Shackelford Pharma Executives Mark Godsy and Dr. Alan Shackelford to Present Promising Data on Neurological Treatment, Hosted by Dr. David Sans at EF Hutton

Vancouver BC, Canada (October 24, 2024) — Shackelford Pharma Inc. (“Shackelford” or the “Company”), a pharmaceutical company developing medicines for neurological diseases with significant unmet patient needs, is pleased to participate in a Webinar, hosted by EF Hutton, on Thursday October 31, 2024 at 12:00pm ET.
Dr. Alan Shackelford gained national attention for his breakthrough treatment of a young Dravet Syndrome patient with cannabinoids. She went from ~300 grand mal seizures a week to near remission. Based upon Dr. Shackelford’s real-world experience, Shackelford Pharma, Inc., was formed to develop medicines for neurological diseases with significant unmet patient needs.
During this webinar, CEO Mark Godsy and co-founder Dr. Alan Shackelford will discuss the company’s real-world data that is the foundation for the company’s development plan leading the company into its planned phase 2 trial. SP1707, a small molecule oral formulation targeting generalized tonic-clonic seizures observed 9-fold improvement in 1 year seizure remission rates over what is typically expected in this seizure type giving Shackelford confidence that the company may see clinically significant effectiveness when they progress into Phase 2. Importantly, this retrospective data seems to be tracking closely with what was observed with FINTEPLA® in open label studies and better than those observed with EPIDIOLEX®.
David Sans, FAARM, PhD, MBA, Senior Managing Director of Healthcare Investment Banking at EF Hutton, will be hosting the upcoming webinar. With a distinguished career in biotech and pharma, David joined EF Hutton in December 2023 as Head of Healthcare, where he leverages his extensive expertise in corporate finance, business development, operational, and commercial roles across both large pharmaceutical firms and emerging biotech companies. As the leader of EF Hutton’s Healthcare Transactions, he drives a diverse range of industry transactions, providing strategic insight and support to clients navigating complex healthcare markets. His guidance will add a valuable perspective to the discussion on Shackelford Pharma’s advancements and clinical data.

Webinar Registration : Webinar Registration – Zoom
Questions related to this announcement, or general inquires to the Company can be made by calling the company directly at 1-888-377-4225 Ext.1, or by emailing us at info@shackelfordpharma.com. Additional company information is available on our website www.shackelfordpharma.com.

About Shackelford Pharma Inc.
Based upon Dr. Alan Shackelford’s real-world experience, Shackelford Pharma, Inc., was formed to develop medicines for neurological diseases with significant unmet patient needs. Members of its world class R&D team collectively have over 320 years of drug development experience. This includes having developed 43 FDA approved drugs, 7 with peak annual revenue over $1B USD, and 6 anti-epileptic drugs. Shackelford’s first drug candidate, SP1707, is a small molecule, oral formulation targeting generalized tonic-clonic seizures.
Please visit us at www.shackelfordpharma.com

About EF Hutton

EF Hutton LLC is an investment bank headquartered in New York, NY, which provides strategic advisory and financing solutions to middle market and emerging growth companies. EF Hutton has a proven track record of offering superior strategic advice to clients across the globe in any sector, with access to capital from the USA, Asia, Europe, UAE, and Latin America.

EF Hutton is a leader on Wall Street, having raised over $16 billion in capital across more than 275 transactions through various product types. Since 2022, by deal count, the firm has been #1 in US IPO issuance and #1 in SPAC issuance, per Bloomberg and SPAC Insider. EF Hutton is one of the most active investment banks in the middle of the market space. For more information, please visit efhutton.com.

Forward Looking Statements
This news release may contain forward-looking statements. within the meaning of applicable securities laws including under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. Some of the statements herein constitute forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms, or other comparable terminology. To the extent that this document contains forward-looking statements regarding our business, please be advised that our actual financial condition, operating results, and business performance may differ materially from that projected or estimated by us in forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made.


