and EBITDA have compounded annually at 50% and 90%, respectively, as the company scales its platform.

The market continues to reward this rapid expansion, with ApolloMed trading at a premium valuation of 50x P/E. Bulls believe the company’s strategy and competitive moats position it for continued acceleration as value-based care proliferates.

Meanwhile, bears argue that ApolloMed’s nosebleed valuation leaves little room for error. There are also concerns around rising fragmentation in California’s Medicaid market challenging operators.

However, with impressive unit economics and strong execution thus far, ApolloMed has many convinced it can maintain momentum. The CFC deal offers further validation of the company’s model and market opportunity. Investors will be watching closely for successful integration and financial accretion.

If ApolloMed can effectively leverage CFC to penetrate Medicaid and value-based arrangements more deeply, the deal may be looked back upon as an inflection point in the company’s growth story. At minimum, it provides another data point for ApolloMed’s ability to execute on acquisitions rapidly expanding its national footprint – a core piece of the bull thesis.

Release – GeoVax Receives Notice of Allowance for HIV Vaccine Patent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

ATLANTA, GA, October 5, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.

David Dodd, GeoVax President and CEO, commented, “Our development priorities continue to be our next-generation COVID-19 vaccine, currently in Phase 2 clinical trials, and our cancer immunotherapy program, with Gedeptin® as our lead product in a Phase 1/2 clinical trial for advanced head and neck cancer. While we are focusing on these two products in the near-term, our long-term vision includes developing vaccines against other global public health threats such as HIV. Although not currently under active development, our HIV program forms an important part of the dataset underpinning all of our MVA-based development programs. The patent protection associated with the use of this vaccine is an important part of this product platform.”

Mr. Dodd continued, “Earlier this year, data were presented from a clinical study of a combinational HIV therapy that included GeoVax’s HIV vaccine candidate, MVA62B. The goal of the trial was to reduce or eliminate viral replication in the absence of antiviral medications in HIV-positive individuals (a “functional cure”). The data indicated very high levels of immunogenicity of the treatment, particularly the induction of T cell immunity, even though HIV infection compromises the immune system. We are pleased that GeoVax’s MVA-vectored HIV vaccine was selected to be a part of the experimental combination therapy and contributed to the positive findings. MVA62B was also previously tested in multiple clinical trials as a component of vaccine regimens designed to induce immune responses that prevent HIV infection. The team here at GeoVax is committed to help end the HIV epidemic worldwide and recognizes that the consistent results of MVA62B reflected in clinical trials to date may offer promise towards achieving this goal. We remain committed to supporting corporate and/or academic collaborations or partnering of this potentially critically important vaccine.”

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. 

Company Contact: Investor Relations Contact: Media Contact:
info@geovax.com      paige.kelly@sternir.com      sr@roberts-communications.com
678-384-7220 212-698-8699 202-779-0929

Standard BioTools and SomaLogic to Merge, Creating $1B Life Sciences Tools Leader

Posted on by slightbourne@noblecapitalmarkets.com

Standard BioTools and SomaLogic have announced plans to unite through an all-stock merger aimed at creating a diversified life sciences tools platform with over $1 billion in equity value. The deal brings together technologies, expertise and customer bases across genomics, proteomics and other omics fields.

Standard BioTools provides genomic analysis tools catering to academic and clinical research settings. SomaLogic specializes in proteomics technology that profiles proteins for biopharmaceutical drug discovery. Their complementary offerings provide scale, synergies, and cross-selling opportunities.

Under the merger agreement, SomaLogic shareholders will receive 1.11 shares of Standard BioTools stock for each SomaLogic share they own. This values SomaLogic at over $370 million based on recent Standard BioTools share prices.

The combined company expects to generate $80 million in cost synergies by 2026 through optimization of its integrated operations. It will also hold over $500 million in cash to fund growth initiatives and new product development.

