Why AIM ImmunoTech Trading Higher

 AIM ImmunoTech Inc 

AIM

 announced that Roswell Park Comprehensive Cancer Center has reported the complete topline data from its Phase 1 study evaluating Ampligen (rintatolimod) as a component of a Chemokine-Modulating (CKM) regimen for the treatment of early-stage triple-negative breast cancer (TNBC). 

The topline results from the Phase 1 study confirm the positive findings previously presented at the 2022 Society for Immunotherapy of Cancer 37th Annual Meeting in a poster presentation.

Complete topline results confirm that treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC).

The results demonstrated that treatment was well-tolerated with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities (DLTs) or delayed or immune-related toxicities. 

DLT was defined as grade 3 or higher toxicities within the first three weeks. Secondary endpoints included pCR rate where 5/9 (56%) of patients attained pCR, and one more attained ypTmic. 

Tumor and blood biomarkers were also analyzed in exploratory studies.

A Phase 2 study in early-stage TNBC is planned to determine if CKM, including Ampligen, may be a safe and effective alternative to pembrolizumab or pembrolizumab/NAC.

https://www.benzinga.com/general/biotech/23/09/34452108/why-is-cancer-focused-microcap-stock-aim-immunotech-trading-higher-today

Novo Integrated Updates on Buyback, Restructuring

Novo Integrated Sciences, Inc. (NASDAQ: NVOS) (the "Company" or "Novo"), today provides an update with respect to the Company’s Board of Directors (the "Board") conducting a strategic review of the Company to include implementing a future share repurchase program. The Board is considering and evaluating a share buyback of up to $5,000,000 upon closing and full funding of either (i) the $70,000,000 RC Note with a total draw of $57,000,000; or (ii) the SWAG Agreement for the purchase of a precious gem collection. Both transactions have been previously disclosed.

https://finance.yahoo.com/news/novo-integrated-sciences-provides-potential-130000106.html

Day One Completes NDA Submission for Relapsed or Progressive Pediatric Low-Grade Glioma

 Overall response rate (ORR) greater than 50% across three assessment criteria

Median duration of tovorafenib treatment of 15.8 months as of June 5, 2023, with 66% of patients remaining on treatment

FDA filing decision expected by mid-November

https://www.globenewswire.com/news-release/2023/09/11/2740811/0/en/Day-One-Announces-Updated-FIREFLY-1-Data-for-Tovorafenib-and-Completion-of-Rolling-NDA-Submission-to-FDA-for-Relapsed-or-Progressive-Pediatric-Low-Grade-Glioma-pLGG.html

Morgan Stanley strategists tout health stocks in "late cycle" market

 Morgan Stanley equity strategists said on Monday that markets are in a "late cycle" environment, with healthcare stocks poised to benefit because they have both defensive and growth properties.

"We view this year as an extension of the late cycle period often experienced when the (Federal Reserve) is expected to pause or reverse its hawkish policy stance," strategists led by Michael Wilson said in a research note.

Morgan Stanley noted that healthcare has underperformed; the S&P 500 health sector is down 2.5% year-to-date versus a 16.5% rise for the overall index.

But the bank's strategists said they were "overweight" the sector, calling it a "late cycle outperformer given its defensive and growth properties."

"Earnings revisions are turning higher for the cohort and valuation remains attractive," the strategists wrote.

Overall, the strategists' "late cycle playbook" included a "barbell" portfolio approach with defensive growth on one side and energy and industrials - two areas that tend to benefit in strong economies - on the other.

Separately, strategists at BofA Global Research said their US Regime Indicator officially switched to a "recovery" phase for the economy, with metrics such as inflation and GDP improving.

Previous recovery regimes have seen pro-cyclical areas such as financials fare well, while utilities and other defensive groups lagged, BofA said in a note on Sunday.

Meanwhile, the recovery phase has also seen value and higher risk stocks lead, BofA wrote.

