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Release – PDS Biotech Announces Interim 24-Month Survival Rate of 74% in Immune Checkpoint Inhibitor Naïve Head and Neck Cancer Patients Treated with PDS0101 in Combination with KEYTRUDA® (pembrolizumab)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • Interim VERSATILE-002 data for the first-line treatment of recurrent or metastatic head and neck cancer patients who were immune checkpoint inhibitor (ICI) naïve; published 24-month survival rate of less than 30% for approved ICI1.
  • Received feedback from US Food and Drug Administration (FDA) on the Company’s amended Investigational New Drug (IND) application allowing initiation of VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.
  • 12-month overall survival (OS) rate of 56% in ICI refractory patients; published median 12-month OS rate of 17% with no salvage chemotherapy following tumor progression on ICI (ICI Refractory)2*.
  • Well tolerated with no patients having Grade 4 or 5 combination treatment-related adverse events.
  • Interim VERSATILE-002 data and VERSATILE-003 Phase 3 trial design to be discussed during Key Opinion Leader (KOL) Roundtable today at 8:00 a.m. EDT.

PRINCETON, N.J., Oct. 03, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced updated interim data based on an August 2nd cut off from the VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable, recurrent, or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations whose cancer has returned or spread – ICI naïve and ICI refractory. The ICI naïve group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI refractory group included patients who had not responded to multiple prior treatments, including ICI therapy. Data presented at ASCO was based on a January 13th cut off.

“The updated interim data from our VERSATILE-002 clinical trial further validates the potential of PDS0101 when combined with KEYTRUDA® to address the urgent need for more effective therapies that are well tolerated and allow advanced recurrent and metastatic HPV16-positive head and neck cancer patients to live significantly longer lives than current approaches,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Following feedback from the FDA, we look forward to evaluating this promising combination treatment in the VERSATILE-003 Phase 3 clinical trial, which we expect to initiate in the fourth quarter of 2023. VERSATILE-003 will investigate the efficacy and safety of PDS0101 combined with KEYTRUDA® compared to KEYTRUDA® monotherapy in ICI-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary endpoint for the study will be overall survival.”

VERSATILE-002: ICI Naïve

Highlights of the interim data from the ICI naïve cohort include:

  • 24-month overall survival (OS) rate is 74%; published 24-month survival rate of less than 30% for approved ICI1.
  • 12-month OS rate is 80%; published results of 30-50% with approved ICIs1.
  • Tumor shrinkage seen in 60% (31/52) of patients.
  • Confirmed overall response rate (ORR) is 27% (14/52) to date.
  • Median progression-free survival (PFS) is 8.1 months to date; published results of 2-3 months PFS with approved ICIs1.
  • 13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE; published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy1.
  • 60% (33/55) of patients have CPS score of 1-19 (who generally have a weaker response to KEYTRUDA®), and 40% (22/55) have CPS score >20 (who generally have a higher response to KEYTRUDA®).

VERSATILE-002: ICI Refractory

The goal of this ICI refractory cohort was to confirm and to better understand the role of PDS0101 in prolonging the survival of advanced HPV16-positive head and neck cancer patients who received PDS0101 in combination with KEYTRUDA®. This analysis is also intended to provide insight to the contribution of PDS0101 to overall survival in the National Cancer Institute-led study evaluating the combination of PDS0101, PDS0301 (antibody conjugated IL12), and an ICI.

Highlights of the interim data from the ICI refractory cohort include:

  • The 12-month OS rate is 56%. The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Refractory)2*.
  • 0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.
  • 4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.

“We are pleased with the OS results and knowledge gained from the ICI refractory cohort of VERSATILE-002. In agreement with our Data Monitoring Committee (DMC), we will not progress to stage 2 of this cohort in VERSATILE-002. As previously announced, we have no plans to further develop this combination for ICI refractory patients,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “PDS0101 appears to immunologically alter the patient’s tumor microenvironment to promote survival. This important data will help inform our development plans for PDS0101.”

Key Opinion Leader Roundtable
Today, Tuesday, October 3, 2023, from 8:00 – 9:00 AM EDT, the Company will host a Key Opinion Leader (KOL) Roundtable on Addressing Current and Future Treatments for Recurrent/Metastatic Human Papillomavirus (HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and the Potential Application of PDS0101, including a discussion of the interim data from the VERSATILE-002 trial.

