Tag: Biotechnology

Ocugen (OCGN) – Ocugen Completes Phase 1 Dosing For OCU410 In Dry AMD

Posted on by cpereira@noblefcm.com


Friday, July 26, 2024

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.

Escalating Dose Stage Has Completed Dosing. Ocugen reported completion of the escalating dose stage of its Phase 1/2 ArMaDa trial testing OCU410 in Geographic Atrophy (GA), a late-stage complication of dry age-related macular degeneration (dry AMD). OCU410 uses Ocugen’s “master regulatory gene” approach, with a single injection to deliver the nuclear receptor gene RAR-related orphan receptor A (RORA). This gene regulates pathways that lead to dry age-related macular degeneration.

Next Stage In Phase 1/2 Trial Expected In 3Q24. The Phase 1/2 ArMaDa trial is testing OCU410 in geographic atrophy (GA), a lesion secondary to dry AMD at 14 retina surgical centers in the US. The first stage of the trial administered three escalating doses of OCU410. The second stage will randomize patients into three arms at a ratio of 1:1:1 to compare the medium and high dosage levels to a control group. Endpoints will be efficacy and safety.


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Dexcom’s Stock Plummets: A Wake-Up Call for the Diabetes Management Giant

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Dexcom shares dropped over 40% in a single day, the worst in company history.
– Disappointing Q2 revenue and lowered full-year guidance shocked investors.
– Internal issues, not market changes, appear to be the primary cause of the downturn.

Dexcom, a leader in diabetes management technology, experienced a seismic shock on Friday, July 26, 2024, as its stock plunged more than 40% following a disappointing second-quarter earnings report. This dramatic fall, erasing approximately $18 billion in market capitalization, marks the company’s worst single-day performance since its 2005 IPO.

The catalyst for this financial tremor was Dexcom’s Q2 revenue report, which fell short of analyst expectations. Despite a 15% year-over-year increase to $1 billion, it missed the projected $1.04 billion target. More alarmingly, the company significantly lowered its full-year revenue guidance from $4.20-$4.35 billion to $4.00-$4.05 billion, a reduction that caught many investors off guard.

During the earnings call, CEO Kevin Sayer attributed the shortfall to several internal factors. A major restructuring of the sales team led to disruptions in customer relationships, particularly affecting the crucial durable medical equipment (DME) channel. The company also faced challenges with lower-than-expected new customer acquisition and reduced revenue per user, partly due to rebates offered for their new G7 continuous glucose monitor.

The magnitude of the guidance cut raised eyebrows among analysts. JPMorgan downgraded Dexcom’s stock, expressing shock at the level of disruption caused by internal reorganization. However, they and other analysts, including those from William Blair and Leerink, maintained that these issues are likely transient and should not significantly impact Dexcom’s long-term trajectory.

Interestingly, Dexcom’s woes do not appear to be linked to broader market trends, such as the rising popularity of GLP-1 weight loss treatments. Instead, the company’s stumbles seem largely self-inflicted, a fact that has both frustrated and perplexed market watchers.

Looking ahead, Dexcom is pinning hopes on its new over-the-counter continuous glucose monitor, Stelo, cleared by the FDA in March 2024 and set for an August launch. Designed for Type 2 diabetes patients who don’t use insulin, Stelo represents a significant expansion of Dexcom’s addressable market.

Despite the current turmoil, some analysts believe the market’s reaction may be overblown. Leerink analysts, in particular, argue that the magnitude of the sell-off is excessive given the likely temporary nature of Dexcom’s challenges.

Nevertheless, the incident serves as a stark reminder of the volatility inherent in the healthcare technology sector. It underscores the importance of effective execution, particularly in sales and customer relationship management, even for established market leaders.

As Dexcom works to right the ship, investors and industry observers will be watching closely. The company’s ability to overcome these short-term hurdles and leverage opportunities like the Stelo launch will be crucial in regaining market confidence.

While the road ahead may be bumpy, Dexcom’s strong market position and innovative product pipeline suggest that this may be a temporary setback rather than a long-term decline. However, the company will need to demonstrate improved execution and a clear path to recovery in the coming quarters to fully reassure investors and regain its market momentum.

Release – Ocugen, Inc. Announces Completion of Dosing In Subjects With Geographic Atrophy Secondary To dAMD In High-Dose Cohort Of Phase 1/2 ArMaDa Clinical Trial Of OCU410—A Novel Modifier Gene Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

July 25, 2024

PDF Version

• Initiated Phase 2 clinical trial

MALVERN, Pa., July 25, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a novel modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 1 million people in the United States.

