WAKEFIELD, MA / ACCESSWIRE / March 7, 2022 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today reported findings from data review of the Company's Brilacidin Phase 2 COVID-19 study and compassionate use of Brilacidin in critically-ill COVID-19 patients.
马萨诸塞州韦克菲尔德/ACCESSWIRE/2022年3月7日/临床阶段生物制药公司创新制药公司（OTCQB: IPIX）（“公司”）今天报告了对该公司Brilacidin 2期 COVID-19 研究的数据审查结果，以及对危重病人 COVID-19 患者同情地使用布里拉西丁。
"Based on analyses of our Phase 2 trial results, Brilacidin showed promising treatment effects in NEWS2 clinical improvement scores and among patients with the most elevated biomarker levels," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "These results, along with observations on the compassionate use of Brilacidin in COVID-19 related to dosing, as well as data being generated from ongoing scientific collaborations, are informing paths forward for our Brilacidin antiviral program. We believe Brilacidin has merit to help address COVID-19 and can play a role in preparing for future pandemics, given Brilacidin's unique immunomodulatory and antiviral properties. Progress in the Brilacidin antiviral program largely will be dependent upon obtaining government funding for additional clinical development and leveraging external research relationships. Going forward, our business focus will be to advance Brilacidin in other disease areas and to pursue new business opportunities through joint ventures and other investments."
创新制药首席执行官里奥·埃利希表示：“根据对我们的2期试验结果的分析，Brilacidin在 NEWS2 临床改善评分和生物标志物水平最高的患者中显示出令人鼓舞的治疗效果。”“这些结果，以及对与剂量有关的 COVID-19 中以同情心方式使用Brilacidin的观察，以及正在进行的科学合作生成的数据，为我们的Brilacidin抗病毒计划的前进道路提供了指导。我们认为，鉴于Brilacidin独特的免疫调节和抗病毒特性，Brilacidin有助应对 COVID-19，并且可以在为未来的疫情做准备方面发挥作用。Brilacidin抗病毒计划的进展在很大程度上将取决于获得政府资助以进行额外的临床开发和利用外部研究关系。展望未来，我们的业务重点将是推动Brilacidin在其他疾病领域的发展，并通过合资企业和其他投资寻求新的商机。”
Summary of Brilacidin COVID-19 Trial Design and Results
Brilacidin COVID-19 试验设计和结果摘要
The Phase 2 trial (see NCT04784897) was a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin treatment in addition to current standard-of-care (SoC) compared to SoC alone, in 120 hospitalized patients with moderate-to-severe COVID-19.
2期试验（参见 NCT04784897）是一项随机、双盲、安慰剂对照的多中心研究，旨在评估Brilacidin治疗在120名中度至重度 COVID-19 住院患者中，与单独使用SoC相比，除了目前的标准护理（SoC）之外的疗效和安全性。
Study treatment, Brilacidin IV or saline IV (placebo), was administered as 3 doses or 5 doses. For efficacy analyses, the main comparison was between the Brilacidin 5-dose group and the pooled placebo group.
研究疗法，即Brilacidin IV或盐水静脉注射（安慰剂），分3剂或5剂给药。在功效分析方面，主要比较的是Brilacidin 5剂量组和合并安慰剂组。
Even with randomization--stratified by age (<= 65 yrs, >65 yrs) and severity (moderate, severe)--patients allocated to the Brilacidin treatment groups exhibited a greater degree of disease burden at baseline, as reflected by higher, on average, elevated biomarker levels (e.g., CRP, viral load), in contrast to the pooled placebo group.
即使采用随机分组（按年龄（65 岁）和严重程度（中度、重度）进行分层，分配到Brilacidin治疗组的患者在基线时仍表现出更大的疾病负担，这与合并安慰剂组相比，生物标志物水平（例如CRP、病毒载量）升高所反映的那样。
As previously released, Brilacidin did not show a difference compared to placebo in reducing Time to Sustained Recovery Through Day 29, the study's primary endpoint based on clinical status. There was also no difference in mortality between active and placebo, with both groups experiencing low mortality rates (7 percent) compared to other studies that evaluated patients with moderate-to-severe COVID-19. Beneficial Brilacidin treatment effects, however, were observed in NEWS2 secondary endpoints, as well as on the primary endpoint in patient subgroups, as summarized below.