A live webcast of the event will be available online in the Investor Relations section of the Company’s website at https://www.pdsbiotech.com/index.php/investors. A replay will be available for 90 days following the webcast.

1*Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a randomized, open-label phase 3 study; Lancet 2019; 394(10212):1915-1928. *No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101.
https://www.opdivo.com/head-and-neck-cancer
https://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/
2Bila M, Van Dessel J, Smeets M, Vander Poorten V, Nuyts S, Meulemans J, Clement PM. A Retrospective Analysis of a Cohort of Patients Treated With Immune Checkpoint Blockade in Recurrent/Metastatic Head and Neck Cancer. Front Oncol. 2022 Jan 27;12:761428. doi: 10.3389/fonc.2022.761428. PMID: 35155226; PMCID: PMC8828639. *No controlled or comparative studies have been conducted between PDS0101 and no salvage chemotherapy.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.

About VERSATILE-003
The VERSATILE-003 Phase 3 clinical trial is a randomized, active comparator-controlled study designed to investigate the safety and efficacy of PDS0101 combined with KEYTRUDA® compared to KEYTRUDA® monotherapy in ICI-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary efficacy endpoint for VERSATILE-003 is overall survival. The Phase 3 study is expected to involve approximately 90-100 clinical sites globally.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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 PDS0101, PDS0203 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 PDS0101, PDS0203 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; 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. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Release – InPlay Oil Corp. Confirms Monthly Dividend for October 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on IPOOF

CALGARY, AB, Oct. 2, 2023 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.015 per common share payable on October 31, 2023, to shareholders of record at the close of business on October 16, 2023. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.

About InPlay Oil Corp.

InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.

www.inplayoil.com

SOURCE InPlay Oil Corp.

For further information: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634

Investors Take Interest in MAIA Biotechnology as FDA Clears Path for Cancer Drug Trial

Posted on by slightbourne@noblecapitalmarkets.com

Shares of MAIA Biotechnology were trading higher Tuesday after the company announced that the FDA has cleared its application to test its experimental cancer therapy THIO in patients in the United States.

MAIA Biotech is developing THIO as a novel immunotherapy approach for advanced non-small cell lung cancer (NSCLC). With FDA clearance of its Investigational New Drug (IND) application, the company can now include U.S. cancer patients in its ongoing mid-stage trial evaluating THIO’s safety and efficacy.

This regulatory win is driving investor enthusiasm and higher trading volume for MAIA stock today.

About MAIA Biotech and THIO

MAIA Biotech is a clinical-stage immunotherapy company aiming to improve cancer treatment by targeting telomeres. Telomeres play an important role in cancer cell survival and resistance to standard therapies.

The company’s lead therapy THIO represents a first-in-class telomere-targeting agent for NSCLC. Early preclinical research indicates THIO can induce cancer cell death and stimulate anti-tumor immune responses.

MAIA is positioning THIO as a second or third line of treatment for NSCLC patients who have stopped responding to initial immunotherapy. The company sees THIO’s novel approach as a way to improve outcomes in this hard-to-treat population.

Phase 2 Trial Details

THIO is currently being tested in a Phase 2 clinical trial involving sites across Europe, Asia Pacific, and now with FDA clearance, the United States.

The trial is evaluating THIO in combination with the PD-1 checkpoint inhibitor Libtayo in advanced NSCLC patients. Researchers want to see if giving THIO first to “prime” the immune system, followed by Libtayo, can enhance and prolong the immune response against cancer cells.

The primary goal is assessing THIO’s safety and antitumor activity based on overall response rates. Secondary goals include evaluating biomarkers and overall survival. The trial expects to enroll approximately 90 patients total.

Next Steps for MAIA

While still early stage, the FDA clearance represents an important milestone for MAIA as it works to expand THIO’s potential reach. Being able to include U.S. sites should support faster enrollment and generate data from a larger, more diverse patient population.

Positive Phase 2 results would support advancing to a pivotal Phase 3 study, which the company hopes could lead to regulatory approval. MAIA sees a multi-billion dollar market opportunity in later-line NSCLC treatment.

The company is also exploring THIO’s potential in other cancer types like melanoma, prostate cancer, and multiple myeloma.

