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When Minutes Matter

Sollievo Pharmaceuticals is seeking to improve safety for healthcare staff with our first product, Proviza. Proviza is a fast-acting sedative developed to address the rising incidence of injuries and abuse to healthcare staff when treating agitated and aggressive patients. Sollievo Pharmaceuticals is pre-revenue and in the development and scale-up stages.

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This Reg CF offering is made available through StartEngine Capital, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
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REASONS TO INVEST

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7 out of 10 emergency physicians say emergency department violence is increasing and half have been physically assaulted at work. Proviza was developed to address this public health crisis.*

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We believe Sollievo has the potential of disrupting an estimated $1.2B global market by introducing one of the fastest and most consistent intramuscular sedatives available to emergency departments struggling to control violent and aggressive patients.**

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An abbreviated development pathway - modifying an existing approved drug provides the potential for a shorter investment horizon compared to traditional drug development.***

TEAM

Robert Schultz, Ph.D.

Robert Schultz, Ph.D. • President and CEO, Director

Dr. Schultz has held progressively significant responsibilities in both scientific and executive management positions during his 40-year career in the pharmaceutical and medical device industries. His development and commercial experience range from oral, inhalation, and liquid dosage forms. As President of REVA Medical, he lead the company to the approval of Fantom, the first fully radiopaque drug-eluting bioresorbable coronary scaffold. His expertise in developing combination products, and proven ability to lead internal and external resources in the startup environment provides Sollievo with the practical and strategic leadership it needs to navigate the drug development and commercial processes. 

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Peter Schineller

Peter Schineller • Commercial Strategic Advisor

During his 35-year career, Mr. Schineller has held executive positions, CMO, SVP, and CCO at major pharmaceutical companies, including Novartis, Abbott, and Pfizer. He co-founded Veras Pharmaceuticals where he was the CCO. Novartis acquired the Veras product line. Mr. Schineller's success in commercializing drug products makes him an ideal advisor to guide the company's marketing and commercial launch strategies to ensure the successful uptake of its lead product Proviza. 

With Sollievo, Peter works on average 1 hour per week and on an as-needed basis. 

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Steve King, BPharm

Steve King, BPharm • Business Development

Experienced Senior Manager with a 30-year history of working in the Pharmaceutical industry. Strong professional skills in Business Development, Alliance Management, Licensing, CMC Outsourcing, Biotechnology, Drug Development, and Pharmaceutical Project Management. Steve is responsible for identifying, sourcing, and contract negotiations with potential manufacturing partners and suppliers.

Steve has been working with Sollievo for the past year 

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*Information provided by the American College of Emergency Physicians (source)

**Market statistics obtained from Transparency Market Research, “Acute Agitation and Aggression Treatment Market: Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019–2027”

***Information provided by the U.S. Food & Drug Administration and Premier Consulting (sourcesource)


In Emergency Healthcare Environments, Minutes Matter

Sollievo Pharmaceuticals is positioned to introduce one of the first new innovations in injectable benzodiazepines in decades with our debut product Proviza®. Aimed at addressing the skyrocketing injury rates among doctors and nurses when treating acutely agitated and violent patients, Proviza's rapid sedation has the potential to lower injury risk, improve workplace safety, and decrease associated hospital costs.


*Proviza® is currently in the prototype and development stage and is not currently not available for general use.


Benzodiazepines entered the market in the 1960s and have since been used to relax and sedate patients, yet little innovation towards the development of new intramuscular drugs or delivery methods to improve the time or variability in the onset of sedation has taken place since then. (source)


At Sollievo, we believe it's time for a change, and with our proprietary approach, frontline healthcare staff can maintain a safer environment with Proviza's fast intramuscular absorption, rapid sedation, and medium duration.

The Problem


Emergency Department Violence is a Growing Health Crisis

Violence against healthcare workers is a national health crisis, and according to firsthand reports, has continued to get worse. The American College of Emergency Physicians cites that 7 out of 10 emergency physicians report an increase in emergency department violence, with 80% of the pool surveyed citing an impact on patient care as a result. (source)


In addition to affecting patient care, violence in healthcare environments is costly for hospitals and harmful to frontline staff. ER nurses are injured at a rate 5x greater than other major industries, with 25% of psychiatric nurses experiencing disabling injuries from patient assaults at some point in their career.


