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SHPH, new 52 week low
$SHPH Shuttle Pharma Provides Third Quarter 2024 Corporate Update
https://www.globenewswire.com/news-release/2024/11/13/2980735/0/en/Shuttle-Pharma-Provides-Third-Quarter-2024-Corporate-Update.html
GAITHERSBURG, Md., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the third quarter ended September 30, 2024.
Shuttle Pharma’s recent highlights include the following:
Successfully dosed first three patients in the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with brain tumors (glioblastoma). Ropidoxuridine is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat glioblastoma, a deadly malignancy of the brain with no known cure. Additional patients are currently undergoing screening for enrollment in the trial.
Finalized agreements with all six of the planned site enrollment locations which will be administering the Phase 2 clinical trial following the Company’s entry into agreements with Georgetown University Medical Center and UNC Medical Center. The Company previously entered agreements with the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida.
Paid off the entirety of the outstanding balance due under Shuttle Pharma’s Senior Secured Convertible Note issued on January 11, 2023. The initial balance of the Note was $4.3 million and was originally repayable over a 26-month period ending March 11, 2025.
Completed a $4.5 million public offering priced At-The-Market under Nasdaq rules. The Company intends to use the net proceeds from this offering to fund IND-enabling and Phase 1 and 2 clinical trials of product candidates, including payments that will be made to the clinical research organization supporting the Phase 2 clinical trial for Ropidoxuridine, and for working capital and general corporate purposes.
The Company also closed on a convertible note and warrant offering, receiving a total of $790,000 in gross proceeds, including $237,500 invested by the Company’s Chief Executive Officer, Dr. Anatoly Dritschilo.
Cash balance as of October 31, 2024 was $4.1 million.
“We made tremendous progress over the past few months to advance our Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma, with the first three patients dosed in October 2024,” stated Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “The initial patient dosing followed the successful engagement of all six of the planned clinical trial site locations, each of which are nationally recognized cancer centers that are most likely to treat IDH wild-type, methylation negative glioblastoma patients – the target of the clinical trial. The initiation of the Phase 2 trial is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies.”
“Beyond these critical clinical developments, we also made progress in improving our balance sheet and funding the Phase 2 clinical trial. I want to thank all of the investors who have committed to helping us advance our mission to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma,” Dr. Dritschilo concluded.
$SHPH Shuttle Pharma Pays Off Senior Secured Convertible Note
https://www.globenewswire.com/en/news-release/2024/10/29/2971226/0/en/Shuttle-Pharma-Pays-Off-Senior-Secured-Convertible-Note.html
GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced that, during the third quarter of this year, it paid off the entirety of the outstanding balance due under its Senior Secured Convertible Note (“Note”) issued on January 11, 2023.
The initial balance of the Note was $4.3 million and was originally repayable over a 26-month period ending March 11, 2025. During the term of the note, Shuttle Pharma made periodic cash payments totaling $1.3 million and equity issuances totaling 1,094,970 shares (on a post reverse split basis). As a result, the Company now has a total of 2,946,099 shares outstanding. Additionally, in October 2024, Shuttle Pharma closed on a convertible note and warrant offering, receiving a total of $790,000 in gross proceeds, including $237,500 invested by the Company’s Chief Executive Officer, Dr. Anatoly Dritschilo.
“The elimination of the convertible note along with obtaining the bridge funding provides us with added flexibility to advance our ongoing Phase 2 clinical trial for the treatment of patients with glioblastoma,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “Over the past few months, Shuttle Pharma has made progress on a number of key activities. Along with our paydown of the convertible note and raising interim bridge funding, we have entered into agreements with six trial sites, five of which are now fully prepared to begin treating patients in the Phase 2 clinical trial. I look forward to maintaining our focus towards achieving our goal of increasing cancer cure rates, prolonging patient survival, and improving the quality of life for patients suffering from glioblastoma.”
