Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q24 Reported With Clinical Trial Updates. Ocugen reported 1Q24 loss of $11.9 million or $(0.05) per share, and gave updates on progress of its clinical trial during the quarter. Its three main ophthalmic disease programs continued their progress and completed stages of development. Data announcements and milestones are expected for the rest of FY2024. Cash on March 31, 2024 was $26.4 million.
OCU400 Phase 3 Trial Expected Shortly. The Phase 3 trial for OCU400, known as the liMeliGhT incorporating “Master Gene Therapy” into its name, has received FDA clearance and is expected to begin treating retinitis pigmentosa (RP) patients in 2Q24. The trial has a planned enrollment of 150 patients, divided into an arm with 75 RHO mutation patients and 75 patients with any RP associated mutation (gene agnostic). The primary endpoint is luminance dependent navigation assessment (LDNA. As results from the Phase 1/2 study in Leber congenital amaurosis (LCA) become available, the trial could be expanded enroll LCA patients later in 2024.
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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.
Refer to the full report for the price target, fundamental analysis, and rating.
Clinical Trial Treatment Continues With Milestones Ahead. GeoVax reported a 1Q24 loss of $5.6 million or $(2.47) per share. The company gave updates for its three trials testing GM04S1 and its Phase 1/2 trial testing Gedeptin, including the expected announcement about future clinical development for Gedeptin. Cash on March 31, 2024 was $0.8 million.
Gedeptin Is Finishing Its Phase 1/2 Study. The Phase 1/2 trial testing Gedeptin in advanced head and neck cancer has completed enrollment, with the next steps of development in planning stages. The current plan is to continue development in head and neck cancer, with an announcement coming regarding future trials. This could include testing in combination with an immune checkpoint inhibitor (ICI). Trial data and development announcements are expected in 3Q24.
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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.
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.
Pivotal Trial Data Expected During 2Q24. Unicycive reported an Operating Loss of $9.2 million, with a Net Loss of $21.2 million or $(0.61) per share. Importantly, the pivotal trial for OLC, its phosphate binder in development to treat hyperphosphatemia in kidney dialysis patients, is on schedule to report topline data in 2Q24. We anticipate an FDA filing for approval in 2H24. Cash on March 31, 2024, was $48.9 million.
OLC Data in 2Q24 With NDA Expected Later In 2024. The pivotal trial is an open-label single arm study. Its primary endpoint is tolerability, with secondary endpoints of safety and pharmacokinetics. Statistical analysis is not required. The trial has a target enrollment of 60 patients. Once the study is completed, a new drug application (NDA) is expected shortly afterward. We anticipate standard FDA review time, with approval in mid-2025.
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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.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Clinical Milestones Are On Schedule. Cocrystal reported 1Q loss of $4.0 million or $(0.39) per share. During the quarter, the company made progress on its clinical trials and reiterated upcoming milestones for its Phase 1 trial testing CDI-988 in norovirus and COVID-19 and its Phase 2a trial testing CC-42344 in influenza. Cash on March 31, 2024, was $21.8 million.
Results Expected Shortly From The CC-42344 Influenza Virus Program. CC-42344 is an oral PB2 inhibitor in development against a broad spectrum of pandemic and seasonal influenza stains. Enrollment for the current Phase 2a human-challenge study was completed in May 2024. This trial is being conducted in the UK, with data expected to be reported in 2H24. The company has received FDA guidance on the IND filing requirements for Phase 2b trials. The IND filing is expected in 2H24.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Cadrenal Therapeutics Reported 1Q2024. Cadrenal announced a 1Q24 loss of $1.7 million or $(0.10) per share. The company continues to prepare for the Phase 3 clinical trial testing tecarfarin, its anticoagulant, in patients having atrial fibrillation associated with end stage renal disease (AFib with ESRD). This has included hiring a Chief Operating Officer and entering into manufacturing contracts for clinical trial supplies and materials. The cash balance on December 31 was $6.6 million.
Tecarfarin Received Its Second Orphan Drug Designation. As discussed in our Research Note on April 12, the FDA granted Orphan Drug designation for tecarfarin as an anticoagulant in patients with implanted mechanical circulatory support devices. This includes patients with ventricular assist devices (VADs) and total artificial hearts. The lead indication, AFib with ESRD, has also received Orphan Drug designation.
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PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
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 Trial Design Will Test Two Drugs Against Standard Of Care. PDS Biotech held a KOL event featuring two prominent oncologists to discuss head and neck cancer and its clinical program data. The presentations included a review of current treatments and its two Phase 2 studies. The new Phase 3 study design was announced, now planned with three arms to test Versamune HPV with Keytruda, Versamune HPV and PDS01ADC with Keytruda, and Keytruda alone.