正如先前发布的那样，与安慰剂相比，Brilacidin在将持续恢复时间缩短至第29天方面没有显示出差异，这是该研究基于临床状况的主要终点。活性药物和安慰剂之间的死亡率也没有差异，与其他评估中度至重度 COVID-19 患者的研究相比，两组的死亡率都很低（7％）。但是，在 NEWS2 次要终点以及患者亚组的主要终点中观察到了有益的Brilacidin治疗效果，总结如下。
Pharmacokinetic (PK) analysis (from measured plasma sample concentrations) provided comparable estimations to those seen previously in the Brilacidin IV program, although exposure was generally greater than observed prior (when comparing patients on similar treatment regimens for the indication of acute bacterial skin and skin structure infections [ABSSSI]). These new PK data will help inform any future Brilacidin IV dosing strategies.
药代动力学（PK）分析（根据测得的血浆样本浓度）提供了与之前在Brilacidin IV计划中看到的相似的估计值，尽管暴露量通常大于先前观察到的暴露量（比较使用类似治疗方案的患者以了解急性细菌性皮肤和皮肤结构感染的适应症时 [ABSSSI]）。这些新的PK数据将有助于为未来的Brilacidin IV给药策略提供信息。
Brilacidin was generally well-tolerated by patients, with an overall safety profile in COVID-19 patients consistent with previous clinical studies. The incidence of patients with at least one treatment-emergent adverse event (TEAE) was higher for Brilacidin treatment compared to placebo. However, the proportion of patients with TEAEs is similar across groups (72 percent on active, 65 percent on placebo) after excluding the Brilacidin-related adverse events of tingling (paresthesia) and hypoesthesia (numbness), which are known, transient, mostly mild, non-serious adverse events related to Brilacidin IV treatment. The incidence of serious adverse events was the same (12 percent on active, 12 percent on placebo), and no serious adverse events were reported as related to study treatment.
患者对Brilacidin的耐受性普遍良好，COVID-19 患者的总体安全状况与先前的临床研究一致。与安慰剂相比，Brilacidin治疗中出现至少一次治疗紧急不良事件（TEAE）的患者的发生率更高。但是，在排除与Brilacidin相关的刺痛（感觉异常）和感觉减退（麻木）等不良事件后，各组TEAE患者的比例相似（活跃时为72％，安慰剂为65％），这些不良事件是已知的、短暂的、与Brilacidin静脉注射治疗相关的不良事件。严重不良事件的发生率相同（活性药物为12％，安慰剂为12％），并且没有报告与研究治疗相关的严重不良事件。
Secondary Endpoint Analysis
次要终点分析
- NEWS2 Scores (Intent-to-Treat Population)
- NEWS2 分数（意向治疗人群）
More patients in the Brilacidin 5-dose group achieved and maintained, for at least 24 hours, a National Early Warning Score 2 (NEWS2) of <=2. By 10 days (from randomization), 97 percent of the Brilacidin 5-dose group had achieved this NEWS2 endpoint compared to 84 percent of patients in the pooled placebo group. A NEWS2 score of 2 or less is clinically meaningful as an aggregate score of 4 or less translates to low clinical risk, per NEWS2 criteria.
在Brilacidin 5剂量组中，有更多患者在至少24小时内达到并维持了
The mean change from baseline in NEWS2 was greater for the Brilacidin treatment groups than for the pooled placebo group, at all assessment timepoints (Study Days 3, 5, 8, 11, 15, and 29).
在所有评估时间点（研究第3、5、8、11、15和29天），Brilacidin治疗组的 NEWS2 与基线的平均变化均大于合并安慰剂组。
NEWS2 is an ordinal scale developed by the U.K.'s Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention and is considered a valuable tool for management of COVID-19. NEWS2 is based on certain physiological parameters--respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse, level of consciousness, and temperature. NEWS2 has been used as an endpoint for several COVID-19 clinical trials.