Why Investors are Excited

FDA clearance of THIO’s IND removes a key regulatory hurdle for MAIA. Being able to test the therapy in the major U.S. market is critical for the smaller biotech company.

Today’s stock move reflects investors’ increased confidence in THIO’s outlook and MAIA’s ability to execute on development plans. If the Phase 2 trial goes well, it would further validate THIO’s novel approach and cancer-fighting potential.

While still highly speculative given the early stage, MAIA represents an intriguing immunotherapy play for investors interested in emerging approaches for hard-to-treat cancers. The company’s focus on telomere biology and unique combination strategy with Libtayo differentiate it from other biotechs.

MAIA stock could continue to be volatile in the months ahead as Phase 2 data approaches. But the FDA clearance has put a spotlight on this previously lesser known name. For investors open to some risk, MAIA may be a cancer immunotherapy stock to have on the radar.

Take a look at more research on MAIA Biotechnology by Noble Capital Markets Senior Research Analyst Robert LeBoyer.

Labrador Gold Corp. (NKOSF) – Drilling to Resume Next Week

Posted on by cpereira@noblefcm.com


Tuesday, October 03, 2023

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

The final stretch. Drilling at Labrador Gold’s 100%-owned Kingsway gold project is targeting the Appleton Fault over a 12-kilometer strike length. The drilling is part of the company’s ongoing 100,000-meter diamond drilling program of which 83,000 meters of drilling has been completed. The company is beginning to receive assays back from the laboratory for samples from approximately 8,877 meters of core which will be released in batches once they have been interpreted. With ~C$11.5 million in cash, Labrador Gold is well-funded to complete the remaining 17,000 meters of planned drilling.

Drilling resumes next week. Labrador Gold expects to resume drilling next week with three rigs. Drilling will target the Gap Zone between the Big Vein and Pristine targets, the Knobby Occurrence, and the Golden Glove target. Permits have been received to drill in the Gap Zone and in the area south of the Big Vein target to the southern boundary of the property which encompasses the Knobby Occurrence and Golden Glove. 


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The $8 Billion Trial of Fallen Crypto Titan Sam Bankman-Fried Begins

Posted on by slightbourne@noblecapitalmarkets.com

The criminal trial of Sam Bankman-Fried, the disgraced founder of bankrupt crypto exchange FTX, kicks off on Tuesday in New York. Bankman-Fried faces seven charges related to allegedly misusing billions in customer funds to cover losses at his hedge fund, Alameda Research. If convicted on all counts, he could face over 100 years in prison.

The charges include wire fraud, conspiracy to commit wire fraud, securities fraud, conspiracy to commit money laundering, and conspiracy to commit bank fraud. Prosecutors claim Bankman-Fried orchestrated “one of the biggest financial frauds in American history” by funneling customer deposits from FTX to Alameda to cover bad bets.

Up to $8 billion in customer money has allegedly gone missing. The government’s star witnesses will likely be former Alameda CEO Caroline Ellison and FTX co-founder Gary Wang, both of whom have pleaded guilty to charges and are cooperating.

The trial is anticipated to last 6 weeks. Jury selection begins Tuesday morning. Bankman-Fried has pleaded not guilty, and his defense may argue he was following lawyer guidance and unaware his actions were illegal. A second trial on additional charges is set for March 2024.

The Rise and Fall of Sam Bankman-Fried

Bankman-Fried first made his name in 2017 exploiting arbitrage opportunities in bitcoin prices across exchanges. He launched trading firm Alameda Research to capitalize on these trades. Alameda’s success led to the 2019 founding of FTX, which offered innovative crypto trading products.

Bankman-Fried amassed a $26 billion personal fortune at one point. He became a major political donor and crypto’s poster child. But in 2022, as crypto prices crashed, his empire crumbled. Regulators allege Bankman-Fried secretly used FTX customer deposits to cover Alameda’s losses from the start.

Though FTX claimed to have robust risk management, it had little record-keeping. Alameda lost $3.7 billion despite claims it was profitable. It used FTX customer funds and overvalued FTT tokens as collateral for billions in loans. Lenders issued margin calls in 2022, but Alameda lacked assets to cover debts.

The Collapse and Charges

When FTX’s reliance on customer funds was exposed, customers raced to withdraw. But FTX didn’t have their money. Bankman-Fried tried unsuccessfully to find investors for a bailout. He claimed publicly that assets were fine, but privately admitted billions were missing. FTX paused withdrawals, and Bankman-Fried turned to rival Binance for a takeover.