“Currently, there are two FDA approved anti-complement therapies for GA, which targets only one pathway for a disease that has a multifactorial and complex etiology,” said Majda Hadziahmetovic, MD, Associate Professor of Ophthalmology, Vitreoretinal Diseases and Surgery, Duke University Eye Center, and the lead investigator for the OCU410 Phase 1/2 trial. “Though these treatments are a significant milestone, they provide limited benefits and involve a continuous regimen of multiple intravitreal injections over several years. This modifier gene therapy could potentially transform the landscape of GA treatment.”

Three subjects received a single subretinal administration of the highest dose (200 µL of 1.5×1011 vg/mL) being tested, which completed the dosing for the Phase 1 stage of the trial. The ArMaDa clinical trial for OCU410 is being performed at 14 leading retinal surgery centers across the United States.

“We are very encouraged about the potential of OCU410 as a one-time treatment option for GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen.

We have initiated a Phase 2 clinical trial that will assess the safety and efficacy of OCU410 in a larger group of patients who will be randomized into either of two treatment groups (medium- or high-dose) or a control group.

The Company will continue to provide clinical updates on a periodic basis.

About the Phase 1/2 ArMaDa clinical trial
The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with geographic atrophy and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-escalation study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

About dry age-related macular degeneration (dAMD) and geographic atrophy (GA)
Dry age-related macular degeneration (dAMD) affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 utilizes an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of geographic atrophy.

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

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

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

Release – MAIA Biotechnology Announces New Updates From Phase 2 Trial Of Novel Cancer Treatment Agent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

July 23, 2024 4:11am EDT

  • THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments
  • 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announces positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:

  • 6 patients remain on treatment following at least 12 months of therapy.
  • Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
  • Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.

“Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options.”

  1. https://www.sciencedirect.com/science/article/pii/S0169500217304373

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 nucleotide 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 and activates 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 THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

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.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released July 23, 2024

Augmedix and Commure Join Forces in $139 Million Healthcare AI Deal

Posted on by slightbourne@noblecapitalmarkets.com

In a significant move that could reshape the landscape of healthcare technology, Augmedix, Inc. (Nasdaq: AUGX) has announced its acquisition by Commure, Inc. The all-cash transaction, valued at approximately $139 million, marks a pivotal moment in the evolution of ambient AI and medical documentation solutions.

Announced on July 19, 2024, the deal will see Augmedix stockholders receive $2.35 per share, representing a substantial premium of 169% over the company’s recent trading history. This acquisition not only provides a windfall for Augmedix investors but also signals a strong vote of confidence in the company’s innovative approach to reducing administrative burdens in healthcare.

Augmedix, a pioneer in ambient AI medical documentation, has made significant strides in liberating clinicians from time-consuming paperwork. By leveraging artificial intelligence to transform natural conversations into organized medical notes and structured data, Augmedix has been at the forefront of enhancing clinical efficiency and decision support.

Commure, the acquiring company, is no stranger to healthcare innovation. As a leading provider of technology solutions to healthcare systems, Commure has been working to streamline operations and improve patient care across hundreds of care sites. The merger with Augmedix aligns perfectly with Commure’s mission to make health the focus of healthcare by eliminating distractions and keeping providers connected to their patients.

Manny Krakaris, CEO of Augmedix, expressed enthusiasm about the deal, stating, “This proposed transaction with Commure provides certainty and a premium value for our stockholders, representing a transformative next step in Augmedix’s mission.” He emphasized the potential for scaling ambient documentation solutions and accelerating the development of innovative features and AI capabilities.

Tanay Tandon, CEO of Commure, shared a similar sentiment, highlighting the strategic importance of the acquisition. “We’re taking a huge step forward in building the health AI operating system of the future,” Tandon remarked, underlining the goal of consolidating various point solutions into a single, integrated platform for healthcare providers and operations teams.

The transaction is expected to close in late Q3 or early Q4 of 2024, subject to approval by Augmedix stockholders and other customary closing conditions. Upon completion, Augmedix will transition from a publicly-traded company to a wholly-owned subsidiary of Commure, operating as a private entity.

This merger comes at a critical time in healthcare, as the industry grapples with burnout among medical professionals and the need for more efficient, patient-focused care. By combining Augmedix’s expertise in ambient AI documentation with Commure’s broad reach and resources, the newly formed entity aims to address these challenges head-on.

The deal also reflects the growing importance of AI in healthcare. As language models and AI technologies continue to advance, their potential to transform medical practice becomes increasingly clear. This acquisition positions the combined company at the forefront of this transformation, with the potential to set new standards in healthcare IT and clinical workflow optimization.

