Category: Health

Release – Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

November 11, 2024 7:00am EST 

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– FDA sets PDUFA Action Date of June 28, 2025

– Company Preparing for 2025 Commercial Launch –

LOS ALTOS, Calif., Nov. 11, 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 that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis.

“We are thrilled with the FDA acceptance of our first NDA, a significant milestone towards our efforts to bring this important treatment option to patients with kidney disease if approved,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “CKD patients on dialysis with hyperphosphatemia are often saddled with an onerous treatment regimen that includes having to take as many as 12 pills per day. OLC may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of the number and size of pills per dose, and the pills are swallowed instead of chewed for added convenience. With our NDA now under review, we are preparing to commercialize and launch OLC in the second half of 2025, if approved.”

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

As previously announced, the FDA granted a waiver for the NDA application PDUFA fees, representing a significant savings of approximately $4 million for Unicycive.

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. OLC has over thirty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is expected to exceed $2.5 billion, with the United States accounting for more than $1 billion of that total2. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

1Reason Research, LLC 2022 survey. Results here.
2Fortune Business InsightsTM, Hyperphosphatemia Treatment Market, 2021-2028 

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

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.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released November 11, 2024

Ocugen (OCGN) – 3Q24 Reported As We Look Forward To Clinical Showcase Data

Posted on by cpereira@noblefcm.com


Monday, November 11, 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.

Clinical Trials Continued, Capital Was Raised, and New Data Expected. Ocugen reported a loss for 3Q24 of $13.0 million or $(0.05) per share. The company reported continued enrollment in all of its ongoing clinical trials and has scheduled a Clinical Showcase meeting in New York on Tuesday, November 12, 2024. We expect the meeting presentations to include data updates from the clinical trials. In August, Ocugen completed a stock offering that raised $35 million to end 3Q24 with $38.7 million in cash. After the quarter ended, the company added $30 million in debt funding. 

OCU400 in Retinitis Pigmentosa (RP) Is On Schedule. The company confirmed that the Phase 3 liMeliGhT (pronounced “Limelight”) trial continues to enroll patients and is on schedule to complete enrollment in 1H25. An approval by Health Canada will allow patient enrollment at up to 5 Canadian sites. The FDA has approved an expanded access program (EAP) to allow patients  to be treated outside of the clinical trials before OCU400 receives market approval.


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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. 

Release – Ocugen Provides Business Update with Third Quarter 2024 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

November 8, 2024

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Conference Call and Webcast Today at 8:30 a.m. ET

  • Subsequent to quarter-end, closed $30 million in debt financing
  • OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) on track to complete enrollment in 1H2025
  • OCU410 is currently in Phase 2 of the Phase 1/2 ArMaDa clinical trial
  • Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial approved enrollment for the second phase of the Phase 1/2 clinical trial
  • New data on Phase 1/2 clinical trials for OCU410, OCU410ST and OCU400 to be presented at upcoming Clinical Showcase

MALVERN, Pa., Nov. 08, 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, biologics, and vaccines, today reported third quarter 2024 financial results along with a general business update.

“I am very encouraged by the progress of our gene therapy programs and the clinical and regulatory milestones achieved in the third quarter of 2024, including the expansion of the OCU400 Phase 3 liMeliGhT clinical trial into Canada,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “With the recent equity and debt financings, we have sufficient cash-on-hand to continue supporting our robust ophthalmology pipeline and extend our cash runway into 1Q2026.”

As OCU400 is advancing through Phase 3 clinical development, the expanded access program (EAP) for adult patients with early to advanced RP makes it possible to reach a greater segment of the RP patient population—300,000 in the U.S., Canada, and Europe combined. Additionally, including Canadian patients in the OCU400 Phase 3 liMeliGhT trial may allow for broader commercialization with the U.S. and Europe. These accomplishments and consistent trial enrollment are bringing the Company even closer to providing a potential one-time treatment for life to patients living with RP.

Phase 2 of the OCU410 Phase 1/2 ArMaDa clinical trial is underway and will assess the safety and efficacy of OCU410 in a larger group of patients who are randomized into either of two treatment groups (medium- or high-dose) or a control group. OCU410 is being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 2-3 million people in the U.S. & EU. Current FDA-approved treatments address only the complement system and require approximately 6-12 intravitreal injections per year, whereas OCU410 addresses all four pathways linked with dAMD pathophysiology and is delivered through a single subretinal injection. There remains no approved product to treat GA in the EU.

