WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc., (NASDAQ: SXTP, SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company.

华盛顿，2024年3月14日（环球通讯社）--专注于开发传染病新药的制药公司60度制药公司（纳斯达克：SXTP，SXTPW）（“60度制药”或“公司”）今天宣布，美国食品和药物管理局（FDA）已表示打算在2024年4月，而不是公司预期的2024年3月，就公司的巴贝斯虫病试验发表任何评论。

The protocol submission mechanism as directed by the FDA, i.e., under the Company’s existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame..

FDA指示的方案提交机制，即根据公司现有的（而不是新的）研究性新药申请，在技术上不需要FDA在指定的时间范围内做出回应。。

The Company is continuing preparations for a June 1, 2024 start date as previously communicated.

如前所述，公司正在继续准备2024年6月1日的开工日期。

Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

Tafenoquine是2018年FDA批准的抗疟疾药物的活性成分，用于预防18岁及以上患者的疟疾。

About ARAKODA® (tafenoquine)

阿拉科达® （tafenoquine）

Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country.

塔非诺喹是由沃尔特里德陆军研究所发现的。2018年，Tafenoquine在美国被批准为ARAKODA®，在澳大利亚被批准为KODATEF®。两者均于2019年商业启动，目前通过各自国家的药品批发商网络进行分销。

They are available at retail pharmacies as a prescription-only malaria prevention drug..

它们在零售药店可以作为处方药预防疟疾。。

According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less frequent dosing for prophylaxis for malaria. ARAKODA® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below..

据美国疾病控制与预防中心（Centers for Disease Control and Prevention）称，他非诺喹（tafenoquine）的终末半衰期约为16天，这可能为减少疟疾预防用药频率提供潜在优势。ARAKODA®不适合所有人，患者和开处方者应审查以下重要的安全信息。。

ARAKODA® (tafenoquine) Important Safety Information

ARAKODA®（tafenoquine）重要安全信息

ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

ARAKODA®是一种抗疟药，用于预防18岁及以上患者的疟疾。

Contraindications

禁忌症

ARAKODA® should not be administered to:

ARAKODA®不应用于：

Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status.

葡萄糖-6-磷酸脱氢酶（G6PD）缺乏或G6PD状态未知的患者。

Lactating women who are breastfeeding when the infant is found to be G6PD deficient or if G6PD status is unknown.

当发现婴儿缺乏G6PD或G6PD状态未知时，正在哺乳的哺乳期妇女。

Patients with a history of psychotic disorders or current psychotic symptoms.

有精神病病史或目前有精神病症状的患者。

Patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines or any component of ARAKODA®.

对他非诺喹，其他8-氨基喹啉或ARAKODA®的任何成分具有已知超敏反应的患者。

Warnings and Precautions

警告和注意事项

Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

溶血性贫血：由于溶血性贫血的风险，在开具ARAKODA®之前必须进行G6PD检测。监测患者溶血的体征或症状。

G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant’s G6PD status before breastfeeding begins..

妊娠或哺乳期G6PD缺乏症：当给予G6PD缺陷胎儿的孕妇时，ARAKODA®可能会导致胎儿伤害。怀孕期间不建议使用ARAKODA®。缺乏G6PD的婴儿可能因母乳接触ARAKODA®而有溶血性贫血的风险。母乳喂养前检查婴儿的G6PD状态。。

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

高铁血红蛋白血症：已观察到血液高铁血红蛋白无症状升高。如果出现高铁血红蛋白血症的体征或症状，请开始适当的治疗。

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible..

精神病影响：在有精神病或精神分裂症病史的患者中观察到严重的精神病不良反应，剂量与批准剂量不同。如果出现精神病症状（幻觉、妄想或思维或行为严重混乱），请考虑尽快停止ARAKODA®治疗并由心理健康专业人员进行评估。。

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy.

超敏反应：服用ARAKODA®后观察到严重的超敏反应。如果发生超敏反应，请进行适当的治疗。

Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia and hypersensitivity reactions may be delayed in onset and/or duration.