For the healthcare community, this merger promises a future where technology works seamlessly in the background, allowing medical professionals to focus more on patient care and less on administrative tasks. It also signals a trend towards consolidation in the healthcare tech sector, as companies seek to create more comprehensive, integrated solutions.

As the healthcare industry watches this deal unfold, many will be eager to see how the combined strengths of Augmedix and Commure will translate into practical improvements for clinicians, patients, and health systems alike. With the backing of Commure’s resources and the innovative spirit of Augmedix, the future of AI-driven healthcare solutions looks brighter than ever.

Cocrystal Pharma (COCP) – CDI-988 Reaches Milestone In Phase 1 Trial For Norovirus and Coronavirus

Posted on by cpereira@noblefcm.com


Friday, July 19, 2024

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.

CDI-988 Completes Phase 1 SAD Trial. Cocrystal announced that CDI-988 has completed the single ascending dose stage of the Phase 1 trial for CDI-988, its oral protease inhibitor in development for norovirus and coronavirus. The trial was designed to test the safety and tolerability of CDI-988, as well as its pharmacokinetics. The results justify moving forward to the multiple ascending dose (MAD) stage, expected later in FY2024.

SAD Study Was Designed To Test Basic Safety. The SAD trial was a double-blind trial to test a single oral administration of escalating doses ranging from 100 mg to 600 mg of CDI-988. The objectives were to determine basic safety, tolerability, and pharmacokinetics including food effects. There were no serious adverse events or treatment-emergent adverse events, with no laboratory or exam abnormalities. Safety and tolerability were considered sufficient to continue to the next stage of the trial.


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Release – Unicycive Therapeutics Granted Patent On UNI-494 To Treat Acute Kidney Injury By The United States Patent And Trademark Office (USPTO)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

July 17, 2024 7:03am EDT Download as PDF

ENSURES INTELLECTUAL PROPERTY PROTECTION UNTIL 2040

LOS ALTOS, Calif., July 17, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent No. 12,036,211 by the United States Patent and Trademark Office (USPTO) for UNI-494.

The patent, valid until 2040, secures protection of a method of treating a disease or a condition selected from acute kidney injury or contrast induced nephropathy by administering the UNI-494 compound. The UNI-494 compound covered in the method of use claims is not limited to a particular salt, dose or type of administration. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease.

“We are pleased to receive this patent from the USPTO, which ensures intellectual property protection for many years to come,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This Method of Use patent for UNI-494 is an important component of our strategy to become a leader in the development of drugs that target kidney disease. UNI-494 is currently in an ongoing Phase 1 clinical trial and recently received Orphan Drug Designation in Delayed Graft Function, a form of acute kidney injury. This patent helps protect our approach and expands our portfolio as we look to develop novel treatments for kidney diseases.”

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in the second half of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined on the basis of increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

About Unicycive Therapeutics

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

Forward-looking statements

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

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released July 17, 2024

Release – GeoVax to Raise Approximately $3.1 Million of Gross Proceeds in Offering Priced At-the-Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Atlanta, GA, July 11, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into a definitive securities purchase agreement with a certain institutional investor for the purchase and sale of 1,085,000 shares of the Company’s common stock (or common stock equivalents) at a price of $2.86 per share in a registered direct offering priced at-the-market under Nasdaq rules.

In addition, in a concurrent private placement, the Company will issue to the investor warrants to purchase up to 2,170,000 shares of common stock. The warrants have an exercise price of $2.86 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of stockholder approval.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $3.1 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about July 12, 2024, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-277585) previously filed with the Securities and Exchange Commission (the ”SEC”) and declared effective by the SEC on March 13, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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®, which recently completed enrollment 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                         austin.murtagh@precisionaq.com                        sr@roberts-communications.com 
678-384-7220 212-698-8696 202-779-0929

Unicycive Therapeutics (UNCY) – Patient Survey Data From Pivotal Trial Shows Patients Prefer OLC

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, July 11, 2024

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 Included A Patient Satisfaction Survey. In late June, Unicycive released safety, efficacy, and dosing data from its Pivotal trial for OCL. As discussed on our Research Note on June 26, over 90% of the patients were able to reach target serum phosphate levels. The trial included a pre-specified patient survey asking about ease of use, satisfaction, and overall preference that shows patients prefer OLC over their current phosphate binders. We see this as an important point that could make it the best treatment in a $1 billion drug category.

