Dyadic International Inc (DYAI) 2023 Q2 法說會逐字稿

Good evening and welcome to Dyadic International's second-quarter 2023 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded today, August 9, 2023.

晚上好，歡迎參加 Dyadic International 2023 年第二季財務業績電話會議。 （操作員說明）謹此提醒，本次電話會議於今天（2023 年 8 月 9 日）錄製。

I would now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

我現在想將電話轉給 Dyadic 財務長 Ping Rawson 女士。請繼續。

Thank you. Good evening and welcome, everyone, to Dyadic International's second-quarter 2023 conference call. I hope you have had the opportunity to review Dyadic's press release announcing financial results for the quarter ended June 30, 2023, and the recent company highlights. You may access our release in the Form 10-Q under the Investors section of the company's website at dyadic.com.

謝謝。晚上好，歡迎大家參加 Dyadic International 2023 年第二季電話會議。我希望您有機會閱讀 Dyadic 宣布截至 2023 年 6 月 30 日的季度財務業績的新聞稿以及公司最近的亮點。您可以在公司網站 dyadic.com 投資者部分下的 10-Q 表格中取得我們的新聞稿。

On today's call, our President and CEO, Mark Emalfarb, will give a review of our second-quarter business and corporate highlights, including a summary of our recent research and business development efforts. Our Chief Business Officer, Joe Hazelton, will join Mark for the business updates. I will follow with a review of our financial results in more detail. We will then hold a brief Q&A session.

在今天的電話會議上，我們的總裁兼執行長 Mark Emalfarb 將回顧我們第二季的業務和公司亮點，包括我們最近的研究和業務開發工作的總結。我們的首席商務長 Joe Hazelton 將與 Mark 一起了解業務最新動態。接下來我將更詳細地回顧我們的財務表現。然後我們將舉行簡短的問答環節。

At this time, I would like to inform you that certain commentary made in this conference call may be considered forward-looking statements, which involve risks and uncertainties and other factors that could cause Dyadic's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. Dyadic expressly disclaims any duty to provide updates to its forward-looking statements, whether because of new information, future events, or otherwise. Participants are directed to the risk factors set forth in Dyadic's reports filed with the SEC.

目前，我想通知您，本次電話會議中所做的某些評論可能被視為前瞻性陳述，其中涉及風險和不確定性以及其他可能導致Dyadic 的實際結果、表現、科學或其他方面或成就的因素。與這些前瞻性陳述中明示或暗示的內容有重大差異。 Dyadic 明確表示不承擔任何更新其前瞻性聲明的義務，無論是由於新資訊、未來事件或其他原因。參與者應注意 Dyadic 向 SEC 提交的報告中列出的風險因素。

It is now my pleasure to pass the call to our CEO, Mark Emalfarb. Mark?

現在我很高興將電話轉給我們的執行長 Mark Emalfarb。標記？

Thank you, Ping. Hello, everyone, and thank you for joining Dyadic's second-quarter 2023 conference call. We've continued the momentum seen in the first quarter of 2023 as our C1 technology continues to garner praise and recognition for its speed and efficiency in the US and internationally for academia, industry, and government agencies. In addition, our Dapibus platform has gained significant traction in both the alternative protein and bioindustrial markets. We are delivering multiple new research collaborations and strong revenue growth of 38.5% year over year for the first six months of this year.

謝謝你，平。大家好，感謝您參加 Dyadic 2023 年第二季電話會議。我們延續了 2023 年第一季的勢頭，我們的 C1 技術因其速度和效率繼續在美國和國際學術界、工業界和政府機構贏得讚譽和認可。此外，我們的 Dapibus 平台在替代蛋白質和生物工業市場上都獲得了顯著的吸引力。今年前 6 個月，我們開展了多項新的研究合作，營收年增 38.5%。

On today's call, Joe and I will highlight the significant technological advances and recent business development successes we have and continue to achieve across each of our core markets. We are excited about our current and future prospects for growth in our revenues while continuing the ongoing long-term collaborations with Janssen, Phibro/Abic, Rubic, and others.

在今天的電話會議上，喬和我將重點介紹我們在每個核心市場中已經取得的並將繼續取得的重大技術進步和最近的業務發展成功。我們對目前和未來的收入成長前景感到興奮，同時繼續與 Janssen、Phibro/Abic、Rubic 等公司進行長期合作。

The continued positive data from our first in-human Phase 1 study and our recently announced advancements in our internal serum albumin projects have accelerated the opportunities to enter into additional collaborations and partnerships like the recently announced two memorandum of understandings with the Italian government's Fondazione Biotecnopolo di Siena, which performs the functions of an anti-epidemic hub with a particular focus on the development and production of vaccines and monoclonal antibodies for the treatment of emerging, epidemic, pandemic pathologies, and also Bangladesh's essential drugs company-limited EDCL, the state-owned pharmaceutical company under the Ministry of Health and Family Welfare of Bangladesh, to facilitate biopharmaceutical research, preclinical development, cGMP production, and clinical development for the prevention and control of diseases and improvement of public health programs in Bangladesh. We believe we are at or near the precipice of applying both of our microbial protein production platforms, C1 and Dapibus, to develop antigens, antibodies, enzymes, and other proteins across each of our core verticals that we believe will lead to monetization that will significantly increase shareholder value for Dyadic and our collaborators.

我們的第一項人體1 期研究的持續積極數據以及我們最近宣布的內部血清白蛋白項目的進展加速了建立更多合作和夥伴關係的機會，例如最近宣布的與意大利政府Fondazione Biotecnopolo di 的兩項諒解備忘錄錫耶納履行抗流行病中心的功能，特別注重開發和生產用於治療新出現的流行病和大流行性疾病的疫苗和單克隆抗體，以及孟加拉國基本藥物有限公司EDCL（國家藥物管理局）。孟加拉國衛生和家庭福利部旗下的製藥公司，旨在促進生物製藥研究、臨床前開發、cGMP 生產和臨床開發，以預防和控制疾病並改善孟加拉國的公共衛生計劃。我們相信，我們正處於或接近應用我們的微生物蛋白質生產平台C1 和Dapibus 的邊緣，在我們的每個核心垂直領域開發抗原、抗體、酶和其他蛋白質，我們相信這將帶來顯著的貨幣化.為 Dyadic 和我們的合作者增加股東價值。

What makes the C1 filamentous fungal protein production platform unique versus traditional cell lines currently used to manufacture vaccines and biologic drugs is the ability to produce safe and effective therapies in unparalleled quantities with the speed and cost required for pandemic and global health care needs. We've repeatedly shown that the C1 platform is up to 300 times more productive than baculovirus insect cells, which are being used in both human and animal health to produce vaccines.

與目前用於生產疫苗和生物藥物的傳統細胞系相比，C1 絲狀真菌蛋白生產平台的獨特之處在於，它能夠以無與倫比的數量生產安全有效的療法，同時滿足大流行病和全球醫療保健需求所需的速度和成本。我們一再證明，C1 平台的生產力比桿狀病毒昆蟲細胞高出 300 倍，桿狀病毒昆蟲細胞被用於人類和動物健康領域來生產疫苗。

And C1 also is significantly shorter fermentation times and no viruses that need to be removed in downstream processing versus either the baculovirus or Chinese hamster ovary, CHO, cells, enabling the production and release of recombinant vaccines more rapidly in greater quantities and at lower costs than traditional cell lines currently being used today. These characteristics, coupled with the data from our first-in-human study of a C1-produced antigen has led to the increased awareness and interest in our C1 protein production platform for recombinant protein vaccine development and production in human and animal health.