But the deal fell through as the extent of missing funds and mismanagement was revealed. Bankman-Fried resigned, and FTX filed bankruptcy on November 11, 2022. The DOJ arrested Bankman-Fried in the Bahamas in December on fraud and money laundering charges. Prosecutors allege he knowingly misled investors and misused billions in customer deposits from the very start.

Billions Remain Missing

While FTX’s bankruptcy team has recovered over $7 billion so far, billions more in customer funds remain unaccounted for. Bankman-Fried was previously hailed as an effective altruist who touted crypto’s potential for good. But regulators say greed and deception drove FTX from the beginning. The human toll of lost life savings won’t be fully known for some time.

Bankman-Fried now faces the prospect of spending most of his life in prison. The outcome of the trial could shape crypto regulation going forward. But the damage to retail investors and confidence in the industry has already been done. Crypto may never fully shed the stain of FTX’s epic collapse.

Bond Market Signals Recession Warning As Yields Invert

Posted on by slightbourne@noblecapitalmarkets.com

The bond market is sounding alarm bells about the economic outlook. The yield on the 2-year Treasury briefly exceeded the 10-year yield this week for the first time since 2019. Known as a yield curve inversion, this phenomenon historically signals a recession could be on the horizon.

While not a guarantee, yield curve inversions have preceded every recession over the past 50 years. Here is what is happening in the bond market and what it could mean for investors.

Why Did Yields Invert?

Yields on short-term bonds like 2-year Treasuries tend to track the Federal Reserve’s policy rate. With the Fed aggressively hiking rates to combat inflation, short-term yields have been rising quickly.

Meanwhile, long-term yields like the 10-year are influenced by investors’ growth and inflation expectations. As optimism over the economy’s trajectory wanes, investors have been driving down long-term yields.

This dynamic inversion, where short-term rates exceed longer-duration ones, reflects mounting concerns that the Fed’s rate hikes will severely slow economic activity. Markets increasingly fear rates may cause a hard landing into recession.

Image credit: Cnbc.com

Growth and Inflation Concerns Intensify

The yield curve has flashed the most negative signal since the lead up to the pandemic recession. This suggests investors see a lack of catalysts for growth on the horizon even as inflation remains stubbornly high.

Ongoing supply chain problems, the war in Ukraine putting pressure on food and energy prices, and fears of a housing market slowdown are all weighing on outlooks. There is a sense the Fed lacks effective tools to bring down inflation without crushing the economy.

Meanwhile, key economic indicators like manufacturing surveys have weakened significantly. This points to activity already slowing ahead of when rate hikes would take full effect.

Implications for Investors

The risks of a recession are rising. Yield curve inversions have foreshadowed every recession since the 1950s. However, they have also sometimes occurred 1-2 years before downturns start.

This suggests investors should prepare for choppiness, but not panic. Rotating toward more defensive stocks like healthcare and consumer staples can help portfolios better weather volatility. At the same time, cyclical sectors like tech and industrials could face more pressure.

In fixed income, short-term bonds may offer opportunities as the Fed potentially cuts rates during a downturn. But credit-sensitive sectors like high-yield bonds and leveraged loans could struggle if defaults rise.

While uncertainty abounds, the inverted yield curve highlights the delicate balancing act ahead for the Fed and concerns over still-high inflation. Investors will be closely watching upcoming data for signs of how quickly the economy is slowing. For now, caution and safe-haven assets look to be in favor as recession worries cast a long shadow.

Biotech Poised for a Powerful Comeback

Posted on by slightbourne@noblecapitalmarkets.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Release – Aurania Provides Update And Directors Receive Options In Lieu Of Fees

Posted on by aweinsoff@channelchek.com

Research News and Market Data on AUIAF

Aurania Resources Ltd. (TSXV: ARU; OTCQB: AUIAF; Frankfurt: 20Q) (“Aurania” or the “Company”) provides a brief update and announces that its directors received their quarterly director fees in the form of stock options in lieu of cash for the period ended September 30th (see press release dated April 12, 2023).

