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RespireRx Pharmaceuticals股份有限公司宣布获得国防部奖,资助确定CX1739安全性和有效性的2期临床研究

RespireRx Pharmaceuticals Inc. Announces a Department of Defense Award to Fund a Phase 2 Clinical Study to Determine the Safety and Efficacy of CX1739

BioSpace 等信源发布 2024-05-29 20:48

可切换为仅中文


Glen Rock, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals, Inc. (OTC Pink Markets: RSPI) (RespireRx or the Company), focused on the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is delighted to announce that the United States Department of Defense (DOD) has approved a $1.8 million translational research award to Shirley Ryan AbilityLab to fund a two stage Phase 2A and 2B clinical study in order to determine the safety and efficacy of CX1739, its lead clinical AMPAkine, to improve bladder function and motor activity in individuals with spinal cord injury (SCI).

新泽西州格伦洛克(GlenRock),2024年5月29日(环球通讯社)--Respirex Pharmaceuticals,Inc.(OTC Pink Markets:RSPI)(Respirex或the Company),专注于发现和开发创新和革命性的治疗方法,以对抗由神经元信号中断引起的疾病,很高兴地宣布,美国国防部(DOD)已批准向ShirleyRyan AbilityLab授予180万美元的转化研究奖,以资助一项两阶段的2A和2B临床研究,以确定其领先的临床氨苄类药物CX1739改善脊髓损伤(SCI)患者膀胱功能和运动活动的安全性和有效性。

This grant award supports the ongoing collaboration among scientist teams led by Milap Sandhu, PT, PhD, research scientist at Shirley Ryan AbilityLab, a rehabilitation research hospital in Chicago, and Dr. Arnold Lippa from RespireRx and Dr. David Fuller from the University of Florida..

该赠款支持由芝加哥康复研究医院Shirley Ryan AbilityLab的研究科学家Milap Sandhu,PT,PhD,以及Respirex的Arnold Lippa博士和佛罗里达大学的David Fuller博士领导的科学家团队之间正在进行的合作。。

The U.S. Army Medical Research Acquisition Activity, in support of the Congressionally Directed Medical Research Program (CDMRP), is the awarding and administering acquisition office and this work will be supported by the Department of Defense, in the amount of $1,793,411, through the Spinal Cord Injury Research Program under Award No.

支持国会指导医学研究计划(CDMRP)的美国陆军医学研究采购活动是授予和管理采购办公室,这项工作将由国防部通过第号奖项下的脊髓损伤研究计划提供1793411美元的支持。

HT94252410497. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense..

HT94252410497。意见、解释、结论和建议均为作者的意见、解释、结论和建议,不一定得到国防部卫生事务助理部长或国防部的认可。。

Shirley Ryan AbilityLab has been ranked number one in rehabilitation by U.S. News & World Report since 1991 and cares for patients with the most severe, complex conditions, including SCI.

自1991年以来,ShirleyRyanAbilityLab一直在《美国新闻与世界报道》的康复领域排名第一,负责照顾包括SCI在内的病情最严重、最复杂的患者。

As the Principal Investigator, Dr. Sandhu will conduct the clinical trials at Shirley Ryan AbilityLab. Dr. Sandhu and Shirley Ryan AbilityLab have been allocated $1.8 million to conduct the actual clinical study of which RespireRx has been allocated $252,200 to manufacture and formulate the clinical material, as well as update and submit the CX1739 investigational new drug application (IND).

作为首席研究员,Sandhu博士将在ShirleyRyanAbilityLab进行临床试验。Sandhu博士和Shirley Ryan AbilityLab已获得180万美元用于进行实际临床研究,RespireRx已获得252200美元用于制造和配制临床材料,以及更新和提交CX1739研究性新药申请(IND)。

Budget projections have determined that these amounts should be sufficient to pay for manufacturing and clinical costs and the plan is to begin testing in patients by the 4th quarter 2024. The trial will consist of two stages, the first being a Phase 2A will be an ascending single dose safety and efficacy study and the second Phase 2B will consist of a double blind, placebo-controlled study in which participants will be given CX1739 or placebo twice daily for a total of seven days..

预算预测已经确定,这些金额应该足以支付制造和临床费用,计划在2024年第四季度开始对患者进行测试。该试验将分为两个阶段,第一阶段为2A期,将进行单剂量递增安全性和有效性研究,第二阶段为2B期,将进行双盲安慰剂对照研究,参与者将每天两次给予CX1739或安慰剂,共七天。。

As we have disclosed in an earlier press release and peer review publications, traumatic SCI often results in neurogenic bladder dysfunction that produces a plethora of urological complications leading to reductions in the quality of life and an increased risk of premature death. Restoration of bladder function is ranked as one of the highest priorities by individuals with SCI (Bourbeau et al., Spinal Cord 58:1216–1226; 2020).

正如我们在早期的新闻稿和同行评议出版物中所披露的那样,创伤性脊髓损伤常导致神经源性膀胱功能障碍,产生过多的泌尿系统并发症,导致生活质量下降和过早死亡的风险增加。脊髓损伤患者将膀胱功能的恢复列为最高优先事项之一(Bourbeau等,脊髓58:1216-1226;2020)。

Current treatment approaches usually require interventions such as catheterization for urinary voiding, which have their own set of potentially significant risks and complications. World-wide incidence rates range from 12 to 59 cases per million depending on the country (Amidei et al., SpinalCord60:812-819; 2022) and of these 70 - 84% showed neurogenic bladder dysfunction (Kumar et al., World Neurosurgery113:e345–e363;2018)..

目前的治疗方法通常需要干预措施,如导尿排尿,这有其自身的一系列潜在的重大风险和并发症。根据国家的不同,世界范围内的发病率从每百万分之12到59不等(Amidei等人,SpinalCord60:812-819;2022),其中70-84%表现为神经源性膀胱功能障碍(Kumar等人,世界神经外科113:e345-e363;2018)。。

“I am delighted and grateful for this government funding that now allows us to extend Dr. Fuller's preclinical studies into the human domain. If CX1739 produces the same effects in humans that it has produced in animals, it potentially represents a novel and needed treatment for SCI,” said Dr. Sandhu..

桑德胡博士说:“我很高兴并感谢政府的资助,现在我们可以将富勒博士的临床前研究扩展到人类领域。如果CX1739在人类身上产生的效果与在动物身上产生的效果相同,那么它可能代表了一种新的和需要的SCI治疗方法。”。。

Dr. Arnold Lippa, CEO and CSO of RespireRx, commented that, “CX1739 has successfully completed multiple Phase 1 safety trials and Phase 2 proof of concept trials demonstrating target engagement. With this new non-dilutive funding, we have begun planning to conduct translational, Phase 2 studies in SCI patients late this year.

Respirex首席执行官兼首席运营官Arnold Lippa博士评论道:“CX1739已成功完成多项第一阶段安全性试验和第二阶段概念验证试验,证明了目标参与。有了这项新的非稀释性资金,我们已开始计划在今年年底对SCI患者进行转化性第二阶段研究。

We believe that this research has the potential to represent a breakthrough in the treatment of SCI, where it is badly needed.”.

我们相信这项研究有可能代表SCI治疗方面的突破,这是急需的。”。

He added that, “It has been a pleasure to work with Dr. Fuller, a long-time RespireRx collaborator, and his team of scientists. In a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles, he has demonstrated the ability of RespireRx’s lead AMPAkines to improve motor nerve activity and muscle function in a number of animal models of SCI, including respiration and bladder functions..

他补充道:“很高兴与Respirex的长期合作者Fuller博士及其科学家团队合作。在由美国国立卫生研究院资助的一系列重要研究中,他已经证明了Respirex的铅氨苄在许多SCI动物模型中改善运动神经活动和肌肉功能的能力,包括呼吸和膀胱功能。。

About RespireRx Group

关于Respirex Group

RespireRx Pharmaceuticals Inc. and its subsidiaries and business units (RespireRx Group) are discovering and developing medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including epilepsy, pain, attention deficit hyperactivity disorder (ADHD), recovery from SCI, certain neurological orphan diseases and obstructive sleep apnea (OSA).

Respirex Pharmaceuticals Inc.及其子公司和业务部门(Respirex Group)正在发现和开发用于治疗精神和神经系统疾病的药物,重点是治疗影响数百万人的疾病,但治疗选择很少或很差,包括癫痫,疼痛,注意力缺陷多动障碍(ADHD),脊髓损伤恢复,某些神经系统孤儿疾病和阻塞性睡眠呼吸暂停(OSA)。

The RespireRx Group is developing a pipeline of new and repurposed drug products based on our broad patent portfolios for two drug platforms: (i) neuromodulators, which include GABAkines and AMPAkines, proprietary chemical entities that positively modulate (positive allosteric modulators or “PAMs”) GABAA receptors and AMPA-type glutamate receptors, respectively, and (ii) pharmaceutical cannabinoids, which include dronabinol, a synthetic compound that acts upon the nervous system’s endogenous cannabinoid receptors..

Respirex集团正在开发一系列新的和重新利用的药物产品,基于我们针对两个药物平台的广泛专利组合:(i)神经调节剂,包括GABAkines和AMPAkines,积极调节(正变构调节剂或“PAMs”)GABAA受体和AMPA型谷氨酸受体的专有化学实体,以及(ii)药物大麻素,包括屈大麻酚,一种作用于神经系统内源性大麻素受体的合成化合物。。

The RespireRx Group holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.

Respirex集团拥有专有许可证,并拥有某些化合物家族的专利和专利申请或权利,这些化合物声称其化学结构及其在治疗各种疾病中的用途,以及已知药物的新用途。

EndeavourRx: Neuromodulators

EndeavourRx:神经调节剂

AMPAkines. Through an extensive translational research effort from the cellular level through Phase 2 clinical trials, RespireRx has developed a family of novel, low impact AMPAkines, including CX717, CX1739 and CX1942 that may have clinical application in the treatment of CNS-driven neurobehavioral and cognitive disorders, SCI, neurological diseases, and certain orphan indications.

安帕金斯。通过从细胞水平到2期临床试验的广泛转化研究工作,Respirex开发了一系列新型,低影响的AMPAKINE,包括CX717,CX1739和CX1942,可能在治疗中枢神经系统驱动的神经行为和认知障碍,脊髓损伤,神经系统疾病和某些孤儿适应症方面具有临床应用。

Our lead clinical compounds, CX717 and CX1739, have successfully completed multiple Phase 1 safety trials. Both compounds have also completed Phase 2 proof of concept trials demonstrating target engagement, by antagonizing the ability of opioids to induce respiratory depression..

我们的主要临床化合物CX717和CX1739已成功完成多项1期安全性试验。这两种化合物还通过拮抗阿片类药物诱导呼吸抑制的能力,完成了第二阶段概念验证试验,证明了目标参与。。

AMPAkines have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant improvement of symptoms observed in a Phase 2 human clinical trial of CX717 in adult patients with ADHD. Statistically significant therapeutic effects were observed within one week.

AMPAkines在ADHD动物模型中表现出积极的活性,这些结果已被转化为在成年ADHD患者中CX717的2期人类临床试验中观察到的症状的统计学显着改善。在一周内观察到统计学上显着的治疗效果。

We believe AMPAkines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non-stimulants, such as Straterra® (atomoxetine), and without the drawbacks of amphetamine-type stimulants. In a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles, Dr.

我们认为,安帕金可能代表了一种新型的非兴奋剂治疗ADHD的方法,其起效速度比其他非兴奋剂(如Straterra®(阿莫西汀))更快,并且没有苯丙胺类兴奋剂的缺点。在由美国国立卫生研究院(National Institutes of Health)资助的一系列重要研究中,Dr。

David Fuller (University of Florida), a long-time RespireRx collaborator, has demonstrated the ability of CX1739 and CX717, RespireRx’s lead AMPAkines, to improve motor nerve activity and muscle function in a number of animal models of SCI. The DOD has recently approved a $1.8 million grant to fund a Phase 2A/2B clinical study of CX1739 in individuals with SCI..

David Fuller(佛罗里达大学)是Respirex的长期合作者,他已经证明了Respirex的铅AMPAkines CX1739和CX717在许多SCI动物模型中改善运动神经活动和肌肉功能的能力。国防部最近批准了180万美元的拨款,用于资助SCI患者CX1739的2A/2B期临床研究。。

GABAkines. Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. and on behalf of its EndeavourRx business unit, RespireRx has in-licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile with reduced side effects.

加巴金。根据与威斯康星大学密尔沃基研究基金会有限公司(University of Wisconsin Milwaukee Research Foundation,Inc.)签订的许可协议,Respirex代表其奋进事业部拥有某些选择性作用的加巴金的许可权,因为它们能够在高度特异的GABAA受体亚群上选择性扩增抑制性神经传递,从而产生独特的功效,减少副作用。

Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse.

临床前研究已经证明,在没有或产生镇静,运动障碍,耐受性,依赖性和滥用倾向大大降低的情况下,它们在广泛的神经和精神疾病动物模型中的功效,包括癫痫,疼痛,焦虑和抑郁。

EndeavourRx currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain..

奋进者目前正专注于开发用于治疗癫痫和疼痛的KRM-II-81。。

KRM-II-81 has displayed a high degree of anti-convulsant activity in a broad range of preclinical studies, including in treatment resistant and pharmaco-resistant animal models. Not only was KRM-II-81 highly effective in these models, but pharmaco-resistance or tolerance did not develop to its anti-convulsant properties.

KRM-II-81在广泛的临床前研究中显示出高度的抗惊厥活性,包括抗治疗和抗药物动物模型。KRM-II-81不仅在这些模型中非常有效,而且药物抗性或耐受性并未发展到其抗惊厥特性。

These latter results are particularly important because pharmaco-resistance occurs when medications that once controlled seizures lose efficacy as a result of chronic use and it is a principal reason some epileptic patients require brain surgery to control their seizures. In support of its potential clinical efficacy, translational studies have demonstrated the ability of KRM- II-81 to dramatically reduce epileptiform electrical activity when administered in situ to brain slices excised from treatment-resistant epileptic patients who underwent surgery..

后面的这些结果特别重要,因为一旦控制癫痫发作的药物由于长期使用而失去疗效时,就会发生药物耐药性,这是一些癫痫患者需要进行脑部手术来控制癫痫发作的主要原因。为了支持其潜在的临床疗效,转化研究表明,当对接受手术的难治性癫痫患者切除的脑切片进行原位给药时,KRM-II-81能够显着降低癫痫样电活动。。

In addition, KRM-II-81 has displayed a high degree of analgesic activity in a broad range of preclinical studies. In intact animal models of pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic..

此外,KRM-II-81在广泛的临床前研究中显示出高度的镇痛活性。在完整的疼痛动物模型中,KRM-II-81的镇痛效果与常用镇痛药相当或更高。同时,KRM-II-81没有表现出镇静和运动障碍等副作用,但更重要的是,它不会产生耐受性,依赖性,呼吸抑制或表明滥用责任的行为改变,这些都是由阿片类药物产生的麻醉品,是阿片类药物流行的核心。。

ResolutionRx: Pharmaceutical Cannabinoids.

ResolutionRx:药用大麻素。

ResolutionRx Ltd (Australian Company Number a/k/a ACN 664 925 651) was formed in Australia on January 11, 2023 by RespireRx as an unlisted public company. RespireRx has contributed by sublicense and license with ResolutionRx, its sleep apnea drug development program subject to certain liabilities. ResolutionRx now engages in the research and development (R&D) associated with that program, initially for the development of a new formulation of dronabinol for use in a Phase 3 clinical trial and the filing of regulatory approval for the treatment of OSA.

ResolutionRx Ltd(澳大利亚公司编号a/k/a ACN 664 925 651)于2023年1月11日由RespireRx在澳大利亚成立,是一家未上市的上市公司。RespireRx通过ResolutionRx的再许可和许可做出了贡献,ResolutionRx是其睡眠呼吸暂停药物开发计划的一部分,需要承担一定的责任。ResolutionRx现在从事与该计划相关的研究与开发(R&D),最初用于开发用于3期临床试验的屈大麻酚新制剂,并提交治疗OSA的监管批准。

The current total budget for that program over the next several years is approximately US$16.5 million, most, but not all of which is expected to be eligible for the Australian R&D Tax Incentive (R&DTI). The R&DTI in the case of ResolutionRx is anticipated to be approximately 43.5% of qualified R&D expenditures.

该计划在未来几年的当前总预算约为1650万美元,预计其中大部分(但不是全部)都有资格获得澳大利亚研发税收激励(R&DTI)。在ResolutionRx的情况下,R&DTI预计约为合格研发支出的43.5%。

Dronabinol, an endocannabinoid receptor agonist, has already demonstrated significant improvement in the symptoms of OSA in two Phase 2 clinical trials. OSA is a serious respiratory disorder that impacts an estimated 90 million people in the United States, Australia, the United Kingdom and Germany and that has been linked to increased risk for hypertension, heart failure, depression, and diabetes.

内源性大麻素受体激动剂屈大麻酚已经在两项2期临床试验中显示出OSA症状的显着改善。OSA是一种严重的呼吸系统疾病,在美国、澳大利亚、英国和德国估计有9000万人受到影响,并且与高血压、心力衰竭、抑郁症和糖尿病的风险增加有关。

There are no approved drug treatments for OSA..

