Phio Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Business Update


First-in-human clinical study of PH-762 for the treatment of advanced melanoma open for enrollment

IND-enabled studies for PH-894 are expected to be completed in the second half of 2022

MARLBOROUGH, Mass., May 12, 2022 / PRNewswire/ – Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company that is developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL ™) therapeutic platform, today reported its financial results for the quarter ended . March 31, 2022 and provides business updates.

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“We are pleased that enrollment is open for our first human clinical trial for PH-762 at the Gustave Roussy Institute, one of the largest cancer centers in Europe. This study will evaluate the safety, tolerability, pharmacokinetics and checkpoint anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. The clinical study will show a dose increase of PH-762 with top-line data from the first group of patients expected in the first quarter of 2023, ”said Drs. Geert Cauwenbergh, Principal Executive Officer of Phio. “In addition, the new preclinical data we recently presented at the AACR Annual Meeting demonstrates the potential of PH-894 to be used in the treatment of patients who do not respond to anti-PD-1 therapy, or patients. which improved after the initial treatment response.with checkpoint inhibitors.The reaction of the investment community when this data was presented, confirmed the relevance of a compound such as PH-894, an INTASYL compound which specifically targets BRD4, in patients who may not respond or return after PD-1 therapy. We expect to finalize IND-enabled studies for PH-894 in the second half of 2022, “concluded Drs. Cauwenbergh.

Quarterly Review and Recent Corporate Updates

  • Enrollment is open for the Company Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma.
  • Presented new in vivo data at the AACR Annual Meeting 2022 provide strong justification for the clinical use of PH-894, a BRD4-targeting, self-delivering RNAi, as monotherapy, as well as in combination with systemic PD-1 therapy.
  • Continue to develop the PH-3861, a dual-target INTASYL towards PD-1 and BRD4. Last year this program reported data showing PH-3861 obtained complete treatment of tumors in a in vivo model of hepatoma and exceeded the effectiveness of small -molecule and antibody suppression treatments to the same targets. In addition, local INTASYL therapy has been shown to induce a systemic anti-tumor response with clearance of untreated distal tumor.

Upcoming Pipeline Milestones

  • IND-enabled studies for PH-894 are expected to be completed in the second half of 2022.
  • On track to report top-line data from the first group of patients with advanced melanoma in the clinical trial for PH-762 in the first quarter of 2023.
  • Additional data publications on the Company’s pipeline programs.

Financial Results

Money position

on March 31, 2022the Company has cash already $ 20.5 million compared to $ 24.1 million on December 31, 2021. The Company expects its current money to be sufficient to fund its current planned operations until the second quarter of 2023.

Research and Development Costs

Research and development costs are estimated $ 1.6 million for the quarter is over March 31, 2022compared to estimates $ 2.4 million for the quarter is over March 31, 2021. The reduction was primarily due to preclinical studies and manufacturing costs to support the Company’s clinical trial of PH-762, which was completed in the previous year period, offset by rising CRO costs in preparation for the launch. of the Company’s clinical trial of PH -762 and staff -related costs due to the increase in the number of people compared to last year.

General and Administrative Expenses

Total and administrative costs are estimated $ 1.1 million for the quarter is over March 31, 2022compared to estimates $ 1.2 million for the quarter is over March 31, 2021. The decrease was primarily due to a reduction in legal and patent fees offset by an increase in the cost of stock-based compensation.

Net Loss

The net loss is $ 2.6 millionor $ 0.19 each part, for the quarter ended March 31, 2022compared to $ 3.4 millionor $ 0.32 each part, for the quarter ended March 31, 2021. The reduction in net loss is mainly due to the reduction in research and development costs as described above.

About Phio Pharmaceuticals Corp.

Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology company that is developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (INTASYL ™) therapeutic platform. The Company’s efforts focus on silencing tumor-induced suppression of the immune system through the proprietary INTASYL platform equipped with immune cells and tumor microenvironment. Our goal is to create powerful INTASYL therapeutic compounds that can arm immune effector cells to overcome tumor immune escape, thus giving patients a powerful new treatment option that goes beyond current treatment methods. For more information, visit the Company’s website, www.phiopharma.com.

Looking Ahead Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “intends,” “believes,” “expects, “” indicates, “” plans, “” anticipates, “” suggests, “” may, “” would, “” should, “” potential, “” designed by, “” will, “” proceed, “” estimate, “” predict, “” target, “” predict, “” can “and similar references, although not all forward-looking statements have these words. The forward statements are not historical facts or guarantees of future performance. These statements are based solely on our current beliefs, expectations and assumptions about the future of our business, future plans and strategies, projections, expected events and trends, the economy and other futures. 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 much of this is beyond our control. Our actual results may differ materially from those shown in the expected statements as a result of a number of key factors, including, but not limited to, the impact on our business and operations of the ongoing coronavirus pandemic, the development of our product. candidates, results from our preclinical and clinical activities, our ability to implement business strategies, our ability to develop our product candidates with collaborative partners, and the success of any such as collaborations, the timeline and duration for the progress of our product candidates into clinical development, the timing or possibility 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 may be able to establish and maintain for the rights of intellectual property comprising our technology platform, ou r ability to obtain future financing, merk ado and other conditions and those identified in our Annual Report on Form 10-K and consecutive Quarterly Reports on Form 10-Q under the caption “Risk Factors” and other filings regularly made by SEC companies. Readers are encouraged to review these risk factors and not to act on any forward-looking statements, as the actual consequences may differ from what our expected statements suggest. Phio does not intend to update forward-looking statements to reflect a change in views, events or circumstances that will occur after the date of this release, unless required by law.

Contact Phio Pharmaceuticals Corp.
[email protected]

Investor Contact
Ashley R. Robinson
LifeSci Advisors
[email protected]

PHIO PHARMACEUTICALS CORP.

COMPLETE OPERATIONAL STATEMENTS

(Amounts in the thousands, excluding share and per share data)

(Not audited)







Three Months Ended
March 31,




2022



2021


Operating costs:









Research and development


$

1,586



$

2,429


General and administrative



1,054




1,209


Total operating costs



2,640




3,638


Loss of operation



(2,640)




(3,638)


Total other (cost) income



(2)




231


Net loss


$

(2,642)



$

(3,407)


Net loss per share: Basic and diluted


$

(0.19)



$

(0.32)


Weighed average number of common features outstanding
Basic and diluted



13,564,129




10,680,395


PHIO PHARMACEUTICALS CORP.

CONSOLIDATED BALANCE SHEET

(Amounts in thousands)

(Not audited)










March 31,
2022



December 31,
2021


ASSETS









dough


$

20,459



$

24,057


Restricted cash



50




50


Prepaid cost



1,158




620


Right to use asset, net



253




283


Property and equipment, net



215




133


Other properties



27




27


Total assets


$

22,162



$

25,170


LIABILITY AND STOCKHOLDERS ‘EQUITY









Accounts paid


$

329



$

283


Accumulated costs



2,117




2,660


Liability to rent



265




295


Total equity of stockholders



19,451




21,932


General obligations and equity of stock owners


$

22,162



$

25,170


SOURCE Phio Pharmaceuticals Corp.



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