On September 29, 2023, each director was granted 26,800 stock options at an exercise price of $0.235 in lieu of their director fees for Q3 2023. An aggregate of 107,200 stock options were granted. The stock options will be exercisable for three years and will vest on September 29, 2023.  The Company will grant stock options equivalent in fair value to the director fees forfeited each quarter during 2023, at an exercise price of one cent above the closing price of Aurania’s shares the day prior to the grant and exercisable at any time for a period of three years following the date of issuance.

Update on Ecuador and France

The next President of Ecuador will be determined in a run-off election on October 15.  The two candidates, Luisa Gonzalez (UNES – Correa’s party) and Daniel Noboa (ADN – centrist, business-aligned) are expected to be supportive of responsible mining.  Gonzalez was in first place with 34% of the votes on August 20th, and Daniel Noboa held 24% of the votes at that time. The winning candidate will be in power until the next president is elected in Ecuador’s regularly scheduled election in the first half of 2025.  After the first-round results, Noboa emerges as the candidate with the most promising prospects for the presidency in the upcoming second round. This is because González’s room for growth on her 34 percent showing remains limited to those supportive of Correa’s former Socialist government (2007-2017).  Noboa, by contrast, is positioned to secure substantial backing from voters who had initially supported a variety of “anti-Correísmo” candidates.  At time of writing, Noboa is ahead in the polls, from 5-8%.  He has already met with the Ecuador Chamber of Mines, of which Aurania is a member, and recognizes the importance of mining to the Ecuador economy.  Whomever wins the election will take office in December.

In the meantime, Aurania’s CSR team continues to work with local communities in Ecuador to advance various social programs and initiatives within the areas of the Company’s key targets, strengthening the bonds with the communities and improving the social license the Company has. The management team’s focus is to work on those initiatives with the higher potential to create value for our shareholders in Ecuador and France, where the applications for mineral exploration permits, announced in July 2023, are being processed. The Company will report on those activities as new developments occur.

About Aurania

Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucú Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.

Click here to view the full press release dated October 2, 2023 on Aurania’s website including contact details and forward-looking statements.

Release – Great American Cookies And Marble Slab Creamery Open At Cook Children’s Medical Center In Fort Worth

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

10/02/2023

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Dessert Duo’s New Co-Branded Location Marks FAT Brands ’ Continued Expansion into Non-Traditional Venues

LOS ANGELES, Oct. 02, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Great American Cookies, Marble Slab Creamery and 16 other restaurant concepts, announces the opening of a co-branded Great American Cookies and Marble Slab Creamery location at Cook Children’s Medical Center in Fort Worth, Texas. Situated in the first floor of the newly expanded Dodson Specialty Clinics, the new store underscores FAT Brands’ strategic approach to broadening its footprint in non-traditional spaces.

“The opening of our co-branded Great American Cookies and Marble Slab Creamery location at Cook Children’s reinforces FAT Brands’ commitment to executing a diverse growth strategy that brings our 18 restaurant brands to a wider audience,” said Taylor Wiederhorn, Chief Development Officer at FAT Brands. “With this new opening, FAT Brands continues to demonstrate adaptability and a forward-thinking approach in the ever-evolving franchise landscape.”

For nearly 40 years, Marble Slab Creamery has been an innovator in the ice cream space, dreaming up the frozen slab technique and offering homemade, small-batch ice cream with free unlimited mix-ins, shakes in a variety of flavors, and ice cream cakes.

Since 1977, Great American Cookies has baked up a reputation for not only being the creator of the Original Cookie Cake, but also for its famous chocolate chip cookie recipe. Other craveable menu items include decadent Double Doozies™, made with delectable icing sandwiched between two cookies.

Great American Cookies and Marble Slab Creamery at Cook Children’s Medical Center is located in the Dodson Specialty Clinics, which is found at 1500 Cooper St., Fort Worth, TX 76104. The store will be open from 8 a.m. to 5 p.m. Monday through Friday to hospital guests, staff and patients. For more information on Great American Cookies, visit www.greatamericancookies.com. For more information on Marble Slab Creamery, visit www.marbleslab.com.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 18 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Smokey Bones, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

About Great American Cookie s

Founded on a family chocolate chip cookie recipe in 1977, Great American Cookies believes that pure, simple delight is part of living a full life. Serving the Original Cookie Cake, fresh baked cookies in a variety of flavors, brownies, and Double Doozies™, we promise to treat you to bites of bliss that prove how sweet life can be. With more than 400 bakeries across the country and internationally in Bahrain, Guam, Saudi Arabia, and treats available to ship right to your door, the sweet spot is always close to home. For more information, visit www.greatamericancookies.com.