Standard BioTools CEO Michael Egholm touted SomaLogic’s proteomics capabilities as an ideal fit to accelerate his company’s strategy in the over $100 billion life science tools industry. The deal diversifies Standard BioTools’ portfolio beyond genomics while leveraging its global commercial infrastructure.

SomaLogic provides proteomic analysis that reveals functional expressions of genes, filling a key gap left by genomics. Its SOMAscan platform uses aptamer-based technology to measure thousands of proteins in biological samples.

Take a moment to take a look other biotech companies by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage list.

The technology has become an industry leader in enabling biopharma researchers to identify and validate new drug targets. SomaLogic has relationships with nine of the ten largest pharma companies along with partnerships like its recently launched proteogenomics offering with Illumina.

Standard BioTools plans to tap into these biopharma relationships to cross-sell its genomic analysis tools. Meanwhile, SomaLogic can leverage Standard BioTools’ strong presence selling to academic labs. The combined customer base spans nearly all major end markets.

SomaLogic interim CEO Adam Taich called the merger an opportunity to better serve translational and clinical research customers while creating shareholder value. The healthy $500 million cash position provides ample capital to fund the commercial ramp.

Standard BioTools increased its 2023 revenue outlook to $100-105 million following the merger news. SomaLogic maintained its full-year guidance of $80-84 million. Together, the combined entity expects to generate over $180 million this year.

The boards of both companies have unanimously approved the transaction. Major shareholders holding around 16% of Standard BioTools stock and 1% of SomaLogic have also committed support through voting agreements.

The deal is expected to close in the first quarter of 2024 after securing shareholder and antitrust regulatory approvals. The combined company will operate under the Standard BioTools name and stock ticker, with dual headquarters in South San Francisco and Boulder, Colorado.

Standard BioTools has undergone major changes after a period of underperformance, divesting its sequencing business earlier this year. The merger with SomaLogic continues its strategic shift toward life science research tools.

Together, the companies aim to accelerate development of new diagnostics and precision medicines through their multi-omics technology. Providing genomics, proteomics and other readouts on disease samples provides deeper insights to researchers.

With scale, synergies, ample resources, and multi-pronged revenue opportunities, the combined Standard BioTools and SomaLogic expects to occupy a strengthened position in the competitive life science tools space. Their integration marks the continued consolidation in the industry amid rising demand for omics-based research capabilities.

Cancer Drug Developer Immunome To Merge With Morphimmune in Quest For Targeted Therapies

Posted on by slightbourne@noblecapitalmarkets.com

Immunome, a clinical-stage biotech developing novel antibody drugs for cancer, plans to merge with private peer Morphimmune in an all-stock deal. The combined company will unite complementary technology platforms with the goal of creating best-in-class targeted oncology therapies.

Morphimmune brings its proprietary Targeted Effector platform designed to selectively deliver anti-cancer payloads directly to tumor cells. Immunome contributes its human memory B cell interrogation platform that can identify novel antibodies against disease-associated antigens.

The merged entity, which will operate under the Immunome name, intends to submit 3 IND applications within 18 months after the transaction closes. The deal is expected to be completed by the end of 2023.

Leading the charge as new Immunome CEO will be current Morphimmune chief Clay Siegall, an industry veteran who previously founded and led Seattle Genetics for over two decades. Siegall built Seagen into a multi-billion cancer drug company on the back of its antibody-drug conjugate (ADC) technology.

His experience commercializing ADCs, which similarly target treatments directly to tumors, is highly relevant. Siegall called the merger “the first step in establishing a preeminent oncology company.”

The transaction will also bring in $125 million via a concurrent private placement from healthcare institutional investors. Participants include Enavate Sciences, EcoR1 Capital, Redmile Group, and Janus Henderson.

The fresh funding will support advancement of Immunome’s lead asset, a novel IL-38 targeting antibody. It originates from the company’s memory B cell interrogation platform, which sorts through patient blood samples to uncover new therapeutic candidates.

