0001533040
false
0001533040
2023-01-04
2023-01-04
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported):
January 4, 2023
PHIO
PHARMACEUTICALS CORP.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
001-36304 |
|
45-3215903 |
|
(State or other jurisdiction of incorporation
or organization) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
257 Simarano Drive, Suite 101
|
|
| Marlborough, Massachusetts |
01752 |
| (Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: (508) 767-3861
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each
class of securities: |
|
Trading
Symbol(s): |
|
Name
of exchange on which registered: |
| Common
Stock, par value $0.0001 per share |
|
PHIO |
|
The
NASDAQ Capital
Market |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 5.07. Submission of Matters to a Vote
of Security Holders.
On January 4, 2023, Phio Pharmaceuticals Corp. (the “Company”)
held a special meeting of its stockholders (the “Special Meeting”). At the Special Meeting, the Company’s stockholders
voted on the following proposal, as described in the Company’s Definitive Proxy Statement, filed on Schedule 14A on November 30,
2022 (the “Proxy Statement”): approval of an amendment to the Company’s Amended and Restated Certificate of Incorporation
to effect a reverse stock split of the outstanding shares of the Company’s common stock, at a ratio of not less than 1-for-2 and
not greater than 1-for-25, with the exact ratio and effective time of the reverse stock split to be determined by the Board of Directors
of the Company (the “Reverse Stock Split Proposal”).
The Company had 13,667,973 shares of common stock and one share of
Series D preferred stock (the “Preferred Stock”) issued and outstanding at the close of business on November 17, 2022, the
record date for eligibility to vote at the Special Meeting, and there were present at the Special Meeting (in person virtually or represented
by valid proxy) a total of 6,500,381 shares of common stock and one share of Preferred Stock.
As previously described in in the Company’s Proxy Statement,
the holder of record of the one outstanding share of Preferred Stock was entitled to 17,500,000 votes, had the right to vote only on the
Reverse Stock Split Proposal, and such votes were automatically voted in the same proportion as the shares of common stock voted on the
Reverse Stock Proposal. Holders of the Company’s common stock were entitled to one vote per share.
The Reverse Stock Split Proposal submitted to a vote of the Company’s
stockholders at the Special Meeting was approved. The ratio and effective date of the reverse stock split will be reported on a separate
Current Report on Form 8-K once approved by the Company’s Board of Directors.
At the Special Meeting, the Company’s stockholders voted in the
following manner with respect to the Reverse Stock Split Proposal:
| For |
Against |
Abstain |
| 19,728,800 |
4,120,599 |
150,982 |
Item 7.01. Regulation FD Disclosure.
On January 6, 2023, the Company posted an updated investor presentation
and webcast on its website at www.phiopharma.com. A copy of the investor presentation is attached hereto
as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure.
The information furnished under this Item 7.01 of this Current Report
on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information
be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
|
|
|
PHIO PHARMACEUTICALS CORP. |
| |
|
|
|
|
| |
|
|
|
| Date: January 6, 2023 |
|
|
|
By: |
/s/
Robert Bitterman |
| |
|
|
|
|
Name: Robert Bitterman
Title: Interim Executive Chairman |
Exhibit 99.1
1 www.phiopharma.com I Ticker: PHIO (NASDAQ) Phio Pharmaceuticals Proprietary Innovations in Immuno - oncology (I/O) Therapeutic Applications