與桿狀病毒或中國倉鼠卵巢CHO 細胞相比，C1 的發酵時間也顯著縮短，並且不需要在下游處理中去除任何病毒，從而能夠比C1 更快、更大量、更低成本地生產和釋放重組疫苗。目前使用的傳統細胞系。這些特徵，加上我們首次對 C1 產生的抗原進行人體研究的數據，提高了人們對我們用於人類和動物健康領域的重組蛋白疫苗開發和生產的 C1 蛋白生產平台的認識和興趣。

Earlier this quarter, we provided an update on the first-in-human Phase 1 trial for DYA-100, a recombinant protein RBD COVID-19 booster vaccine candidate. The data from this trial is helping to establish a safety record with regulatory agencies for proteins produced from our C1 protein production platform. We're continuing to expand the traction of the C1 platform and receiving through multiple grant applications submitted in collaboration with US and other scientists globally for a wide variety of infectious disease candidates, such as seasonal and pandemic influenza, H5N1 bird flu, Sudan Ebola virus, Marburg virus, RVFV, West Nile virus, Powassan, as well as second-generation COVID-19 vaccine candidates.

本季度早些時候，我們提供了 DYA-100 首次人體 1 期試驗的最新信息，DYA-100 是一種重組蛋白 RBD COVID-19 加強疫苗候選藥物。該試驗的數據有助於監管機構為我們的 C1 蛋白質生產平台生產的蛋白質建立安全記錄。我們正在繼續擴大C1 平台的吸引力，並透過與美國和全球其他科學家合作提交的多項撥款申請來接收各種候選傳染病，例如季節性和大流行性流感、H5N1 禽流感、蘇丹伊波拉病毒、馬堡病毒、RVFV、西尼羅河病毒、Powassan，以及第二代 COVID-19 候選疫苗。

To ensure C1 can produce therapeutic proteins, such as infectious disease monoclonal antibodies with the appropriate quality, we've expressed a number of third-party monoclonal antibodies, or mAbs, which were assayed by multiple independent external parties, from big [smooth] pharma to biotech to academia, who reported the neutralizing and binding activity assays demonstrated great similarity between C1-produced mAbs and CHO-produced mAbs.

為了確保 C1 能夠生產治療性蛋白質，例如具有適當品質的傳染病單株抗體，我們表達了許多來自大型 [smooth] 製藥公司的第三方單株抗體或 mAb，這些抗體經過多個獨立外部方的檢測從生物技術到學術界，他們報告的中和和結合活性測定顯示C1 產生的mAb 和CHO 產生的mAb 之間有很大的相似性。

The next step was evaluating these proteins in animal studies, where we observed that a C1-produced monoclonal antibody for COVID-19 demonstrated comparability to the comparator CHO produced monoclonal antibody, with no signs of antibody mediated enhancement in a non-human primate study.

下一步是在動物研究中評估這些蛋白質，我們觀察到C1 產生的針對COVID-19 的單株抗體與比較CHO 產生的單株抗體具有可比性，在非人靈長類動物研究中沒有抗體介導增強的跡象。

In June 2023, a manuscript was submitted to a peer-reviewed scientific journal titled Filamentous Fungus-Produced Human Monoclonal Antibody Provides SARS-CoV-2 Protection in Hamster and Non-Human Primate Models. This was done in collaboration with Dr. Albert Osterhaus and several other authors. The manuscript describes the safety and efficacy results with a C1 cell-produced monoclonal antibody obtained from studies in hamsters and non-human primates. This data is critical for our potential partners as they select cell lines to produce their commercial targets to ensure that their products have the quality standards and safety profile required for clinical and regulatory development.

2023 年 6 月，一篇題為《絲狀真菌產生的人類單株抗體在倉鼠和非人類靈長類動物模型中提供 SARS-CoV-2 保護》的同行評審科學期刊提交了一份手稿。這是與 Albert Osterhaus 博士和其他幾位作者合作完成的。該手稿描述了從倉鼠和非人靈長類動物研究中獲得的 C1 細胞產生的單株抗體的安全性和有效性結果。這些數據對於我們的潛在合作夥伴至關重要，因為他們選擇細胞系來生產其商業目標，以確保其產品具有臨床和監管開發所需的品質標準和安全性。

Dyadic must stay at the forefront of scientific advancement. We also have been focusing on designing better-performing molecules. We've developed C1 cells to express complex proteins, such as conjugating antigens and ferritin nanoparticles. The interest in ferritin-based vaccines have been increasing due to their safety and ability to enhance immunogenicity. Nanoparticle candidates against a wide range of pathogens are now in clinical trials in diseases such as influenza, Epstein-Barr, and SARS-CoV-2.

Dyadic 必須走在科學進步的最前線。我們也一直致力於設計性能更好的分子。我們開發了 C1 細胞來表達複雜的蛋白質，例如綴合抗原和鐵蛋白奈米粒子。由於鐵蛋白疫苗的安全性和增強免疫原性的能力，人們對它們的興趣不斷增加。針對多種病原體的奈米顆粒候選物目前正在針對流感、Epstein-Barr 和 SARS-CoV-2 等疾病進行臨床試驗。

Manufacturing challenges related to particle heterogeneity, improper folding of fused antigens, and productivity and cost still need to be overcome, and we feel that the C1 platform is uniquely positioned to address some of these challenges. We are also developing other technologies to increase vaccine efficacy and durability to improve targeting methods and new more powerful adjuvants. We developed and are testing several antigens with the AMHC targeting system for influenza and COVID-19, as well as an antigen that included a trimerization domain.

與顆粒異質性、融合抗原折疊不當以及生產率和成本相關的製造挑戰仍然需要克服，我們認為 C1 平台具有獨特的優勢，可以解決其中一些挑戰。我們也正在開發其他技術來提高疫苗的功效和耐久性，以改進標靶方法和新的更強大的佐劑。我們開發並正在測試針對流感和 COVID-19 的 AMHC 標靶系統的多種抗原，以及包含三聚化結構域的抗原。

With our partner, Virovax, we are evaluating new and improved adjuvants with C1-produced ferritin nanoparticle antigens in relevant disease areas, such as COVID-19, pandemic influenza, as well as encephalitis and meningitis in animal trials. These advancements enable Dyadic's partners with the potential to develop more effective and longer-lasting vaccines across a wide range of infectious and other diseases. They have the potential to be manufactured using C1 cells rapidly in larger quantities more affordably.

我們與我們的合作夥伴Virovax 一起，正在動物試驗中評估新的和改進的佐劑與C1 產生的鐵蛋白奈米顆粒抗原在相關疾病領域的作用，例如COVID-19、大流行性流感以及腦炎和腦膜炎。這些進步使 Dyadic 的合作夥伴有可能針對多種傳染病和其他疾病開發更有效、更持久的疫苗。它們有可能使用 C1 電池快速、大批量、更經濟地製造。

We've continued our focus on building and sustaining longer-term strategic partnerships with leading pharmaceutical companies and partners, such as Janssen Pharmaceuticals, which continues to show positive results, as well as advancing commercial products and clinical development of human and animal health vaccines with Rubic One Health for the African continent and the recent production of C1-expressed omicron antigens under cGMP guidelines for potential COVID-19 vaccine with epigen in India.

我們繼續致力於與領先的製藥公司和合作夥伴建立和維持長期戰略合作夥伴關係，例如楊森製藥公司，該公司繼續顯示出積極的成果，並推進人類和動物健康疫苗的商業產品和臨床開發。非洲大陸的Rubic One Health 以及最近在印度根據cGMP 指南生產C1 表達的omicron 抗原，用於印度帶有Epigen 的潛在COVID-19 疫苗。

Furthermore, in today's press release, we announced that we signed a memorandum of understanding with the Fondazione Biotecnopolo di Siena, or FBS. FBS's function is to perform as an anti-pandemic hub with a particular focus on the development and production of vaccines and monoclonal antibodies for the treatment of emerging, epidemic, pandemic pathologies.

