Phio Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update
Phio Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update
Marlborough, Massachusetts–(Newsfile Corp. – August 14, 2024) – Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today reported its financial results for the quarter ended June 30, 2024 and provided a business update.
Phio Pharmaceuticals Corp.(NASDAQ:PHIO)是一家臨床階段的生物技術公司,其專有的INTASYL siRNA基因沉默技術旨在增強免疫細胞的殺傷腫瘤細胞能力。今天,該公司公佈了2024年6月30日止一季度的財務報告並提供了業務更新。
Recent Corporate Updates
最近的公司更新
The Phase 1b clinical trial for our lead product candidate, PH-762, received a positive safety recommendation from the Safety Monitoring Committee (SMC). There were no dose-limiting toxicities, or clinically relevant treatment-emergent adverse events in the initial cohort receiving intratumoral PH-762. The injections were well tolerated. The SMC recommended dose escalation and enrollment of the next planned cohort in the clinical study.
The clinical trial is currently enrolling patients for the 2nd cohort.
A fifth clinical trial site has been added to our Phase 1b study of PH-762. The University of Pittsburgh Medical Center (UPMC) Department of Dermatology joins four other sites engaged in the clinical study: The George Washington University-Medical Faculty Associates in Washington, D.C; Banner MD Anderson Cancer Center in Gilbert, Arizona; Integrity Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio.
An additional patent in a family of patents covering INTASYL compounds that target aging skin disorders was recently granted in South Korea. The patent covers the INTASYL RXI-185 compound that treats aging and skin disorders, including photo-aging. RXI-185 is a potent silencer of MMP1 expression in the skin, interrupting ultraviolet radiation (UVR) induced collagen breakdown, thereby improving and/or slowing the progression for skin thickening, elasticity and wrinkles.
Phio entered into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 545,286 shares of common stock of the Company, originally issued in February 2020 through December 2023, having exercise prices between $324.00 and $9.72 per share, at a reduced exercise price of $5.45 per share. The gross proceeds to the Company from the exercise of these warrants were approximately $3.1 million.
A reverse Stock Split became effective on July 5, 2024. Every nine (9) shares of the Company's common stock were combined into one (1) share of common stock, with no change to the par value of $0.0001 per share. This reduced the Company's outstanding common stock from approximately 4.6 million shares to approximately 0.5 million shares. The reverse stock split affects all stockholders uniformly and will not alter any stockholder's percentage interest in the Company's common stock, except for adjustments that may result from the treatment of fractional shares.
On July 19, 2024, we received written notice from The Nasdaq Stock Market LLC that stated that the Company was now in compliance with the minimum $1.00 bid price requirement for continued listing on the Nasdaq Capital Market.
Phio announced appointment of Robert M. Infarinato to the position of vice president and chief financial officer effective August 1, 2024. He will serve in the capacity of Principal Financial Officer including responsibility for accounting, finance, treasury, investor relations and administration.
We entered into an exploratory collaboration with a global, multi-billion dollar skin care company regarding opportunities for Phio's proprietary compounds targeting cosmeceutical skin care applications.