From Morphimmune, a potent TLR7 agonist and radioligand therapy are currently in preclinical testing. The TLR7 program stimulates the immune system against cancer cells when targeted via Morphimmune’s effector platform. The radioligand directly delivers cell-killing radiation.

Siegall highlighted the productive synergy between Morphimmune’s delivery technology and Immunome’s antibody generation engine. The combined company will be able to pursue a wider array of novel targets across multiple therapeutic modalities.

For investors, the merger and additional capital provide Immunome with a deeper pipeline and strengthened financial footing. The $125 million infusion should fund operations well into 2024 even with increased R&D activity.

The more diversified targeted therapy portfolio also helps mitigate risk, with programs based on different mechanisms of action. This provides more shots on goal for achieving clinical success and advancing partnership opportunities.

However, Immunome stock initially fell on news of the deal, indicating some investors were unimpressed by the initial progress made since its August 2020 IPO. The cash position was also becoming strained, likely necessitating the additional financing.

But the opportunity to start fresh under industry ace Siegall may give the story new appeal. His track record of building shareholder value and delivering oncology drugs could reinvigorate Immunome.

The merger puts all the pieces in place to become a fully integrated cancer therapy player. Immunome now has platform technology, industry expertise, development capabilities and a strengthened balance sheet.

Execution will be key, but Siegall’s involvement is about as good as it gets in terms of leadership. For long-term investors, Immunome may offer an intriguing backdoor into the vision of one of biotech’s most accomplished CEOs.

Lilly Makes $1.4 Billion Bet on Radioactive Cancer Drugs with POINT Biopharma Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly is expanding its cancer treatment portfolio into a promising new area by acquiring POINT Biopharma, a company developing radioactive drugs that precisely target tumors, for $1.4 billion.

POINT specializes in radioligand therapies, an emerging approach to cancer treatment that uses radioactive particles linked to molecules that bind to receptors on cancer cells. This enables the radiation to selectively kill tumors while limiting damage to healthy tissue.

Lilly is paying $12.50 per share in cash for POINT, an 87% premium over the stock’s latest closing price. The deal will give Lilly control of POINT’s pipeline of radioligand therapy candidates, which includes two late-stage experimental drugs.

One drug, PNT20021, targets prostate cancer tumors by binding to a protein called PSMA. Study data expected later this year will show whether it extends the lives of men with metastatic castration-resistant prostate cancer.

The other late-stage drug, PNT20031, homes in on neuroendocrine tumor cells via their somatostatin receptors. It may provide a new option for patients with advanced gastroenteropancreatic neuroendocrine tumors.

Take a look at PDS Biotechnology, a clinical stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies.

Beyond these lead programs, POINT has several earlier stage radioligands in development for cancers of the breast, lung, and brain. Lilly gains full access to progress these toward human testing.

The deal also gives Lilly two specialized facilities Point has built to produce and research radioligands. Manufacturing the drugs involves linking medical radioisotopes like actinium-225 to the targeting molecules, which requires nuclear expertise.

Jacob Van Naarden, head of Lilly’s oncology division, touted the promise of radioligands to safely destroy cancer while avoiding the side effects of traditional chemo. “We are excited by the potential of this emerging modality,” he said.

Lilly has been growing its cancer treatment business in recent years through deals for other firms’ drug candidates and technologies. The POINT acquisition similarly expands Lilly’s footprint into an area well-suited for precision medicine.

The U.S. Food and Drug Administration has already approved over a half dozen radioligand therapies from Lilly competitors like Novartis. Their success is driving a surge of investment and deal-making in the radiopharmaceutical field.

But analyst Geoffrey Porges of SVB Securities thinks Lilly overpaid for POINT. “We believe the valuation fails to reflect the very high risks inherent in drug development,” he wrote in a note to investors.

Porges added that Lilly may need to invest over $2 billion more to fully develop POINT’s pipeline over the next 5-7 years, with no certainty the drugs will pan out.

Lilly expects the acquisition to close by the end of 2023 after gaining required antitrust and regulatory approvals. The majority of POINT shareholders also must tender their shares as part of the agreement.