此外，在今天的新聞稿中，我們宣布與錫耶納生物技術基金會 (Fondazione Biotecnopolo di Siena, FBS) 簽署了一份諒解備忘錄。 FBS 的功能是作為抗流行病中心，特別注重開發和生產用於治療新出現的流行病和大流行病的疫苗和單株抗體。

Scientific development at FBS is led by one of the world's foremost leading experts in vaccine development, Dr. Rino Rappuoli. Dr. Rappuoli is known globally for his work in vaccines and immunology. Prior to his role at FBS, Dr. Rappuoli was the global head of vaccines research for Novartis vaccines and diagnostics, and most recently served as the Chief Scientist and Head of External R&D at the vaccines division of GlaxoSmithKline, GSK.

FBS 的科學發展由世界上最重要的疫苗開發專家之一 Rino Rappuoli 博士領導。拉普奧利博士因其在疫苗和免疫學方面的工作而享譽全球。在加入 FBS 之前，Rappuoli 博士曾擔任諾華疫苗和診斷部門疫苗研究的全球主管，最近擔任葛蘭素史克 (GlaxoSmithKline) 和葛蘭素史克 (GSK) 疫苗部門的首席科學家和外部研發主管。

FBS is prepared and equipped to conduct research and development, clinical study, regulatory approval, manufacturing, commercialization of vaccines and therapeutic proteins using the company's C1 protein production platform. Discussions are also ongoing with several parties interested in the potential of C1 for additional developed and developing countries.

FBS 已準備好並具備利用該公司的 C1 蛋白生產平台進行疫苗和治療性蛋白的研發、臨床研究、監管審批、製造和商業化的能力。與對 C1 對於其他已開發國家和發展中國家的潛力感興趣的多個方面的討論也在進行中。

Our refined human health objectives include a focus on shorter-term product commercialization opportunities that have less time, cost, and risk associated with development. We're continuing to improve our capability to have an internal pipeline of proteins and enzymes with commercial proteins and potential across our core verticals, whose utilization is not dependent on lengthy clinical development programs or human trials. This is expected to decrease our timeline to revenue, potential, and commercialization opportunities.

我們完善的人類健康目標包括專注於短期產品商業化機會，這些機會與開發相關的時間、成本和風險更少。我們正在繼續提高我們的能力，以擁有具有商業蛋白質的蛋白質和酶的內部管道以及我們核心垂直領域的潛力，其利用不依賴於漫長的臨床開發計劃或人體試驗。預計這將縮短我們實現收入、潛力和商業化機會的時間表。

Earlier this week, we provided an update on one of these internal projects, namely the recombinant serum albumin. The global serum albumin market is an approximate $5.7 billion market growing at over 6% a year due to the increased use across a multitude of markets in human and animal health. In the pharmaceutical segment, serum albumin is not only being developed as a potential treatment for disease, but it's currently used in product development of vaccines as a diagnostic tool and a common reagent in R&D.

本週早些時候，我們提供了其中一個內部項目的最新信息，即重組血清白蛋白。全球血清白蛋白市場規模約為 57 億美元，由於人類和動物健康領域多個市場的使用量不斷增加，其年增長率超過 6%。在製藥領域，血清白蛋白不僅被開發為潛在的疾病治療方法，而且目前還作為診斷工具和研發中的常用試劑用於疫苗產品開發。

There are many different grades of albumin and price points across these and other markets. Dyadic has the potential to produce animal-free serum albumin at competitive pricing due to our highly productive C1 and Dapibus microbial platforms using low-cost media.

這些市場和其他市場有許多不同等級的白蛋白和價格點。由於我們使用低成本培養基的高產量 C1 和 Dapibus 微生物平台，Dyadic 有潛力以具有競爭力的價格生產無動物血清白蛋白。

In addition to the clinical data being generated, we are protecting our technology with a robust IP estate. Earlier this year, Dyadic received a notice of allowance from the US Patent and Trademark Office for a patent application whose claims cover the development and manufacture of seasonal and pandemic vaccines from the company's C1 protein production platform. This timely patent allowance comes as we announced earlier this year that Dyadic is at the forefront of vaccine development with more than a half-dozen animal trials being carried out last year and additional animal trials which are ongoing or scheduled with C1-produced antigens for influenza, for example, H5N1 bird flu, and other infectious diseases.

除了產生的臨床數據外，我們還透過強大的智慧財產權保護我們的技術。今年早些時候，Dyadic 收到了美國專利商標局批准一項專利申請的通知，該專利申請的權利要求涵蓋利用該公司的 C1 蛋白生產平台開發和生產季節性和大流行性疫苗。這項及時的專利授權是在我們今年早些時候宣布Dyadic 處於疫苗開發的最前沿之際獲得的，去年進行了六項以上的動物試驗，還有正在進行或計劃使用C1 產生的流感抗原進行的動物試驗比如說H5N1禽流感，以及其他傳染病。

There is a global unmet need for more effective and more available flu vaccines. It has been reported that the human seasonal influenza vaccine market alone is currently valued at approximately USD8 billion and expected to grow to over USD12 billion by 2028 with multivalent vaccines leading the market.

全球對更有效、更容易取得的流感疫苗的需求尚未得到滿足。據報道，目前僅人類季節性流感疫苗市場價值就約為80億美元，預計到2028年將成長至120億美元以上，其中多聯疫苗將佔據市場主導地位。

There are many similarities in the needs between the human and animal health market for vaccines and therapeutic proteins, and we are leveraging our science across these core verticals. What makes animal health an attractive segment for Dyadic is the margin sensitivity of this market and the significant impact the outbreak can have on the global supply chain and potentially human health.

人類和動物健康市場對疫苗和治療性蛋白質的需求有許多相似之處，我們正在這些核心垂直領域中利用我們的科學。動物健康對 Dyadic 來說是一個有吸引力的領域，因為該市場的利潤敏感性以及疫情可能對全球供應鏈和潛在的人類健康產生的重大影響。

The recognition, data, and scientific advancements we are generating have not only accelerated our efforts in human health, they are translating into increased interest in our other core verticals such as animal health as demonstrated in today's announcement that we have expanded our collaboration with Phibro/Abic and have started another collaboration with a new animal health partner on a fully funded project targeting a livestock antigen to be produced in a C1 platform. This is why we believe the C1 production platform can be a global solution to emerging infectious disease threats and pandemic response, and not just humans, but also in animal health.

我們所獲得的認可、數據和科學進步不僅加速了我們在人類健康方面的努力，而且還轉化為對我們其他核心垂直領域（例如動物健康）的興趣的增加，正如今天宣布的我們擴大了與Phibro / 的合作所證明的那樣。Abic 已開始與新的動物健康合作夥伴就一個全額資助的項目開展另一項合作，該項目的目標是在 C1 平台上生產牲畜抗原。這就是為什麼我們相信 C1 生產平台可以成為應對新出現的傳染病威脅和疫情應對的全球解決方案，不僅適用於人類，也適用於動物健康。

As we mentioned late last year, we announced that we had achieved a record antigen production level of 10 grams per liter of a livestock antigen, demonstrating that our platforms can produce very large quantities of antigens for infectious disease. In addition to the production of large quantities of antigens, antibodies, and therapeutic proteins, these products can also be made rapidly and at low cost, making C1 a potential pandemic preparedness platform for response or stockpiling.