About Marble Slab Creamery

Since dreaming up the frozen slab technique and serving fresh homemade, small-batch Ice Cream in-store since 1983, Marble Slab Creamery has always known how to dream big. We sprinkle our customers with imagination and promise to inspire with infinite Ice Cream possibilities to feed your curiosity and capture cravings. With our always free mix-in philosophy, delicious Ice Cream and Shakes in a variety of flavors, hand-rolled waffle cones, and Ice Cream Cakes, imagination has no limits. Today, Marble Slab Creamery is enjoyed by consumers across the globe with locations in Bahrain, Canada, Kuwait, Saudi Arabia, Guam, Puerto Rico, and the United States. For more information, visit www.marbleslab.com.

About Cook Children’s Medical Center

Cook Children’s is more than a health care system: we strive to be an extension of your family, growing with your child from their first steps to adulthood. By collaborating to deliver on our Promise—to improve the well-being of every child in our care and our communities, we connect the dots for our patients. Between primary and specialty. Between home and medical home. Between short-term care and long-term health.

Based in Fort Worth, Texas, we’re 8,000+ dedicated team members strong, passionately caring for over 1.5 million patient encounters each year. Our integrated, not-for-profit organization spans two medical centers (including our new, state-of-the-art location in Prosper), two surgery centers, a physician network, home health services and a health plan. It also includes Child Study Center at Cook Children’s, Cook Children’s Health Services Inc., and Cook Children’s Health Foundation.

And our impact extends beyond the borders of Texas. We proudly treat children from virtually every state in the nation and 32 countries. By seeing the world through the eyes of children and their families from all backgrounds, we’re able to shape health care suited to them: connected by kindness, imagination and respect—with an extra dose of magical wonder.

Discover more at cookchildrens.org.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168

Kim Brown, APR, Cook Children’s
Kim.brown3@cookchildrens.org
817-266-3728

Source: FAT Brands Inc.

Release – CVG Announces Election of Melanie K. Cook to Board of Directors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVGI

October 2, 2023

NEW ALBANY, Ohio, Oct. 02, 2023 (GLOBE NEWSWIRE) — Commercial Vehicle Group (the “Company” or “CVG”) (NASDAQ: CVGI) announced today that its Board of Directors (the “Board”) has elected Melanie K. Cook as an independent director to the Board, effective September 26, 2023. Ms. Cook will serve on the Audit and Compensation committees of the Board. Ms. Cook will stand for re-election at the Company’s 2024 Annual Meeting of Stockholders.

Ms. Cook, 51, brings tremendous operating experience and expertise in a multitude of business areas. Ms. Cook retired as Chief Operating Officer of GE Appliances (a global appliance manufacturer and a Haier Company). Her professional experience includes: Chief Operating Officer of GE Appliances from 2017 until retirement in 2021; previously Vice President Sourcing from 2014 to 2017. Prior to GE Appliances, she held multiple roles within General Electric including within the Corporate Audit Staff. Ms. Cook’s nearly 30 years of global experience includes business unit leadership roles with full profit and loss responsibility, product lifecycle management, digitization, end-to-end supply chain, global sourcing and finance/audit across multiple industries globally. Ms. Cook’s public company board experience includes serving as an independent Director of Badger Meter, Inc. (BMI: NYSE) since February 2022, where she serves on the Audit and Compliance Committee of the Board. Ms. Cook holds a Bachelor of Science in Business Administration, with a specialty in Decision and Information Sciences, from the University of Florida.

Ms. Cook stated, “It is an honor to join CVG’s Board and I look forward to adding my perspective to the Board room.”

Robert Griffin, Chairman of the Board, welcomed Director Cook to the Board. Mr. Griffin added, “We are very pleased to have Ms. Cook join the CVG Board, bringing tremendous skills and significant experience in areas of critical importance to the Company and enhancing our Board’s capabilities as we guide the Company through the execution of its strategy.”

About CVG

At CVG, we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Investor Relations Contact:
Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

Media Contact:
Patrick Woolford
Patrick.woolford@cvgrp.com

Source: Commercial Vehicle Group, Inc.