"These would mark a reversal of 2023's mega-cap growth leadership," BofA said in the note.

https://finance.yahoo.com/news/morgan-stanley-strategists-tout-health-164913627.html

NY Fed Survey: Big Fall In Household Finanancial Sentiment, Long-Term Inflation Seen at 15 Month High

 After four months of declines in the 1-Year inflation expectation as reported by the NY Fed's consumer survey, August saw a reversal in this series which traditionally is also a proxy for the price of oil (which just hit a 2023 high this morning), however this was offset by a small decline in 3 year inflation expectations. However, the most concerning observations was that the inflation outlook at the 5-year point hit the highest since march 2022 while households turned even less optimistic about their financial situation.

Here are the details: as shown in the chart below, while inflation expectations at the one-year horizon were slightly higher at 3.63% in Aug. from the previous month’s 3.55%, three-year-ahead inflation expectations, conversely, fell to 2.79% from 2.91%. Finally, 5-year-ahead inflation expectations rose from 2.90% to 3.00%, the highest since March 2022.

The report also noted that median inflation uncertainty (the uncertainty expressed regarding future inflation outcomes) was unchanged at the one-year-ahead horizon and decreased at the three- and five-year-ahead horizons.

Turning to median home price growth expectations, the survey found that these increased by 0.3% point to 3.1%, its highest reading since July 2022... which of course is just the opposite of what the Fed wants to achieve, and suggests that the Fed's tightening plans have failed miserably at slowing the growth in what is arguably the most important asset class for the US middle class. The increase was most pronounced for respondents under the age of 60 and those with a high school education or less.

Next, turning to year-ahead commodity price expectations, these rose across the board in August, increasing by 0.4% for gas (to 4.9%), 0.1% for food (to 5.3%), 0.8% for the cost of medical care (to 9.2%), and 0.2% for the cost of college education (to 8.2%) and rent (to 9.2%).

But while the latest reversal in the downward trend of inflation is troubling, what is even more concerning was the report's finding that the median expected growth in household income fell to 2.94% (the decline was largest for respondents with a high-school education or less) to the lowest since July 2021...

... prompting the report authors to write that "perceptions about current credit conditions and expectations about future conditions both deteriorated."  Digging into the details of the household finance survey reveals substantial deterioration across all indicators, and especially when it comes to applying - or receiving - new credit:

• Median household spending growth expectations fell by 0.1 percentage point to 5.3%.
• Perceptions of credit access compared to a year ago deteriorated in August, with the share of households reporting it is harder to obtain credit than one year ago hitting a new series high. Expectations for future credit availability also deteriorated in August, with the share of respondents expecting it will be harder to obtain credit in the year ahead increasing.
  • The application rate for any kind of credit over the past twelve months declined to 40.3 percent from 40.9 percent in February, its lowest reading since October 2020. Application rates declined to 11.9 percent for auto loans and 12.5 percent for credit card limit requests, but increased to 24.8 percent for credit cards, 6.5 percent for mortgages, and 5.3 percent for mortgage refinances.
  • The overall rejection rate for credit applicants increased to 21.8 percent, the highest level since June 2018. The increase was broad-based across age groups and highest among those with credit scores below 680.
  • The rejection rate for auto loans increased to 14.2 percent from 9.1 percent in February, a new series high. It increased for credit cards, credit card limit increase requests, mortgages, and mortgage refinance applications to 21.5 percent, 30.7 percent, 13.2 percent, and 20.8 percent, respectively.
  • The proportion of respondents reporting that they are likely to apply for one or more types of credit over the next twelve months rose to 26.4 percent from 26.1 percent in February.
  • The average reported probability that a loan application will be rejected increased sharply for all loan types. It rose to 30.7 percent for auto loans, 32.8 percent for credit cards, 42.4 percent for credit limit increase requests, 46.1 percent for mortgages, and 29.6 percent for mortgage refinance applications. The readings for auto loans, mortgages, and credit card limit increase requests are all new series highs.
• The average perceived probability of missing a minimum debt payment over the next three months fell by 0.6 percentage point to 11.1%.
• The median expectation regarding a year-ahead change in taxes (at current income level) declined by 0.2 percentage point to 4.1%.
• Laughably, the median year-ahead expected growth in government debt declined to 8.9%, its lowest reading since February 2020: just the opposite will happen.
• The mean perceived probability that the average interest rate on saving accounts will be higher in 12 months decreased by 0.8 percentage point to 30.1%.
• Perceptions about households’ current financial situations compared to a year ago deteriorated slightly in August, with the share of households reporting a worse situation compared to a year ago rising. Similarly, year-ahead expectations about households’ financial situations deteriorated in August with the share of households expecting a worse financial situation in one year from now rising.
• The mean perceived probability that U.S. stock prices will be higher 12 months from now decreased by 1.9 percentage points to 35.2%.