Video clips from Royal Melbourne Hospital. (sourcesourcesource)


Sollievo believes our solution can directly reduce this incidence of verbal and physical abuse that healthcare staff experience daily.


The Solution


Proviza Can Deliver Fast Sedation for Improved Healthcare Staff Safety

Sollievo is dedicated to improving workplace safety for our frontline ER healthcare professionals tasked with treating agitated and violent patients.


We believe our benzodiazepine product, Proviza, can deliver the fastest-acting intramuscular sedative in its class, with our research demonstrating a four-fold faster median time to peak concentration than the leading market solution (Lorazepam) and a 15-fold reduction in patient-to-patient variability. 



Faster and consistent time to sedation of violent patients requires rapid and consistent drug delivery to the bloodstream.


*Proviza performance is anticipated based on previous preclinical and clinical studies of Avizafone, the active ingredient in Proviza.


Sollievo’s proprietary technology is key to turbocharging Proviza’s absorption from the injection site. Avizafone, the active ingredient in Proviza, is an extremely water-soluble drug. In contrast, the other intramuscular injectable benzodiazepines, are highly water-insoluble.


When injected into the muscle, these insoluble drugs prefer the comfort of the muscle and fat tissue at the injection site. Therefore, absorption from the muscle tissue is slow, leading to large patient variability in the blood levels and the onset of sedation.


Avizafone ignores the tissues surrounding the injection site, flying from the muscle into the more friendly bloodstream. There, it is rapidly converted by natural enzymes in the blood to Diazepam, an FDA-approved, efficacious, and safe benzodiazepine.



Another potential advantage of Proviza beyond fast sedation and predictable performance, is that it provides a useful duration of action lasting between 2-4-hours. In contrast, the duration of sedation for Lorazepam of 6-8 hours may interfere with timely diagnosis and treatment of the patient (source).

The Market


Sollievo Pharmaceuticals is Aiming to Disrupt a $1.2B Market

On average, current injectable sedatives take between 15-40 minutes for effects to act. Proviza’s target onset of action is less than 10 minutes, which we believe is a game-changing solution to reduce injury risk to the ER staff when treating violent patients. 


Market statistics obtained from Transparency Market Research, “Acute Agitation and Aggression Treatment Market:

Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019–2027”



Sollievo believes Proviza is the product to disrupt the sedative and antipsychotics markets. The global intramuscular acute agitation and aggression treatment market is estimated at $1.2B* and is predicted to have a CAGR of 5.1%.

*Market statistics obtained from Transparency Market Research



When presented with the drug's product profile, emergency physicians that we've spoken to have stated that, when available, they would prescribe Proviza in 60% of their cases.


Our Traction


Fast Track Examination Granted & Two Patents Pending

Since the start of 2022, six more states have passed or initiated legislation intended to protect healthcare workers from workplace violence. The awareness of the need for solutions to this epidemic is growing daily, validating the need for the unique solution that Proviza will be able to provide.


Currently, Sollievo Pharmaceuticals has two patent applications pending. The first is for the manufacturing process of the drug substance, with the second for a method of use to treat acute agitation and aggression.


Sollievo was granted fast-track examination of its method of use application by the USPTO for Proviza’s potential role in treating COVID-19 patients.


We additionally have engaged senior commercial and marketing advisors to facilitate the integration of the company’s regulatory, clinical, and commercial strategies to best position Proviza for launch and rapid market penetration.

Why Invest


Help Us Provide a Risk-Reducing Therapeutic Solution to our Frontline Healthcare Workers

We want Sollievo to be recognized as a bold leader overcoming the inertia of the pharma industry to find new solutions, while increasing the awareness of the plight of ER nurses, doctors, and other healthcare professionals.


In our view, the benefits of Proviza have the potential to disrupt the existing market, providing improved care for acutely agitated & aggressive patients. Help us support the medical community at large as we seek to provide a risk-reducing therapeutic solution to our frontline healthcare workers.