Release – PDS Biotech Announces PDS0101 Combined with Chemoradiotherapy Associated with Rapid Decline in Circulating Tumor DNA (ctDNA/cfDNA)

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Research News and Market Data on PDSB

  • Study evaluated levels of circulating cell-free HPV DNA (cfDNA) in patients with locally advanced cervical cancer in the IMMUNOCERV Phase 2 clinical trial and patients receiving standard of care (SOC) treatment
  • Patients treated with PDS0101 had greater clearance of cfDNA as compared to those treated with SOC (at week 5, 91.7% vs. 53.1%, P=0.0179)
  • Data presented during oral presentation at ASTRO 2023 Annual Meeting

PRINCETON, N.J., Oct. 02, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced data demonstrating lead candidate PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy (CRT) was associated with a rapid decline in human papillomavirus (HPV) circulating cell-free DNA (cfHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial were featured in an oral presentation by Aaron Seo, MD, PhD, of The University of Texas MD Anderson Cancer Center, at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting in San Diego, CA.

The IMMUNOCERV Phase 2 trial is investigating PDS0101 in combination with SOC CRT in the treatment of cervical cancer patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes. HPV is the primary cause of cervical cancer with over 99% caused by HPV infection, and cfHPV-DNA can be detected in the blood of patients with cervical cancer. HPV type 16 (HPV16) is the most prominent subtype associated with cervical cancer. The study presented at ASTRO 2023 evaluated the relationship between the levels of circulating cfHPV-DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer. 

“We are encouraged by this data from the IMMUNOCERV trial, which highlight the potential of PDS0101 to positively impact cfDNA, an emerging biomarker of clinical response in cervical and other HPV-related cancers,” said Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “The findings complement previously presented IMMUNOCERV data which suggested PDS0101 promotes the induction of multifunctional CD8 killer T cells that were associated with declines in circulating tumor DNA and a clinical response with greater than 60% tumor shrinkage at mid-point evaluation in 100% of high-risk cervical cancer patients on the trial. We look forward to continuing to address the unmet needs of patients suffering from HPV-positive cancers such as cervical cancer.”

Sixty-one patients with cervical cancer were included in the analysis either as part of a SOC treatment banking protocol (n=44) or as part of the IMMUNOCERV Phase 2 clinical trial combining PDS0101 with SOC (n=17). Longitudinal plasma samples were collected from each patient at baseline, during weeks 1, 3, and 5, and at 3-4 months after CRT.

In the study, HPV16 was detected in 59% of tumors and 70% of cfDNA. The median cfDNA at baseline was 28.15 copies/mL, with a range of 0 to 206,030 copies/mL.

The presentation at ASTRO 2023 highlighted the following data:

  • Earlier and greater proportion of cfDNA clearance with PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3% clearance after 3 weeks vs. 30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs. 53.1% with SOC (p=0.0179)
  • Baseline cfDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement; 100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes

“HPV16 cfDNA represents a novel biomarker with the potential to help oncologists make more informed treatment decisions for their patients with HPV16-positive cancers. This early data are encouraging, and we will continue to evaluate patients to determine any potential correlations between cfDNA clearance and clinical outcomes. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and ongoing clinical outcomes,” said study principal investigator Ann Klopp, MD, PhD, Professor of Radiation Oncology at MD Anderson. “I look forward to the continued evaluation of PDS0101 in combination with standard-of-care chemoradiotherapy.”

About Versamune®
Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically active immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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 PDS0101, PDS0203 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 PDS0101, PDS0203 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; 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. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contact:
Gina Cestari
6 Degrees
Phone: +1 (917) 797-7904
Email: gcestari@6degreespr.com

Release – Shawn Mural Named Senior Vice President and Chief Financial Officer at V2X

Posted on by aweinsoff@channelchek.com

Research News and Market Data on VVX

10/02/2023

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MCLEAN, Va., Oct. 2, 2023 /PRNewswire/ — V2X, Inc. (NYSE: VVX), today announced Shawn Mural has been appointed as its Senior Vice President and Chief Financial Officer (CFO). In this role, Mural will oversee all finance and accounting functions, including controllership, finance operations, planning, tax, treasury, investor relations, and corporate development.

