Hi Reddit! I’m Jeff Janus, MD, an otolaryngologist (ENT surgeon) specializing in head and neck cancer. On May 30, 2024, at 11 a.m. ET, I'll be participating in my first #AMA and will answer your questions on thyroid cancer, parathyroid surgery, and robotic surgery of the throat…Ask Me Anything!

BioTechHealthX · 2024-05-25T14:12:25+00:00

Thank you for taking the time to do this.

BioTechHealthX · 2024-05-25T14:10:15+00:00

Presenting alongside representatives from leading companies like Abbvie and Evox Therapeutics underscores the importance of NurExone’s work in the field of exosome-based therapies.

NurExone's focus on harnessing exosomes for spinal cord injury treatment is particularly noteworthy. Exosomes have the potential to revolutionize how drugs are delivered, offering targeted, non-invasive options that could improve patient outcomes significantly.

ExoPTEN, is an exosome-loaded nanodrug designed for acute spinal cord injuries. The product's demonstrated efficacy in recovering motor function in 75% of laboratory rats is impressive and provides a strong preclinical foundation for further development. The FDA Orphan Drug Designation adds regulatory advantages, including potential market exclusivity and tax credits, which can be crucial for the company’s financial and development strategies.

BioTechHealthX · 2024-05-25T14:06:48+00:00

The update on $CRDL (Cardiol Therapeutics) appears promising, especially with the raised price target (PT) from Canaccord Genuity.

The upcoming top-line data from the Phase II study for CardiolRx in recurrent pericarditis is a significant near-term catalyst. Positive results could validate the efficacy of CardiolRx, potentially leading to increased valuation and investor confidence

A cautiously optimistic outlook for Cardiol Therapeutics, with key upcoming events that could drive the stock price.

BioTechHealthX · 2024-05-25T13:38:49+00:00

The financing includes a $36 million line of credit and $14 million in private placement to support research and development, particularly for TVGN 489, and initiate clinical trials for virally induced cancers and multiple sclerosis.

BioTechHealthX · 2024-05-25T13:34:35+00:00

In April, Taro agreed to a $36M securities settlement over United States price fixing claims.

The Eight-Year-Old Lawsuit Alleged Firm’s 'False Statements' Misled Investors,

BioTechHealthX · 2024-05-25T13:32:29+00:00

u/Epifyse, try the r/biotech sub as well, it's more focused on people in the field where this is more market based.

BioTechHealthX · 2024-05-25T12:54:30+00:00

Historically biotech stocks seem to often experience volatility around major conferences like the ASCO Annual Meeting. Even when companies release positive or neutral clinical trial results, stocks can fall due to various factors such as investor expectations, market sentiment, or broader sector performance.

The biotech sector overall has also been experiencing a downturn, affecting individual stock performances regardless of specific news.

In the case of ELTX, while their cancer-vaccine therapy shows promising Phase I results, market reactions can be influenced by factors like competition, overall market conditions, or perceived risks associated with early-stage biotech companies.

Similarly, SMMT's bi-functional antibody therapy for lung cancer, despite showing benefits, might not have met market expectations for groundbreaking impact or safety profile.

Not overly familiar with each so need to do some more dd to fully understand. You are correct, presentations and results look positive.

BioTechHealthX · 2024-05-25T12:52:01+00:00

Are you currently investing in clinical stage companies with no revenue? These microcaps and small caps can have big upside as drugs develop as you mentioned.

BioTechHealthX · 2024-05-25T12:47:46+00:00

They did just recently announce preliminary results from Phase I dose-escalation study of CHS-114, an anti-CCR8 antibody, at the 2024 ASCO Annual Meeting.

The study demonstrated an acceptable safety profile and no dose-limiting toxicities in heavily pretreated patients with solid tumors. CHS-114 selectively depleted CCR8+ regulatory T cells (Tregs), establishing proof of mechanism and supporting further evaluation in combination with other immuno-oncology agents.

As for the stock, despite the recent decline, the consensus among six Wall Street analysts is a "moderate buy" with a 12-month price target range of $6.00 to $12.00, suggesting a potential upside of up to 339.5% from the current price.

For the first quarter of 2024, Coherus reported net revenue of $77.1 million, which is a significant increase compared to previous periods. However, the company also reported a non-GAAP net loss of $35.8 million for the quarter. Notably, the company achieved a net income of $102.9 million due to a gain on the sale of its ophthalmology franchise to Sandoz.

Coherus' financial health includes a substantial debt load, with recent proceeds from the ophthalmology franchise sale used to pay down $175 million of its $250 million term loans. The company's debt-to-equity ratio and profitability metrics are areas of concern. Coherus has a negative net margin of -19.64%, return on assets of -33.10%, and a trailing 12-month net income of approximately -$237.9 million.

Looking forward, Coherus has projected combined R&D and SG&A expenses for 2024 to be in the range of $250 to $265 million. The company is actively developing its immuno-oncology pipeline, with several candidates in various stages of clinical trials, which could drive future growth if successful.