迟发性不良反应：由于ARAKODA®的半衰期长（约16天），精神病，溶血性贫血，高铁血红蛋白血症和超敏反应的发作和/或持续时间可能会延迟。

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams and anxiety.

不良反应：最常见的不良反应（发生率大于或等于1%）是：头痛，头晕，背痛，腹泻，恶心，呕吐，丙氨酸转氨酶升高，晕动病，失眠，抑郁，异常梦和焦虑。

Drug Interactions

药物相互作用

Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

避免与作为有机阳离子转运蛋白-2或多药和毒素挤出转运蛋白底物的药物共同给药。

Use in Specific Populations

在特定人群中使用

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®.

哺乳期：建议女性在治疗期间和最后一剂ARAKODA®后3个月内不要母乳喂养G6PD缺陷婴儿或G6PD状态未知的婴儿。

To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1- 888-834-0225 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ARAKODA® full prescribing information is here.

要报告可疑的不良反应，请联系60度制药公司（电话：1-888-834-0225）或FDA（电话：1-800-FDA-1088）或www.FDA.gov/medwatch。ARAKODA®完整的处方信息在这里。

About 60 Degrees Pharmaceuticals, Inc.

约60度制药公司。

60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals achieved FDA approval of its lead product, ARAKODA® (tafenoquine) for malaria prevention, in 2018.

60度制药公司成立于2010年，专门开发和销售用于治疗和预防影响数百万人生活的传染病的新药。2018年，60度制药公司获得FDA批准其主要产品ARAKODA®（tafenoquine）用于预防疟疾。

60 Degrees Pharmaceuticals also collaborates with prominent research organizations in the U.S., Australia and Singapore. The 60 Degrees Pharmaceuticals mission has been supported through in-kind funding from the United States Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company.

60度制药还与美国、澳大利亚和新加坡的知名研究机构合作。美国国防部和私人机构投资者（包括总部位于加拿大的泛美专业制药公司Knight Therapeutics Inc.）的实物资助为60度制药公司的使命提供了支持。

60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com..

60度制药公司总部位于华盛顿特区，在澳大利亚拥有一家控股子公司。更多信息，请访问www.60degreespharma.com。。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements.

本新闻稿可能包含1995年《美国私人证券诉讼改革法案》安全港条款所指的“前瞻性声明”。前瞻性陈述反映了当前对未来事件的看法。当在本新闻稿中使用“预期”、“相信”、“估计”、“期望”、“未来”、“打算”、“计划”或这些术语的否定词以及与我们或我们的管理层相关的类似表达时，可以识别前瞻性陈述。

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions.

前瞻性陈述既不是历史事实，也不是未来表现的保证。相反，它们仅基于我们目前对业务未来、未来计划和战略、预测、预期事件和趋势、经济和其他未来状况的信念、期望和假设。

Because forward-looking statements relate to the future, they 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 and financial condition may differ materially from those indicated in the forward-looking statements.

由于前瞻性陈述与未来有关，因此它们受到难以预测的固有不确定性、风险和环境变化的影响，其中许多不在我们的控制范围内。我们的实际业绩和财务状况可能与前瞻性报表中显示的结果和财务状况存在重大差异。

Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in .

因此，您不应该依赖这些前瞻性陈述。可能导致我们的实际业绩和财务状况与前瞻性报表中所示存在重大差异的重要因素包括：对我们持续经营的能力存在重大怀疑；我们可能没有资格享受澳大利亚政府的研发退税；如果我们无法成功开发，请获得FDA的批准，并提供塔非诺喹（ARAKODA®或其他方案）或Celgosivir的非疟疾预防适应症的商业化。

Media Contacts:

媒体联系人：

Sheila A. Burke

希拉·A·伯克

SheilaBurke-consultant@60degreespharma.com

SheilaBurke-consultant@60degreespharma.com

(484) 667-6330

(484) 667-6330

Investor Contact:

投资者联系人：

Patrick Gaynes

Patrick Gaynes

patrickgaynes@60degreespharma.com

patrickgaynes@60degreespharma.com

(310) 989-5666

(310) 989-5666