Although the forward-looking statements in this document are based on our beliefs, assumptions, and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements, or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as may be required by law, to re-issue this document or otherwise make public statements updating our forward-looking statements.


Undue reliance on forward-looking statements, and, in evaluating these forward-looking statements, readers should specifically consider various factors, including the risks outlined under the heading “Risk Factors” in documents we file with the SEC.

Shackelford Pharma Inc. Announces Positive Data from Retrospective Analysis

Vancouver BC, Canada (February 6, 2023) — Shackelford Pharma Inc. (“Shackelford” or the “Company”), a pharmaceutical company developing medicines for neurological diseases with significant unmet patient needs, is pleased to share the compilation and retrospective analysis of additional real-world data backing its development of SP1707, a small molecule oral formulation targeting an undisclosed seizure type. SP1707 is the development name/number of the Company’s first drug candidate that contains the active ingredient used by Dr. Alan Shackelford. Ultimately, SP1707 is being developed as a proprietary oral cannabinoid formulation that is amenable to being dosed once daily in patients.

“This analysis of Dr. Shackelford’s real-world experience strongly supports our reason to believe we have a path to Phase 2 clinical trials,” stated Dr. Susan Learned, Head of R&D at Shackelford. “This exciting human efficacy and safety data will be used to support our Investigational New Drug (“IND”) submission to the FDA. The observed 9-fold improvement in 1 year seizure remission rates over what is typically expected in this seizure type gives us confidence that we may see clinically significant effectiveness when we progress into Phase 2.    Importantly, this retrospective data seems to be tracking closely with what was observed with FINTEPLA® (fenfluramine) in open label studies and better than those observed with EPIDIOLEX®”.

Compiled from Dr. Shackelford’s real-world experience, the collected data shows that in adult and pediatric patients with a specific seizure type, patients taking his cannabinoid-based treatment for at least one year experienced clinically significant positive outcomes. The analysis of results (as of January 12, 2023) are shown in the table below. Published data from Jazz Pharmaceutical plc.’s cannabidiol (“CBD”) based product, EPIDIOLEX®, are shown as a comparator.

 Key insights from this analysis:

1) Over 350 patient years of real-world data from Dr. Shackelford’s database in treating patients with epilepsy. Adult and pediatric patients had been suffering from epilepsy for up to 46 years and 16 years, respectively, prior to being put on SP1707, suggesting overall, this has been a treatment for a refractory population.

2) Responder rates (meaning at least a 50% reduction in seizure frequency over a 1-year treatment period) were 71% in adults and 60% in pediatrics — which is aligned with the response rates initially seen in FINTEPLA® (fenfluramine) open label studies, and better than those observed with EPIDIOLEX®.

3) Importantly, 1 year seizure remission rates, which were similar between adults and children were 40-44% (greater than those observed with EPIDIOLEX®).  Compared to baseline or expected 1 year seizure remission rates for this type of seizure, SP1707 elicited an approximate 9-fold improvement.

4) The safety and tolerability data for SP1707 has been positive, with only 2% of adult patients and no children reporting any adverse events.  This compares favorably to EPIDIOLEX® and other antiepileptic medicines.

 

Dr. Shackelford’s Real-World Experience Compared with Published Data from Jazz Pharmaceuticals plc.

 

SP1707

SP1707

EPIDIOLEX®

EPIDIOLEX®

 

Adult

Pediatric

Pediatric RCTs

EAP

Demographics

 

 

 

 

Number of Patients

82

13

61-76 per indication

892

Male/Female

47/35

8/5

N/A

464/428

SZ/Epilepsy Duration Prior to SP1707 Treatment

Mean= 15.55; Up to 46 yrs

Mean=6.6; Up to 16 yrs

<18 yrs

N/A (age range 0-75, median 12 yrs)

Duration of Follow-Up (years)

307 

49 

~14-20

1755

Disease Outcomes: Benefit Comparison

 

 

 

 