Finally, looking at the state of the labor market, we finds that...

• Median one-year-ahead expected earnings growth rose by 0.1 percentage point to 2.9% in August. The series has been moving within a narrow range of 2.8% to 3.0% since September 2021.
• Mean unemployment expectations—or the mean probability that the U.S. unemployment rate will be higher one year from now—increased by 1.8 percentage points to 38.5%, remaining below its 12-month trailing average of 40.2%.
• The mean perceived probability of losing one’s job in the next 12 months rose by 2.0 percentage points to 13.8%, its highest reading since April 2021. The mean probability of leaving one’s job voluntarily in the next 12 months also increased by 1.9 percentage points to 18.9%. Both increases were most pronounced for respondents with a high school education or less and annual household income below $50k.
• The mean perceived probability of finding a job (if one’s current job was lost) decreased by 0.1 percentage point to 55.7%.

Putting it all together, inflation expectations (especially longer-term) are once again rising and hit the highest in 15 months, while household perceptions about their current financial situations and expectations for the future deteriorated sharply.

More in the full report here.

https://www.zerohedge.com/economics/ny-fed-survey-finds-sharp-deterioration-household-finanancial-sentiment-long-term

Herophilus: Transaction with Genentech for Next-Generation Drug Discovery

 Herophilus, a leading biotechnology company with the mission to discover neurotherapeutics to cure complex brain diseases, today announced that Genentech, a member of the Roche Group, has acquired its proprietary high-throughput human organoid-based drug discovery platform comprising the Orchard™, Orchestra™, and OrCA™ technologies. Herophilus will continue to advance its own ongoing neurotherapeutic research programs.

“Since our founding in 2017, Herophilus’s vision has been to leverage the parallel revolutions in human complex in vitro brain models, scaled laboratory automation, and scientific machine learning to break the decades-long logjam in neuroscientific drug discovery. We are thrilled that Genentech will combine Herophilus’ platform with its exceptional drug development ability and experience to accelerate this vision,” said Saul Kato, CEO and Co-founder of Herophilus.

This transaction provides the Genentech and Roche R&D units with these three components of Herophilus’ discovery platform:

• Orchestra: Comprehensive hybrid-cloud enterprise-scale software system for instrument and automation control, experiment tracking, provenant data and metadata management, high-performance microscopy imaging and video data visualization and exploration, data annotation and rapid machine learning pipeline development
• OrCA: Modular Organoid Culture and Assay scaled experimental system, comprising five function-specific workcells and a library of optimized biology protocols for low-variability, tuned organoid culture and high-content, high-throughput phenotypic assays
• Orchard: Protocol library for high-quality reprogramming and genetic engineering of organoid-optimized stem cell lines and access to a diversified neurological disease patient stem cell biobank

https://www.biospace.com/article/releases/herophilus-announces-strategic-transaction-with-genentech-for-next-generation-drug-discovery-platform/

Therapeutic Solutions: Advancement in Stem Cell Therapy of Frontotemporal Dementia

 Therapeutic Solutions International, Inc. (TSOI), announced today the development of a new therapeutic approach for treatment of Frontotemporal Dementia, by combining the activation of endogenous anti-inflammatory cells in the nervous system, together with regenerative cell intervention in the form of stem cell therapy, and molecules capable of activating endogenous stem cells already present in the patient.

The therapy, for which a patent application has been filed, has demonstrated positive preliminary data in an animal model of the condition. The Company plans to make the therapy available to “no option” patients with this condition through the Veltmeyer Institute under the “Right to Try Law”.

https://www.biospace.com/article/releases/therapeutic-solutions-international-reports-landmark-advancement-in-stem-cell-therapy-of-frontotemporal-dementia/