---

Caution: New Drug - Limited by Federal law to investigational use


ABOUT

HEADQUARTERS
32452 Spyglass Court
San Juan Capistrano, CA 92675
WEBSITE
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Sollievo Pharmaceuticals is seeking to improve safety for healthcare staff with our first product, Proviza. Proviza is a fast-acting sedative developed to address the rising incidence of injuries and abuse to healthcare staff when treating agitated and aggressive patients. Sollievo Pharmaceuticals is pre-revenue and in the development and scale-up stages.

TERMS

Sollievo Pharmaceuticals
Overview
PRICE PER SHARE
$2
DEADLINE
Dec. 17, 2022 at 7:59 AM UTC
VALUATION
$20M
FUNDING GOAL
$10K - $1.07M
Breakdown
MIN INVESTMENT
$400
MAX INVESTMENT
$120,000
MIN NUMBER OF SHARES OFFERED
5,000
MAX NUMBER OF SHARES OFFERED
535,000
OFFERING TYPE
Equity
SHARES OFFERED
Common Stock

Maximum Number of Shares Offered subject to adjustment for bonus shares

*Maximum number of shares offered subject to adjustment for bonus shares. See bonus info below.

Voting Rights of Securities Sold in this Offering

Voting Proxy. Each Subscriber shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Subscriber’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Subscriber, (i) vote all Securities, (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the Subscriber pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Subscriber is an individual, will survive the death, incompetency and disability of the Subscriber and, so long as the Subscriber is an entity, will survive the merger or reorganization of the Subscriber or any other entity holding the Securities. However, the Proxy will terminate upon the closing of a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.

Investment Incentives & Bonuses*

Time-Based:

Super Early Bird Bonus

Invest within the first four weeks and receive 20% bonus shares.

Early Bird Bonus

Invest in weeks five & six and receive 15% bonus shares.

Amount-Based:

Company Bonus

Invest $500+ and receive 5% bonus shares. 

Silver Bonus

Invest $1,000+ and receive 10% bonus shares. 

Gold Bonus

Invest $5,000+ and receive 15% bonus shares. 

Platinum Bonus

Invest $10,000+ and receive 20% bonus shares

*All perks occur when the offering is completed.

The 10% StartEngine OWNer's Bonus

Sollievo Pharmaceuticals, Inc. will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.

This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Common Stock at $2.00 / share, you will receive 10 additional shares of Common Stock, meaning you'll own 110 shares of Common Stock for $200. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.

This 10% Bonus is only valid during the investors' eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.

Investors will receive the highest single bonus they are eligible for among the bonuses based on the amount invested and time of offering elapsed (if any). Eligible investors will also receive the Owner’s Bonus in addition to the aforementioned bonus.

Irregular Use of Proceeds

The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments. Inter company debt or back payments.

PRESS

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CEOWORLD Magazine

Leading in a Virtual World

ALL UPDATES

12.06.22

Sollievo's Campaign Closes in 10 days

Our StartEngine campaign is closing soon. Thank you to all of our current investors! If you haven’t yet invested, you can still do so until December 16th.  Invest today and become part of the team that is actively targeting a reduction in the injury rate of the healthcare professionals faced with the dangerous job of treating violent patients daily in the ER. 

 Below are five excellent reasons to INVEST TODAY!  


12.02.22

Sollievo's Current Offering is Closing Soon

11.28.22

Preventing Healthcare Violence


11.22.22

Drug Shortages Impact Patient Care



Since the pandemic, shortages of the drugs used to put patients on respirators, treat epileptic seizures, and sedate agitated and violent patients continue to occur.   Upon approval, Proviza will provide an excellent alternative to midazolam and lorazepam during times of high demand or when manufacturing issues limit their availability.


 

11.15.22

Notice of Material Change in Offering

[The following is an automated notice from the StartEngine team].

Hello! Recently, a change was made to the Sollievo Pharmaceuticals offering. Here's an excerpt describing the specifics of the change:


Issuer is extending campaign end date


When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.