Indication

Undisclosed

Undisclosed

DS, LGS, TSC

TRE

Responder Rate (>/=50% reduction in seizure frequency over 1 year period)

71% (24/34)

60% (6/10))

~45% @ 14 wks

53% @48 wks

1 YR Seizure Remission Rate (in patients with 1+ seizures in prior year with at least 1 year follow up post SP1707 treatment initiation)

44% (15/34)

40% (4/10)

6-7% @14 wks

11% @48 wks

Expected 1 YR Seizure Remission Rate 

4-5%

4-5%

4-5%

4-5%

Increase in 1 YR Seizure Remission Rate over expected

~9X

~9X

~1.5X

~2X

Disease Outcomes: Safety

 

 

 

 

Adverse Events

2% (2/82)

0% (0/13)

Up to 12%

7%

Key:

RCT: randomized controlled trial

EAP: expanded access program

N/A: not available

SZ: Seizures

DS: Dravet Syndrome

LGS: Lennox-Gastaut Syndrome

TSC: Tuberous Sclerosis Complex

TRE: Treatment Resistant Epilepsy

 

A Pre-Investigational New Drug Meeting with the FDA occurred in September 2022 and the Company intends to submit an Investigational New Drug submission in the second half of 2023. This will allow the company to proceed to its planned Phase 2 trial pending FDA response and funding.  The initial Phase 2 study of SP1707 in epilepsy patients will use an immediate-release oral formulation of SP1707 that will mimic the release characteristics of the cannabinoid that Dr. Shackelford used in his real-world experience treating patients.   

Questions related to this announcement, or general inquires to the Company can be made by calling us directly at 1-888-377-4225 Ext.1., or by emailing us at info@shackelfordpharma.com. Additional company information is available on our website www.shackelfordpharma.com, where you are also be able to sign up to receive updates from Shackelford Pharma Inc. as we advance our clinical program.

On behalf of the Board of Directors

Mark Godsy, CEO

This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities in the United States. In the United States under the Securities Act of 1933, any offer to sell securities must either be registered with the United States Securities and Exchange Commission (SEC) or meet certain qualifications to exempt it from such registration. An offering circular on Form 1-A was filed with the Securities and Exchange Commission (“SEC”) and was qualified by the SEC as of December 12, 2022, as amended. The offering of these securities is made only by means of an offering circular on Form 1-A.

About Shackelford Pharma Inc.

Based upon Dr. Alan Shackelford’s real-world experience, Shackelford Pharma, Inc., was formed to develop medicines for neurological diseases with significant unmet patient needs. Members of its world class R&D team collectively have over 320 years of drug development experience. This includes having developed 43 FDA approved drugs, 7 with peak annual revenue over $1B USD, and 6 anti-epileptic drugs. Shackelford’s first drug candidate, SP1707, is a small molecule, oral formulation targeting a specific seizure type.

Please visit us at www.shackelfordpharma.com

 

Forward Looking Statements


This news release may contain forward-looking statements. within the meaning of applicable securities laws including under the United States Private Securities Litigation Reform Act of 1995.  Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. Some of the statements herein constitute forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms, or other comparable terminology. To the extent that this document contains forward-looking statements regarding our business, please be advised that our actual financial condition, operating results, and business performance may differ materially from that projected or estimated by us in forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made.

Although the forward-looking statements in this document are based on our beliefs, assumptions, and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements, or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as may be required by law, to re-issue this document or otherwise make public statements updating our forward-looking statements.

Undue reliance on forward-looking statements, and, in evaluating these forward-looking statements, readers should specifically consider various factors, including the risks outlined under the heading “Risk Factors” in documents we file with the SEC.

Shackelford Pharma Congratulates Team & SAB Members on Publication

Shackelford Pharma congratulates O’Neill D’Cruz, a member of Shackelford’s clinical development team, and our Scientific Advisory Board Members Emilio Perucca and Jeffrey Buchhalter, co-authors of the article “EEG Parameters as Endpoints in Epilepsy Clinical Trials- An Expert Panel Opinion Paper” published this month in Epilepsy Research.