我們的主要產品PH-762的10億期臨床試驗獲得了安全性推薦,沒有劑量限制的毒性,並在初步接受腫瘤內PH-762的隊列中沒有出現臨床相關的治療後不良事件。注射劑耐受性好。安全性監測委員會(SMC)建議劑量遞增並招募下一個計劃隊列的臨床研究對象。
該臨床試驗目前正在招募第二個隊列的患者。
我們針對PH-762的一項10億期臨床研究已經添加了第五個臨床試驗站點。匹茲堡大學醫學中心(UPMC)皮膚科部加入了其他四個參與臨床研究的試驗站點:華盛頓特區的喬治華盛頓大學醫學學院,亞利桑那州吉爾伯特的Banner MD Anderson癌症中心,佛羅里達州德爾雷海灘的Integrity Research Clinical Associates和俄亥俄州都柏林的Centricity Research。
針對治療衰老皮膚疾病的INTASYL化合物系列專利中的另一項已在韓國獲得授權,該專利涵蓋了治療老化和皮膚疾病(包括光老化症)的INTASYL RXI-185化合物。 RXI-185是皮膚MMP1表達的有效沉默劑,能夠阻斷UVR誘導的膠原蛋白降解,從而改善和/或減緩皮膚變厚,彈性和皺紋的進展。
Phio簽署了最終協議,行使了增持權,購買公司545286股普通股,該股票最初是在2020年2月至2023年12月發行的,行使價格介於324.00美元和9.72美元之間,行使價格爲每股5.45美元。公司從這些認股權行使中獲得的總收入約爲310萬美元。
股票向後拆分於2024年7月5日生效。每9股公司的普通股合併成一股普通股,每股的面值不變是0.0001美元。這將公司的流通普通股從約460萬股減少到約50萬股。股票拆分會均勻影響所有股東,不會改變任何股東在公司普通股中的百分比利益,但存在涉及碎股的調整。
2024年7月19日,我們收到了納斯達克證券交易所的書面通知,稱該公司現已符合納斯達克資本市場繼續上市的最低1.00美元要約價格要求。
Phio宣佈任命Robert m. Infarinato爲副總裁兼首席財務官,任期自2024年8月1日生效。他將擔任首席財務官職務,包括負責會計、財務、財務、投資者關係和行政工作。
我們與一家全球多億美元的護膚公司進行了探索性合作,探討了Phio專有化合物在美容護膚應用方面的機會。
Financial Results
財務結果
Cash Position
現金淨額
At June 30, 2024, the Company had cash of $4.7 million as compared with $8.5 million at December 31, 2023.
截至2024年6月30日,公司現金爲470萬美元,而2013年12月31日爲850萬美元。
In July 2024, the Company entered into inducement letter agreements with certain holders of the Company's existing warrants to purchase up to an aggregate of 545,286 shares of common stock at a reduced exercise price of $5.45 per share. In consideration for the immediate exercise of the existing warrants, the Company agreed to issue five and one-half year term Series C warrants to purchase up to 583,098 shares of common stock and eighteen month term Series D warrants to purchase up to 507,474 shares of common stock, both at an exercise price of $5.45. The net proceeds to the Company are expected to be approximately $2.6 million, after deducting placement agent fees and offering expenses.
在2024年7月,本公司與公司現有認股權的某些持有人簽訂了誘因信函協議,以降低每股5.45美元的行使價格,購買公司普通股的最多545,286股。爲了立即行使現有認股權,公司同意發行五年半期的C系列認股權,以購買最多583,098股普通股,以及18個月期的D系列認股權,以購買最多507,474股普通股,行使價格爲5.45美元。考慮到發行商的費用和發行費用,公司的淨收益預計約爲260萬美元。
Research and Development Expenses
研發費用
Research and development expenses were $0.9 million for the three months ended June 30, 2024 as compared with $1.4 million for the three months ended June 30, 2023, a decrease of 37%. The decrease was primarily driven by a decrease in clinical consulting fees incurred in connection with our IND filing for PH-762 in the prior year period in addition to the Company's cost rationalization measures in transitioning from a research company to a product development company resulting in decreases in salary-related costs, including stock-based compensation expense, and lab supplies associated with the reduction in headcount.
2024年6月30日結束的三個月中的研究和開發費用爲90萬美元,2013年6月30日結束的三個月爲140萬美元,下降了37%。主要因爲去年期間與我們在PH-762的IND申報審批有關的臨床諮詢費用的減少和公司成本策略措施把研究公司轉型爲產品開發公司,從而導致減少人員數目相關的工資成本,包括薪酬基數補償費用和與減少人員數目相關的實驗室用品等。
General and Administrative Expenses
一般行政費用
General and administrative expenses were $1.0 million for the three months ended June 30, 2024 as compared with $1.2 million for the three months ended June 30, 2023, a decrease of 10%. The decrease was primarily due to decreases in salary-related expenses for the Company's President & CEO and in professional fees related to consulting as compared to the prior year period.