正如我們在去年年底提到的，我們宣布我們已經達到了創紀錄的每公升牲畜抗原 10 克的抗原生產水平，這表明我們的平台可以生產大量的傳染病抗原。除了生產大量抗原、抗體和治療性蛋白質外，這些產品還可以快速、低成本生產，使 C1 成為潛在的疫情應對或儲存平台。

Our third vertical of alternative proteins is yet another area of great excitement. For Dyadic, and one which we believe also holds near-term potential promise in terms of opportunity and revenue, exploiting this segment does not require a significant departure from our human and animal health pursuits in terms of technical capability or resource requirements. Dyadic is continuing to dedicate resources and support for the existing and future projects within this rapidly growing market.

我們的替代蛋白質的第三個垂直領域是另一個令人興奮的領域。對於 Dyadic 來說，我們相信它在機會和收入方面也具有近期潛在前景，利用這個細分市場並不需要在技術能力或資源需求方面顯著偏離我們的人類和動物健康追求。 Dyadic 將繼續為這個快速成長的市場中的現有和未來項目提供資源和支援。

Dyadic has launched its Dapibus platform, a filamentous fungal-based microbial gene expression and protein production platform. Dapibus is further designed and customized to enable the rapid development and large-scale manufacture of low-cost enzymes, protein metabolites, and other biologic products for use in non-pharmaceutical applications, such as food, nutrition, health, and wellness.

Dyadic 推出了 Dapibus 平台，這是一個基於絲狀真菌的微生物基因表現和蛋白質生產平台。 Dapibus 經過進一步設計和定制，能夠快速開發和大規模生產低成本酵素、蛋白質代謝物和其他生物產品，用於非製藥應用，如食品、營養、健康和保健。

One area of focus within this segment is the dairy protein and enzyme market. We announced today initial positive analytical results for the successful expression of casein proteins using Dapibus, our non-pharmaceutical protein production platform. Growing global demand for protein-enriched foods is expected to drive casein market growth while the use of casein for industrial applications such as plastics, chemicals, and synthetic fibers is driving market expansion. This further demonstrates our commitment to developing commercial opportunities that transect more than one core vertical.

該細分市場的重點領域之一是乳製品蛋白質和酵素市場。我們今天宣布了使用我們的非藥物蛋白質生產平台 Dapibus 成功表達酪蛋白的初步積極分析結果。全球對富含蛋白質的食品不斷增長的需求預計將推動酪蛋白市場的成長，而酪蛋白在塑膠、化學物質和合成纖維等工業應用中的使用正在推動市場擴張。這進一步表明我們致力於開發跨越多個核心垂直領域的商業機會。

I will now turn the call over to our Chief Business Officer, Joe Hazleton, to provide a more detailed update on our Phase 1 trial progress and discuss our business development efforts across our core verticals. Joe?

我現在將把電話轉給我們的首席商務官 Joe Hazleton，以提供有關我們第一階段試驗進展的更詳細的最新信息，並討論我們在核心垂直領域的業務開發工作。喬？

Thank you, Mark. I'm happy to report that the Phase 1 trial for DYAI-100 is progressing as planned. For background, to establish a track record of safety in humans for antigens produced from our C1 protein production platform, the ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled trial to evaluate the safety and immune response of the DYAI-100 COVID-19 recombinant protein booster vaccine in 30 healthy adults in South Africa at two different dose levels.

謝謝你，馬克。我很高興地報告，DYAI-100 的第一階段試驗正在按計劃進行。作為背景，為了建立我們的 C1 蛋白生產平台生產的抗原在人體中的安全性追蹤記錄，正在進行的 1 期試驗是一項隨機、雙盲、安慰劑對照試驗，旨在評估 DYAI-南非30 名健康成年人接種了100 種新冠肺炎(COVID-19) 重組蛋白加強疫苗，接種劑量為兩種不同劑量等級。

There are eight scheduled patient visits throughout the 180-day trial period, with safety data being collected throughout the trial and immunogenicity assessments scheduled on six of the eight visits. Dosing of all patients was completed in late February, and we currently project the last patient last visit to take place near the end of August, with the clinical study report being available in the late third or early fourth quarter. Patients in both the high- and low-dose cohorts have reached day 90, with all patients in the low-dose group reaching day 180 from initial dosing.

在 180 天的試驗期間，計劃進行 8 次患者就診，在整個試驗過程中收集安全數據，並在 8 次就診中的 6 次安排免疫原性評估。所有患者的給藥均已於 2 月下旬完成，我們目前預計最後一位患者的最後一次訪視將在 8 月底左右進行，臨床研究報告將在第三季末或第四季初提供。高劑量組和低劑量組的患者均已達到第 90 天，低劑量組的所有患者從初始給藥起均已達到第 180 天。

Earlier this quarter, the Data Safety Monitoring Board evaluated the 29-day data for all patients and found no major vaccine-related safety events at either dose level, and to date, there have been no serious and local or systemic adverse events reported. While the primary endpoint is safety, an immune response was produced at both the low- and high-dose levels. Given the evolving regulatory and market outlook for COVID, we're currently working through with the Rubic One Health, our South African partner, to evaluate the next development phase of the DYAI-100 COVID-19 booster vaccine candidate, pending the final results of the study and the market conditions.

本季度早些時候，數據安全監測委員會評估了所有患者的 29 天數據，發現任一劑量水平均未發生與疫苗相關的重大安全事件，迄今為止，尚未報告嚴重的局部或全身不良事件。雖然主要終點是安全性，但低劑量和高劑量水平都會產生免疫反應。鑑於新冠肺炎不斷變化的監管和市場前景，我們目前正在與我們的南非合作夥伴 Rubic One Health 合作，評估 DYAI-100 COVID-19 候選加強疫苗的下一開發階段，等待最終結果。研究和市場狀況。

With the expected results later this year, we continue to validate the C1 platform to reduce clinical development risk for our partners, and adding to our strong repository of safety, efficacy, and productivity data regarding the C1 protein production system across a wide range of vaccines and antibodies. For the human and animal health markets, the overall result is that the recombinant vaccine development and production of the C1 platform is ready for full commercialization. Increased recognition that the C1 platform is generating, coupled with the continued advancement of our scientific data, is leading to business opportunities across our core verticals.

根據今年稍後的預期結果，我們將繼續驗證C1 平台，以降低合作夥伴的臨床開發風險，並添加到我們強大的有關各種疫苗的C1 蛋白生產系統的安全性、有效性和生產力數據的儲存庫中和抗體。對於人類和動物健康市場，總體結果是C1平台的重組疫苗開發和生產已準備好全面商業化。 C1 平台所產生的認可度不斷提高，加上我們科學數據的不斷進步，正在為我們的核心垂直領域帶來商機。

In addition to the new vaccine project with a top-five pharmaceutical company and a large infectious disease market, we have expanded our licensing agreement with Rubic One Health going beyond COVID vaccines and encompassing not just human health and therapeutic proteins, but also animal health pharmaceutical products. This provides Rubic the potential for a broader number of commercializable opportunities in multiple product segments. We've also renewed and expanded our research collaboration with Uvax, and this collaboration is expected to help Uvax overcome gene expression challenges using the C1 protein production platform for human health.

除了與排名前五的製藥公司和龐大的傳染病市場的新疫苗項目外，我們還擴大了與Rubic One Health 的許可協議，超出了新冠疫苗的範圍，不僅涵蓋人類健康和治療性蛋白質，還涵蓋動物保健藥品產品。這為 Rubic 在多個產品領域提供了更多商業機會的潛力。我們也更新並擴大了與 Uvax 的研究合作，此次合作預計將有助於 Uvax 利用 C1 蛋白生產平台克服基因表現挑戰，促進人類健康。

Beyond the acceleration of human health vaccine collaborations, we're seeing increased interest and traction in animal health as well. In addition to extending our research collaboration with Phibro/Abic to apply newly developed techniques and methods to further increase the expression level of recombinant livestock antigen using C1, the collaboration with Phibro/Abic has also expanded to include the development of additional antigens for use in livestock animal health applications. And in June, we entered another fully funded collaboration with a new animal health company to develop a different antigen for livestock animals.