Link to the article: https://authors.elsevier.com/c/1fxZ33HDXae9E4 

Shackelford Pharma Inc. Selected to Present at Life Science BC Invest in BC

Shackelford Pharma Inc. Selected to Present at Life Science BC Invest in BC

Vancouver BC, Canada (October 16, 2022) — Shackelford Pharma Inc., a pharmaceutical company developing medicines for neurological diseases with significant unmet patient needs, is proud to be selected to present at the upcoming “Life Sciences BC Invest in BC” Event. This annual event is an opportunity to bring together stakeholders in the healthcare innovation ecosystem. The two-day event includes company pitches, presentations, and panel discussions, giving entrepreneurs a platform to share their stories and receive feedback and engagement from a wide range of investor stakeholders. Investor participants include angel investors, venture capital, corporate venture, and foundations. Shackelford Pharma will be sharing our unique story with this audience for the first time, as we look to establish our presence in the biotech community and secure investment that will support our growth as a pharmaceutical development company focused on the endocannabinoid system.

Inquires to the Company can be made by calling us directly at 1-888-377-4225 Ext.1., or by emailing us at investors@shackelfordpharma.com.

Additional company information is available on our website www.shackelfordpharma.com, where you are also be able to sign up to receive updates from Shackelford Pharma Inc. as we advance our clinical program.

Mark Godsy, CEO

 

About Shackelford Pharma Inc.
Based upon Dr. Alan Shackelford’s real-world experience, Shackelford Pharma, Inc., was formed to develop medicines for neurological diseases with significant unmet patient needs. Members of Its world class R&D team collectively have over 320 years of drug development experience. This includes having developed 43 FDA approved drugs, 7 with peak annual revenue over $1B USD, and 6 anti-epileptic drugs. Shackelford’s first drug candidate, SP1707, is a small molecule, long-acting oral formulation targets a specific seizure type.

 

Please visit us at www.shackelfordpharma.com

 

Forward Looking Statements


This news release may contain both historical and forward-looking statements. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. Some of the statements herein constitute forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms, or other comparable terminology. To the extent that this document contains forward-looking statements regarding our business, please be advised that our actual financial condition, operating results, and business performance may differ materially from that projected or estimated by us in forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made.
Although the forward-looking statements in this document are based on our beliefs, assumptions, and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements, or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as may be required by law, to re-issue this document or otherwise make public statements updating our forward-looking statements.

 

This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities in the United States. In the United States under the Securities Act of 1933, any offer to sell securities must either be registered with the United States Securities and Exchange Commission (SEC) or meet certain qualifications to exempt it from such registration. An offering circular on Form 1-A was filed with the Securities and Exchange Commission (“SEC”) and was qualified by the SEC as of August 20, 2020. The offering of these securities was made only by means of an offering circular on Form 1-A.

Shackelford Pharma Formalizes Scientific Advisory Board

Vancouver BC, Canada (October 16,
2022) — Shackelford Pharma Inc. (“Shackelford” or the “Company”), a pharmaceutical company developing medicines for neurological diseases with significant unmet patient needs, is pleased to announce the formal establishment of its Scientific Advisory Board (“SAB”). Shackelford’s SAB is a fully independent board composed of nine accomplished medical professionals
with deep experience in the fields of neuroscience and epilepsy.

The Scientific Advisory Board is tasked with providing objective and strategic advice to Shackelford’s Research
and Development team, as it progresses its drug development efforts towards Phase 2 clinical trials and beyond. Shackelford has named Nathan B. Fountain, M.D. Director, F.E. Dreifuss Comprehensive Epilepsy Program & Director, EEG and Epilepsy
Fellowships at the University of Virginia School of Medicine, Charlottesville, Virginia as the Chair of the Scientific Advisory Board.

The SAB will be advising an accomplished R&D team that collectively has over 320 years of drug development experience, which includes having developed 43 FDA approved drugs, including 6 anti-epileptic drugs, and 7 drugs with peak annual revenue over $1B USD.