2024年6月30日結束的三個月中,一般和行政費用爲100萬美元,2013年6月30日結束的三個月爲120萬美元,下降了10%。主要由於與前一年期間相比,公司總裁和CEO的薪酬支出以及與諮詢有關的專業費用減少。
Net Loss
淨虧損
Net loss was $1.8 million for the three months ended June 30, 2024 as compared with $2.5 million for the three months ended June 30, 2023. The decrease in net loss was primarily due to the changes in research and development expenses, as described above.
截至2024年6月30日,淨損失爲180萬美元,而2013年6月30日爲250萬美元。淨虧損的減少主要由於研究和開發費用的變化,如上文所述。
About Phio Pharmaceuticals Corp.
關於Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells. INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for specialized formulations or drug delivery systems. INTASYL drugs precisely down regulate specific proteins that inhibit the body's ability to overcome chronic diseases and other disorders.
Phio Pharmaceuticals Corp.(納斯達克:PHIO)是一家臨床階段的生物技術公司,其專有的INTASYL siRNA基因沉默技術旨在使免疫細胞更有效地殺死腫瘤細胞。 INTASYL是唯一專注於免疫腫瘤學治療的自我傳遞RNAi技術,無需專業配方或藥物輸送系統。 INTASYL藥物精確地下調那些抑制身體克服慢性疾病和其他疾病的特定蛋白質。
For additional information, visit the Company's website, .
有關詳細信息,請訪問公司的網站。
Forward-Looking Statements
前瞻性聲明
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. These statements are based only on our current beliefs, expectations and assumptions and 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 inflationary pressures, rising interest rates, recession fears, 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.
本新聞稿包含根據1995年《私人證券訴訟改革法》的前瞻性陳述。儘管並非所有前瞻性陳述都包含這些詞語:「意圖」、「相信」、「預期」、「表明」、「計劃」、「期望」、「暗示」、「可能」、「將」、「繼續」、「估計」、「預測」、「瞄準」、「預測」、「可能」等相似的參考字眼,但在全部情況下,這些字眼都表達了類似的意思。這些陳述僅基於我們目前的信仰、期望和假設,並且容易受到難以預測和很難控制的固有不確定性、風險和環境變化的影響。在我們的前瞻性陳述中,我們的實際結果可能會因爲許多重要因素而與表達的陳述有所不同,包括但不限於,通貨膨脹壓力、利率上升、經濟衰退、產品候選-的發展,預臨床和臨床活動,執行業務策略的能力,我們能否與合作伙伴共同開發我們的產品候選,以及任紐此類合作的成功,將我們的產品候選推進臨床進展的時間和持續時間,提交和獲得監管文件和批准的時間或可能性,如果獲批,我們努力商業化我們的產品候選的成功,在臨床活動中爲我們的產品候選製造和供應,併爲商業用途獲批准備的能力,建立和維護覆蓋我們技術平台的知識產權的保護範圍,得到未來的融資,市場和其他情況,以及我們在《10-k》年度報告和後續《10-Q》季度報告中確定的那些因素,該公司定期向美國證券交易委員會提出的其他備案。讀者被敦促回顧這些風險因素,並且不得憑藉任何前瞻性陳述行事,因爲實際結果可能與我們的前瞻性陳述所考慮的結果不同。Phio不承諾更新前瞻性陳述以反映此公告之後發生的其不意見,⽇期或環境,除非法律要求這麼做。
Contact:
Phio Pharmaceuticals Corp.
ir@phiopharma.com
聯繫方式:
Phio Pharmaceuticals Corp.
