GeoVax报告2016年第二季度财务业绩，并提供企业更新

StephenW

August 05, 2016 09:00 ET
GeoVax Reports 2016 Second Quarter Financial Results and Provides Corporate Update

Ongoing Vaccine Programs in Zika, HIV, Hemorrhagic Fevers, Hepatitis B and Cancer

ATLANTA, GA--(Marketwired - Aug 5, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines using its novel platform technology, announced its financial results for the three and six months ended June 30, 2016 and provided the following corporate update.

Management Commentary

Robert T. McNally Ph.D., GeoVax's President and CEO, commented, "GeoVax had an active and productive second quarter of 2016, as we continued to demonstrate the broad utility of our MVA-VLP vaccine platform, with the launch of a new program to develop a vaccine for treatment of chronic Hepatitis B infections. Our product pipeline now encompasses four distinct infectious disease areas including HIV, Zika, Hemorrhagic Fever Viruses (Ebola, Sudan, Marburg and Lassa), and Hepatitis B, as well as a program in Cancer Immunotherapy, which itself may generate multiple disease targets."

"With our HIV vaccine program," Dr. McNally continued, "we announced in June the filing of an Investigational New Drug (IND) application with the FDA for the next human clinical trial (HVTN 114) of our preventive HIV vaccine, GOVX-B11. HVTN 114 will be conducted by the HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Diseases (NIAID). The IND has now been cleared, setting the stage for patient enrollment which HVTN now expects to begin in early November. During the quarter, NIAID also awarded us two SBIR grants, totaling $1.7 million which will fund additional non-human primate studies in support of our clinical program, as well as advancing development of our vaccine for the version of HIV affecting Sub-Saharan Africa. And most recently, NIAID awarded us a Staged Vaccine Development contract of up to $7.8 million for the production of the DNA component of GOVX-B11 in sufficient quantities for advanced human clinical trials, including a phase 2b efficacy trial."

"We also had exciting developments during the second quarter with our hemorrhagic fever virus (HFV) vaccine program," Dr. McNally added. "Our goal with this program is to develop both individual vaccines, as well as a single tetravalent (four-component) vaccine to protect against four lethal hemorrhagic fever viruses -- Ebola-Zaire, Ebola-Sudan, Marburg, and Lassa. We have now shown that our individual vaccines produce non-infectious virus-like particles in each of the disease targets -- an important demonstration of the mechanism of action by which our vaccine platform technology delivers a safe, effective, and durable immune response. We also completed a study in non-human primates which showed complete (100%) protection against a lethal Ebola virus challenge after a single inoculation -- an important proof-of-concept demonstration. The commercial opportunity for our HFV program is quite attractive, particularly for Lassa fever, given the endemic nature of the virus. We foresee the individual vaccines being used in epidemic or biothreat situations, while the tetravalent vaccine is being developed for protection of the millions of individuals who live in at-risk areas, travelers, military personnel, and healthcare workers."

"Our Zika vaccine program continues to be a top priority for our company, especially now with the spread of the virus into the southern U.S.," Dr. McNally concluded. "Our collaborations with the University of Georgia and the CDC are helping to advance this program and we anticipate additional progress reports in the near future. Our vaccine constructs for the immuno-oncology program are complete and planning is underway for animal testing.

Financial Review

GeoVax reported a net loss of $575,835 ($0.02 per share) for the three months ended June 30, 2016, compared to $676,203 ($0.02 per share) for the same period in 2015. For the six months ended June 30, 2016, the Company's net loss was $1,872,114 ($0.05 per share) as compared to $1,376,657 ($0.04 per share) in 2015.

The Company reported revenues of $166,280 and $213,880 for the three-month and six-month periods of 2016, respectively, related to grants from the NIH in support of its HIV/AIDS vaccine development efforts. This compares to $71,474 and $174,898 of grant revenue reported for the comparable periods of 2015. As of June 30, 2016, there is $921,083 in approved grant funds remaining and available for use.

Research and development (R&D) expenses were $397,576 and $835,580 for the three-month and six-month periods of 2016, respectively, as compared to $384,653 and $788,282 for the comparable periods of 2015. R&D expenses include direct costs funded by NIH grants, as well as other vaccine manufacturing and testing costs. General and administrative (G&A) expenses were $344,818 and $1,251,323 for the three-month and six-month periods of 2016, respectively, as compared to $364,889 and $766,330 for the comparable periods of 2015.

GeoVax reported cash balances of $215,130 at June 30, 2016, as compared to $1,060,348 at December 31, 2015. During July and August (thru August 4) the Company received $344,500 in net proceeds from the exercise of outstanding stock purchase warrants. Summarized financial information is attached. Further information concerning the Company's financial position and results of operations are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. The Company's development programs are focused on vaccines against HIV, Zika Virus, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa). GeoVax also recently began programs to evaluate the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

StephenW

2016年8月5日09:00 ET
GeoVax报告2016年第二季度财务业绩，并提供企业更新

正在进行的疫苗项目在兹卡，艾滋病，出血热，乙型肝炎和癌症

佐治亚州亚特兰大 - （Marketwired - 2016年8月5日） - GeoVax实验室公​​司（OTCQB：GOVX），一家生物技术公司，开发利用其新颖的平台技术人用疫苗，公布其财务业绩截至6月30日的三个月和六个月，2016年，并提供以下企业更新。

管理评论

罗伯特·麦克纳利T.博士，GeoVax公司总裁兼首席执行官，评论说：“GeoVax了积极和富有成效的第二季度的2016年，随着我们继续证明我们的MVA-VLP疫苗平台的广泛的实用性，通过推出新的程序开发疫苗治疗慢性乙型肝炎的感染。我们的产品线现在包括四个不同的传染病领域，包括HIV，兹卡，出血热病毒（埃博拉病毒，苏丹，马尔堡和拉沙），以及B型肝炎，以及程序在癌症免疫疗法，其本身可能产生多个疾病靶点“。

“随着我们的HIV疫苗计划，”麦克纳利博士继续说，“我们在六月宣布与我们的预防性艾滋病疫苗，GOVX-的FDA在未来人类的临床试验（HVTN 114）的研究性新药（IND）申请的提交B11。HVTN 114将艾滋病毒疫苗试验网络（HVTN）与国家过敏和传染病研究所（NIAID）的资金来进行。该IND已经被清除，设置患者登记阶段这HVTN目前预计开始十一月初，在本季度，NIAID也被授予了我们两个SBIR补助金，共计170万$，这将支持我们的临床计划的资助另外的非人灵长类动物的研究，以及推动我们的疫苗的研制艾滋病毒影响子版本-Saharan非洲。而最近，NIAID授予美国高达780万$分步疫苗开发合同生产GOVX-B11的足够数量的先进的人体临床试验，其中包括一个阶段2B药效试验的DNA成分。“

“第二季度我们的出血热病毒（出血热病毒）疫苗节目中我们也有令人振奋的发展，”麦克纳利博士补充说。 “我们这个项目的目标是开发包括个人的疫苗，以及作为一个单一的四价（四元）疫苗，以保护对四名致命的出血热病毒 - 埃博拉 - 扎伊尔，埃博拉 - 苏丹，马尔堡和拉沙我们有现在表明，我们的个体的疫苗产生非感染性病毒样颗粒在各疾病靶 - 作用的机制，通过它我们的疫苗平台技术提供一个安全，有效，和持久的免疫应答的重要示范我们还完成在非人灵长类这表明对一个致命的埃博拉病毒挑战完成（100％）保护单一接种后的一项研究 - 验证的概念，具有重要的示范我们的出血热病毒程序中的商业机会是相当有吸引力的，特别是对拉沙发烧，鉴于病毒的特有性质，我们预见到各个疫苗在疫情或生物威胁的情况下被使用，而四价疫苗被用于数以百万计谁在危险地区，游客，军人生活在个人的保护开发，和医护人员“。

“我们兹卡疫苗项目仍然是我们公司的首要任务，特别是现在随着病毒蔓延到南部的美国，”麦克纳利博士总结说。 “我们与佐治亚大学和疾控中心合作正在帮助推动这一计划，我们预计在不久的将来取得更多进展报告。我们的疫苗构建了免疫肿瘤项目已​​完成，规划正在进行动物试验。

财经评论

GeoVax报道$ 575835（每股$ 0.02）截至2016年6月30日的三个月净亏损，相比于$六七六二○三（每股$ 0.02）于2015年同期的截至2016年6月30日，公司的净六个月亏损为$一百八十七万二千一百十四（每股$ 0.05）相比，$一百三十七万六千六百五十七（每股$ 0.04）于2015年。

该公司公布的$一十六万六千二百八十〇和2016年的三个月和六个月期213880 $的收入，分别与来自美国国立卫生研究院资助支持其艾滋病毒/艾滋病疫苗的开发工作。与此相比，$七万一千四百七十四和报告的2015年可比期间2016年截至6月30日，授收入174898 $，有$九二一〇八三在核准的剩余补助资金，并可以使用。

研究与发展（R＆D）费用分别为$ 397576和2016年，三个月和六个月期835580 $，比$三十八万四千六百五十三并为2015年的研发费用可比期间的788282 $包括由美国国立卫生研究院拨款资助的直接成本，以及其他疫苗的制造和测试成本。一般及行政（G＆A）开支分别为$三四四八一八和2016年三个月和6个月期1251323 $，比$三六四八八九和2015年的可比期间的766330 $。

GeoVax报道$二一五一三零现金余额2016年6月30日相比，$一○六○三四八于2015年12月31日，七月和八月期间（直通8月4日）公司收到$ 344,500的所得款项净额发行股票认股权证的行使。财务资料附后。有关公司的财务状况和经营业绩的进一步信息包含在向美国证券交易委员会提交的10-Q的季度报告。

关于GeoVax

GeoVax实验室，Inc.是一家临床阶段的生物技术公司利用其MVA-VLP疫苗平台开发针对传染病的人用疫苗。该公司的发展计划都集中在防治艾滋病毒，病毒兹卡和出血热病毒（埃博拉病毒，苏丹，马尔堡，拉沙）疫苗。 GeoVax最近也开始程序，以评估使用其MVA-VLP平台在癌症免疫治疗，以及用于治疗慢性乙型肝炎感染的治疗用途。 GeoVax的疫苗平台支持体内生产从一人的细胞接受疫苗非感染VLP的，模仿自然感染，刺激既体液和免疫系统识别，预防和控制目标感染的细胞臂。欲了解更多信息，请访问www.geovax.com。