Over a series of conferences during the third quarter 2024, Ocugen had the opportunity to provide an update on its three clinical-stage modifier gene therapies to significant investor audiences as well as industry decision-makers during meetings like the Cell & Gene Meeting on the Mesa hosted by the Alliance for Regenerative Medicine.

“It is imperative to continue educating our key stakeholders about the differentiated mechanism of action of our gene-agnostic modifier gene therapy platform,” said Dr. Musunuri. “Unlike other product candidates in development to treat blindness diseases, our approach leverages master gene regulators that reset the functional network—rather than targeting a single mutation—and restore overall health to the retina. Our data continues to support the potential to treat multiple disease mutations with a one-time therapy for life.”

While gene therapy remains the primary focus for the Company, Ocugen continues to pursue funding opportunities across the portfolio to ensure that its innovative platforms reach the people who need them.

A clinical showcase, providing updates from Ocugen’s ongoing gene therapy trials, will be held on November 12, 2024, and will include preliminary safety and efficacy data from the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy and Phase 1/2 OCU410ST GARDian clinical trial for Stargardt disease, along with RP and LCA data updates from the OCU400 Phase 1/2 clinical trial.

Ophthalmic Gene Therapies—First-in-class

  • OCU400 – Enrollment continues in the Phase 3 liMeliGhT clinical trial and Health Canada approved enrollment across a maximum of 5 sites in Canada. FDA approved EAP for the treatment of adult patients with RP who may benefit from the mechanism of action of OCU400.
  • OCU410 – Actively recruiting patients in Phase 2 of the Phase 1/2 ArMaDa clinical trial. Preliminary safety and efficacy update on OCU410 Phase 1/2 ArMaDa clinical trial will be shared at upcoming clinical showcase.
  • OCU410ST – DSMB approved proceeding to Phase 2 of the Phase 1/2 GARDian clinical trial. Preliminary safety and efficacy update will be shared at upcoming clinical showcase.

Ophthalmic Biologic Product

  • OCU200 – FDA cleared the investigational new drug application for the Phase 1 clinical trial evaluating OCU200. The Company is planning to initiate the OCU200 Phase I clinical trial this quarter.

Third Quarter 2024 Financial Results

  • With the recent $30 million debt financing and $35 million equity financing in the third quarter, the cash runway now extends into 1Q2026.
  • The Company’s cash and restricted cash totaled $39.0 million as of September 30, 2024, compared to $39.5 million as of December 31, 2023.
  • Total operating expenses for the three months ended September 30, 2024 were $14.4 million and included research and development expenses of $8.1 million and general and administrative expenses of $6.3 million. This compares to total operating expenses for the three months ended September 30, 2023 of $16.1 million that included research and development expenses of $7.0 million and general and administrative expenses of $9.1 million.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 9923172
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, expected cash runway into the first quarter of 2026, the ability to initiate new clinical programs, 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 annual and 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 

View Full Release Here.

Cadrenal Therapeutics (CVKD) – Cadrenal Reports 3Q24 With Tecarfarin Progress Updates

Posted on by cpereira@noblefcm.com


Friday, November 08, 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.

Financial Condition Improved In 3Q24. Cadrenal reported a loss of $2.4 million or $(2.18) per share, adjusted for the 1-for-15 reverse split on August 20, 2024. This loss was slightly less than our projections. Cash on September 30 was $4.4 million, excluding financing that brought in $9.8 million after the close of the quarter. The company reported that its current cash balance was approximately $11.3 million on November 7, 2024.

The Tecarfarin Made Progress In Its Next Indication. Cadrenal held a Type-B meeting with the FDA to discuss the planned Phase 3 trial for use of tecarfarin in patients with left ventricular assist devices. The company will use the guidance and comments from the meeting to design the pivotal trial. Cadrenal also continued to discuss collaborating with Abbott about a clinical trial with patients that have the Abbott HeartMate 3, the only LVAD available in the United States. Cadrenal has Orphan Drug designation for the LVAD indication, providing a strong incentive for collaborations.