NEWS2 是英国开发的序数量表。”的皇家内科医师学院旨在识别需要重症监护干预的临床快速恶化风险患者，被认为是管理 COVID-19 的宝贵工具。NEWS2 基于某些生理参数——呼吸率、血氧饱和度、补充氧气、收缩压、脉搏、意识水平和体温。NEWS2 已被用作多项 COVID-19 临床试验的终点。
Post-Hoc Analysis
事后分析
- Inflammatory Biomarkers: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
- 炎症生物标志物：具有最高四分位数基线值的患者亚组（每个协议人群）
For those patients with baseline values for C-Reactive Protein (CRP) in the highest quartile (4th quartile), all patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29, compared to 77 percent of patients in the pooled placebo subgroup. Time to sustained recovery was on average shorter in the Brilacidin 5-dose subgroup compared to placebo.
对于那些C反应蛋白（CRP）基线值处于最高四分位数（4）的患者第四 四分位数），Brilacidin 5剂量亚组的所有患者在第29天均实现了持续康复，而合并安慰剂亚组的患者这一比例为77％。与安慰剂相比，Brilacidin 5剂量亚组的持续恢复时间平均较短。
Additionally, for those patients with baseline values for Interleukin-6 (IL-6) in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (89 percent compared to 67 percent on placebo). Time to sustained recovery also was on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients.
此外，对于白介素-6（IL-6）基线值处于最高四分位数的患者，在Brilacidin 5剂量亚组中，有更多患者在第29天实现持续康复（89％，而安慰剂为67％）。与安慰剂相比，对于这四分位数患者，Brilacidin 5剂量亚组的持续康复时间平均也更短。
Both CRP and IL-6 levels, when elevated at baseline, have been shown to predict worse outcomes in COVID-19 patients and our data was consistent with this. These two biomarkers have been used by other pharmaceutical companies as enrollment criteria to target COVID-19 patient populations most likely to benefit from treatment. The NIH-sponsored clinical evaluation of Humanigen's drug, lenzilumab (ACTIV-5/BET-B), was updated to include, as the trial's primary endpoint, survival without ventilation by 28 days in patients with baseline CRP levels under 150mg/l.
当基线水平升高时，CRP 和 IL-6 水平都被证明可以预测 COVID-19 患者的预后会更差，我们的数据与此一致。这两种生物标志物已被其他制药公司用作入组标准，以瞄准最有可能从治疗中受益的 COVID-19 患者群体。美国国立卫生研究院赞助的对Humanigen的药物伦齐鲁单抗（ACTIV-5/BET-B）的临床评估已更新，将基线CRP水平低于150mg/l的患者在不通气的情况下存活28天作为该试验的主要终点。
- Viral Load Biomarker: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
- 病毒载量生物标志物：具有最高四分位基准值的患者亚组（每个协议人群）
For those patients with baseline values for viral load in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (92 percent compared to 82 percent on placebo). Time to sustained recovery was also on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients. This is notable given median time from symptom onset to treatment randomization averaged 9.53 days in the Brilacidin COVID-19 trial, and thus likely occurred after peak viral load in most patients.
对于那些病毒载量基线值处于最高四分位数的患者，在Brilacidin 5剂量亚组中，更多的患者在第29天实现了持续康复（92％，而安慰剂的这一比例为82％）。与安慰剂相比，该四分位数患者的Brilacidin 5剂量亚组的持续康复时间平均也更短。考虑到在Brilacidin COVID-19 试验中，从症状发作到治疗随机分组的平均时间为9.53天，因此很可能发生在大多数患者的病毒载量达到峰值之后，这一点值得注意。
- Time from Onset of Symptoms to Randomization (Per Protocol Population)
- 从症状出现到随机分组的时间（每个协议人群）
If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study's primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
如果患者在 COVID-19 症状出现后不到 7 天内开始研究治疗，则与合并安慰剂组（p=0.03）相比，Brilacidin 5 剂量组的患者实现持续康复的速度更快。对于这些患者群体，从症状发作开始就使用Brilacidin进行早期治疗似乎对持续康复时间（该研究的主要终点）产生潜在的积极影响，这表明在疾病初期发作时可以治疗的病例可能是Brilacidin治疗的有吸引力的靶向人群。
Multiple monoclonal antibodies targeting COVID-19, as well as the oral COVID-19 antiviral molnupiravir (Lagevrio™), failed in hospitalized patients but later achieved success in treating earlier-stage disease. The antiviral remdesivir (Veklury™) also recently exhibited substantial benefit in non-hospitalized COVID-19 patients, including an 87 percent lower risk of hospitalization or death than placebo after a 3-day intravenous course of the drug.
