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Phio Pharmaceuticals Reports 2021 Year End Financial Results and Provides Business Update Company transitioning into a clinical stage company with start of the first clinical study for lead program, PH-762. Marlborough,

Key Takeaway: Pharmaceuticals Reports 2021 Year End Financial Results and Provides Business Update Company transitioning into a clinical stage company with start of the first clinical study for lead program, PH-762. Marlborough, Mass., March 22, 2022/PRNewswire/ -- Phio Pharmaceuticals Cor

Full Press Release Details

Pharmaceuticals Reports 2021 Year End Financial Results and Provides Business Update
Company transitioning
into a clinical stage company with start of the first clinical study for lead program, PH-762.
Marlborough, Mass., March 22, 2022/PRNewswire/
-- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based
on its proprietary self-delivering RNAi (INTASYL ) therapeutic platform, today reported its financial results for the year ended
December 31, 2021 and provided a business update.
"Over the past year, we have made significant progress moving
towards the initiation of our first-in-human clinical studies for our lead program, PH-762, in 2022. Currently, we are on track to start
enrolling patients in the first of these trials, a Phase 1b study of PH-762 in advanced melanoma, in the coming weeks," said Dr.
Gerrit Dispersyn, President and CEO of Phio. "I am proud of the Phio team's execution of our preclinical program for PH-762,
which has generated a steady stream of positive data and supported our regulatory strategy. These studies were conducted during the second
year of the ongoing global pandemic, which has proven to be a difficult period of time for the team, yet we incurred only minor delays
to our original timelines. I believe the achievement of these milestones within the stated timeframes speak to the strength of our team
and the assets in our pipeline, as well as our INTASYL platform. We look forward to continuing to deliver on our current development pipeline
in 2022 as our business fulfills its transition into a clinical stage company."
Quarter in Review and Recent Corporate Updates
Granted clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe.
Presented new data in an in vivo hepatocarcinoma model that show PH-762 administered locally cleared untreated distal tumors, which indicates a systemic immune response.
Initiated efficacy animal studies with INTASYL-based antiviral compounds against SARS-CoV-2 infection, the virus that causes COVID-19, following collection of positive results from in vitro studies under this development program.
Upcoming Pipeline Milestones for 2022
At December 31, 2021, the Company had cash
of $24.1 million as compared with $14.2 million at December 31, 2020. The Company expects its current cash will be sufficient to fund
currently planned operations to the second quarter of 2023.
Research and Development Expenses
Research and development expenses were approximately
$8.9 million for the year ended December 31, 2021, compared to approximately $3.7 million for the year ended December 31, 2020. The increase
in research and development expenses was primarily due to manufacturing costs for the Company's PH-762 and PH-894 INTASYL compounds,
fees for the required preclinical studies in support of the Company's clinical trials for PH-762 and CRO and consulting related
costs to support the initiation of the Company's clinical trials as compared to the same period in the prior year.
General and Administrative Expenses
General and administrative expenses were approximately
$4.6 million for the year ended December 31, 2021, compared to approximately $5.1 million for the year ended December 31, 2020. The decrease
in general and administrative expenses was primarily due to a decrease in patent and legal fees partially offset by increases in the use
of an outside consultant to support business development activities and corporate insurance premiums.
Net loss was $13.3 million, or $1.04 per share,
for the year ended December 31, 2021, compared with $8.8 million, or $1.92 per share, for the year ended December 31, 2020. The increase
in net loss was primarily attributable to the increase in research and development expenses related to the Company's manufacturing
of its INTASYL compounds and preclinical activities in preparation for the start of its clinical trial with PH-762, as described above.
The change in net loss per share was primarily due to an increase in the number of shares outstanding as a result of the Company's
capital raise activities as compared to the prior year period.
About Phio Pharmaceuticals
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology
company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (INTASYL ) therapeutic
platform. The Company's efforts are focused on silencing tumor-induced suppression of the immune system through its proprietary INTASYL
platform with utility in immune cells and the tumor micro-environment. Our goal is to develop powerful INTASYL therapeutic compounds that
can weaponize immune effector cells to overcome tumor immune escape, thereby providing patients a powerful new treatment option that goes
beyond current treatment modalities. For additional information, visit the Company's website, www.phiopharma.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends,"
"believes," "anticipates," "indicates," "plans," "expects," "suggests," "may,"
"would," "should," "potential," "designed to," "will," "ongoing," "estimate,"
"forecast," "target," "predict," "could" and similar references, although not all forward-looking
statements contain these words. Forward-looking statements are neither historical facts nor assurances of future performance. These statements
are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies,
projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which
are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result
of a number of important factors, including, but not limited to, the impact to our business and operations by the ongoing coronavirus
pandemic, the development of our product candidates, results from our preclinical and clinical activities, our ability to execute on business
strategies, our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the
timeline and duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and
approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product
candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain
for intellectual property rights covering our technology platform, our ability to obtain future financing, market and other conditions
and those identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors"
and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance
on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not
undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of
this release, except as required by law.
Contact Phio Pharmaceuticals Corp.
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per
Twelve Months Ended December 31,
2021 2020
Operating expenses:
Research and development $ 8,886 $ 3,716
General and administrative 4,625 5,077
Total operating expenses 13,511 8,793
Operating loss (13,511 ) (8,793 )
Total other income (expense) 224 (1 )
Net loss $ (13,287 ) $ (8,794 )
Net loss per share: Basic and diluted $ (1.04 ) $ (1.92 )
Weighted average number of common shares outstanding Basic and diluted 12,830,809 4,587,346
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
December 31, 2021 December 31, 2020
ASSETS
Cash $ 24,057 $ 14,244
Restricted cash 50 50
Prepaid expenses and other current assets 620 870
Right of use asset, net 283 400
Property and equipment, net 133 157
Other assets 27 18
Total assets $ 25,170 $ 15,739
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $ 283 $ 728
Accrued expenses 2,660 1,352
Lease liability 125 116
Lease liability, net of current portion 170 295
Long-term debt - 231
Total stockholders' equity 21,932 13,017
Total liabilities and stockholders' equity $ 25,170 $ 15,739
Last updated: Mar 22, 2022