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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. 

Schwazze (SHWZ) – Reports Preliminary 3Q24 Results

Posted on by cpereira@noblefcm.com


Friday, November 08, 2024

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Joe Gomes, CFA, 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.

Preliminary 3Q24 Results. Last night, Schwazze reported preliminary 3Q24 results. We believe the ongoing audit of past results is likely causing a delay in reporting results. According to the release, 3Q24 revenue is expected to be approximately $42 million, and adjusted EBITDA is expected to be approximately $11 million. In 3Q23, Schwazze reported revenue of $46.7 million and adjusted EBITDA of $14.1 million. We had estimated revenue of $44.5 million and adjusted EBITDA of $10.3 million.

Making Progress. In spite of the challenging operating environment, Schwazze continued to generate momentum from its retail growth and optimization initiatives in the quarter, reflected by the Company once again outpacing two highly competitive markets while generating sequential improvements in profitability and positive cash flow from operations. Management noted increased store traffic in both Colorado and New Mexico.


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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. 

Astrana Health to Acquire Prospect Health in $745 Million Deal, Expanding U.S. Healthcare Network

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Astrana will acquire Prospect Health to expand its U.S. provider network across four key states.
– The transaction includes a $1,095 million bridge financing, backed by major financial institutions.
– The acquisition aligns with Astrana’s mission to provide localized, high-quality healthcare, benefiting 1.7 million members.

Astrana Health, Inc. (NASDAQ: ASTH), a technology-driven healthcare provider, has entered a definitive agreement to acquire Prospect Health, a healthcare system with a robust network in California, Texas, Arizona, and Rhode Island. This acquisition is valued at $745 million and aims to expand Astrana’s reach across critical U.S. markets, enabling coordinated, high-quality care for approximately 1.7 million Americans. Expected to close by mid-2025, the transaction will mark a significant expansion for Astrana in the U.S. healthcare sector.

Astrana’s acquisition of Prospect Health includes an array of healthcare assets such as the Prospect Health Plan, medical groups in four states, a pharmacy (RightRx), and Foothill Regional Medical Center in California. Prospect currently serves around 610,000 members across Medicare Advantage, Medicaid, and Commercial plans through its 3,000 primary care providers and 10,000 specialists. The acquisition will allow Astrana to strengthen its position as a leading U.S. healthcare delivery platform, focused on providing accessible, high-value care.

Astrana will fund the purchase with a combination of cash and a $1,095 million senior secured bridge commitment from Truist Bank and J.P. Morgan. The transaction includes an extended closing timeline, aiming for regulatory approvals and completion by mid-2025. The combined network will also bring substantial integration risks, given the complexity of merging operations across multiple states and entities. However, Astrana anticipates that its investment in infrastructure improvements will help ensure local, personalized care in each region.

CEO Brandon K. Sim noted that the acquisition represents a union of two organizations with a shared mission of patient-centric care. Prospect’s established presence in markets like Southern California will allow Astrana to expand beyond its current regions, particularly into Orange County, where Astrana has limited operations. This geographic expansion, coupled with Astrana’s technology-enabled healthcare model, will provide a scalable solution for accessible healthcare in diverse communities.

Astrana expects Prospect to generate approximately $1.2 billion in revenue, with adjusted EBITDA of around $81 million for 2024. This acquisition aligns with Astrana’s strategy to grow through value-based care and increase its reach across new markets while ensuring continuity of care for Prospect’s patients. According to CFO Tom Holloway, Astrana projects the transaction to be immediately accretive to earnings per share, excluding expected synergies, thus enhancing shareholder value over the long term.

Jim Brown, CEO of Prospect, expressed optimism about the partnership, highlighting shared cultural values and operational synergies between the companies. He emphasized that the acquisition will create a larger, more coordinated care network that offers improved access, quality, and efficiency for patients. The integrated healthcare system will enable Astrana to expand its end-to-end technology capabilities and support local healthcare infrastructure with continued investment in infrastructure and patient services.

Release – Cadrenal Therapeutics Provides Third-Quarter Corporate Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Nov. 7, 2024 — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) (the “Company” or “Cadrenal”), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to provide safer and superior anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions, today provided a corporate update coinciding with the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.

Recent Highlights

  • In early September, Cadrenal leadership met with the U.S. Food and Drug Administration (FDA) to discuss its tecarfarin Phase 3 clinical trial protocol in left ventricular assist device (LVAD) patients and is continuing these discussions.
  • Cadrenal advanced Abbott collaboration discussions regarding Cadrenal’s pivotal clinical trial in patients with the Abbott LVAD HeartMate 3, the only LVAD available in the U.S.
  • Also, in October 2024, Cadrenal joined the Corporate Council of the Anticoagulation Forum (AC Forum), the largest professional organization of anticoagulation specialists committed to advancing the quality and safety of chronic anticoagulation care globally. Through participation in the Corporate Council, Cadrenal will collaborate with the AC Forum as it works to educate and engage the organization’s 15,000 healthcare professional members to improve outcomes for patients on anticoagulants.
  • Cadrenal and its pharmaceutical contract development and manufacturing organization (CDMO) completed the operational readiness activities necessary to supply active pharmaceutical ingredients and clinical trial materials in accordance with current good manufacturing principles (cGMP).
  • On October 24, 2024, Cadrenal announced that it successfully raised approximately $5.1 million through its at-the-market facility (ATM).
  • On November 1, 2024, Cadrenal announced the exercise of warrants generating gross proceeds of approximately $4.7 million.
  • Recent financing transactions totaling $9.8 million increased its cash balance to approximately $11.3 million and strengthened its balance sheet. The net proceeds provide Cadrenal with additional working capital as it advances tecarfarin toward a pivotal Phase 3 trial.
  • Q3 2024 operating expenses were $2.5 million, including $0.3 million of non-cash expenses.
  • Cash used in operating activities totaled $2.2 million during Q3 2024.
  • Cash and cash equivalent balance of $11.3 million as of November 7, 2024.

“Momentum is building from our achievement of several critical milestones toward beginning a pivotal clinical trial to evaluate tecarfarin’s superiority to warfarin in LVAD patients,” said Quang X. Pham, Founder, Chairman, and Chief Executive Officer of Cadrenal Therapeutics. “These accomplishments span finance, operations, partner relations, and clinical development and enhance our ability to execute our strategic plan going into 2025.

“Efficiently raising nearly $10 million in recent weeks bolsters funds for operational and clinical development needs. At the same time, we are progressing our dialogue with the FDA and Abbott and moving ahead with our CDMO to manufacture tecarfarin for our Phase 3 trial,” continued Pham.

Tecarfarin is the only anticoagulant in development worldwide for patients with implanted cardiac devices and other rare cardiovascular conditions. The oral and reversible drug has been uniquely designed to overcome many of the challenges patients experience with warfarin and to fill a need unmet by direct oral anticoagulants (DOACs) that are contraindicated or not recommended by leading cardiology associations for these individuals. If approved, tecarfarin may be a safer and more effective chronic anticoagulant for LVAD patients in the U.S.

In addition, tecarfarin may prove valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. These include individuals with end-stage renal disease and atrial fibrillation or those with mechanical heart valves and hard-to-control anticoagulation, as determined by International Normalized Ratio (INR) measurements of how long it takes the blood to clot.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, more effective chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds, and deaths than warfarin, the most commonly used anticoagulant for these patients, despite its prevalent adverse events, drug-to-drug interactions, and frequent dosing changes. Cadrenal is focused on evaluating tecarfarin’s superiority to warfarin in these patients where DOACs are not recommended in the treatment guidelines of leading cardiology associations. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted LVADs as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is opportunistically planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit www.cadrenal.com to learn more.

About Tecarfarin

Tecarfarin is a Phase 3-ready drug candidate that Cadrenal is developing to overcome many of warfarin’s challenges and fill the need for a safer and more effective VKA chronic anticoagulant. Tecarfarin is anticipated to improve outcomes and result in fewer major events for warfarin-dependent patients. Extensive data indicates that the efficacy of tecarfarin, metabolized via a different pathway than warfarin, is not affected by drug-drug interactions and kidney impairment, which are common in these patients. Phase 2/3 clinical trials show that tecarfarin may offer enhanced stability and time in therapeutic range (TTR) that inversely correlate with major events. Tecarfarin is the only new anticoagulant being developed for patients with implanted cardiac devices or rare cardiovascular conditions. Treatment with tecarfarin aims to improve anticoagulation for these underserved patients and their healthcare providers who face difficulties in managing warfarin’s wide variability and risk of gastrointestinal bleeds.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding our planned pivotal trial to evaluate tecarfarin’s effectiveness for LVAD patients, the success of the Company’s collaborative efforts with Abbott, tecarfarin potentially being a safer and more effective chronic anticoagulant for patients with LVADs, tecarfarin filling a need unmet by DOACs that are contraindicated or not recommended, the commencement of trials to evaluate tecarfarin’s superiority to warfarin in LVAD patients and potentially bring the Company’s better anticoagulation solution to those in need, and tecarfarin proving valuable for other patients where warfarin is not providing recommended anticoagulation because of genetic warfarin resistance or renal impairment making warfarin metabolism difficult. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to improve anticoagulation treatment in patients, the ability of the Company to advance tecarfarin with patients with left ventricular assist devices (LVADs), the collaborative efforts with Abbott being successful and those with AFib and ESKD, the collaboration with Abbott being successful and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/cadrenal-therapeutics-provides-third-quarter-corporate-update-302298290.html

SOURCE Cadrenal Therapeutics, Inc.

Release – MAIA Biotechnology Announces Participation by Director Stan Smith, Ph.D. in Recent Private Placement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

November 07, 2024 8:47am EST Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that independent director Stan V. Smith, Ph.D. made an individual purchase of 100,000 shares of MAIA’s common stock, and warrants to purchase 100,000 shares, of MAIA’s common stock for an aggregate purchase price of $225,900 as part of the Company’s recent private placement of common stock and warrants announced by the Company on October 28, 2024, and which closed on November 1, 2024.

“As one of our original investors, Stan has participated in nearly every private placement financing round since our Company’s inception. We are grateful for his consistent participation in our financings and for his long-time service on our Board,” said Vlad Vitoc, M.D., Chairman and CEO of MAIA.

Stan Smith, Ph.D. commented, “As a private investor in MAIA, I believe the science behind the THIO franchise, coupling telomere targeting and immunogenicity, can be disruptive in the treatment markets for multiple difficult-to-treat cancer types.”

Dr. Smith is president of Smith Economics Group, Ltd. in Chicago, providing economic and financial consulting nationwide. Trained at the University of Chicago and specializing in litigation economics, Dr. Smith co-authored the first textbook on the subject of economic damages. Dr. Smith has served as an adjunct professor at the University of Chicago and at DePaul University College of Law where he created the first course in the United States in forensic economics.

Additional details on the private placement can be found in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 29, 2024, at www.sec.gov.

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 November 7, 2024

Release – Ocugen Secures $30 Million in Debt Funding

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

November 7, 2024

PDF Version

MALVERN, Pa., Nov. 07, 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, biologics, and vaccines, today announced that on November 6, 2024, the Company entered into a new $30 million credit facility with Avenue Venture Opportunities Fund, L.P., a fund of Avenue Capital Group. Proceeds from the facility are intended for general corporate purposes, capital expenditures, working capital, and general and administrative expenses.

The credit facility, which has a term of 4 years, provided $30 million fully funded on the closing date.

“We are pleased to enter into this relationship with Avenue Capital Group that provides what we believe is a shareholder-friendly financing for the Company,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen. “This additional working capital will support the clinical development of our three, first-in-class modifier gene therapies and provide adequate funding to near completion of the OCU400 Phase 3 liMeliGhT clinical trial and prepare for the BLA and MAA submissions.”

This most recent financing is part of Ocugen’s diversified strategy to fund the business and appropriately allocate resources across the portfolio.

“We are pleased to partner with Ocugen with this financing as the Company drives its next chapter of growth, based on its novel scientific platforms and dedication to fighting blindness diseases,” said Chad Norman, Senior Portfolio Manager, Avenue Capital.

With net proceeds from this facility and current cash, cash equivalents, and restricted cash, the Company’s expected cash runway extends into the first quarter of 2026.

Chardan and Titan Partners Group, a division of American Capital Partners, acted as financial advisors to Ocugen on the transaction.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s 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.

About Avenue Venture Opportunities
The Avenue Venture Debt Funds seek to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies, focusing generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt funds are part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets under management of approximately $12.2 billion, visit www.avenuecapital.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; expectations regarding the satisfaction of closing conditions, timing of the funding and the anticipated use of proceeds; Ocugen’s financial condition and expected cash runway into the first quarter of 2026; and 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 annual and 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 – GoHealth Reports Third Quarter 2024 Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Nov 07, 2024 at 7:00 AM EST

CHICAGO, Nov. 07, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (NASDAQ: GOCO) (“GoHealth” or the “Company”), a leading health insurance marketplace and Medicare-focused digital health company, today announced financial results for the three and nine months ended September 30, 2024.

Third Quarter Highlights

  • Third quarter 2024 net revenues of $118.3 million, a $13.7 million decrease compared to $132.0 million in the prior year period.
  • Third quarter 2024 Submissions were 166,195, a 2.9% increase compared to 161,550 Submissions in the prior year period, with strong contributions from GoHealth’s internal captive agents, partially offset by a decline in Submissions from the external GoPartner Solutions (“GPS”) agents.
  • Third quarter 2024 net income of $15.4 million, an improvement of $71.6 million compared to a net loss of $56.2 million in the prior year period.
  • Third quarter 2024 Adjusted EBITDA(1) of negative $12.1 million, a decrease of $0.6 million compared to negative $11.5 million in the prior year period.
  • Third quarter 2024 trailing twelve months (“TTM”) positive cash flow from operations of $35.1 million, an increase of $38.3 million compared to TTM negative cash flow from operations of $3.2 million in the prior year period.
  • Refinanced Credit Facility, establishing new five-year term with new lender group.
  • Completed the strategic acquisition of e-TeleQuote Insurance, Inc. (“e-TeleQuote”), adding approximately $90.5 million in contract assets and $22.5 million in cash (inclusive of the Company’s initial $5.0 million investment), and recording a $77.4 million gain on bargain purchase, reinforcing GoHealth’s aspirations to expand its market leadership and operational capacity.
  • Achieved an 11.0% improvement in Direct Operating Cost per Submission(2) in the third quarter of 2024 compared to the prior year period, through advancements in artificial intelligence (“AI”), automation, and marketing efficiencies, along with targeted operational improvements.
  • Appointed Brendan Shanahan as Chief Financial Officer, who brings over 30 years of healthcare and financial strategy expertise to GoHealth.

“Our third-quarter results underscore the strength of our ongoing transformation into a Medicare engagement company. We’ve helped over 650,000 consumers navigate Medicare options through tools like PlanFit CheckUp, and with the addition of e-TeleQuote’s 400 agents, we’re prepared to efficiently serve the demand surge we are seeing in this year’s Medicare Annual Enrollment Period (“AEP”). We believe these developments reinforce GoHealth’s leadership in the eBroker space, positioning us for sustained growth and profitability,” said Vijay Kotte, CEO of GoHealth.

“The acquisition of e-TeleQuote not only added $90.5 million in contract assets and $22.5 million in cash (inclusive of our initial $5.0 million investment), but also provided a substantial gain on bargain purchase of $77.4 million, boosting our financial position,” Kotte continued. “This strategic move expanded our agent capacity ahead of a pivotal AEP, which we believe will enable us to capitalize on market demand. As the competitive landscape shifts, GoHealth aims to stand out, ready to support the millions of consumers facing benefit reductions or coverage losses.”

“GoHealth’s third-quarter results reflect disciplined cost management, as we reduced our Direct Operating Cost per Submission(2) by 11.0%, despite broader market challenges. These efficiency gains and a focus on high-quality lead generation underscore our commitment to driving profitable growth, especially as we progress through AEP,” said Brendan Shanahan, CFO of GoHealth. “With over $77 million gained through the e-TeleQuote acquisition, we believe we’re positioned with the liquidity and flexibility needed to drive long-term value, even as we expand our agent base during this critical AEP.”

“This AEP, we’re seeing unprecedented disruption, with over two million consumers losing coverage and more than six million experiencing reduced benefits. We believe GoHealth’s investments in AI-driven technology, an expanded agent network, and our focus on consumer engagement uniquely position us to lead through these market changes, delivering both growth and improved customer experience,” said Kotte.