多种靶向 COVID-19 的单克隆抗体以及口服 COVID-19 抗病毒莫努匹拉韦（Lagevrio™）在住院患者中失效，但后来在治疗早期疾病方面取得了成功。抗病毒药物瑞德西韦（Veklury™）最近在非住院的 COVID-19 患者中也表现出显著的益处，包括静脉注射该药3天后的住院或死亡风险比安慰剂低87％。
- Standard-of-Care (SoC)
- 护理标准 (SoC)
Review of Brilacidin Phase 2 COVID-19 trial data showed most patients (>87 percent) received treatment with systemic corticosteroids (generally at high doses, and for long durations), and treatment with mucolytics (>82 percent), antivirals (>68 percent), analgesics (>56 percent), immunosuppressants (>45 percent), anti-thrombotic agents (>97 percent), and other supportive medications as SoC for COVID-19.
对Brilacidin 2期COVID-19 试验数据的审查显示，大多数患者（>87％）接受了全身性皮质类固醇治疗（通常是高剂量且持续时间长），以及粘液溶解剂（>82％）、抗病毒药物（>68％）、镇痛药（>56％）、免疫抑制剂（>45％）、抗血栓药物（>97％）的治疗，以及其他支持药物，如 COVID-19 的 SoC。
These seemingly aggressive SoC treatment strategies are likely attributable to the Delta variant of SARS-CoV-2, which became prevalent during trial enrollment and has been associated with significantly higher in-hospital mortality compared to earlier SARS-CoV-2 variants. Such implementation of a more aggressive COVID-19 SOC, as has been reported by other companies evaluating COVID-19 trial results, may have contributed to an overall lessening of observable Brilacidin treatment effects.
这些看似激进的SoC治疗策略很可能归因于SARS-CoV-2的Delta变体，该变体在试验入组期间变得很普遍，与早期的SARS-CoV-2变体相比，院内死亡率明显更高。正如其他评估 COVID-19 试验结果的公司所报告的那样，这种更具侵略性的 COVID-19 SOC 的实施可能导致可观察到的布里拉西丁治疗效果总体减弱。
Brilacidin Compassionate Use in COVID-19-Observed Treatment Effects
Brilacidin Compassionate 在 COVID-19 观察到的治疗效果中的应用
Noticeable treatment effects attributed to the compassionate use of Brilacidin were reported by investigators. Patients receiving compassionate use of Brilacidin were at extremely advanced stages of disease and had exhausted other conventional treatment options. Compassionate use cases comprised Brilacidin being administered to critically-ill COVID‑19 patients over a longer duration (up to 10 days of treatment) than in the Phase 2 COVID-19 clinical trial (3 and 5 day dosing), with some patients also receiving higher and more frequent (twice daily) dosing. There appeared to be a potentially favorable treatment response based on increased Brilacidin dosing. For the Brilacidin compassionate use cases, in general, investigators observed more stable disease with initial improvements evident on chest x-rays and in COVID-19 disease biomarkers (e.g., CRP and ferritin). While nearly all of these critically-ill patients ultimately succumbed to severe hypoxic respiratory failure (secondary to COVID-19 viral pneumonia) and expired, survival time for these patients who initially were not expected to live beyond a few days was appreciably extended.
