Speranza Therapeutics

Bridging the gap between hope and healing

Speranza Therapeutics

Bridging the gap between hope and healing

Boca Raton, FL
Biotechnology
Health Tech
Speranza Therapeutics is a medical device and biotech company that develops, distributes, and clinically supports medical devices and generic drugs that treat a variety of disease states and conditions. More than a company that supplies a drug or device to a patient or physician, we provide solutions as part of a medical protocol and we aim to produce positive outcomes for struggling patients in areas with unmet needs.

$10,233

raised
6
Investors
$7.67M
Valuation
$6.89
Price per Share
$399.62
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
Reg CF
Offering

$10,233

raised
6
Investors
$7.67M
Valuation
$6.89
Price per Share
$399.62
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
Reg CF
Offering

Rewards

Get rewarded for investing more into Speranza Therapeutics:

$599+
Investment
StartEngine Owner’s Bonus
This offering is eligible for the StartEngine Owner’s 10% Bonus program. For details on this program, please see the Offering Summary section below.
$5,000+
Investment
Tier 1
Invest $5,000+, and receive 2% Bonus Shares
$15,000+
Investment
Tier 2
Invest $15,000+, and receive 5% Bonus Shares
$30,000+
Investment
Tier 3
Invest $30,000+, and receive 10% Bonus Shares

Reasons to Invest

We believe Speranza is addressing unmet needs - our newest device speaks directly to the OUD (opioid use disorder) market, with potential for expansion into other indications, such as acute pain management, Parkinson's disease, and PTSD
Developing an affordable over-the-counter (OTC) product aimed at the underserved oncology population receiving chemotherapy.
Experienced management team - The co-founders of Speranza have proven track records in healthcare and are experienced executives

Overview


A New Generation of Healing

Speranza Therapeutics is on a mission to remove inherent challenges in delivering treatment to patients in need through proven, clinically effective therapeutics and technologies. We are dedicated to providing better patient outcomes while decreasing the cost of care for those who live with diseases and conditions that are traditionally ignored by larger medical companies. To do this, we distribute and clinically support innovative drugs and medical devices requiring FDA approval or clearance.

The Problem


For Many Patients, Clinical Care is Not Prioritized

From the start, Speranza’s mission has been to concentrate on diseases and conditions that have been largely ignored due to a lack of focus from larger medical companies. Even if there are therapies for certain conditions available, patients are faced with high prices and limited accessibility. Our first two products focus on the unmet needs of Opioid Use Disorder (OUD) withdrawal symptoms (this product is currently available on the market) and on Oral Mucositis patients (this product is currently in development with expected launch in 2022), who develop such conditions after receiving chemotherapy and radiation due to head and neck cancers.


The Market


An Epidemic on the Rise

Speranza Therapeutics S.T. Genesis

Opioid Use Disorder Population

 

From a clinical standpoint, opioid withdrawal is one of the most powerful factors driving opioid dependence and addictive behaviors.

 

In the U.S, prescription opioid abuse has increased substantially over the past 20 years, and using prescription opioids for non-medical use has also reached epidemic proportions - resulting in the deaths of thousands of Americans each year.

 

Since the pandemic, the opioid epidemic in the United States has reached new heights - with a 30% rise in opioid overdose and death in 2020. The global opioid use disorder (OUD) market is projected to grow from $2.68 billion in 2021 to $4.81 billion by the year 2028.



Sources: JECCR, WonderCDC.gov, PubMed NCBI, Parkinson.org, PTSD.VA.gov, NCCIH, Pubmed, CDC.gov, Delveinsight Report and Perspectives, Oral Mucositis (OM) Epidemiology Forecast to 2027, September, 2018.



Soothe-OM

Oral Mucositis Population

 

There are approximately 2.1 million patients in the U.S that develop Oral Mucositis after they begin chemotherapy and radiation. Unfortunately, this condition occurs 90% of the time within this patient population and the solutions are severely lacking.


This condition is better known as internal mouth sores. These mouth sores become so inflamed and painful that it prevents patients from eating and drinking. The lack of food and hydration may lead to increased hospital admissions, a decreased use of chemotherapy due to rapid weight loss, and eventual death due to lack of chemotherapy and radiation. 


THE Solution


An alternative way to help patients in recovery & cancer patients

Speranza Therapeutics provides solutions as part of a medical protocol that will produce positive outcomes for struggling patients, making us more than just a company that supplies drugs or devices to patients and physicians.


As such, our company is currently spearheading efforts into two products. The first is S.T. Genesis, an FDA-cleared medical device, designed to help reduce a patient’s withdrawal symptoms when opioid use is discontinued by targeting the areas of the brain that are responsible for these symptoms.