We Consider Patient Preference To Be A Strong Point. OLC was developed as an improved formulation of Fosrenol (lanthanum citrate) that would require fewer and smaller pills. This was intended to improve compliance and maintain phosphate levels in the proper range. The Pivotal study for the NDA application showed sufficient safety, tolerability, and effective dose levels, with a pre-specified patient survey to collect post-treatment opinions.


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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. 

GeoVax Labs (GOVX) – Looking Forward To Continued Progress In 2H24

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, July 10, 2024

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.

GeoVax Reached Important Milestones For Both Platforms During 1H2024. The first half of 2024 has been a transformational period for GeoVax. A Phase 2 trial testing CM04S1 as a booster vaccine for COVID-19 reported initial data in February, then received a BARDA grant to conduct a large Phase 2b in June. The Gedeptin gene therapy program in head and neck cancer reported interim Phase 1/2 data showing successful proof-of-concept. Both programs are moving forward with additional milestones in 2H24.

BARDA Grant Allocates $367 Million For A Phase 2b Trial. In June, GeoVax announced that it has received a grant from BARDA to conduct a Phase 2b trial testing CM04S1 as a booster vaccine to protect healthy patients from COVID-19. As discussed in our Research Note on June 28, the grant terms include payments to GeoVax for clinical supplies and regulatory costs of $24.3 million (which could be increased to $45 million). The balance will be payable to Allucent, the CRO that will conduct the trial.


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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. 

PDS Biotechnology (PDSB) – Midyear Review: Has PDS Turned The Corner?

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, July 09, 2024

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.

Amended Phase 3 Clinical Trial Will Test Two Drugs. During 2Q24, the design of the Phase 3 trial testing Versamune HPV with Keytruda added a second treatment arm to test Versamune, PDS01ADC, and Keytruda against the active control arm of Keytruda alone. We believe this new trial design answers several questions that have caused PDSB to stagnate over the past year. A meeting with the FDA to ensure alignment on the trial design is expected during July 2024.

Thoughtful Consideration Has Led To Improved Trial Design. There are several points from the Phase 2 trial data that lead us to believe that adding the third arm to Phase 3 study improves its design. We believe the Triple-combination could have more rapid enrollment, produce data for product approvals, and support extensive use as a first-line therapy.


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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. 

Lilly Expands Immunology Footprint with $3.2 Billion Morphic Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Eli Lilly and Company (NYSE: LLY) announced on July 8, 2024, its plans to acquire Morphic Holding, Inc. (NASDAQ: MORF) for $3.2 billion, marking a significant expansion of its presence in the immunology space. This strategic move aims to enhance Lilly’s pipeline in inflammatory bowel disease (IBD) treatments and broaden its portfolio of oral integrin therapies.

Under the agreement, Lilly will pay $57 per share in cash for all outstanding Morphic shares, representing a substantial 79% premium over Morphic’s closing stock price on July 5, 2024. The transaction, approved by both companies’ boards of directors, is expected to close in the third quarter of 2024, pending customary closing conditions and regulatory approvals.

At the heart of this acquisition is Morphic’s lead program, MORF-057, a selective oral small molecule inhibitor of α4β7 integrin. This promising compound is currently undergoing multiple Phase 2 studies for the treatment of ulcerative colitis and Crohn’s disease, two prevalent forms of IBD. The oral nature of MORF-057 could offer significant advantages over existing injectable therapies, potentially improving patient compliance and quality of life.

Dr. Daniel Skovronsky, Chief Scientific Officer of Lilly and President of Lilly Research Laboratories, highlighted the potential impact of oral therapies in IBD treatment. “Oral therapies could open up new possibilities for earlier intervention in diseases like ulcerative colitis, and also provide the potential for combination therapy to help patients with more severe disease,” he stated. This acquisition underscores Lilly’s commitment to developing first-in-class molecules in gastroenterology, an area where the company has been making substantial investments.

The deal also brings Morphic’s preclinical pipeline into Lilly’s fold, including molecules targeting autoimmune diseases, pulmonary hypertensive diseases, fibrotic diseases, and cancer. This addition further diversifies Lilly’s research and development efforts, potentially opening new avenues for therapeutic breakthroughs.

For Morphic, this deal represents a validation of its Integrin Technology platform and years of research. Dr. Praveen Tipirneni, CEO of Morphic Therapeutic, expressed confidence in Lilly’s ability to maximize MORF-057’s potential. “Lilly brings unparalleled resources and commitment to the inflammation and immunology field,” he noted, adding that the acquisition could “unlock new possibilities in IBD treatment.”

The transaction comes amid rapid growth in the global IBD therapeutics market. With the increasing prevalence of IBD worldwide and the limitations of current treatments, there is a significant unmet need for novel, more effective therapies. Lilly’s acquisition of Morphic positions the company to potentially capture a larger share of this expanding market and address critical patient needs.

