PHIO Shareholder/Stockholder Letter Transcript:
2024
Phio Pharmaceuticals Corp.
Annual Report
Dear Stockholder:
I m excited to share with you recent highlights in Phio s continuing journey
toward development of our lead INTASYL siRNA compound, PH-762, for
intratumoral treatment of cutaneous carcinomas.
Our dose escalating Phase 1b clinical study recently completed four dose
escalating cohorts, and we are now enrolling what we expect to be the 5th and
in the Phase 1b study. To date, we have experienced no dose
limiting toxicities which otherwise could have prevented us from increasing the
drug concentration of PH-762 in each subsequent cohort. Equally noteworthy
has been PH-762 s response rate on target lesions at the 5-week
observation point in the Phase 1b study. Of the 15 patients treated thus far in
the Phase 1b study, 13 presented with cutaneous squamous cell carcinoma
(cSCC) as a target lesion. Through completion of the 4th cohort at the 5-week
observation point, ve patients had a 100% pathological response (complete
cure). One patient experienced a greater than 90% response (near complete
response) and one other showed >50% response (partial response). The result
for one patient is pending. Of the patients who did not respond, none
experienced progression of the disease. The remaining two patients in the study
included one metastatic stage 4 melanoma and one metastatic stage 4 Merkel
cell. The melanoma patient did not respond to treatment; however, the Merkel
cell patient did experience a partial response, notwithstanding the late stage of
the disease.
Clinical study activities were accompanied by another important milestone in
the drug development pathway: advancing the CMC (Chemistry, Manufacturing
and Controls) program. CMC activities center on securing an-FDA compliant
manufacturing site capable of producing active pharmaceutical ingredient (API)
in commercial scale quantities. To that end, we recently executed a drug
substance development services agreement with a reputable U.S.
manufacturing site known for its expertise specializing in oligonucleotide
chemistry. The site is strategically located in the Northeastern United States,
accessible to Phio s technical team and with implications, should
that become a future economic matter.
We made a few changes in our operations. As previously reported, we undertook
a cost rationalization program in the 1st quarter of 2024, closing our
administration and laboratory facility in Marlborough, MA. We now lease a
small laboratory space at Biomedical Initiatives in Worcester, MA. We also
relocated our corporate headquarters from Marlborough, Massachusetts to
King of Prussia, Pennsylvania, in the heart of the mid-Atlantic biopharma
corridor. We have access to administrative space at the headquarters of Life
Science Pennsylvania in King of Prussia, PA., the terms for which are
economically attractive . The site is central to the majority of our
employees and contracted subject matter experts. Pennsylvania also
certain tax advantages at the state level not available in Massachusetts. Finally,
we changed our outside auditor, now engaging Grant Thornton LLP, which has a
strong biopharma healthcare practice presence in the greater Philadelphia
area.
Regarding intellectual property, we initiated patent application centered
on the use of our compounds in combination with other immuno-oncology
compounds and expanding the number of therapeutic targets. Conversely, we
also cost rationalized a number of patent applications
did not justify continued expenditures in certain geographies or where
applications were deemed to have diminishing value.
During the last 12 months Phio participated in a number of prestigious medical
symposiums, including presentations of posters and abstracts at ASCO, SITC
and ASCGT. Most noteworthy, however, were invitations for podium
presentations at the American Academy of Dermatology and Society for
Investigative Dermatology, to present from our PH-762
Phase 1b study .
On the communications front, we took actions to increase our investor visibility
among a broader range of target audiences. We engaged with Renmark
Financial Communications, which has reach into a broad range of retail
investors throughout North America. Since last November, Phio reached out to
nine varied geographic targets through webcast virtual non-deal road shows.
Phio also established an association with Sidoti & Company, a long established
investors. The
culmination of investor outreach was the assumption of research coverage in a
detailed, comprehensive report from HC Wainwright Investment Bank research.
On behalf of the Phio Board of Directors and Management, I want to thank you
for your continued interest and investment in our company. Our objective
continues to be to drive shareholder value for you as we continue on our
mission to eliminate cancer in ways that others cannot. We strive to execute
our strategy through lean infrastructure and targeted
deployment of funds, leveraging our patented INTASYL technology platform,
which is designed to make our immune cells
cells.
Sincerely,
Robert Bitterman
Chairman, President and CEO
Phio Pharmaceuticals Corp.
7/30/2025 Letter Continued (Full PDF)