Applied to the patient's ear, the noninvasive, non-surgical intervention of S.T. Genesis transitions patients through the first critical phase of opioid detoxification by administering neurostimulation treatment over the course of 120 hours (5 days).  Within 20 minutes, the device significantly helps reduce a patient’s symptoms of opioid withdrawal as they transition to longer term treatment.  The first 5 days of withdrawal are the most critical time of treatment when approximately 30% of patients abandon treatment and leave Against Medical Advice (AMA). S.T. Genesis has proven to reduce AMA rates by 50%.


This product solves two problems: 1) It helps to prevent relapse (currently 59% relapse within one week of discharge), and 2) it increases revenue for the treatment provider by keeping patients compliant with treatment.


Clinical Opiate Withdrawal Score (COWS)


Some other advantages of S.T. Genesis include:


  • Lightweight and compact design
  • Ideal for inpatient or outpatient settings
  • Non-surgical, drug-free medical devicequick and easy to apply device by any healthcare professional
  • Profound, immediate effect on patients. Within the first 30 minutes, patients start to feel relief from the pain and anxiety associated with opioid withdrawal. Within 60 minutes, the patient's clinical presentation averages 93% improvement from the time of admission.
  • Provides mobility during treatment so the patient can engage in group activities


Oral Mucocitis (OM) also known as internal mouth sores that develops in 90% of patients treated with chemotherapy and radiation due to head and neck cancers. OM is a painful and debilitating condition preventing patients from eating or swallowing, resulting in tremendous weight loss. It can lead to a discontinuation of chemotherapy and radiation which could result in death. Speranza’s second product, Soothe-OM, is a mucoadhesive product that when swirled gently around the mouth, results in the formation of a protective coating over the oral mucosa (or mucus membrane) in the mouth and throat. When used as directed Soothe-OM can prevent or severely reduce the progression of OM during chemotherapy and radiation treatments helping patients stay on chemotherapy and radiation regimens. Based on our research, products similar to this on the market today are either too expensive, too hard to obtain, or simply do not work. 


With some modifications, we will launch a generic version of a current product called MuGard, to offer an over-the-counter mucoadhesive product that is more affordable and accessible to a large patient market.


*This is a mock-up image of this product. This product is not currently available on the market.



Speranza's Portfolio Strategy for Growth


The following includes a set of growth goals we are aiming for including:


  • Initial launch of next-generation S.T. Genesis device and “own” the neuromodulation industry market as it relates to the opioid epidemic. Targets include patients, telemedicine, addiction treatment centers, and private practice psychiatrists.
  • Adding new indications for S.T. Genesis in Acute/Chronic Pain, PTSD, and Parkinson’s Disease to clinically support widespread options for device use.
  • Launching a generic version of MuGard for oral mucositis and introducing a new, branded product for oral mucositis.
  • Launching 2 new products (medical device or drug) over the next 2-3 years.
  • Secure new products through the generic market or by working with big pharma on obtaining the rights on their sunset list of drugs.

why invest



Bridging the gap between hope and healing

Speranza Therapeutics is revolutionizing patient care with paradigm shifts by introducing new products and protocols to serve unmet needs. Whereas the opioid medication industry has relied on its decades-long business model and not adopted an alternative treatment option, Speranza Therapeutics' noninvasive, non-surgical device can be easily placed on patients and provide rapid relief in minutes. Cancer patients with limited access to a vital medication to ease mouth sores will have an affordable OTC option at their local pharmacy. 


The products currently available to our target patient populations simply aren’t moving the needle enough, meaning there is an immense need for our innovative devices and disruptive protocols.  




Here’s what we’ve accomplished to date:


  • Q1 2020 - S.T. Genesis device is launched
  • Q2 2020 - Operationalized reimbursement for S.T. Genesis
  • Q1 2021 - Submitted CMS application for unique reimbursement HCPCS code
  • Q2 2021 - Launched new sales and marketing campaign
  • Q2 2021 - De-formulation of MuGard to create renamed Soothe-OM product
  • Q3 2021 - Signed agreement with Native Health Advisors to introduce S.T. Genesis to top tribes in the community, Blue Cross Blue Shield of AZ and area hospital systems
  • Q4 2021 - Partnered with Aware Recovery Care to use S.T. Genesis in its In-Home Addiction Treatment program, launched aggressive marketing campaign with TV interviews and an informative video


Future plans for S.T. Genesis include moving the device manufacturing to a U.S.-based location and developing S.T. Genesis 2.0.  The next-generation device is being developed to offer:


  • Patent opportunities
  • Bluetooth or other wireless capabilities
  • Biometrics/withdrawal symptoms monitoring through cell phone, desktop, or laptop
  • Smaller design, improving the overall aesthetics
  • More comfortable, needles and overall layout of leads
  • Longer battery life


Speranza is planning additional trials for FDA clearance to use S.T. Genesis for other diseases and disorders such as PTSD, Parkinson’s Disease, and Acute/Chronic Pain. Future applications could include using the S.T. Genesis in place of prescription pain and anxiety medications.