OSA没有批准的药物治疗方法。。

Because dronabinol is already FDA approved for the treatment of AIDS related anorexia and chemotherapy induced nausea and vomiting, RespireRx and ResolutionRx further believe that its repurposing strategy would only require, in the United States, approval by the FDA of a 505(b)(2) new drug application (NDA), an efficient regulatory pathway that allows the use of publicly available data..

由于屈大麻酚已被FDA批准用于治疗艾滋病相关的厌食症和化疗引起的恶心和呕吐,RespireRx和ResolutionRx进一步认为,其重新利用策略在美国只需要FDA批准505(b)(2)新药申请(NDA),这是一种允许使用公开数据的有效监管途径。。

Additional information about RespireRx and the matters discussed herein can be obtained on the RespireRx website at www.RespireRx.com or RespireRx’s filings with the U.S. Securities and Exchange Commission (the SEC) at www.sec.gov. Additional information about ResolutionRx and the matters discussed herein can be obtained on the ResolutionRx website at https://www.resolutionrx.com.au..

有关Respirex和本文讨论的事项的更多信息,请访问Respirex网站www.respirex.com或Respirex向美国证券交易委员会(SEC)提交的文件www.SEC.gov。有关ResolutionRx和本文讨论的事项的更多信息,请访问ResolutionRx网站https://www.resolutionrx.com.au..

Not a Securities Offering or Solicitation

非证券发行或招揽

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sales of securities in any jurisdiction in which such offer, solicitation or sale of securities would be unlawful before registration or qualification under the laws of such jurisdiction..

本通信不构成出售要约或招揽购买任何证券的要约,也不构成在任何司法管辖区内出售证券的要约、招揽或出售证券在根据该司法管辖区的法律注册或获得资格之前是非法的。。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Company intends that such forward-looking statements be subject to the safe harbor created thereby.

本新闻稿包含经修订的《1933年证券法》(以下简称“证券法”)第27A节和经修订的《1934年证券交易法》(以下简称“交易法”)第21E节所指的某些前瞻性声明,公司打算将这些前瞻性声明置于由此产生的安全港之下。

These might include statements regarding the Company’s future plans, targets, estimates, assumptions, financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors..

这些可能包括关于公司未来计划、目标、估计、假设、财务状况、业务战略和其他未来运营计划和目标的声明,以及关于研究和开发工作的假设和预测,包括但不限于临床前和临床研究设计、执行、时间安排、成本和结果、未来产品需求、供应、制造、成本、营销和定价因素。。

In some cases, forward-looking statements may be identified by words including “assumes,” “could,” “ongoing,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” “contemplates,” “targets,” “continues,” “budgets,” “may,” or the negative of these terms or othercomparableterminology,althoughnotallforward-lookingstatementscontainthesewords,andsuchstatements may include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company’s product candidates, (iv) reorganization plans, and (v) the need for, and availability of, additional financing.

在某些情况下,前瞻性陈述可以用“假设”、“可能”、“正在进行”、“潜在”、“预测”、“项目”、“应该”、“将会”、“预期”、“相信”、“打算”、“估计”、“预期”、“计划”、“设想”、“目标”、“继续”、“预算”、“可能”或这些术语的否定词或其他可比术语来识别,尽管不包括所有前瞻性陈述,这些陈述可能包括但不限于以下陈述:(i)未来的研究计划、支出和结果,(ii)潜在的合作安排,(iii)公司候选产品的潜在效用,(iv)重组计划,以及(v)额外的需求和可用性融资。

Forward-looking statementsare based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materiallydifferentfromtheinformationexpressedorimpliedbytheforward-lookingstatementsinthispressrelease..

前瞻性陈述基于陈述时可用的信息,涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致我们的结果、活动水平、绩效或成就与新闻稿中前视陈述所表达的信息存在重大差异。。

These factors include but are not limited to, regulatory policies or changes thereto, available cash, research and development results, issuance of patents, competition from other similar businesses, interest of third parties in collaborations with us, and market and general economic factors, and other risk factors disclosed in “Item 1A.

这些因素包括但不限于监管政策或其变化、可用现金、研发成果、专利发布、其他类似企业的竞争、第三方与我们合作的利益、市场和一般经济因素以及“项目1A”中披露的其他风险因素。

Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023 (the 2022 Form 10-K). We have not yet filed our Annual Report on Form 10-K for the year ended December 31, 2023..

2023年4月17日提交给美国证券交易委员会的截至2022年12月31日财年的10-K表年度报告(2022年10-K表)中的“风险因素”。截至2023年12月31日,我们尚未以表格10-K提交年度报告。。

You should read these risk factors and the other cautionary statements made in the Company’s filings as being applicable to all related forward-looking statements wherever they appear in this press release. We cannot assure you that the forward-looking statements in this press release will prove to be accurate and therefore current and prospective investors, as well as current and potential collaborators and other current and potential stakeholders, are encouraged not to place undue reliance on forward-looking statements.

您应该阅读这些风险因素和公司文件中的其他警示声明,因为这些警示声明适用于本新闻稿中出现的所有相关前瞻性声明。我们无法向您保证,本新闻稿中的前瞻性声明将被证明是准确的,因此鼓励当前和未来的投资者,以及当前和潜在的合作者以及其他当前和潜在的利益相关者不要过度依赖前瞻性声明。

You should read this press release completely. Other than as required by law, we undertake no obligation to update or revise these forward-looking statements, even though our situation may change in the future..

你应该彻底阅读这份新闻稿。除法律要求外,我们没有义务更新或修改这些前瞻性声明,即使我们的情况在未来可能会发生变化。。

We caution current and prospective investors, as well as current and potential collaborators and other current and potential stakeholders, not to place undue reliance on any forward-looking statement that speaks only as of the date made and to recognize that forward-looking statements are predictions of future results, which may not occur as anticipated.

我们提醒当前和未来的投资者,以及当前和潜在的合作者以及其他当前和潜在的利益相关者,不要过度依赖任何仅在所作日期发表的前瞻性声明,并认识到前瞻性声明是对未来结果的预测,这可能不会像预期的那样发生。

Actual results could differ materially from those anticipated in the forward-looking statements and from historical results, due to the risks and uncertainties described in the 2022 Form 10-K, in our quarterly reports on Form10-Q,inourCurrentReportsonForm8-K,andotherreportsthatwefilewithorfurnishtotheSECandinthis press release, as well as others that we may consider immaterial or do not anticipate at this time.

由于2022年表格10-K、我们在表格10-Q的季度报告、inourCurrentReportsonForm8-K和其他我们在本新闻稿中提供的报告以及我们目前可能认为不重要或不预期的其他报告中描述的风险和不确定性,实际结果可能与前瞻性声明和历史结果中的预期结果存在重大差异。

These forward- looking statements are based on assumptions regarding the Company’s business and technology, which involve judgments with respect to, among other things, future scientific, economic, regulatory and competitive conditions, collaborations with third parties, and future business decisions, all of which are difficult or impossible to predict accuratelyandmanyofwhicharebeyondtheCompany’scontrol.Althoughwebelievethattheexpectationsreflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct.

这些前瞻性陈述基于对公司业务和技术的假设,其中涉及对未来科学、经济、监管和竞争条件、与第三方的合作以及未来业务决策的判断,所有这些都很难或不可能准确预测公司的控制权。尽管我们相信我们的前瞻性声明中反映的期望是合理的,但我们不知道我们的期望是否会被证明是正确的。

Our expectations reflected in our forward-looking statements can be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties, including those described in the 2022 Form 10-K, in our quarterly reports on Form 10-Q, in our Current Reports on Form 8-K, and other reports that we file with or furnish to the SEC and in this press release.

我们在前瞻性陈述中反映的预期可能会受到我们可能做出的不准确假设或已知或未知风险和不确定性的影响,包括2022年10-K表、10-Q表季度报告、8-K表当前报告以及我们向SEC提交或提供的其他报告以及本新闻稿中描述的风险和不确定性。

These risks and uncertainties are not exclusive and further information concerning us.

这些风险和不确定性并不是关于我们的独家和进一步信息。

Company Contact:

公司联系人:

Jeff Margolis

杰夫·马戈利斯

Senior Vice President, Chief Financial Officer, Treasurer and Secretary

高级副总裁、首席财务官、财务主管和秘书

RespireRx Pharmaceuticals Inc.

RespireRx制药股份有限公司。

126 Valley Road, Suite C

山谷路126号C室

Glen Rock, NJ 07452

新泽西州格伦洛克07452

Telephone: 917-834-7206

电话:917-834-7206

Email: jmargolis@respirerx.com

电子邮件jmargolis@respirerx.com

www.respirerx.com

www.respirerx.com