2 This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests” and similar expressions are intend ed to identify forward - looking statements. These statements are based on Phio Pharmaceuticals Corp.’s (the “Company”) current beliefs and expectations. Such st atements include, but are not limited to, statements about the impact to our business and operations by the recent coronavirus outbreak, the future dev elo pment of the Company’s products (including timing of clinical trials and related matters associated therewith), the expected timing of certain devel opm ental milestones, expectations and assumptions regarding the results of our preclinical studies, potential partnership opportunities, the Company’s competit ion and market opportunity and pro forma estimates. The inclusion of forward - looking statements should not be regarded as a representation by the Company t hat any of its plans will be achieved. Actual results may differ from those set forth in this presentation due to risks and uncertainties in the Compa ny’ s business, including those identified under “Risk Factors” in the Company’s most recently filed Annual Report on Form 10 - K and in other filings the Company periodically makes with the U.S. Securities and Exchange Commission. The Company does not undertake to update any of these forward - looking statements t o reflect a change in its views or events or circumstances that occur after the date of this presentation. Forward Looking Statements
• Founded by Nobel Laureate Craig Mello who discovered RNAi • RNAi has broad therapeutic applications across multiple cell types • Phio focuses on Immuno - oncology therapy in dermatological cancers Phio Pharmaceuticals: A History of Innovation
4 www.phiopharma.com I Ticker: PHIO (NASDAQ) INTASYL Technology and Compounds
INTASYL Ρ • Patented, self - delivering RNAi technology • Effective against multiple gene targets • Silences genes that tumors utilize to evade the immune system • Makes immune cells more effective in killing cancer cells Continuing the Innovation Today
• Chemically modified siRNAs precisely target any cell type • Simplified structure enables naked compound delivery — No specialized formulations or delivery systems • Adaptable for use in both Intratumoral and Adoptive Cell Therapy • Efficient in multiple gene targeting compared to gene editing What Makes INTASYL Unique
7 Program Target(s) & Indication Discovery Preclinical Proof of Concept Product Development IND Enabling Studies IND Filing or equivalent Pilot Clinical Studies Pivotal Clinical Studies PH - 762 (US) PD - 1 cSCC, Metastatic Melanoma, HNSCC PH - 762 (EU) PD - 1 Metastatic Melanoma PH - 762 Enhanced TIL Study ( AgonOx Partner) PD - 1 Metastatic Melanoma, HNSCC PH - 894 (US) BRD - 4 Metastatic Melanoma, HNSCC, HCC, TNBC INTASYL Ρ Pipeline Portfolio Enrolling Patients
8 www.phiopharma.com I Ticker: PHIO (NASDAQ) INTASYL Market Potential
• Underserved need — 3.5 million incidences of solid tumors each year in US • $123 b estimated market revenue in 2023 in direct solid tumor cancer treatments • Determinate success factors for therapies — Efficacy, safety, tolerability, convenience, pharma - economics Market potential for Immuno - oncology
10 Potential for Cutaneous Squamous Cell Carcinoma (cSCC) and Melanoma Treatment cSCC incidence: 51% (1.8 m patients) Melanoma incidence: 3% (100,000 patients) All solid tumors, excluding basal cell carcinoma
• Metastatic patients: ~3.5% • ~ 50% non - responsive to treatment with monoclonal antibodies — some subject to off target auto - immune side effects • Neoadjuvant procedure with INTASYL may offer ‘tissue sparing’ via tumor shrinkage Underserved Medical Needs in cSCC
12 www.phiopharma.com I Ticker: PHIO (NASDAQ) Competitive Landscape
13 Unique Position Compete Stand Alone Collaborate
• Partnerships: Complimentary Co - development — AgonOx relationship : TILs & PH762 — Antibody companies — Other cell therapy: NK cells • Out licensing — INTASYL compounds Collaboration Strategy
15 www.phiopharma.com I Ticker: PHIO (NASDAQ) Phio Pharmaceuticals Leadership and Finance
• Robert Bitterman /Executive Chairman • Linda Mahoney/VP Project Development • James Cardia, PhD, VP of Scientific Operations • Caitlin Kontulis , VP Finance Leadership
17 Combined Peak Year Revenues ~$ .75B to $1.1B 762 IT/ACT Melanoma, cSCC and HNSCC Projected NPV ~$200M to $470MM Cash (at 12/31/2022) ~$11.0MM Burn rate $3.0M / quarter Cash runway Q4 2023 Common shares outstanding (as of 12/31 /2022 ) 13.7M Market Cap (as of 12/31/2022 ) $5.1M Shareholder approval to execute a reverse split up to 25:1 Targeted Next Capital Raise ($15 - $17MM) Q1 2022 – Q2 2023* *(Funding for PH - 762 cSCC, Melanoma; and ACT Melanoma, HNSCC) Financial Summary
18 www.phiopharma.com I Ticker: PHIO (NASDAQ) Thank you.