With an emphasis on innovation, access, and experience, our team is dedicated to combating this ongoing crisis by providing real, healing solutions in this space. 


Invest in Speranza Therapeutics to improve patient outcomes!



In the Press

Journal of Substance Use

Percutaneous electrical nerve field stimulation to reduce clinical opiate withdrawal: a case series

Life Science Newswire

Speranza Therapeutics announces value-based program for opioid detox facilities program vows to reduce costly facility Against Medical Advice (AMA) leave rates

Offering Summary


Company

:

Speranza Therapeutics, Inc.

Corporate Address

:

433 Plaza Real Suite 275, Boca Raton, FL 33432

Offering Minimum

:

$9,997.39

Offering Maximum

:

$1,069,996.33

Minimum Investment Amount

(per investor)

:

$399.62











Terms


Offering Type

:

Equity

Security Name

:

Common Stock

Minimum Number of Shares Offered

:

1,451

Maximum Number of Shares Offered

:

155,297

Price per Share

:

$6.89

Pre-Money Valuation

:

$7,666,881.95











*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.

Investment Incentives and Bonuses*

Time Based:

Friends and Family Early Birds

Invest within the first week and receive 15% Bonus Shares 

Super Early Bird Bonus

Invest in the second week and receive 10% Bonus Shares

Early Bird Bonus

Invest in the third week and receive 5% Bonus Shares

Tier 1 - $5,000+

Invest $5,000+, and recieve 2% Bonus Shares

Tier 2 - $15,000+

Invest $15,000+, and recieve 5% Bonus Shares

Tier 3 - $30,000+

Invest $30,000+, and recieve 10% Bonus Shares

*All perks occur when the offering is completed.

The 10% StartEngine Owners' Bonus

Speranza Technologies, 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 $6.89 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $689. 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 only receive a single bonus, which will be the highest bonus rate they are eligible for.

Insider Investment Notice

Officers, directors, executives, and existing owners with a controlling stake in the company (or their immediate family members) may make investments in this offering. Any such investments will be included in the raised amount reflected on the campaign page.

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.

Show More
Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$1,204,058.00 USD
$1,532,092.00 USD
Cash And Cash Equivalents
$34,245.00 USD
$32,002.00 USD
Accounts Receivable
$7,700.00 USD
$129,134.00 USD
Short Term Debt
$2,116,970.00 USD
$869,977.00 USD
Long Term Debt
$0.00 USD
$0.00 USD
Revenues And Sales
$126,310.00 USD
$789,775.00 USD
Costs Of Goods Sold
$187,705.00 USD
$518,475.00 USD
Taxes Paid
$0.00 USD
$12,177.00 USD
Net Income
-$1,969,611.00 USD
-$1,594,376.00 USD

Risks

A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.


Updates

Scheduled Speaking Event for Sal Rafanelli, CEO

6 days ago

Join ENET on Tuesday June 21 to learn about exit strategies from Sal Rafanelli, RPh, who has built a career on his passion for providing excellent patient care and creating innovative companies.

Educating Providers, Parents, and Patient Advocates

10 days ago

Speranza would like to thank A New PATH for the opportunity to be a guest speaker at their recent board meeting. Members included Addiction Providers, Parents of those suffering from addiction, and Patient Advocates. We introduced S.T. Genesis as we discussed the need to manage opioid withdrawal during detox, the first step of addiction treatment. Speranza appreciates passionate groups like A New PATH and our shared commitment to helping patients through recovery.

Panelist Discussion Spotlight at National Native American Conference

19 days ago

Speranza's Vaughn Bell spoke in a panelist discussion at RES2022 around impacting the opioid crisis and how to work with Native American providers, leaders, and communities to improve health and address addiction within the Tribal Nations. Honored to be working with Native Health Advisors as we spoke to a highly engaged group of leaders about how to bring about change! We were honored to be panelists in a presentation about solutions that can bring about systemic health changes for Native American struggling with addiction.

Announcing a New Engagement with Equicare Partners, LLC

24 days ago

Equicare Partners has pre-existing clients and prospects in Federally Qualified Health Centers (FQHC) and Certified Community Behavioral Health Clinics (CCBHC) that support underserved areas and populations across the U.S.  FQHCs and CCBHCs are funded by Medicare and Medicaid.  Both are eligible for grants for special needs.  Equicare Partners has developed focused go-to-market strategies and sales plans to get S.T. Genesis into these markets. These organizations focus on behavioral health so their populations have a high percentage of addiction where S.T. Genesis can be of great value.

Notice of Material Change in Offering

26 days ago

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

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


Campaign is extending their end date by 60 days


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.