ir@phiopharma.com
PR Contact
Michael Adams
Bridge View Media
adams@bridgeviewmedia.com
公關聯繫方式
Michael Adams
Bridge View Media
adams@bridgeviewmedia.com
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
PHIO製藥公司
簡明合併利潤表
(除股份和每股數據外,單位:千元)
(未經審計)
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
Operating expenses: | ||||||||||||
Research and development | $ | 866 | $ | 1,383 | $ | 2,014 | $ | 3,517 | ||||
General and administrative | 1,048 | 1,164 | 2,109 | 2,632 | ||||||||
Total operating expenses | 1,914 | 2,547 | 4,123 | 6,149 | ||||||||
Operating loss | (1,914) | (2,547) | (4,123) | (6,149) | ||||||||
Total other income (expense), net | 68 | (2) | 123 | (2) | ||||||||
Net loss | $ | (1,846) | $ | (2,549) | $ | (4,000) | $ | (6,151) | ||||
Net loss per common share: Basic and diluted | $ | (3.62) | $ | (13.27) | $ | (7.85) | $ | (38.52) | ||||
Weighted average number of common shares outstanding: Basic and diluted |
510,188 | 192,054 | 509,542 | 159,663 |
截至三個月結束 6月30日 |
截至2022年4月30日的六個月內 6月30日 |
|||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
營業費用: | ||||||||||||
研究和開發 | $ | 866 | $ | 1,383 | $ | 2,014 | $ | 3,517 | ||||
一般和管理費用 | 1,048 | 1,164 | 2,109 | 2,632 | ||||||||
總營業費用 | 1,914 | 2,547 | 4,123 | 6,149 | ||||||||
營業虧損 | (1,914) | (2,547) | (4,123) | (6,149) | ||||||||
總其他收入(費用),淨額 | 68 | (2) | 123 | (2) | ||||||||
每股數據 | $ | (1,846) | $ | (2,549) | $ | (4,000) | $ | (6,151) | ||||
每股普通股的淨損失:基本和稀釋後 | $ | (-3.62) | $ | (13.27) | $ | (7.85) | $ | (38.52) | ||||
普通股平均發行量: 基本和稀釋 |
510,188 | 192,054 | 509,542 | 159,663 |
PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
PHIO製藥公司
簡明合併資產負債表
(金額以千爲單位,除了股份數據)
(未經審計)
June 30, 2024 |
December 31, 2023 |
|||||
ASSETS | ||||||
Cash and cash equivalents | $ | 4,698 | $ | 8,490 | ||
Prepaid expenses and other current assets | 594 | 832 | ||||
Right of use asset | – | 33 | ||||
Property and equipment, net | 1 | 6 | ||||
Other assets | 3 | 3 | ||||
Total assets | $ | 5,296 | $ | 9,364 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Accounts payable | $ | 335 | $ | 657 | ||
Accrued expenses | 1,188 | 942 | ||||
Lease liability | – | 35 | ||||
Total liabilities | 1,523 | 1,634 | ||||
Total stockholders' equity | 3,773 | 7,730 | ||||
Total liabilities and stockholders' equity | $ | 5,296 | $ | 9,364 |
6月30日, 2024 |
12月31日 2023 |
|||||
資產 | ||||||
現金及現金等價物 | $ | 4,698 | $ | 8,490 | ||
資產預付款和其他流動資產的變動 | 594 | 832 | ||||
使用權資產 | – | 33 | ||||
資產和設備,淨值 | 1 | 6 | ||||
其他 | 3 | 3 | ||||
總資產 | $ | 5,296 | $ | 9,364 | ||
負債和股東權益 | ||||||
應付賬款 | $ | 335 | $ | 657 | ||
應計費用 | 1,188 | 942 | ||||
租賃負債 | – | 35 | ||||
負債合計 | 1,523 | 1,634 | ||||
股東權益合計 | 3,773 | 7,730 | ||||
負債和股東權益合計 | $ | 5,296 | $ | 9,364 |
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