Mr. Mural joins V2X from RTX Corporation and its subsidiaries (“RTX”), where he served in various capacities of increasing responsibility and most recently as Vice President of Finance and CFO of Raytheon. Over his 24 years at RTX, Shawn’s experience in various leadership roles, as well as managing large integration and operational excellence-related activities, will help support the future growth of V2X.

“As we continue to the next phase of the company’s growth, Shawn brings strong financial leadership and deep knowledge and understanding of the aerospace and defense industry,” said Chuck Prow, President and Chief Executive Officer of V2X. “I look forward to working alongside him as we continue to execute the V2X strategy.”

This appointment follows Susan Lynch’s retirement from the company. The V2X team thanks Susan for her dedicated service and wishes her every success in future endeavors.

About V2X 
V2X builds smart solutions designed to integrate physical and digital infrastructure – from base to battlefield – by aligning people, actions, and outputs. Formed by the merger of Vectrus and Vertex, we bring a combined 120 years of successful mission support. Our lifecycle solutions improve security, streamline logistics, and enhance readiness.

The Company delivers a comprehensive suite of integrated solutions across the operations and logistics, aerospace, training, and technology markets to national security, defense, civilian and international clients. Our global team of approximately 15,000 employees brings innovation to every point in the mission lifecycle, from preparation to operations to sustainment, as it tackles the most complex challenges with agility, grit, and dedication.

Media Contact
Angelica Spanos Deoudes
Senior Media Strategist
Communications@goV2X.com
571-338-5195

Investor Contact 
Michael Smith
Vice President, Treasury, Corporate Development and Investor Relations
IR@goV2X.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/shawn-mural-named-senior-vice-president-and-chief-financial-officer-at-v2x-301943910.html

SOURCE V2X, Inc.

Release – Eledon Pharmaceuticals Appoints Kidney Transplant Specialist Dr. Allan Douglas Kirk to Board of Directors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

IRVINE, Calif., Oct. 02, 2023 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the appointment of Allan Douglas Kirk, M.D., Ph.D., to its Board of Directors. Dr. Kirk is internationally recognized for his work in organ transplantation, with a specialized focus on kidney transplants and transplant immunology. He is currently Chairman of the Department of Surgery and Surgeon-in-Chief at Duke University School of Medicine. He is also the David C. Sabiston, Jr. Professor of Surgery, a Professor of Integrative Immunobiology, and a Professor of Pediatrics at Duke.

“We are pleased to have Dr. Kirk join our Board of Directors at a pivotal time at the company following initiation of our Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Dr. Kirk’s renowned expertise in the field of organ transplantation, including kidney transplantation, will be incredibly valuable as we advance tegoprubart in clinical development on our mission to fulfill an urgent unmet need for the thousands of patients in need of an organ transplant. I look forward to working closely together.”

“Organ transplantation remains an area of significant unmet need – a need that is often overlooked or underrecognized – and my decades of research have been driven by my desire to improve immunosuppression regimens for transplant patients. Transplant recipients deserve new treatment options with better efficacy and fewer side-effects to help protect their transplanted organs,” said Dr. Kirk. “I am proud to join the Eledon team on their mission to bring patients a novel treatment option that has the potential to transform immunosuppression and improve the lives of patients.”

Dr. Kirk served as the inaugural Chief of the Transplantation Branch for the National Institute of Diabetes and Digestive and Kidney Diseases and has been a principal investigator for multiple clinical trials, including the first-in-human experience with novel immunosuppressive agents. Dr. Kirk has helped pioneer the use of co-stimulation pathway blockade to prevent organ rejection in transplant patients. He has a special interest in immune management of transplant recipients, including therapies that influence T cell co-stimulation pathways and adjuvant therapies that facilitate co-stimulation blockade to prevent the rejection of transplanted organs without undue suppression of protective immunity. His research is directed toward understanding transplant rejection and translating this understanding into improved therapies for transplant recipients. He has co-authored hundreds of peer-reviewed journal publications.

Dr. Kirk is a member of the Duke Transplant Center and is a core faculty member of the Duke Innovation & Entrepreneurship program. He also previously served as Editor-in-Chief for the American Journal of Transplantation. Dr. Kirk earned an M.D. from Duke University School of Medicine, a Ph.D. from Duke University and a B.S. from Old Dominion University.

About Eledon Pharmaceuticals and tegoprubart (formerly AT-1501)

Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (also called “CD154”), a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about planned clinical trials and the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals