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Phio Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update

Phio Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update

phio pharmaceuticals报告2024年第二季度财务业绩并提供业务更新
Phio Pharmaceuticals ·  08/14 00:00

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)是一家临床阶段的生物技术公司,其专有的INTASYL siRNA基因沉默技术旨在增强免疫细胞的杀伤肿瘤细胞能力。今天,该公司公布了2024年6月30日止一季度的财务报告并提供了业务更新。

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.

  • 我们的主要产品PH-762的10亿期临床试验获得了安全性推荐,没有剂量限制的毒性,并在初步接受肿瘤内PH-762的队列中没有出现临床相关的治疗后不良事件。注射剂耐受性好。安全性监测委员会(SMC)建议剂量递增并招募下一个计划队列的临床研究对象。

  • 该临床试验目前正在招募第二个队列的患者。

  • 我们针对PH-762的一项10亿期临床研究已经添加了第五个临床试验站点。匹兹堡大学医学中心(UPMC)皮肤科部加入了其他四个参与临床研究的试验站点:华盛顿特区的乔治华盛顿大学医学学院,亚利桑那州吉尔伯特的Banner MD Anderson癌症中心,佛罗里达州德尔雷海滩的Integrity Research Clinical Associates和俄亥俄州都柏林的Centricity Research。

  • 针对治疗衰老皮肤疾病的INTASYL化合物系列专利中的另一项已在韩国获得授权,该专利涵盖了治疗老化和皮肤疾病(包括光老化症)的INTASYL RXI-185化合物。 RXI-185是皮肤MMP1表达的有效沉默剂,能够阻断UVR诱导的胶原蛋白降解,从而改善和/或减缓皮肤变厚,弹性和皱纹的进展。

  • Phio签署了最终协议,行使了增持权,购买公司545286股普通股,该股票最初是在2020年2月至2023年12月发行的,行使价格介于324.00美元和9.72美元之间,行使价格为每股5.45美元。公司从这些认股权行使中获得的总收入约为310万美元。

  • 股票向后拆分于2024年7月5日生效。每9股公司的普通股合并成一股普通股,每股的面值不变是0.0001美元。这将公司的流通普通股从约460万股减少到约50万股。股票拆分会均匀影响所有股东,不会改变任何股东在公司普通股中的百分比利益,但存在涉及碎股的调整。

  • 2024年7月19日,我们收到了纳斯达克证券交易所的书面通知,称该公司现已符合纳斯达克资本市场继续上市的最低1.00美元要约价格要求。

  • Phio宣布任命Robert m. Infarinato为副总裁兼首席财务官,任期自2024年8月1日生效。他将担任首席财务官职务,包括负责会计、财务、财务、投资者关系和行政工作。

  • 我们与一家全球多亿美元的护肤公司进行了探索性合作,探讨了Phio专有化合物在美容护肤应用方面的机会。

Financial Results

财务结果

Cash Position

现金净额

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,公司现金为470万美元,而2013年12月31日为850万美元。

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,本公司与公司现有认股权的某些持有人签订了诱因信函协议,以降低每股5.45美元的行使价格,购买公司普通股的最多545,286股。为了立即行使现有认股权,公司同意发行五年半期的C系列认股权,以购买最多583,098股普通股,以及18个月期的D系列认股权,以购买最多507,474股普通股,行使价格为5.45美元。考虑到发行商的费用和发行费用,公司的净收益预计约为260万美元。

Research and Development Expenses

研发费用

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日结束的三个月中的研究和开发费用为90万美元,2013年6月30日结束的三个月为140万美元,下降了37%。主要因为去年期间与我们在PH-762的IND申报审批有关的临床咨询费用的减少和公司成本策略措施把研究公司转型为产品开发公司,从而导致减少人员数目相关的工资成本,包括薪酬基数补偿费用和与减少人员数目相关的实验室用品等。

General and Administrative Expenses

一般行政费用

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日结束的三个月中,一般和行政费用为100万美元,2013年6月30日结束的三个月为120万美元,下降了10%。主要由于与前一年期间相比,公司总裁和CEO的薪酬支出以及与咨询有关的专业费用减少。

Net Loss

净亏损

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,净损失为180万美元,而2013年6月30日为250万美元。净亏损的减少主要由于研究和开发费用的变化,如上文所述。

About Phio Pharmaceuticals Corp.

