Full Press Release Details
Phio Pharmaceuticals
Reports Year End 2019 Financial Results and Provides Business Update
Marlborough, Mass., March 26, 2020
-- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics
based on its proprietary self-delivering RNAi (INTASYL ) therapeutic platform, today reported its financial results for the
full year ended December 31, 2019 and provided a business update.
"Our progress in 2019, along
with the bolstering of our balance sheet, now positions us to further unlock the value of our immuno-oncology programs based on
our self-delivering RNAi (INTASYL ) therapeutic platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "With new data from animal studies becoming available, we look forward to continuing our R&D momentum in 2020, including the
transition towards the clinical development stage of our lead candidate PH-762. We also continue to leverage our RNAi platform
to establish research collaborations with leading companies and academic institutions. We recently announced a new collaboration
and option agreement with Medigene AG, further building on our previously announced research collaboration with the
Helmholtz Zentrum M nchen to design and develop novel candidates in adoptive cell therapy."
Year in Review and Recent Corporate
| Phio has developed a product platform based on our INTASYL technology that allows easy, precise, rapid and selective non-genetically modified programming of cells. It can be used to improve immune cells used in adoptive cell transfer (ACT therapy) and to reduce immunosuppression in the tumor microenvironment (TME). The use of INTASYL to improve ACT can be done ex vivo , during cell manufacturing. The direct therapeutic use of INTASYL compounds towards the TME can be done in vivo by local delivery to the tumor in the patient. Both applications of our INTASYL technology result in improved immunotherapy. | ||
| Lead product candidate PH-762 is designed to elicit checkpoint blockade by inhibiting PD-1 receptor expression in T cells. Recent data developed in-house and with our collaborators, has shown that PH-762 can elicit PD-1 checkpoint blockade by silencing PD-1 receptor expression resulting in enhanced T cell activation and tumor cytotoxicity, and shows the potential of PH-762 in both ACT and TME applications. The Company expects that PH-762 can be ready to enter the clinic with a partner in ACT therapy in the second half of 2020, and for direct therapeutic use towards the TME through intra-tumoral injection in 2021. |
Conference Presentations and Poster
At December 31, 2019, the Company had
cash of $6.9 million as compared with $14.9 million at December 31, 2018. This does not include the $9.74 million in gross proceeds
the Company raised through two equity offerings completed in February 2020. The Company expects its cash will be sufficient to
fund currently planned operations for at least the next 12 months.
Research and Development Expenses
Research and development expenses were
approximately $4.3 million for the years ended December 31, 2019 and 2018, respectively. Research and development expenses were
consistent year over year primarily as a result of a reduction in the Company's legacy clinical trial-related expenses which
ended in 2018; offset by increased use of third-party CROs to support preclinical immuno-oncology research efforts in 2019.
General and Administrative Expenses
General and administrative expenses
were $4.7 million for the year ended December 31, 2019, compared to $3.2 million for the year ended December 31, 2018. The increase
was primarily due to legal professional fees, recruiting fees related to employee hiring activities and increased proxy-related
fees as a result of the Company's annual and special stockholder meetings held in 2019.
Net loss was $8.9 million or $19.33
per share for the year ended December 31, 2019, compared with $7.4 million or $57.46 per share for the year ended December 31,
2018. The increase was primarily attributable to an increase in operating expenses, discussed above.
Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (Nasdaq:
PHIO) is a 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/or 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 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, 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.
Contact Phio Pharmaceuticals Corp.
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
| For the Three | For the Three | For the Year | For the Year | |||||||||||||
| Months Ended | Months Ended | Ended | Ended | |||||||||||||
| December 31, 2019 | December 31, 2018 | December 31, 2019 | December 31, 2018 | |||||||||||||
| Revenues | $ | - | $ | - | $ | 21 | $ | 138 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,023 | 944 | 4,300 | 4,326 | ||||||||||||
| General and administrative | 1,646 | 790 | 4,708 | 3,176 | ||||||||||||
| Total operating expenses | 2,669 | 1,734 | 9,008 | 7,502 | ||||||||||||
| Operating loss | (2,669 | ) | (1,734 | ) | (8,987 | ) | (7,364 | ) | ||||||||
| Total other income, net | 9 | 7 | 79 | 4 | ||||||||||||
| Loss before income taxes | (2,660 | ) | (1,727 | ) | (8,908 | ) | (7,360 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (2,660 | ) | $ | (1,727 | ) | $ | (8,908 | ) | $ | (7,360 | ) | ||||
| Net loss per share: Basic and diluted | $ | (4.69 | ) | $ | (5.56 | ) | $ | (19.33 | ) | $ | (57.46 | ) | ||||
| Weighted average shares: Basic and diluted | 567,334 | 310,542 | 460,809 | 128,085 |
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
| December 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 6,934 | $ | 14,879 | ||||
| Restricted cash | 50 | 50 | ||||||
| Prepaid expenses and other current assets | 316 | 221 | ||||||
| Total current assets | 7,300 | 15,150 | ||||||
| Right of use asset | 511 | - | ||||||
| Property and equipment, net | 210 | 172 | ||||||
| Other assets | 18 | - | ||||||
| Total assets | $ | 8,039 | $ | 15,322 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 809 | $ | 550 | ||||
| Accrued expenses | 964 | 1,194 | ||||||
| Lease liability | 107 | - | ||||||
| Total current liabilities | 1,880 | 1,744 | ||||||
| Lease liability, net of current portion | 411 | - | ||||||
| Total liabilities | 2,291 | 1,744 | ||||||
| Total stockholders' equity | 5,748 | 13,578 | ||||||
| Total liabilities and stockholders' equity | $ | 8,039 | $ | 15,322 |