The Phase 2 clinical trial has begun enrolling patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients, with more than half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.
$SHPH Shuttle Pharmaceuticals Holdings, Inc. Announces Pricing of $4.5 Million Public Offering Priced At-The-Market Under Nasdaq Rules
https://www.globenewswire.com/en/news-release/2024/10/30/2971356/0/en/Shuttle-Pharmaceuticals-Holdings-Inc-Announces-Pricing-of-4-5-Million-Public-Offering-Priced-At-The-Market-Under-Nasdaq-Rules.html
GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced the pricing of its "reasonable best efforts" public offering with a health-care focused institutional investor for the purchase and sale of up to 2,950,820 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 2,950,820 shares of common stock at a combined offering price of $1.525 per share and accompanying warrant, priced at-the-market under Nasdaq rules (the “Offering”). The Company expects to receive aggregate gross proceeds of approximately $4.5 million, before deducting placement agent fees and other offering expenses, and assuming no exercise of the warrants. The warrants will have an exercise price of $1.40 per share, will be exercisable immediately and will expire five years from the issuance date.
The closing of the Offering is expected to occur on or about October 31, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this Offering to fund IND-enabling and Phase I and II clinical trials of product candidates, including $2.3 million in payments that will be owed to Theradex Systems, Inc., the clinical research organization (CRO) supporting Shuttle Pharma’s Phase II clinical trials for radiation sensitizer Ropidoxuridine, and for working capital and general corporate purposes.
A.G.P./Alliance Global Partners is acting as the lead placement agent for the Offering and Boustead Securities, LLC is acting as a co-placement agent for the Offering.
$SHPH Shuttle Pharma Doses First Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
https://www.globenewswire.com/en/news-release/2024/10/29/2970880/0/en/Shuttle-Pharma-Doses-First-Patients-in-Phase-2-Clinical-Trial-of-Ropidoxuridine-for-Treatment-of-Patients-with-Glioblastoma.html
GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been successfully dosed.
Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.
The Phase 2 clinical trial will be conducted with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma patients. This particular group of patients at this time only have radiation as the standard of care, with more than half of the patients surviving for less than 12 months after diagnosis. The Phase 2 trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dose allowing for the achievement of statistical significance with the end point being that of survival compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
“The initiation of patient dosing in our Phase 2 trial of Ropidoxuridine for the treatment of patients with glioblastoma is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “The results of this trial will be important as Shuttle Pharma looks to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.
More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.
The 7.2 million dollars offering PP should be absorbed on heavy volume. I feel this Company shows promise! Eyeballs should show up on the follow-up of this news
https://www.otcmarkets.com/filing/html?id=17902090&guid=EWL-kHkNOz7-B3h
SHPH new 52 week low
Moving up, looks good.
SHPH new 52 week low
SHPH new 52 week low
news out today:
Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced that TCG GreenChem has successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the Company's upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy.
"Shuttle has been working concomitantly with TCG GreenChem to manufacture API and University of Iowa Pharmaceuticals to develop the formulation and packaging of the drug product into capsules for clinical use. Today's announcement of successfully completing the API manufacturing is an important step in the advancement Ropidoxuridine, our lead clinical sensitizer drug candidate, towards the commencement of our upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy," commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D.
In addition, Shuttle's recent request for a Type B pre-IND meeting with the FDA for guidance on the proposed Phase II clinical trial has been approved with a goal of receiving written responses from the FDA by September 18, 2023. With this, the Company believes it remains on track to commence its Phase II clinical study in the fourth quarter of 2023.
This news delayed one month already, It should be out soon, with this news PPS could be explode
See afternoon buy up as usual.
Pay attention to these sentences, PPS will explode again.
With Ropidoxuridine, we are finalizing details to submit the final protocol details to the FDA at the end of the second quarter of 2023 with commencement of the Phase II clinical trial in brain cancer patients commencing shortly thereafter.
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