研究人员报告了由于同情地使用Brilacidin而产生的明显治疗效果。同情地使用Brilacidin的患者处于疾病的晚期，已经用尽了其他常规治疗方案。富有同情心的用例包括，与2期 COVID-19 临床试验（3天和5天剂量）相比，对COVID-19危重病人施用Brilacidin的时间更长（最多治疗10天），一些患者还接受更高、更频繁的剂量（每天两次）。由于增加Brilacidin剂量，似乎可能出现有利的治疗反应。对于 Brilacidin 同情用例，总体而言，研究人员观察到的疾病更为稳定，胸部 X 光片和 COVID-19 疾病生物标志物（例如 CRP 和铁蛋白）的初步改善显而易见。尽管几乎所有这些危重患者最终都死于严重的缺氧呼吸衰竭（继发于 COVID-19 病毒性肺炎）并已过期，但这些最初预计寿命不会超过几天的患者的存活时间明显延长。
Brilacidin Antiviral Program-Planned Next Steps
Brilacidin抗病毒计划计划采取的下一步措施
Future progress in the broader Brilacidin antiviral program will largely be tied to obtaining government funding for additional clinical development while benefiting from ongoing collaborative research with NIH and other scientists. Brilacidin's broad-spectrum antiviral activity is generating positive data. Publications and conference abstracts related to this research are being prepared.
更广泛的Brilacidin抗病毒计划的未来进展将在很大程度上与获得政府资助以进行额外的临床开发有关，同时受益于与美国国立卫生研究院和其他科学家正在进行的合作研究。Brilacidin的广谱抗病毒活性正在产生积极的数据。正在编写与这项研究有关的出版物和会议摘要。
Given the need for development of new small molecule antivirals and immunomodulators, the Company is planning to submit Brilacidin for possible inclusion in government-sponsored COVID-19 trial platforms, e.g., the NIH ACTIV program. Platform trials, which typically enroll hundreds of patients per treatment arm, can more accurately evaluate the treatment potential of COVID-19 drug candidates. Pursing a biomarker-driven approach, increasing Brilacidin dosing and treatment duration, targeting different patient populations, testing Brilacidin in combination with drugs exhibiting different mechanisms of action (e.g., remdesivir, given strong synergistic in vitro data)--all are possible elements of any future Brilacidin COVID-19 trial design. Compassionate use of Brilacidin also is anticipated to continue, which could further inform Brilacidin's treatment effects in COVID-19. For more details on the Company's Compassionate Use policy, please visit:
鉴于需要开发新的小分子抗病毒药物和免疫调节剂，该公司计划提交Brilacidin，以可能纳入政府赞助的 COVID-19 试验平台，例如美国国立卫生研究院 ACTIV 计划。平台试验通常每个治疗组招收数百名患者，可以更准确地评估 COVID-19 候选药物的治疗潜力。采用生物标志物驱动的方法，延长Brilacidin的剂量和治疗时间，针对不同的患者群体，将Brilacidin与表现出不同作用机制的药物（例如瑞德西韦，鉴于体外协同效应很强）进行联合测试——所有这些都是未来Brilacidin COVID-19 试验设计的可能要素。预计还将继续以同情心方式使用布里拉西丁，这可能会进一步为布里拉西丁在 COVID-19 中的治疗效果提供信息。有关公司同情使用政策的更多详情，请访问：
The Company also plans to seek additional clinical development support from the NIH Antiviral Program for Pandemics (APP). Brilacidin for prophylactic use, including assessing Brilacidin in pre-clinical animal models, is of particular interest due to Brilacidin's blocking and neutralizing antiviral properties and industry investment in developing intranasal-targeted, direct-acting antivirals. Preliminary Brilacidin formulation work for inhaled delivery has been conducted, with the NIH APP a potential avenue to expand on this work, along with exploring the subcutaneous administration of Brilacidin, which has greater than 70 percent bioavailability via this route of administration.
该公司还计划向美国国立卫生研究院流行病抗病毒计划（APP）寻求额外的临床开发支持。由于Brilacidin具有阻断和中和抗病毒特性，以及业界对开发鼻内靶向直接作用的抗病毒药物的投资，包括在临床前动物模型中评估Brilacidin的预防用途特别令人关注。用于吸入给药的Brilacidin的初步配方工作已经完成，NIH APP是扩展这项工作的潜在途径，同时还探索了Brilacidin的皮下给药，通过这种给药途径，Brilacidin的生物利用度超过70％。
Pipeline Advancement, Other Business Opportunities
管道发展，其他商机
Efforts to advance the Brilacidin Oral Mucositis (OM) program are a key focus. The Company is presently exploring timelines and scenario planning-including the option to seek a meeting with the U.S. Food and Drug Administration towards the initiation of a Phase 3 clinical trial evaluating oral rinse Brilacidin as a new treatment for the prevention of OM in head and neck cancer patients receiving chemoradiation. Brilacidin oral formulation development work for Ulcerative Colitis continues. The Company has also been notified by Alfasigma, its licensing partner, of their intent to initiate this year Phase 2 testing of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis.