关于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.(纳斯达克:PHIO)是一家临床阶段的生物技术公司,其专有的INTASYL siRNA基因沉默技术旨在使免疫细胞更有效地杀死肿瘤细胞。 INTASYL是唯一专注于免疫肿瘤学治疗的自我传递RNAi技术,无需专业配方或药物输送系统。 INTASYL药物精确地下调那些抑制身体克服慢性疾病和其他疾病的特定蛋白质。

For additional information, visit the Company's website, .

有关详细信息,请访问公司的网站。

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含根据1995年《私人证券诉讼改革法》的前瞻性陈述。尽管并非所有前瞻性陈述都包含这些词语:“意图”、“相信”、“预期”、“表明”、“计划”、“期望”、“暗示”、“可能”、“将”、“继续”、“估计”、“预测”、“瞄准”、“预测”、“可能”等相似的参考字眼,但在全部情况下,这些字眼都表达了类似的意思。这些陈述仅基于我们目前的信仰、期望和假设,并且容易受到难以预测和很难控制的固有不确定性、风险和环境变化的影响。在我们的前瞻性陈述中,我们的实际结果可能会因为许多重要因素而与表达的陈述有所不同,包括但不限于,通货膨胀压力、利率上升、经济衰退、产品候选-的发展,预临床和临床活动,执行业务策略的能力,我们能否与合作伙伴共同开发我们的产品候选,以及任紐此类合作的成功,将我们的产品候选推进临床进展的时间和持续时间,提交和获得监管文件和批准的时间或可能性,如果获批,我们努力商业化我们的产品候选的成功,在临床活动中为我们的产品候选制造和供应,并为商业用途获批准备的能力,建立和维护覆盖我们技术平台的知识产权的保护范围,得到未来的融资,市场和其他情况,以及我们在《10-k》年度报告和后续《10-Q》季度报告中确定的那些因素,该公司定期向美国证券交易委员会提出的其他备案。读者被敦促回顾这些风险因素,并且不得凭借任何前瞻性陈述行事,因为实际结果可能与我们的前瞻性陈述所考虑的结果不同。Phio不承诺更新前瞻性陈述以反映此公告之后发生的其不意见,⽇期或环境,除非法律要求这么做。

Contact:
Phio Pharmaceuticals Corp.
ir@phiopharma.com

联系方式:
Phio Pharmaceuticals Corp.
ir@phiopharma.com

PR Contact
Michael Adams
Bridge View Media
adams@bridgeviewmedia.com

公关联系方式
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制药公司
简明合并利润表
(除股份和每股数据外,单位:千元)
(未经审计)

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
截至三个月结束
6月30日
截至2022年4月30日的六个月内
6月30日
2024 2023 2024 2023
营业费用:
研究和开发 $ 866 $ 1,383 $ 2,014 $ 3,517
一般和管理费用 1,048 1,164 2,109 2,632
总营业费用 1,914 2,547 4,123 6,149
营业亏损 (1,914) (2,547) (4,123) (6,149)
总其他收入(费用),净额 68 (2) 123 (2)
每股数据 $ (1,846) $ (2,549) $ (4,000) $ (6,151)
每股普通股的净损失:基本和稀释后 $ (-3.62) $ (13.27) $ (7.85) $ (38.52)
普通股平均发行量:
基本和稀释
510,188 192,054 509,542 159,663

PHIO PHARMACEUTICALS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)

PHIO制药公司
简明合并资产负债表
(金额以千为单位,除了股份数据)
(未经审计)

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
2020年6月30日
2024
12月31日
2023
资产
现金及现金等价物 $ 4,698 $ 8,490
资产预付款和其他流动资产的变动 594 832
使用权资产 33
资产和设备,净值 1 6
其他 3 3
总资产 $ 5,296 $ 9,364
负债和股东权益
应付账款 $ 335 $ 657
应计费用 1,188 942
租赁负债 35
负债合计 1,523 1,634
股东权益合计 3,773 7,730
负债和股东权益合计 $ 5,296 $ 9,364
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