Phase 2 Trials Greatly Improved Patient Outcomes. The Phase 2 VERSATILE-002 trial testing Versamune HPV with Keytruda had strong improvements over current treatments in several clinical endpoints. During 2023, PDS discussed the path to approval for Versamune with the FDA. This led to design of the Phase 3 VERSATILE-003 trial testing the two-drug combination, similar to VERSATILE-002.
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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. The Company announced receipt of the California Department of Food Agriculture registration approval for its TerraSante product. MustGrow also received organic certification from California’s Organic Input Material (OIM) Program, specific certification for California. The certification is a requirement for organic products to be sold in California and goes beyond MustGrow’s existing Organic OMRI Listed certifications. California now joins Washington and Oregon as states to authorize product sales of TerraSante.
OIM Program. According to the California Department of Food Agriculture, the OIM program registers materials used for fertilization of organic crops and food production. The material is either bulk or packaged and excludes pesticides. The program is mandated by the Legislature with support from the industry.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
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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 IIT Study Has Started, With Phase 1b Data Kidney Trial Update In June. An Investigator-Initiated Trial (IIT) testing tegoprubart in islet cell transplantation has treated its first patient. Interim data from the Phase 1b trial testing tegoprubart in kidney transplantation was announced, with presentation at a medical meeting scheduled for June 1 to June 5, 2024.
Tegoprubart Is Currently In Two Kidney Transplant Trials. Eledon continues to report follow-up data from its Phase 1b open-label trial for tacrolimus as it enrolls patients in the double-blind Phase 2 BESTOW trial. Tegoprubart acts through a different mechanism than tacrolimus (the current standard treatment), with potential to have greater protection against rejection with improved function.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
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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.
A Distribution Agreement. Yesterday, MustGrow Biologics announced an exclusive distribution agreement with G.S. Long Co., Inc. for MustGrow’s TerraSante biofertility product in Oregon and Washington State. We view this as the next step in revenue generation for the Company, with meaningful revenue now on the horizon for 2025.
Who Is G.S. Long? G.S. Long is a family-owned and operated agricultural chemical and fertilizer retailer headquartered in Central Washington with additional branches located in both Washington and Oregon State. The firm has deep crop consultant capabilities, including experience with biologics, representing generational grower relationships. G.S. Long has over 40 state-licensed Crop Advisors providing a variety of full-service consulting to its farming customers.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*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.
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 Study On Inflammasomes Connects Alzheimer’s Disease With Cardiovascular Disease.Research published in a peer-reviewed journal has shown that Alzheimer’s disease produces inflammasome components that can lead a systemic response, including chronic heart disease and stroke. This study links inflammasomes in the brain to inflammation in distant organs, worsening cardiovascular and other chronic diseases.
Alzheimer’s Brains Produces Inflammasome Components That Travel Through the Circulation. Using models of AD, the study found that parts of the brain had elevated levels of the inflammasome-signaling proteins. When heart ventricles were tested, they also showed significant elevations inflammasome components. Next, serum extracts were administered to cardiovascular cells in culture, resulting in inflammasome activation and significant increases of inflammatory mediators.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*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.
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.
Fiscal Year Results. Management reported revenue of CAD$4.7 million for the year from CAD$6,479 last year. This is due to fees earned from technology license, evaluation, and collaboration agreements. The Company had a net loss of CAD$676,940, or a loss of $0.01 per share, from a loss of CAD$5.6 million or $0.11 last year, with the improvement from the increased revenue.
Balance Sheet and Cash Flow. MustGrow ended the year with CAD$6.8 million in cash, slightly down from CAD$7.0 million last year. The Company used CAD$294,764 in CFFO, an improvement from a use of CAD$3.3 million last year. The improvement was due to the revenue from fees earned. Barring any additional revenue, we estimate that the Company currently has an approximate 15-month runaway before needing new capital.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*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.
Emerging Growth Public Healthcare Company Executive Presentations
Q&A Sessions Moderated by Noble’s Analysts and Bankers
Scheduled 1×1 Meetings with Qualified Investors
Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, is pleased to present the Emerging Growth Virtual Healthcare Conference, taking place April 17th and 18th, 2024. This virtual gathering is set to be an immersive experience, bringing together a unique blend of investors, industry leaders, and experts in the life sciences, healthcare, and medical device sectors.
Part of Noble’s Robust 2024 Events Calendar
The Emerging Growth Virtual Healthcare Conference is part of Noble’s 2024 event programming, featuring a range of c-suite interviews, in-person non-deal roadshows throughout the United States, two more sector-specific virtual equity conferences, and culminating in Noble’s preeminent in-person investor conference, NobleCon20, to be held at Florida Atlantic University in Boca Raton, Florida December 3-4. Keep an eye out for the official press release on NobleCon20 coming soon.