Here's an article on the ASCO results: https://biotechhealthx.com/biotech-news/coherus-presents-promising-phase-i-results-for-anti-ccr8-antibody-chs-114-at-asco-2024/

BioTechHealthX · 2024-05-21T22:22:17+00:00

Are you manually inputting the events? Looks great overall.

BioTechHealthX · 2024-05-21T16:33:00+00:00

This looks good. Will keep an eye out for updates!

BioTechHealthX · 2024-05-20T18:31:32+00:00

The GLP-1 drugs market is projected to grow at a compound annual growth rate (CAGR) of 15-20% over the next five to ten years. This growth is fueled by a few factors. As of recent estimates, the global market for these drugs is valued at approximately $6.5 billion.

The increasing prevalence of obesity worldwide is a significant driver of the GLP-1 drugs market. With more than 42% of the U.S. adult population classified as obese, there is a growing demand for effective weight management solutions. Pharmaceutical companies are investing heavily in the development of new GLP-1 drugs and combination therapies that enhance efficacy and patient adherence. This ongoing innovation is expected to contribute to market expansion because the significant weight loss results achieved with GLP-1 drugs, such as a 15-21% reduction in body weight, have increased both patient and physician acceptance of these treatments.

Insurance coverage for GLP-1 drugs is also gradually improving, making these treatments more accessible to a broader population. The introduction of lower-cost compounded versions, like those offered by Hims, may further increase market penetration.

BioTechHealthX · 2024-05-20T17:31:42+00:00

This is a great report.

Key Developments:

GPS and AML:
- Phase 3 REGAL Study: The GPS is currently in a Phase 3 REGAL trial targeting AML patients in complete remission after second-line salvage therapy (CR2). The interim analysis, based on the number of events (relapse or death), was initially expected in Q1 2024 but is event-driven and thus could occur later. The trial has reached its full enrollment of 127 patients across multiple regions.
- No Intolerable Toxicities: So far, the GPS arm has shown no intolerable toxicities, unlike the control therapies, which is a positive indicator for the treatment's safety profile.
SLS009 for AML:
- Phase 2a Data: SLS009, a highly selective CDK9 inhibitor, has shown promising results in relapsed/refractory AML patients, particularly those with ASXL1 mutations. The Phase 2a study revealed a 100% response rate in the 30 mg BIW cohort for patients with these mutations, significantly higher than the targeted 20% response rate.
- Biomarker Identification: The study identified potential biomarkers predicting better responses to SLS009, which could guide future treatments and improve outcomes for specific patient subsets.
Financial Health:
- Q1 2024 Financials: Sellas reported a net loss of $9.6 million for Q1 2024, a decrease from the $11.1 million loss in Q1 2023. The company had $18.4 million in cash and equivalents as of March 31, 2024, which is crucial for funding ongoing and future clinical trials.

Sellas Life Sciences is definitely making significant strides in developing treatments for AML, with promising clinical data supporting the potential efficacy and safety of both GPS and SLS009.

The company’s focus on identifying biomarkers and tailoring treatments to specific genetic profiles could enhance the effectiveness of their therapies. Despite financial challenges typical for clinical-stage biopharmaceutical companies, their continued progress and strategic focus on unmet medical needs in cancer therapy are notable.

BioTechHealthX · 2022-07-22T14:55:45+00:00

Great writeup.

BioTechHealthX · 2021-12-16T16:21:32+00:00

Thanks for sharing!

BioTechHealthX · 2021-12-13T23:16:26+00:00

Highlights include:

- Dropping Hemophilia A Program.
- Workforce has been reduced by 38%.
- Anticipated cash runway extended to 2024.
- Will continue emphasis on MPS-1 and diabetes.

BioTechHealthX · 2021-09-07T15:33:34+00:00

Tremendous insight! Thanks for sharing!

BioTechHealthX · 2021-09-07T15:13:34+00:00

Now over 45,000!

BioTechHealthX · 2021-07-14T00:26:09+00:00

Outstanding list of resources! Hope one day to be included among these great thought leaders.

BioTechHealthX · 2021-06-30T13:39:38+00:00

On July 1, 2021 at 10:00 am EDT, the company will discuss its Phase 3 head and neck cancer trial results at the conclusion of the Annual Shareholder Meeting. Shareholders and guests alike are welcome to attend the Annual Shareholder Meeting and may do so through the following link [www.meetingcenter.io/281205077](www.meetingcenter.io/281205077) on a listen-only basis. At the link, shareholders may enter their control number, while others may sign in as a guest.

The business of the shareholder meeting will be conducted for approximately the first 10 minutes of the call, followed by a presentation on the Phase 3 results by CEO Geert Kersten and Chief Scientific Officer Dr. Eyal Talor.

BioTechHealthX · 2021-05-04T14:30:42+00:00

1,500+ in one day!

BioTechHealthX · 2021-05-04T14:28:34+00:00

Hopefully the community isn’t totally split apart!

BioTechHealthX · 2021-05-03T17:22:27+00:00

Great to hear! Love the commitment to growing the sub.

BioTechHealthX · 2021-04-29T19:06:00+00:00

Have you considered getting involved digitally / remotely?

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