The deal marks Lilly’s second major oncology purchase in 2022. It paid $1.1 billion earlier in the year access to cancer drug candidates from China’s Zymeworks. With POINT, Lilly is now positioned as a leader across multiple next-wave approaches in the high-stakes race to develop better cancer treatments.

Biotech Poised for a Powerful Comeback

Posted on by slightbourne@noblecapitalmarkets.com

After a fallow period, signs point to the biotech sector regaining its prior momentum. Several factors indicate a pending return to rapid growth and prolific innovation for biotech companies. This prospective resurgence could replicate the boom years of the 1980s and 1990s.

The first driver is scientific advancements that open new possibilities. CRISPR gene editing has revolutionized biotech, allowing cheaper and easier manipulation of genetic code. This enables creation of novel treatments and cures previously out of reach. Other breakthroughs like mRNA vaccines have proven the ability to rapidly develop radically new therapeutic approaches.

Vast amounts of genomic data generated in recent decades have also unlocked new understandings of biologically rooted diseases. By identifying key genetic drivers, drug targets can be validated to produce higher success rates in clinical trials. Failed drug candidates have historically been a major drag on biotech.

Substantial investment capital is also lining up behind biotech again after the sector fell out of favor. While biotech IPOs dropped sharply in 2022, venture funding actually rose to its second highest level ever at $32 billion. Investor appetite remains strong, especially for companies with promising new platforms.

Large cash piles among pharmaceutical giants could further bolster biotech. Big pharma companies have routinely turned to buying biotech firms to fill product pipelines. With major players like Pfizer and Merck holding over $25 billion in deployable cash reserves, expect more dealmaking ahead.

Take a look at several emerging growth biotech companies by looking at Noble Capital Market’s Senior Research Analyst Robert LeBoyer’s coverage list.

Regulatory incentives additionally sweeten the proposition of getting back into biotech. The FDA is actively supporting development in areas like gene therapy, rare diseases, and certain cancers through its pilot programs and priority reviews. This guidance can derisk investments.

The maturing ecosystem around biotech also fuels its potential rebound. Experienced veteran executives can now be tapped to steer startups. Clustering in hubs like Boston and San Francisco persists to provide concentration of talent, capital, and resources.

While risks like high failure rates remain, the ingredients are aligning for biotech’s next generation. Comparisons to the internet boom of the late 1990s resonate, with biotech representing a similar pivotal platform shift. The world’s demographics also underpin demand for new therapies – aging populations in developed nations will drive need.

This fertile environment parallels periods that produced prior biotech booms. In the late 1970s and 80s, the industry arose virtually from scratch around pioneering companies like Genentech and Amgen. The advent of genetic engineering allowed creation of the first biologic drugs.

Another surge came through the 90s as enabling technologies like high throughput screening scaled up the drug discovery process. The mapping of the human genome unleashed another wave of possibilities.

Today’s scientific advances pose an even greater leap, allowing drug development and treatment paradigms hardly imaginable just decades ago. The bounds of human understanding keep expanding.

The stars are aligning for biotech 2.0, an evolution building on past successes but catalyzed by new potentials. It promises to usher in an era of curative therapies, genomic precision, and accelerated innovation. The post-pandemic landscape offers the ideal springboard for this biotech revival.

With therapeutic bottlenecks getting cleared, investor interest rekindling, and confidence restored, expect biotech to reclaim its prior growth trajectory. The lessons of past booms were well learned, leaving companies better positioned to capitalize. Weapons to fight disease grow more powerful by the month.

The public expects and demands new treatments for pressing needs, from cancer to neurological conditions. Demographics favor biotech’s prospects as populations age. An energized ecosystem stands ready to nourish exciting science from lab to market.

The pieces are in place for biotech liftoff. As science unlocks new horizons, investor insight aligns with public health demands, fueling momentum. Biotech’s foundational role in driving modern medical progress is poised to only accelerate. The cycle of innovation spins up again.