除了人類健康疫苗合作的加速之外，我們還看到人們對動物健康的興趣和吸引力不斷增加。除了擴大我們與 Phibro/Abic 的研究合作以應用新開發的技術和方法來進一步提高使用 C1 的重組家畜抗原的表達水平外，與 Phibro/Abic 的合作還擴大到包括開髮用於家畜動物健康應用。六月，我們與一家新的動物保健公司進行了另一項全額資助的合作，為家畜開發一種不同的抗原。

We continue to make great strides in antibodies as well, and we believe that the C1 platform is ready for use in human trials for monoclonal antibodies, bi- and tri-specific antibodies, Fc-Fusion, and other types of therapeutic proteins. The advancement of our antibody development has led to new opportunities and collaborations in human health.

我們在抗體方面也持續取得長足進步，我們相信 C1 平台已準備好用於單株抗體、雙特異性和三特異性抗體、Fc-Fusion 和其他類型治療蛋白的人體試驗。我們抗體開發的進步為人類健康帶來了新的機會和合作。

The MOU we have signed with Italy's Fondazione Biotecnopolo di Siena to conduct research and development through commercialization activities of vaccines and therapeutic proteins using the C1 platform provides Dyadic with a strong partnership to advance development of antibodies for infectious disease through human clinical trials. Additionally, our MOU with Bangladesh's Essential Drugs Company Limited has the potential to expand the utilization of the C1 platform to facilitate research and development through clinical trials for the prevention and control of diseases and improvement of public health programs in Bangladesh and other countries.

我們與義大利錫耶納生物技術基金會簽署了諒解備忘錄，利用C1 平台透過疫苗和治療性蛋白質的商業化活動進行研究和開發，這為Dyadic 提供了強有力的合作夥伴關係，透過人體臨床試驗推進傳染病抗體的開發。此外，我們與孟加拉基本藥物有限公司簽署的諒解備忘錄有可能擴大C1平台的利用，透過臨床試驗促進研究和開發，以預防和控制疾病並改善孟加拉和其他國家的公共衛生計劃。

We are also in late-stage discussions with key pharmaceutical partners to develop monoclonal antibodies for a number of infectious and pandemic preparation. While this is encouraging news, development and approval of pharmaceutical products takes years to complete, which also means that we must continue to focus our efforts on commercialization targets that drive revenue in the near term as well.

我們也與主要製藥合作夥伴進行後期討論，以開發用於多種感染性和大流行病準備的單株抗體。雖然這是令人鼓舞的消息，但藥品的開發和批准需要數年時間才能完成，這也意味著我們必須繼續將精力集中在商業化目標上，以在短期內推動收入。

Earlier this year, we revised our research and development approach, focusing mainly on those projects that have potential commercial outcomes. Examples of this revised approach is the previously mentioned research collaboration with a top five pharmaceutical company to express and produce a vaccine antigen from C1 for human health, the collaboration with a new animal health company to develop a livestock antigen, and new collaborations to develop monoclonal antibodies for pandemic threats. These agreements differ from our traditional research projects in that they grant an option for a future commercialization license for use in their respective markets.

今年早些時候，我們修改了研發方法，主要專注於那些具有潛在商業成果的專案。這種修訂方法的例子包括前面提到的與一家排名前五的製藥公司的研究合作，以表達和生產用於人類健康的C1 疫苗抗原，與一家新的動物保健公司合作開發牲畜抗原，以及開發單株抗體的新合作針對大流行威脅的抗體。這些協議與我們傳統的研究項目不同，因為它們授予未來在各自市場使用的商業化許可的選擇權。

We're leveraging our science across our [curve] verticals as the need for cost-effective ways to produce large quantities of recombinant proteins and enzymes exist, not just in human and animal health, but also in the margin-sensitive segment of alternative proteins. To support our business development efforts across these core verticals, Dyadic is building a portfolio of proteins and enzymes with commercial potential applicable across these verticals, whose utilization are not solely dependent on lengthy clinical development programs or human trials.

我們正在跨[曲線]垂直領域利用我們的科學，因為不僅在人類和動物健康領域，而且在替代蛋白的邊緣敏感領域，都需要經濟有效的方法來生產大量重組蛋白和酶。 。為了支持我們在這些核心垂直領域的業務開發工作，Dyadic 正在建立一個具有商業潛力的蛋白質和酵素組合，適用於這些垂直領域，其利用不僅僅依賴漫長的臨床開發項目或人體試驗。

Last quarter, we shared that Dyadic had expressed human serum albumin and bovine serum albumin stably and at high levels. These types of products are analytically tested against reference samples to ensure they meet the quality control requirements for potential purchases. This is a much shorter and less costly development process than a human vaccine or therapeutic protein.

上個季度，我們分享了 Dyadic 已穩定且高水平地表達人類血清白蛋白和牛血清白蛋白。這些類型的產品根據參考樣品進行分析測試，以確保它們符合潛在購買的品質控制要求。與人類疫苗或治療性蛋白質相比，這是一個更短、成本更低的開發過程。

Now, we are one step closer to commercialization, and initial independent analytical testing of the company's recombinant bovine albumin demonstrated it is structurally equivalent to commercially available animal-derived bovine albumin and recombinant bovine albumin reference products. This puts us a step closer to commercialization and enables business development discussions with several interested companies as we are currently supplying samples to the market.

現在，我們離商業化又更近了一步，對該公司重組牛白蛋白的初步獨立分析測試表明，其在結構上與市售動物源牛白蛋白和重組牛白蛋白參考產品相同。這使我們離商業化又更近了一步，並能夠與幾家有興趣的公司進行業務開發討論，因為我們目前正在向市場提供樣品。

These and other high-value and high-cost targets for non-pharmaceutical applications, such as the recombinant casein proteins Mark mentioned earlier, will require further development to reduce manufacturing costs to satisfy the margin requirements for the alternative protein and food industries, which is where our Dapibus platform is rapidly generating increasing market attention.

這些以及其他非製藥應用的高價值和高成本目標，例如馬克前面提到的重組酪蛋白，將需要進一步開發以降低製造成本，以滿足替代蛋白質和食品行業的利潤要求。我們的Dapibus 平台正在迅速引起越來越多的市場關注。

Casein, for example, acts as an excellent emulsifier, stabilizer, and thickening agent, making it very valuable for various food products. In the dairy sector, casein is crucial for cheese production and enhances the texture of dairy products, such as yogurt and ice cream. In the pharmaceutical sector, casein is used as a stabilizer and excipient in drug formulations, ensuring controlled release and improved bioavailability of medications, and serves as another example of our focus on targets that cut across our core verticals.

例如，酪蛋白可作為出色的乳化劑、穩定劑和增稠劑，使其對各種食品非常有價值。在乳製品行業，酪蛋白對於乳酪生產至關重要，可增強優格和冰淇淋等乳製品的質地。在製藥領域，酪蛋白在藥物配方中用作穩定劑和賦形劑，確保藥物的控釋和提高生物利用度，這是我們專注於跨越核心垂直領域的目標的另一個例子。

To maximize Dyadic's potential to commercialize these high-value targets, we entered a fully funded co-development marketing and commercialization agreement with Fermbox Bio to accelerate our ability to exploit the Dapibus platform and expand Dyadic's non-pharmaceutical product offerings for animal-free recombinant protein applications, such as food, nutrition, wellness, and other bioproducts. This partnership will help further improve the Dapibus platform and will also provide Dyadic with an experienced biomanufacturing partner, which can be leveraged for future products.