(1)Adjusted EBITDA is a non-GAAP measure. For a definition of Adjusted EBITDA and a reconciliation to the most comparable GAAP measure, please see below.
(2)Direct Operating Cost per Submission is an operating metric. For a definition of Direct Operating Cost per Submission and an explanation of its calculation, please see below.
  

Conference Call Details

The Company will host a conference call today, Thursday, November 7, 2024 at 8:00 a.m. (ET) to discuss its financial results. A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations:
John Shave
JShave@gohealth.com 
 
Media Relations:
Pressinquiries@gohealth.com 

View Full Release Here.

Avid Bioservices to be Acquired by GHO Capital and Ampersand in $1.1 Billion Deal

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Avid Bioservices will be acquired by GHO Capital and Ampersand Capital in a $1.1 billion deal, with a 13.8% per-share premium.
– Acquisition to enhance Avid’s biologics CDMO services with expanded resources for development and manufacturing.
– Expected to close in Q1 2025, enabling Avid to operate privately and accelerate its service offerings for the biotechnology sector.

Avid Bioservices, Inc. (NASDAQ: CDMO), a major biologics contract development and manufacturing organization (CDMO), announced its acquisition by GHO Capital Partners LLP and Ampersand Capital Partners for approximately $1.1 billion. The all-cash transaction positions Avid for substantial growth, with the backing of experienced healthcare-focused investors to expand its development and manufacturing capabilities in the biotechnology sector. This acquisition marks a strategic move for GHO and Ampersand, leveraging Avid’s expertise to strengthen their portfolios in the life sciences industry.

Under the agreement terms, GHO and Ampersand will acquire Avid’s outstanding shares for $12.50 each in cash, reflecting a 13.8% premium over Avid’s closing share price and a 21.9% premium over its 20-day average. This values the transaction at $1.1 billion, enhancing Avid’s growth potential within a private company framework where it can develop its offerings with the support of dedicated capital and expanded industry networks.

Alan MacKay and Mike Mortimer, Managing Partners of GHO, expressed their excitement to work with Avid’s team to realize the company’s full potential, calling Avid “an ideal addition” that exemplifies their mission to improve healthcare access through efficient manufacturing and high-quality innovation. The deal will enable Avid to maintain its focus on serving the biotechnology and pharmaceutical sectors, helping it meet growing demand for complex biologics at clinical and commercial stages. Additionally, the acquisition aligns with GHO and Ampersand’s broader healthcare strategies, aiming to optimize Avid’s impact in global markets.

Nick Green, President and CEO of Avid, noted that partnering with GHO and Ampersand comes at an opportune time, as Avid has been strategically expanding to meet a broader range of customer needs. He emphasized that this partnership will further Avid’s impact, positioning it to better serve biopharma innovators by utilizing GHO and Ampersand’s resources. “After years of investment and expansion, now is the right time to move forward as a private company,” Green stated, expressing confidence that this move will significantly enhance Avid’s capabilities.

The acquisition is expected to support Avid’s future projects, including cell line development, CGMP clinical and commercial manufacturing, analytical testing, and expanded services for early-stage programs. This additional support allows Avid to optimize customer offerings, broaden its expertise, and develop new industry capabilities that align with its dedication to quality and regulatory standards.

The acquisition, unanimously approved by Avid’s board of directors, is expected to close in Q1 2025, pending customary approvals. Avid’s shares will no longer be publicly traded after the acquisition, and the company will continue to operate under its current name and brand identity, with its headquarters remaining in Tustin, California. Financial and legal advising for Avid are being handled by Moelis & Company LLC and Cooley LLP, respectively, while GHO and Ampersand are advised by William Blair & Company and Ropes & Gray LLP.

This partnership reflects GHO and Ampersand’s strategic investment approach, enabling Avid to strengthen its leadership in biologics manufacturing and develop solutions that respond to high-growth demand in the industry.

Sonnet BioTherapeutics Announces $5 Million Offering and Surge in Trading Volume

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Sonnet BioTherapeutics priced a $5 million public offering to fund research and trials.
– The offering sparked a significant increase in Sonnet’s trading volume.
– Sonnet advances its FHAB platform with promising cancer treatments like SON-1411 and SON-1010.