From a financial perspective, the $3.2 billion deal represents a significant investment for Lilly. The company will determine the accounting treatment of the transaction as either a business combination or an asset acquisition upon closing, which will impact how it’s reflected in Lilly’s financial results and guidance.

The acquisition has ignited interest across the pharmaceutical industry, with analysts speculating that it could trigger a wave of similar deals in the integrin therapy space. As large pharmaceutical companies seek to bolster their pipelines and secure promising assets in high-growth therapeutic areas, smaller biotechnology firms with innovative platforms may become increasingly attractive targets.

However, Lilly faces the challenge of successfully integrating Morphic’s team and technologies into its existing operations. The company’s ability to manage this integration smoothly will be crucial in realizing the full potential of this deal and translating it into tangible benefits for patients and shareholders alike.

Lilly’s acquisition of Morphic represents a strategic move to strengthen its position in the immunology market, particularly in IBD treatments. With the potential to bring novel oral therapies to patients and expand its research capabilities, this deal could have far-reaching implications for both Lilly and the broader landscape of IBD treatment. As the transaction progresses towards closing, industry observers and patients alike will be watching closely to see how Lilly leverages this significant investment to drive innovation and improve patient outcomes in the years to come.

Ligand Pharmaceuticals Expands Oncology Portfolio with $100 Million APEIRON Biologics Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

In a strategic move to bolster its commercial-stage portfolio, Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) announced on July 8, 2024, its agreement to acquire APEIRON Biologics AG for $100 million in cash. This acquisition marks a significant expansion of Ligand’s oncology footprint, particularly in the realm of rare pediatric cancers.

The crown jewel of this acquisition is QARZIBA® (dinutuximab beta), a highly differentiated oncology drug used in the treatment of high-risk neuroblastoma in patients aged 12 months and above. QARZIBA, which received European Medicines Agency approval in 2017, is currently marketed in over 35 countries by global pharmaceutical company Recordati S.p.A.

Todd Davis, CEO of Ligand, emphasized the strategic importance of this acquisition, stating, “The addition of QARZIBA to our commercial royalty portfolio further supports our growth strategy to invest in high-value medicines that deliver significant clinical value and generate predictable and long-term revenue streams for our investors.”

The deal structure includes the initial $100 million cash payment, with the potential for up to an additional $28 million based on future commercial and regulatory milestones. Specifically, these additional payments are tied to QARZIBA royalties exceeding certain predetermined thresholds by either 2030 or 2034.

From a financial perspective, this acquisition is expected to make an immediate positive impact on Ligand’s bottom line. The company projects that the deal will be accretive to its earnings per share (EPS) by approximately $1.00 on an annualized basis, with a $0.50 impact expected for 2024 alone. In light of this, Ligand has increased its 2024 adjusted EPS guidance by 17% to a range of $5.00-$5.50.

The acquisition of APEIRON represents the sixth key asset added to Ligand’s commercial stage portfolio since the beginning of 2023, underscoring the company’s aggressive growth strategy. This diversification is expected to provide Ligand with a more stable and predictable revenue stream, a key consideration for investors in the volatile biotech sector.

QARZIBA’s unique position as the only immunotherapy for high-risk neuroblastoma marketed across Europe and other parts of the world makes it a particularly valuable addition to Ligand’s portfolio. Neuroblastoma, a rare cancer that primarily affects children, has limited treatment options, highlighting the potential impact of QARZIBA on patient outcomes.

In a parallel move, Ligand has also committed to investing up to $4 million in invIOs Holding AG, a privately held spin-off of APEIRON. This investment is aimed at financing the research and development of three innovative early-stage immuno-oncology assets, further expanding Ligand’s development stage portfolio.

Peter Llewellyn-Davies, CEO of APEIRON, expressed satisfaction with the deal, noting, “This transaction is an important milestone for our company and shareholders. We have spent more than 20 years translating academic research into therapeutic products for diseases with high unmet needs.”

The acquisition is expected to close in July 2024, subject to a 30-day shareholder objection period and other customary closing conditions. Upon completion, it will significantly reshape Ligand’s commercial portfolio and financial outlook.

As the biopharmaceutical industry continues to consolidate and seek ways to mitigate risk while maximizing potential returns, Ligand’s acquisition of APEIRON represents a strategic move to strengthen its position in the oncology market. By focusing on high-value, commercially available assets like QARZIBA, Ligand is positioning itself for sustained growth in the competitive and rapidly evolving pharmaceutical landscape.

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