為了最大限度地發揮Dyadic 將這些高價值目標商業化的潛力，我們與Fermbox Bio 簽訂了全額資助的共同開發行銷和商業化協議，以加快我們利用Dapibus 平台的能力，並擴展Dyadic 的非動物重組蛋白質非藥物產品系列應用，例如食品、營養、健康和其他生物產品。此次合作將有助於進一步完善 Dapibus 平台，並為 Dyadic 提供一個經驗豐富的生物製造合作夥伴，可用於未來的產品。

We believe this can be an accelerator for Dyadic as both our C1 and Dapibus microbial cell lines have the potential to provide our partners the ability to meet timelines, scale, and cost demands for recombinant proteins and enzymes within their respective pharmaceutical or non-pharmaceutical market applications. While the future is bright, we still have work ahead to maximize and monetize the various opportunities that lay before us, and Mark and I are working on revising our strategic plan to ensure we have the right infrastructure and resources to adequately address key business opportunities across our core verticals.

我們相信這可以成為 Dyadic 的加速器，因為我們的 C1 和 Dapibus 微生物細胞係都有潛力為我們的合作夥伴提供滿足各自製藥或非製藥市場中重組蛋白和酶的時間表、規模和成本需求的能力應用程式.雖然未來是光明的，但我們仍然需要努力最大限度地利用擺在我們面前的各種機會並從中獲利，馬克和我正在努力修改我們的戰略計劃，以確保我們擁有正確的基礎設施和資源，以充分應對各領域的關鍵商機。我們的核心垂直領域。

I will now turn the call back to Mark for some final comments on the second quarter. Mark?

現在我將把電話轉回給馬克，徵求對第二季度的一些最終評論。標記？

Thank you, Joe. We will continue to leverage our decades of commercial-scale industrial manufacturing knowledge and experience to accelerate the development process across all our core verticals. In parallel, we remain fiscally responsible with our research and development spending and being strategically focused with our partnerships and collaborations to help fund advancements of our science in critical areas.

謝謝你，喬。我們將繼續利用我們數十年的商業規模工業製造知識和經驗，加速我們所有核心垂直領域的開發過程。同時，我們仍然對我們的研發支出承擔財政責任，並在策略上專注於我們的夥伴關係和合作，以幫助資助我們在關鍵領域的科學進步。

We believe that our C1 platform is well positioned to be an alternative platform in developing next-generation vaccines, antibodies, and other therapeutic proteins for public health and future pandemics, and we are happy to see C1 is gaining more recognition globally within academia, government, and industry. We have refined our business development objectives to focus on core areas where our technologies can have the greatest impact, and we are evaluating new opportunities aligned with our verticals and targeted markets of high potential return, such as alternative proteins.

我們相信，我們的 C1 平台完全有能力成為為公共衛生和未來流行病開發下一代疫苗、抗體和其他治療蛋白的替代平台，我們很高興看到 C1 在全球學術界、政府中獲得更多認可和工業。我們已經完善了業務發展目標，重點關注我們的技術可以產生最大影響的核心領域，並且我們正在評估與我們的垂直行業和高潛在回報目標市場（例如替代蛋白質）相一致的新機會。

With that, I would like to turn the call over to our CFO, Ping Rawson, to run through our financials.

說到這裡，我想將電話轉給我們的財務長 Ping Rawson，以了解我們的財務狀況。

Thank you, Mark. Thank you, everyone, for joining our call today. I will now go over our key financial results for the quarter ended June 30, 2023. You can find additional information in our earnings press release and form 10-Q, which we filed earlier today.

謝謝你，馬克。謝謝大家今天加入我們的電話會議。我現在將回顧我們截至 2023 年 6 月 30 日的季度的主要財務業績。您可以在我們今天早些時候提交的收益新聞稿和 10-Q 表格中找到更多資訊。

Research and development revenue and the license revenue for the second quarter of 2023 increased to approximately $837,000, compared to $659,000 for the same period a year ago. The increase is primarily due to higher individual contract amounts on certain research funding compared to the same period a year ago.

2023 年第二季的研發收入和授權收入增至約 837,000 美元，而去年同期為 659,000 美元。這一增長主要是由於某些研究經費的個人合約金額與去年同期相比有所增加。

Cost of research and development revenue for the second quarter of 2023 increased to approximately $793,000, compared to $411,000 for the same period a year ago.

2023 年第二季的研發收入成本增加至約 793,000 美元，去年同期為 411,000 美元。

R&D expenses for the second quarter decreased by 49.9% to approximately $918,000 compared to $1,831,000 for the same period a year ago. The decrease in R&D expenses for the quarter ended June 30, 2023 versus the same period in 2022 was due to the winding down of activities of contract research organization and consultants to manage and support the preclinical and clinical development, as well as a decrease in CDMP manufacturing costs as the company completed the dosing of Phase 1 clinical trial of the DYAI-100 vaccine candidates in February 2023.

第二季研發費用下降 49.9%，至約 918,000 美元，去年同期為 1,831,000 美元。截至 2023 年 6 月 30 日的季度研發費用較 2022 年同期減少，是由於管理和支持臨床前和臨床開發的合約研究組織和顧問活動的減少，以及 CDMP 的減少該公司於2023 年2 月完成了DYAI-100 候選疫苗的一期臨床試驗劑量，從而降低了製造成本。

G&A expenses for the second quarter decreased by 18.1% to approximately $1,403,000 compared to $1,714,000 for the same period a year ago. The decrease in G&A expenses for the second quarter of 2023 compared to the same period in 2022 includes decreases in legal expenses of $103,000, management incentives of approximately $81,000, business development and investor relations expenses of $75,000, insurance expenses of $37,000, and other decreases of $15,000.

第二季一般管理費用下降 18.1%，至約 1,403,000 美元，去年同期為 1,714,000 美元。與2022 年同期相比，2023 年第二季的一般管理費用減少，包括法律費用減少103,000 美元、管理激勵費用減少約81,000 美元、業務開發和投資者關係費用減少75,000 美元、保險費用減少37,000 美元，以及其他減少額15,000 美元。

Other income for the quarter and six months ended June 30, 2023, was primarily from the sale of our equity interest in Alphazyme, LLC.

截至 2023 年 6 月 30 日的季度和六個月的其他收入主要來自出售我們在 Alphazyme, LLC 的股權。

Net loss for the second quarter of 2023 was approximately $2,153,000, or $0.07 per share, compared to $3,288,000, or $0.12 per share, for the same period a year ago. Net loss for the six months ended June 30, 2023, was approximately $3,109,000, or $0.11 per share, compared to $5,780,000, or $0.20 per share, for the same period a year ago.

2023 年第二季的淨虧損約為 2,153,000 美元，即每股 0.07 美元，而去年同期為 3,288,000 美元，即每股 0.12 美元。截至 2023 年 6 月 30 日的六個月淨虧損約為 3,109,000 美元，即每股 0.11 美元，而去年同期為 5,780,000 美元，即每股 0.20 美元。

As of June 30, 2023, our cash, cash equivalents, and the carrying value of investment-grade securities, including accrued interest, were approximately USD10.2 million compared to USD12.7 million as of December 31, 2022.

截至 2023 年 6 月 30 日，我們的現金、現金等價物及投資等級證券的帳面價值（包括應計利息）約為 1,020 萬美元，而截至 2022 年 12 月 31 日為 1,270 萬美元。

As the company's existing S-3 shelf registration will be expired on August 25, 2023, we filed a new registration statement on Form S3, which contains a base shelf prospectus with the SEC. Meanwhile, we have notified Jeffries to terminate the open market sale agreement with respect to the ATN program, effective August 25, 2023. There have been no sales made under the ATN program with Jeffries. The filing of the shelf registration statement is intended to provide us with the greater financial flexibility to access the capital markets in the future, should it become in the best interest of our shareholders.