Seeking Access to State Opioid Settlement Funds

about 1 month ago

States are beginning to receive funds as the result of settlement agreements totaling $26B with pharmaceutical companies and others involved in the distribution and sale of prescription opioids. With broad discretion as to how these funds may be used, state legislatures are acting to coordinate and direct the uses and disbursement of settlement dollars. Some states have already declared funds to be used for prevention, intervention, treatment, and recovery. Speranza believes S.T. Genesis will fall into the treatment category and is actively petitioning states for consideration.

Native American Tribes Seek Opioid Solutions, NHA to Introduce S.T. Genesis as an Option

about 1 month ago

The drug manufacturer Johnson & Johnson and the opioid distributors AmerisourceBergen, McKesson and Cardinal Health will pay Native American tribes $590 million. The plaintiffs in the case are more than 400 tribes who say the opioid makers and distributors were responsible for the opioid crisis in their communities and say they've faced increased costs in health care, social services, childcare and more as a result. 85% of the settlement will be spent on “drug treatment and related abatement programs,” the tribes' lawyers say. 

Speranza Therapeutics has partnered with Native Health Advisers (NHA), a Native American Woman-owned business, whose focus is integrating new technology to elevate care of Native Americans. NHA will support the use and marketing of S.T. Genesis in their community as a way to help patients through opioid detox. NHA efforts will focus on adding the S.T. Genesis device to hospital systems in the Native health community as well as aid in onboarding patients that have been cleared by a physician to receive the device.

Expansion with Aware Recovery Care

about 2 months ago

Speranza Therapeutics is proud to announce that a trusted partner, Aware Recovery Care, based in Wallingford CT, has expanded their in-home withdrawal management (detox) to the following states: Massachusetts, Maine, Indiana, and Virginia. This is a pinnacle moment for Speranza as Aware has made the S.T. Genesis their standard of care and has purchased 23 additional S.T. Genesis devices for their Opioid Withdrawal Management patients.

Notice of Material Change in Offering

about 2 months ago

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

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


Issuer is extending campaign end date and updating financial information.


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.

Provider Success with S.T. Genesis

2 months ago

The number one reason patients abandon treatment prematurely is the fear of withdrawal symptoms. There is a high cost to providers when patients leave Against Medical Advice (AMA) since the greatest cost to the facility is the admission process. We believe keeping more patients in treatment helps providers and health plans to avoid costly readmissions.

“We have seen an increase in patients afflicted with opioid use disorder abandoning treatment during the first few days of the withdrawal management process,” says Jeffrey Thomas, MHS, LPC, CAADC, CEO of White Deer Run facility in Allenwood, PA. “These patients respond especially well to the device and as a result, have remained engaged in treatment.”

Testimonial from S.T. Genesis Provider

2 months ago

“I have had the unique pleasure of working with the S.T. Genesis PNFS along with the amazing team of professionals at Speranza. S.T. Genesis is one of the most surprising and outstanding treatment options for our patients in detox from opiates. At Aware, we have been able to witness our patients with COWS scores as high as 22-24 decrease to 5-7 within 10 mins with all of their withdrawal symptoms addressed. As a provider in this space for the past 20 years, this is by far the most innovative device and alternative to pharmacological treatment that I have ever witnessed. The Speranza team are innovative, extremely professional, and are the ultimate at customer service, a pleasure to work with.” 

—Shelley Halligan, DNP, PMHNP
Vice President Integrated Medical Services, Aware Recovery Care, Inc.

Speranza to Exhibit at Rx Summit

2 months ago

Rx Summit is a global community of stakeholders "from federal to family" who come together annually to share best practices and strategies for prevention, treatment, and recovery. Speranza will be exhibiting in Booth # 201.  We are excited to be a part of this educational conference and share our innovative device.

Speranza Grows with New Acadia Location

3 months ago

Speranza Therapeutics has distributed S.T. Genesis to trained providers at multiple Acadia Healthcare locations. We are pleased to announce S.T. Genesis is available at another Acadia Healthcare facility.   Acadia is a leading provider of behavioral healthcare services across the United States operating a network of 230 behavioral healthcare facilities in 40 states and Puerto Rico. With more than 20,000 employees serving approximately 70,000 patients daily, Acadia is the largest stand-alone behavioral health company in the U.S.

Upcoming Addiction Conference

3 months ago

Speranza Therapeutics will be exhibiting at the ASAM (American Society of Addiction Medicine) Annual Conference in Hollywood, FL next week. We look forward to educating more addiction treatment professionals about S.T. Genesis' innovative technology.

Show More Updates End of Updates

Comments ({{profileCtrl.startup.comments_count}} total)

{{profileCtrl.newComment.body.length}}/2500
Please sign in to post a comment.
Please use Updates for communications.
{{ profileCtrl.commentsLoading ? 'Loading...' : 'Show More Comments' }}