Full Press Release Details
Petros Pharmaceuticals Announces Capital Raise
Provides Update on Progress Toward Over-the-Counter
(non-prescription) Development of STENDRA
NEW YORK, June 13, 2023 /Globe Newswire/ -- Petros Pharmaceuticals,
Inc. (Nasdaq: PTPI) ("Petros" or "the Company"), a pioneer in expanding consumer access to medication through
the over-the-counter (OTC) pathway, today announces a $15 million private placement financing that will support its continued
progress towards bringing its erectile dysfunction (ED) drug, STENDRA, to non-prescription OTC status.
Petros raised $15 million
from this private placement, which was led by its largest existing shareholders. The funds raised combined with the cash on its balance
sheet ($8.3 million as of March 31, 2023), is expected to provide the Company with a strong cash position that will fund its initiatives
through the end of 2024, enabling significant progress on its pathway to OTC approval as well as partnership opportunities. The closing
of the private placement is subject to customary closing conditions and is expected to occur on or around July 17, 2023.
the completion of a series of initial formative studies, Petros has continued to progress in its development program. Recently, the Company
has conducted three engagements with the U.S. Food and Drug Administration (FDA) reviewing data and receiving guidance, launched a second
pivotal Label Comprehension Study incorporating FDA feedback, and has begun to integrate supportive technology in response to recent FDA
industry-wide guidance and proposed rules. This financing will enable the organization to continue its progress.
have made substantial progress in our efforts to achieve OTC status for STENDRA, which could be the first prescription ED drug to achieve
non-prescription designation," commented Fady Boctor, Petros Pharma's President and Chief Commercial Officer. "The continued
investment and support by our largest shareholders highlight their commitment to our strategy, sharing our excitement and passion. With
this financing we believe we will be well capitalized through 2024 and to the completion of significant milestones along the OTC pathway,
including significant interactions with FDA, multiple data readouts, as well as key technology and developmental partnerships, which we
believe are essential to the successful execution of an OTC strategy.
to Market.us, it is estimated that the total ED market will reach $6.1 billion by 2032 with an average CAGR of 6.8%. The estimated revenue
share for North America alone is 51% of that estimate, and we believe these to be understated based on an observed hesitance on the part
of most men to seek treatment, even with the option to access these via online prescriptions.1
this substantial Rx ED market, we believe that the prospects of expanded nonprescription access of prescription-grade ED therapy has the
potential to significantly multiply this market's growth. With several recently publicized positive OTC switch events, and the potential
for applying the principals of AI to ensure that those who are appropriate to receive it do, we have boldly identified this mission of
developing STENDRA as the potentially first prescription-grade pharmaceutical available without a prescription, as our primary objective
as a company," concluded Mr. Boctor.
believes that its technology platform designed for this program may also apply to future asset candidates, enabling an expansion to the
company's future portfolio and overall opportunity.
About the Private Placement
The Company has executed a securities
purchase agreement for a private placement of preferred stock with an initial conversion price of $2.25 per share, subject to adjustment,
and warrants to acquire up to an aggregate amount of 6,666,668 additional shares of the Company's common stock. The warrants are
exercisable immediately at an exercise price of $2.25 per share, subject to adjustment, and expire five years from the date of issuance.
The Company will file a Current Report on Form 8-K which will contain additional information about the terms of the private placement,
which will be available at www.sec.gov.
were offered and sold in a transaction exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities
Act"), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities
Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. Accordingly,
the preferred stock, warrants and underlying shares of common stock issuable upon conversion or exercise of the preferred stock and warrants
may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from
the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration
statement with the SEC registering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise
of the warrants issued in connection with the private placement.
release is not an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or
jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities
laws of any such state or jurisdiction.
About the OTC Pathway
The process of switching a prescription
medication to over-the-counter (OTC) involves the design of a clear to laymen, shelf-friendly medication label, demonstrated comprehension
of key safety parameters, and proven, appropriate consumer self-selection. The FDA ordinarily requires a consumer tested OTC Drug Facts
label (DFL), Label Comprehension Studies (LCS), Self Selection Studies (SSS), and at least one Actual Use Trial (AUT) demonstrating safe
and appropriate non-practitioner-guided, yet consumer-led use. Recently, a communication by FDA introduced Additional Conditions for Non-prescription
Use (ACNU) criteria that may expand OTC access to several prescription medications and enable innovative tools to help support the switch
originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5)
inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and
effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity.
STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do
not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances
of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or
200 mg) due to side effects compared to 1.7% on placebo. Stendra was designed and developed expressly for erectile dysfunction.
The Company recently undertook a relaunch of Stendra , generating gross revenues of approximately $30 million in 2019. Petros
intends to accelerate the relaunch of Stendra with a well-funded commercial organization and refocused strategy.
STENDRA Important Risk Information
can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop
in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.
take STENDRA if you:
activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can
put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health
with your healthcare provider to ensure you are healthy enough for sex.
can cause serious side effects.
reported side effects include:
you take STENDRA, tell your healthcare provider if you:
your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins,
and herbal supplements. STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may
cause side effects. Especially tell your healthcare provider if you take any of the following:
drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA, as this can lead to increased
chances of headache, dizziness, increased heart rate, or lowered blood pressure.
does not protect against sexually transmitted diseases, including HIV.
common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.
healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of
STENDRA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side
is a prescription medicine used to treat erectile dysfunction (ED). STENDRA is not for use in women or children. It is not known if STENDRA
is safe and e ective in women or children under 18 years of age.
information about Stendra, call 844-458-4887. If you would like to report an adverse event or product compliant, please contact us at
encouraged to report adverse events related to prescription drugs to the FDA.
Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
see full Prescribing Information and Patient Information.
About Petros Pharmaceuticals
Petros Pharmaceuticals is committed to the goal of becoming a world-leading
specialized men's health company by identifying, developing, acquiring, and commercializing innovative therapeutics for men's health issues,
including, but not limited to, erectile dysfunction, endothelial dysfunction, psychosexual and psychosocial ailments, Peyronie's disease,
hormone health, and substance use disorders.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the