由於公司現有的 S-3 擱置註冊將於 2023 年 8 月 25 日到期，因此我們在 S3 表格上提交了新的註冊聲明，其中包含向 SEC 提交的基礎擱置招股說明書。同時，我們已通知 Jeffries 終止與 ATN 計劃相關的公開市場銷售協議，該協議於 2023 年 8 月 25 日生效。尚未與 Jeffries 根據 ATN 計劃進行任何銷售。提交擱置註冊聲明旨在為我們提供更大的財務靈活性，以在未來進入資本市場，如果這符合我們股東的最佳利益的話。

We reiterate our projection for annual cash burn of 2023 will be in the range of USD6 million to USD7 million. Based on our current plan, we expect that our existing cash balance will be sufficient to fund our operations into mid- to late 2024.

我們重申，我們預計 2023 年年度現金消耗將在 600 萬美元至 700 萬美元之間。根據我們目前的計劃，我們預計現有現金餘額將足以為我們的營運提供資金直至 2024 年中後期。

With that, I will now ask the operator to begin our Q&A session. Joe Hazleton will join Mark and I to answer your questions. Each caller will be allowed one question and one follow-up question to provide all callers an opportunity to participate. If time permits, the operator will allow additional questions from those who have already spoken. Operator?

現在，我將要求接線員開始我們的問答環節。喬·黑澤爾頓將與馬克和我一起回答您的問題。每個來電者將被允許提出一個問題和一個後續問題，以便為所有來電者提供參與的機會。如果時間允許，接線員將允許已經發言的人提出其他問題。操作員？

(Operator Instructions) John Vandermosten, Zacks.

（操作員說明）John Vandermosten，Zacks。

Thank you. Good evening, Mark, Kim, and Joe. Let me start off with a question about the share in [Malvern]. That sounds exciting to me as it sounds like it is closer than most of the other assets that you have or arrangements that you have to generating revenues. What remains to be done before that could be product that could be sold and what is the revenue potential there? I know you outlined it is about $5 billion in market size. How would that kind of flow through Dyadic assuming we are able to sell that?

謝謝。晚上好，馬克、金和喬。讓我先問一個關於[馬爾文]股份的問題。這對我來說聽起來很令人興奮，因為聽起來它比您擁有的大多數其他資產或您必須做出的安排更能產生收入。在產品可以出售之前還需要做什麼？那裡的收入潛力有多大？我知道您概述了該市場規模約為 50 億美元。假設我們能夠出售它，那麼這種情況將如何透過 Dyadic 流動？

Joe, do you want to take that?

喬，你想接受這個嗎？

Sure. John, that is a great question. There are a couple of steps left for us to fully commercialize. Obviously, from a licensing standpoint, we are entertaining those options today. For a product that we would potentially look to market ourselves, there is still application testing and making sure we have basically full stability and cGMP requirements that we would need to basically make sure we have a certificate of analysis that performs exactly like what is currently available today. There is still some development work that does need to be done for us to do it ourselves. From a licensing standpoint, we are actually in those discussions today.

當然。約翰，這是一個很好的問題。我們還需要採取幾個步驟才能完全商業化。顯然，從許可的角度來看，我們今天正在考慮這些選項。對於我們可能希望自己推向市場的產品，仍然需要進行應用測試，並確保我們基本上具有完全的穩定性和 cGMP 要求，我們需要基本上確保我們擁有與當前可用產品完全相同的分析證書今天。還有一些開發工作需要我們自己完成。從許可的角度來看，我們今天實際上正在討論這些問題。

Great. I guess just the second part of that question was related to the revenue potential. I think the Albany market is pretty diverse. There are a lot of different uses for it, as you guys have mentioned on the call. What seems to be the most likely end markets for the product that you might produce?

偉大的。我想這個問題的第二部分與收入潛力有關。我認為奧爾巴尼市場相當多元化。正如你們在電話中提到的那樣，它有很多不同的用途。您生產的產品最有可能的最終市場是什麼？

R&D, as well as diagnostics, would be the quickest and easiest market to penetrate. Obviously, there is use in alternative proteins. There is use in other markets. For excipients, drug formulation, drug development, diagnostics, those are the areas because they can be made in a wide range of grades from research grade all the way through cGMP. It really is a wide range of markets that we can get into. It is just a question of what our potential customers want or what we would potentially want to do ourselves.

研發以及診斷將是最快、最容易滲透的市場。顯然，替代蛋白質也有用途。在其他市場也有使用。對於賦形劑、藥物配方、藥物開發、診斷來說，這些都是這些領域，因為它們可以製成從研究級一直到 cGMP 的各種等級。我們可以進入的市場確實很廣泛。這只是我們的潛在客戶想要什麼或我們自己可能想要做什麼的問題。

Great. Regarding the Bangladesh collaboration, there is a serious outbreak of dengue fever. I believe there is, along with that, a serious need for treatment. I don't think there is necessarily a vaccine for that. Is that something that they can produce and you could help them? I am just wondering, since the need is so tremendous, it seems to me that they might be able to get something approved if they had something. I know that the resources there are not what they are in other countries. What might be done there in terms of taking advantage of potentially a more accelerated approval because the need for something is so dire?

偉大的。關於孟加拉的合作，登革熱疫情嚴重。我相信除此之外，還迫切需要治療。我認為不一定有疫苗。這是他們可以生產並且你可以幫助他們的東西嗎？我只是想知道，由於需求如此巨大，在我看來，如果他們有東西的話，他們也許能夠獲得批准。我知道那裡的資源不如其他國家。由於對某些東西的需求如此迫切，因此可以採取哪些措施來利用可能加速批准的機會？

Let me take that call. I have actually been in contact with Bangladesh on that very issue. I have also been in contact with one of the major pharmaceutical companies that produces a dengue vaccine that they have registered but have not registered in the US. So there is an opportunity to develop a dengue vaccine using C1. Dengue, as you may know, is a very difficult vaccine not to produce necessarily but to design.

讓我接那通電話。事實上，我已經就這個問題與孟加拉進行了接觸。我還接觸過一家生產登革熱疫苗的主要製藥公司，他們已經註冊但尚未在美國註冊。因此有機會利用C1開發登革熱疫苗。如您所知，登革熱是一種非常困難的疫苗，不僅難以生產，而且難以設計。

We have been in discussions for at least a year with certain companies, whether they be in India, not just Bangladesh, in the tropic regions where this is a growing problem. Unfortunately, this problem is probably going to be heading into the US as the heat and the temperatures rise. This year, as you can see, temperatures rise dramatically in the United States. There are different diseases that are popping up here that have not been here before.

我們已經與某些公司進行了至少一年的討論，無論他們是在印度，而不僅僅是孟加拉國，還是在熱帶地區，那裡的問題日益嚴重。不幸的是，隨著炎熱和氣溫的升高，這個問題可能會蔓延到美國。正如您所看到的，今年美國的氣溫急劇上升。這裡突然出現了以前從未出現過的不同疾病。

What we have learned from the pandemic is that if we do not control it, it is coming home to roost. We have been working with different developers. One of the benefits we have as a platform company in having worldwide access, whether it be Europe, India, Bangladesh, China, Korea, you name it, Brazil, we are talking to people that have these issues and we are talking to scientists that have ideas. As we have talked about earlier, some of those ideas are being turned into research-funded projects here in the US.

