thinkingonlygreen
2 weeks ago
A Few More
3. Exelixis, Inc.
• Early Price: Exelixis traded for under $1 in 2009 after the financial crisis.
• Drug Success: Exelixis developed Cabometyx (cabozantinib), which is now approved for several cancers, including kidney and liver cancer.
• Outcome: After Cabometyx’s success, Exelixis’ stock rose significantly, and the company achieved a market cap in the billions.
4. Seattle Genetics (now Seagen)
• Early Price: Seattle Genetics’ stock price was under $1 around the year 2000.
• Drug Success: The company developed Adcetris, a drug for certain types of lymphoma, which became a widely used cancer treatment.
• Outcome: Seattle Genetics’ stock saw a substantial increase over the years as Adcetris gained FDA approval for multiple indications, turning it into a profitable, high-value biotech firm.
thinkingonlygreen
2 weeks ago
Certainly. Here are a few examples of cancer drug stocks that traded under $1 at some point and later became very successful:
1. Celgene Corporation (Acquired by Bristol-Myers Squibb)
• Early Price: In the 1990s, Celgene’s stock traded below $1.
• Drug Success: Celgene developed Revlimid, a drug for multiple myeloma, which became one of the best-selling cancer drugs globally.
• Outcome: Celgene’s success led to its acquisition by Bristol-Myers Squibb for $74 billion in 2019. By that time, the stock had risen substantially, making it a remarkable success story.
2. Pharmacyclics (Acquired by AbbVie)
• Early Price: Pharmacyclics was trading under $1 in the early 2000s.
• Drug Success: The company developed Imbruvica, a drug for chronic lymphocytic leukemia (CLL) and other blood cancers, which became a blockbuster.
• Outcome: Pharmacyclics’ success with Imbruvica led to its acquisition by AbbVie for $21 billion in 2015.
rdneum
1 month ago
Form S-3 Registration Filed for shareholder owed for services performed in Phase III Clinical Trial.
PROSPECTUS
CEL-SCI CORPORATION
1,000,000 Shares of Common Stock
This prospectus relates to the possible resale, from time to time, by the selling shareholder identified in this prospectus of up to 1,000,000 shares of our common stock, which were issued in partial payment of amounts owed for services in connection with our confirmatory Phase III clinical trial.
The selling shareholder may offer the shares from time to time as the selling shareholder may determine through public or private transactions or through other means described in the section entitled “Plan of Distribution” or a supplement to this prospectus. The selling shareholder may also sell shares under Rule 144 under the Securities Act of 1933, as amended, if available, rather than under this prospectus.
The registration of these shares does not necessarily mean that the selling shareholder will sell any of its shares. We are not offering for sale any shares of our common stock pursuant to this prospectus. We will not receive any proceeds from the sale of these shares.
DocKB
3 months ago
From Zack's :
CVM: Start Your Engines – FDA Green Lights Confirmatory Registration Study
08/28/2024
By John Vandermosten, CFA
NYSE:CVM
READ THE FULL CVM RESEARCH REPORT
CEL-SCI Corporation (NYSE:CVM) reported its fiscal third quarter on August 15, 2024 with the submission of its Form 10-Q with the SEC and a press release on the following day. Since our previous update for the fiscal second quarter, CEL-SCI has added several new individuals to its ranks, conducted a population analysis and presented data at IDDST for IT-MATTERS and raised additional capital to support the advance of Multikine towards the confirmatory registrational trial.
Financial Review
CEL-SCI recognized no revenues for its fiscal third quarter ending June 30, 2023 and incurred operating expenses totaling $6.7 million during the three-month period. This resulted in a net loss available to common shareholders of ($7.5) million, or ($0.14) per share.
For the quarter ending June 30, 2023 versus the same prior year period:
- Expenses for research and development fell 18% to $4.7 million from $5.7 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease and were partially offset by increased spending to prepare for the confirmatory registration study;
- General and administrative expenses decreased 20% to $2.0 million from $2.5 million on lower consulting fees and employee stock compensation partially offset by other miscellaneous expenses;
- Other non-operating items were $14,000 compared to ($8,000) in the prior year;
- Net interest expense of ($0.2) million compared with ($0.2) million was related to lease liabilities and was relatively constant;
- Modification of warrants totaled ($659,000) compared to zero as several series of warrants received an extension of expiration dates;
- Net loss totaled ($7.5) million versus ($8.4) million or ($0.14) and ($0.19) per share, respectively.
As of June 30, 2024, cash and equivalents totaled $0.4 million. Cash burn for the three-month period amounted to approximately ($4.6) million, up from 3Q:23’s ($5.9) million. Following the end of the quarter, CEL-SCI closed on a gross $10.8 million common stock offering. CEL-SCI holds no debt on its balance sheet.
CEL-SCI Milestones
- Appointment of Mario Gobbo to Board of Directors – April 2024
- Dr. Giovanni Selvaggi joins CEL-SCI as clinical advisor – June 2024
- Presentation at the International Drug Discovery Science & Technology (IDDST) Congress – June 2024
- Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT
- Presented by Dr. Eyal Talor
- CEL-SCI appoints Robert Watson as Chairperson of the Board – July 2024
- Feedback from various regulatory agencies - 2024
- Submission of license application to various agencies – 2024+
- Preparation for Multikine confirmatory trial - 2024
Post-Reporting Period Capital Raise
CEL-SCI announced the closing of its $10.8 million offering on July 29th in a press release. The company sold 10,845,000 shares of stock and pre-funded warrants at $1.00 per share. ThinkEquity served as the placement agent for the transaction. A post transaction summary identified 3,715,000 shares of common stock and 7,130,000 pre-funded warrants were issued.
Population Analysis
In further review of the IT-MATTERS data, CEL-SCI has conducted a bias analysis that was detailed in a July 26th press release. The analysis was conducted to ensure data quality, improve study validity, inform the interpretation of the data and to guide the upcoming confirmatory registration study. The data on patients’ age, sex, race, tumor location and staging find that the active arm and control arm are similar. It finds that the results in the study are reliable, generate reasonable conclusions and minimize the risk of bias.
The bias analysis was conducted for the Phase III study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy). This is the same population which will be drawn from for CEL-SCI’s upcoming confirmatory registration study.
Summary
Since our previous update, CEL-SCI has reported its latest quarterly financial and operational results, conducted a population analysis on the IT-MATTERS subjects, presented data at IDDST and added new faces to its ranks. CEL-SCI continues the planning for its anticipated confirmatory registrational study and raised an additional $10.8 million in July to further this effort. We maintain our valuation of $7.00.