Sonnet BioTherapeutics (NASDAQ: SONN), a clinical-stage biotech company specializing in oncology-focused immunotherapies, has priced a $5.0 million underwritten public offering. The offering includes 1,111,111 shares of common stock, each sold with one common warrant for the purchase of an additional two shares, at a combined price of $4.50 per share. This offering is set to close on or around November 7, 2024, and is expected to generate gross proceeds of approximately $5.0 million before underwriting discounts and commissions.

The proceeds from this offering are intended to fund Sonnet’s ongoing research and development, clinical trials, working capital, and liability repayments, advancing the company’s mission to develop novel biologic therapies for cancer treatment. While the offering is an exciting opportunity for the company to secure necessary funding, it also brings with it potential risks, including the possibility of shareholder dilution through the issuance of new shares and warrants.

Notably, Sonnet’s share price has seen increased volatility today, with trading volume significantly surging. This rise in trading activity follows the announcement of the offering and its anticipated closure. As is often the case with at-the-market offerings under Nasdaq rules, the pricing of the shares could pressure the stock value in the short term. However, investors may also be reacting positively to the financial backing that will enable Sonnet to accelerate the clinical development of its promising drug pipeline.

Sonnet is known for its proprietary FHAB (Fully Human Albumin Binding) platform, which enables the development of biologic drugs designed to target tumor and lymphatic tissues more efficiently. This technology utilizes a human single-chain antibody fragment (scFv) to hitch a ride on human serum albumin, guiding the drug directly to the target tissue for improved therapeutic effectiveness. The FHAB platform is adaptable, enabling the creation of a wide range of therapeutic candidates, including cytokines, peptides, antibodies, and vaccines.

One of Sonnet’s leading therapeutic candidates is SON-1411, a novel bifunctional fusion protein designed to enhance the efficacy of the immune response against cancer. SON-1411 combines IL-18BPR (a receptor that binds IL-18) with IL-12 and is linked to the FHAB platform. This innovative approach is aimed at overcoming limitations observed in previous IL-18-based therapies, which suffered from poor efficacy due to the presence of IL-18 binding protein (IL-18BP) in the tumor microenvironment. By modifying the IL-18 domain, SON-1411 seeks to bypass this issue and enhance the therapeutic potential of IL-18 in cancer treatment.

In addition to SON-1411, Sonnet is also advancing SON-1010, an IL-12-FHAB fusion protein, through clinical trials for solid tumors and ovarian cancer. The company is evaluating SON-1010 in collaboration with Roche, in combination with the immune checkpoint inhibitor atezolizumab, for the treatment of platinum-resistant ovarian cancer. Moreover, Sonnet is working on SON-1210, a combination of IL-12-FHAB and IL-15, for the treatment of solid tumors like pancreatic cancer.

Despite the potential dilution concerns stemming from the offering, the announcement underscores the company’s strategic commitment to advancing its promising drug candidates. As Sonnet BioTherapeutics progresses through clinical trials and secures additional funding, the surge in trading volume today suggests strong market interest in the company’s future prospects. The funding from the offering will be crucial in supporting Sonnet’s clinical trials and advancing the company’s vision of delivering targeted, effective treatments for cancer patients.

Release – PDS Biotech to Announce Third Quarter Financial Results on November 14, 2024 at 8:30 a.m. Eastern Time

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Nov. 06, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that the Company will host a conference call to report financial results for the quarter ended September 30, 2024, and provide a clinical program update on Thursday, November 14, 2024, at 8:30 a.m. Eastern Time.

Conference Call Details

Date: November 14, 2024
Time: 8:30 a.m. Eastern Time
Dial-in: 1-877-704-4453 or 1-201-389-0920
Webcast Registration: Click Here
Call MeTM Registration: Click Here (Available 15 minutes prior to call)

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with these combinations and indicate favorable tolerability.

We believe that the novel investigational mechanisms of action of Versamune® HPV and the combination of Versamune® HPV and PDS01ADC have resulted in compelling results with potential to successfully disrupt a tumor’s internal defenses, while also generating potent, targeted killer T-cells to attack the tumor. We also believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC, and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com