11.08.22

Advocates Working to Stop ED Violence

I invite you to visit  https://www.stopedviolence.org to read the most recent stories of assaults and attacks on emergency department personnel.  This group advocates on behalf of the doctors and nurses who risk injury and abuse daily to ensure that medical care is available when we are most vulnerable.  

Sollievo aims to provide the emergency department with an additional solution for patients exhibiting acute agitation and aggression.   By delivering fast and consistent sedation, the time to calm a patient and return their attention to other patients will benefit us all.

Investing in Sollievo Pharmaceuticals is one way to show your support to those impacted by ED violence. #StopEDViolence

11.04.22

Investor Value Proposition


THE OFFERING MATERIALS MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD-LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE. THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS

11.02.22

Treating acute aggression: Impact on the ER and other patients

11.01.22

Treating violent patients - Impact on the ER

REWARDS

Multiple investments in an offering cannot be combined to qualify for a larger campaign reward.

10%

Stack Venture Club & Rewards!

Members get an extra 10% shares in addition to rewards below!

Venture Club

Venture Club

Venture Club Members earn 10% bonus shares on top of this and all eligible investments for an entire year. Not a member? Sign up at checkout ($275/year).

$500

Company Bonus

Invest $500+ and receive 5% bonus shares.

$1,000

Silver Bonus

Invest $1,000+ and receive 10% bonus shares.

$5,000

Gold Bonus

Invest $5,000+ and receive 15% bonus shares.

$10,000

Platinum Bonus

Invest $10,000+ and receive 20% bonus shares

JOIN THE DISCUSSION

0/2500

AS
Aaron Samuel

3 years ago

I’m a medical student Risperidone is indicated in violent patients what does your medication do?

2

0

MB
Mark Bell

3 years ago

There is definitely a need for better sedation delivery in the ED and within the hospital as well.. I’m curious, if your pitch is quick onset and water solubility of the medication, why are you charting/comparing Avizafone to the longer onset Benzodiazepines (like lorazepam and diazepam), and not Midazolam which has a rapid onset of just a couple and is also water soluble…? Seems like Midazolam would be the better comparison in market competition. Do you all have data comparing these two? Is the variability of peak concentration in Avizafone any lower than Midazolam? Or is the duration the only difference? Thanks, Mark

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1

0

FB
Furaha Bryant

3 years ago

Nice pitch deck! It'll erase all investor-doubt!

3

0

RK
Richard Koch

3 years ago

Is the vision for use in a hospital setting only or do you foresee Paramedics in the field administering to a combative arrestee or patient? Any legal concerns should patients be administered the compound involuntary?

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1

0

VK
Viral Kothary

3 years ago

These are much needed agents in the ED for psych patients, and other acutely agitated patients. Is the intent for avizafone to be used in conjunction with an antipsychotic (haloperidol, ziprazidone, etc) plus and antihistamine (diphenhydramine) which is standard in most acute care hospitals. Also, since avizafone is a prodrug that converts into diazepam, will there be long term issues in evaluating conversion to maintenance therapy? Although it has a faster onset and duration compared to other benzos (lorazepam being the most commonly used), the half life of diazepam is significantly longer than any other benzo. Some effects can still be seen for days after the acute dose is given. Is Sollievo taking this into consideration with your trials? If so, what is being seen with conversion to maintenance therapy? Thanks.

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3

0

RK
Richard Koch

3 years ago

Is the vision for use in a hospital setting or do you foresee Paramedics in the field sticking a combative arrestee or patient? Any legal concerns should "involuntary" recipients who might decide to show their disapproval with a slick lawyer?

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1

0

MK
Mohammad Karim

3 years ago

Since Avizafone is already approved by FDA, do you have to conduct Safety Trial for Proviza?

1

0

RS
Robert Schultz

Sollievo Pharmaceuticals

3 years ago

Hi Mohammad, Avizafone is not currently approved in the U.S. However, in the bloodstream Avizafone is converted to diazepam, which is FDA-approved, therefore only a short-term confirmatory safety trial is required.

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0

MB
Michael Brody

3 years ago

There is a new short-acting benzodiazepine Remimazolam. It’s already FDA approved. How would your product have an advantage?

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3

0

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