The Emerging Growth Virtual Healthcare Conference will feature 2 days of corporate presentations from up to 50 innovative public healthcare, biotech, and medical device companies, showcasing their latest advancements and investment opportunities. Each presentation will be followed by a fireside-style Q&A session proctored by one of Noble’s analyst or bankers, with questions taken from the audience during the presentation. Panel presentations are planned, featuring key opinion leaders in the healthcare sector, providing valuable insights on emerging trends. Scheduled one-on-one meetings with public company executives, coordinated by Noble’s dedicated Investor Outreach team, are also available to qualified investors.
Why Your Company Should Present
Looking to increase awareness in your company and increase liquidity? Paid participation in Noble’s investor conferences, both virtual and in-person, provides that opportunity, with a tailored experience aimed at delivering substantial value. After 40 years of serving emerging growth companies, and the investors who follow them, Noble has built an investor base eager to discover where the next success story lies.
Noble’s investor base is relevant and, in many cases, new to your company. Noble’s dedicated Investor Outreach team provides unmatched exposure to investors that can invest in your company, including small money managers, family offices, RIAs, wealth managers, self-directed investors, and institutions. Most of Noble’s investors specifically seek undervalued, overlooked, emerging investment opportunities.
The cost to present includes your corporate presentation with a Q&A session proctored by one of Noble’s analysts or bankers, a webcast recording, scheduled 1×1 meetings with qualified investors, and marketing on Channelchek.
Benefits for Investors
The emerging growth healthcare space may be poised for a breakout year. The recent dislocation in the healthcare and biotech spaces has created compelling valuation profiles for many companies. Hear directly from the c-suite of the next innovators in this space and learn about new investment opportunities. The Q&A portion of each presentation gives you the opportunity to have your questions answered during or after the proctored session. The planned panel presentations are sure to provide expert insight on growing trends in the healthcare space. And, for qualified investors, one-on-one meetings are available with company executives; scheduled by Noble’s dedicated Investor Outreach team. All from the comfort of your own desk, and at no cost.
The biotech deal scene is heating up, with Eliem Therapeutics becoming the latest to double down on an emerging pipeline through M&A. The clinical-stage company announced it is acquiring private biotech Tenet Medicines for $120 million in stock, while simultaneously raising $120 million in a private placement to fund Tenet’s lead autoimmune disease program.
The transaction allows Eliem to pivot from its previous focus on neurological disorders to prioritize TNT119 – an anti-CD19 antibody that Tenet was developing across multiple autoimmune indications like lupus, immune thrombocytopenia, and membranous nephropathy. With $210 million in projected cash reserves after closing, the combined company plans to rapidly advance TNT119 into Phase 2 studies for systemic lupus erythematosus and immune thrombocytopenia in the second half of 2024.
“TNT119 represents a promising clinical asset across autoimmune diseases where there is a clear need for improved treatments,” said Andrew Levin, Eliem’s Executive Chairman. “This deal allows us to accelerate development of a potential best-in-class therapy while creating value for our shareholders.”
The acquisition continues the torrid pace of deal-making in biotech as companies look to revamp pipelines and build out emerging focus areas through M&A. Just in the first few months of 2024, over $30 billion in biotech acquisitions have been announced according to Bloomberg data.
Major deals included Vertex’s $4.9 billion buyout of Alpine Immune Sciences to gain a promising IgA nephropathy drug, Pfizer’s $43 billion acquisition of Seagen to bolster its oncology portfolio, and Amgen’s $27.8 billion deal for Horizon Therapeutics’ rare disease pipeline. Now Eliem is the latest to join the fray, making a significant bet on the autoimmune space.
“We believe TNT119 has best-in-class potential and could transform treatment for many autoimmune patients,” said Stephen Thomas, who will become interim CEO of the combined company after previously leading Tenet.
In addition to systemic lupus erythematosus and immune thrombocytopenia, TNT119 has also shown preliminary efficacy in treating membranous nephropathy – an autoimmune kidney disorder. By depleting B cells that produce autoantibodies driving the diseases, the therapy could provide a novel approach across this set of serious inflammatory conditions.
To fund TNT119’s ambitious development program, Eliem secured backing from a syndicate of major healthcare investors including RA Capital, Deep Track Capital, Boxer Capital and Janus Henderson in the $120 million private placement.
The wave of biotech deals has been driven by larger players looking to rebuild pipelines, while smaller companies seek resources to push programs forward amid a challenging economic environment and tight funding markets. With its Tenet acquisition, Eliem is aiming to thread that needle – gaining a promising clinical asset while raising enough capital to rapidly usher it through key studies.
For Eliem shareholders, the risky pivot to autoimmune therapies represents a major strategic shift. But if TNT119 can live up to its blockbuster aspirations, it could allow the company to go from an underdog in neurological disorders to a standout in the hot autoimmune space. That big “if” appears to be a gamble Eliem and its investors are willing to take amid biotech’s current deal-making renaissance.