“Attracted by the real-world patient evidence of Dr. Alan Shackelford, I am honoured to have this esteemed Scientific Advisory Board now in place. Their experience spans through neurological conditions, with particular expertise in epilepsy, endocannabinoid pharmacology and drug development, perfectly complementing our R&D team. We look forward
to their invaluable guidance as we work together to develop our first epilepsy clinical candidate SP1707,” stated Susan Learned, Head of R&D at Shackelford.

“Our R&D lead, Dr. Susan Learned has built a world class drug development team within Shackelford that is driving the development of SP1707,” stated Mark Godsy, CEO of Shackelford “The additional insights and experiences being shared by our new SAB will only serve to ensure Shackelford’s research and development activities are as efficient and effective as possible, as we focus on our upcoming FDA submission and Phase 2 clinical trial.”

Click here to watch Dr. Susan
Learned and CEO Mark Godsy speak about Shackelford’s R&D team and new SAB: VIDEO – Shackelford Pharma R&D and SAB Teams

For more information and bios of members of the Company’s SAB team, please visit Shackelford Scientific Advisory Board. For more information and bios of Shackelford’s R&D team, please visit Shackelford R&D Team.

Inquires to the Company can be
made by calling us directly at 1-888-377-4225 Ext.1., or by emailing us at investors@shackelfordpharma.com. Additional company information is available on our website www.shackelfordpharma.com, where you are also be able to sign up to receive updates from Shackelford Pharma Inc. as we advance our clinical program.

On behalf of the Board of Directors

Mark Godsy, CEO

About
Shackelford Pharma Inc.
Based upon Dr. Alan Shackelford’s real-world experience, Shackelford Pharma, Inc., was formed to develop medicines for neurological diseases with significant unmet patient needs. Members of Its world class R&D team collectively
have over 320 years of drug development experience. This includes having developed 43 FDA approved drugs, 7 with peak annual revenue over $1B USD, and 6 anti-epileptic drugs. Shackelford’s first drug candidate, SP1707, is a small molecule,
long-acting formulation targeting a specific seizure type. Please visit us at www.shackelfordpharma.com

 

Forward Looking Statements

This news release may contain both historical and forward-looking statements. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. Some of the statements herein constitute forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will“
and “would” or the negatives of these terms, or other comparable terminology. To the extent that this document contains forward-looking statements regarding our business, please be advised that our actual financial condition, operating results, and
business performance may differ materially from that projected or estimated by us in forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they
were made. Although the forward-looking statements in this document are based on our beliefs, assumptions, and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results,
performance, achievements, or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. We undertake no obligation, other than as may be required by law, to re-issue this document or otherwise make public statements updating our
forward-looking statements.

 

This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities in the United States. In the United States under the Securities Act of 1933, any offer to sell securities must either be registered with the United States Securities and Exchange Commission (SEC) or meet certain qualifications to exempt it from such registration. An offering circular on Form 1-A was filed with the Securities and Exchange Commission (“SEC”) and was qualified by the SEC as of August 20, 2020. The offering of these securities was made only by means of an offering circular on Form 1-A.

Shackelford Pharma Joins LifeScience BC

SPI is a member of LifeSciences BC.

LifeSciences BC is a non-profit, industry association which supports and represents the life science community of British Columbia through leadership, investment, advocacy and promotion of our world-class life science community.

LifeSciences BC undertakes numerous initiatives including; local, national and international partnerships helping to facilitate investment and global partnering opportunities while nurturing economic development in B.C. through the life sciences industry.

https://lifesciencesbc.ca

Shackelford Pharma Joins BIO

Shackelford Pharma is now a member of BIO.

The Biotechnology Innovation Organization (BIO) is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries.

This membership will allow the company to attend networking/partnering events in the biotech industry.

https://www.bio.org

Happy Holidays





Wishing you a Happy Holiday season from the team at Shackelford Pharma.