推进Brilacidin口腔粘膜炎（OM）计划的努力是重点。该公司目前正在探索时间表和情景规划，包括寻求与美国食品药品监督管理局会晤的选项，以启动一项评估口服冲洗液Brilacidin作为预防接受化疗的头颈癌患者OM的新疗法的3期临床试验。治疗溃疡性结肠炎的Brilacidin口服制剂开发工作仍在继续。其许可合作伙伴Alfasigma还通知该公司，他们打算在今年启动Brilacidin治疗溃疡性直肠炎/直肠乙状结肠炎的第二阶段测试。
In other news, the Company is evaluating a number of potential pipeline additions and other unique business opportunities, including investments in medical-related technologies. In certain instances, management is in advanced discussions for products believed to be accretive to revenue by diversifying Innovation's portfolio. The Company will provide updates on all such matters as appropriate.
在其他新闻方面，该公司正在评估一些潜在的新增产品线和其他独特的商机，包括对医疗相关技术的投资。在某些情况下，管理层正在就据信通过分散创新投资组合来增加收入的产品进行深入讨论。公司将酌情提供所有此类事项的最新情况。
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
关于创新制药
Innovation Pharmaceuticals Inc.（IPIX）是一家临床阶段的生物制药公司，正在开发世界一流的创新疗法组合，以解决未满足的医疗需求的多个领域，包括炎性疾病、癌症、传染病和皮肤病。
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its potential impact on SARS-CoV-2 (COVID-19) and other viruses. Other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the United States and other jurisdictions, including without limitation that the Company's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company's need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
前瞻性陈述：本新闻稿包含根据1995年《私人证券诉讼改革法》的安全港条款做出的前瞻性陈述，包括但不限于有关未来药物开发计划的声明、有关Brilacidin的抗病毒能力和治疗潜力及其对SARS-CoV-2（COVID-19）和其他病毒的潜在影响的声明。关于未来产品开发的其他声明，包括与具体适应症有关的陈述，以及除历史事实陈述以外的任何其他陈述。这些陈述涉及风险、不确定性和假设，可能导致公司的实际业绩和经验与这些前瞻性陈述中表达的预期业绩和预期存在重大差异。在某些情况下，公司使用诸如 “预期”、“相信”、“希望”、“估计”、“外观”、“期望”、“计划”、“打算”、“目标”、“潜力”、“可能”、“建议” 等词语和类似表述来确定前瞻性陈述。可能导致实际结果与前瞻性陈述中表达的结果存在重大差异的其他因素包括与开展临床前研究和临床试验以及在美国和其他司法管辖区寻求监管和许可批准相关的风险，包括但不限于该公司的化合物可能无法成功完成临床前或临床测试，或未获得监管部门批准在美国或其他地方销售和销售；先前的测试结果可能不是是在未来的研究和试验中会出现这种情况；公司未来对大量资本的需求和可用性为其运营和研发提供资金，包括根据证券购买协议出售普通股的金额和时间；公司的被许可人可能无法成功完成临床前或临床测试，公司也不会获得里程碑付款。对这些和其他风险因素的更完整描述包含在公司向美国证券交易委员会提交的文件中。其中许多风险、不确定性和假设超出了公司的控制或预测能力。您不应过分依赖任何前瞻性陈述。前瞻性陈述仅代表公司在发表之日目前获得的信息，除非适用的法律或法规要求，否则公司没有义务公开发布为反映本新闻稿发布之日之后的事件或情况或反映意外事件的发生而对任何此类前瞻性陈述进行的任何修订的结果。
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
投资者和媒体联系人
创新制药公司
里奥·埃利希
info@ipharminc.com
SOURCE: Innovation Pharmaceuticals Inc.
来源：创新制药公司