我們從這場大流行病中學到的是，如果我們不控制它，它就會自食其果。我們一直在與不同的開發商合作。作為一家平台公司，我們的優勢之一是可以在全球範圍內進行訪問，無論是歐洲、印度、孟加拉國、中國、韓國，還是巴西，我們正在與有這些問題的人交談，我們正在與科學家交談，有想法。正如我們之前談到的，其中一些想法正在美國轉化為研究資助計畫。

For example, bird flu, which as you may remember is somewhere between 20% and 30% deadly. If that hops into the US or into human beings, we are already getting prepared for that. We have two different bird flu H5N1 ferritin nanoparticle vaccines in development with Virovax that are now in animal studies. In the next 60 to 90 days, we should get our first readout to find out how well those are doing. We think with the ferritin nanoparticle, it will induce higher immunogenic protection, much higher neutralizing antibodies, cellular response, and of course can be made at a very large amount at a very low cost.

例如，您可能還記得，禽流感的致死率在 20% 到 30% 之間。如果病毒進入美國或人類，我們已經準備好了。我們與 Virovax 合作開發了兩種不同的禽流感 H5N1 鐵蛋白奈米顆粒疫苗，目前正在進行動物研究。在接下來的 60 到 90 天內，我們應該得到第一個讀數，以了解它們的表現如何。我們認為，使用鐵蛋白奈米顆粒，它將誘導更高的免疫原性保護、更高的中和抗體、細胞反應，當然可以以非常低的成本大量生產。

Dengue is something that has four different antigens that go into that vaccine and they shift. There are different people with different strategies and we are having those discussions with some of the world's experts in that space, including conversations with the Bangladeshi government.

登革熱疫苗含有四種不同的抗原，這些抗原會改變。不同的人有不同的策略，我們正在與該領域的一些世界專家進行討論，包括與孟加拉國政府的對話。

(Operator Instructions) Dick Williams, Williams Research Group.

（操作員說明）Dick Williams，威廉斯研究小組。

Hi, Mark. Hi, Joe. I just have a color type of question for you, Mark. In terms of the BARDA situation and funding of grants that they're in process of doing through the summer months for smaller grants, I don't know what they consider to be smaller grants, but then very large grants starting, I guess it's September 25-ish. We, I presume, have started or have submitted small grants for whatever you thought were appropriate to develop. So the question is, have we done anything in that area and what would we expect a time frame to know what the government is going to do and who they're going to give these grants to? And then secondarily, do we expect to participate in the larger grants that they'll be giving out after September 25, if you can give color on that?

嗨，馬克。嗨，喬。我只是想問你一個顏色類型的問題，馬克。就 BARDA 的情況和他們在夏季為小額贈款進行的贈款提供資金而言，我不知道他們認為什麼是較小的贈款，但隨後開始了非常大的贈款，我想是 9 月份25歲左右。我認為，我們已經開始或已經提交了小額贈款，用於您認為適合開發的任何專案。所以問題是，我們在該領域做了什麼嗎？我們期望什麼時間框架才能知道政府將要做什麼以及他們將把這些贈款提供給誰？其次，我們是否期望參與他們將在 9 月 25 日之後發放的更大規模的贈款，如果您能具體說明一下？

Yeah. First of all, we have submitted the smaller grants, one or two, maybe three of those in combination with different universities and scientists here in the US for BARDA on that program, which is the advanced COVID-19, but also for other diseases as well. And we're also in discussions with BARDA and FDA and others on how we can participate potentially in larger grants, as you pointed out, whether those are actually going to come September 25, or I think that's a date you have to file by September 25, not actually going to be announced by then. But there is a lot of funding and there's actually BARDA reaching out to certain people and telling them to get a hold of us. So stay tuned and we'll see what happens with some of those conversations we have ongoing.

是的。首先，我們已經與美國不同的大學和科學家聯合向 BARDA 提交了較小的撥款，一到兩筆，也許三筆，用於該項目，即先進的 COVID-19，但也適用於其他疾病，例如出色地。正如您所指出的，我們也正在與 BARDA 和 FDA 以及其他機構討論如何參與更大的撥款，無論這些撥款實際上是在 9 月 25 日發放，還是我認為您必須在 9 月之前提交25日，到那時實際上不會宣布。但是有很多資金，而且實際上 BARDA 正在聯繫某些人並告訴他們聯繫我們。因此，請繼續關注，我們將看看我們正在進行的一些對話會發生什麼。

Okay. Is there any approximate timeline when they're finished with this program that they're doing and all of these grants are handed out? I mean, when we talk about larger grants, in our arena, a larger grant may be a $20-million grant. And of course, in that arena, they've been giving out billion-dollar grants. So when do you think this whole area is going to conclude? And we'll know if we're a player in it and we've got grants or we're not a player in it. Any ideas to that timing?

好的。當他們完成他們正在做的這個項目並發放所有這些贈款時，是否有任何大致的時間表？我的意思是，當我們談論更大的資助時，在我們的領域，更大的資助可能是 2000 萬美元。當然，在這個領域，他們一直在提供數十億美元的補助。那你認為這整個領域什麼時候會結束？我們會知道我們是否是其中的參與者並且我們獲得了資助，或者我們不是其中的參與者。對這個時間有什麼想法嗎？

I don't think they've given us any specific timing ideas, but it's kind of like you pointed out, it's a rolling program. And so we can potentially be in the first wave, second wave, third wave, fourth wave. But we're in discussions with both BARDA and FDA. We're in discussions with people that are applying for some of those grants that maybe potentially want to use C1 to produce their vaccine.

我認為他們沒有給我們任何具體的時間安排想法，但就像你指出的那樣，這是一個滾動計劃。因此，我們有可能處於第一波、第二波、第三波、第四波。但我們正在與 BARDA 和 FDA 進行討論。我們正在與正在申請一些贈款的人進行討論，他們可能希望使用 C1 來生產疫苗。

So you've got to remember, our function and role in that is to produce the antigens in large amounts at low cost rapidly and get the platform used as broadly as possible. All the other funding is going to be going virtually to other people. So whether we get it direct or we participate in it, it's virtually the same thing, ultimately, a commercial product that gets to the clinic.

所以你必須記住，我們的功能和作用是快速、低成本地大量生產抗原，並盡可能廣泛地使用平台。所有其他資金實際上都將流向其他人。因此，無論我們直接獲得還是參與其中，實際上都是一樣的，最終都是進入臨床的商業產品。

We have to be paying us access fees, milestones, and royalties on our C1 technology. So whether that be potential bird flu, dengue, a COVID-19 vaccine, a monoclonal antibody, for things like Marburg Ebola or other things.

我們必須向我們支付 C1 技術的使用費、里程碑費和版稅。因此，無論是潛在的禽流感、登革熱、COVID-19 疫苗、單株抗體、馬堡伊波拉病毒或其他疾病。

So there's a variety of things that we're working with and in discussions with on a big pharma, small biotech, FDA, BARDA, et cetera. And including, obviously, the new relationship we just announced that Joe and I talked about in Italy. And the gentleman there is world-renowned and they're funded by the Italian government for pandemic preparedness for vaccines and antibodies. In that case, we're actually going to be enabling them with the technology to develop these things in-house that they can move forward in the preclinical studies, hopefully up to Phase 2b, where then they can out-license those to big pharmaceutical companies.

因此，我們正在與大型製藥公司、小型生物技術公司、FDA、BARDA 等進行各種合作和討論。顯然，包括我們剛剛宣布的新關係，喬和我在義大利談論過。那裡的那位先生是世界知名的，他們由義大利政府資助，用於疫苗和抗體的大流行準備。在這種情況下，我們實際上將使他們能夠利用技術在內部開發這些東西，以便他們可以在臨床前研究中前進，希望達到 2b 階段，然後他們可以將這些技術授權給大型製藥公司公司。

Robert Smith, Center for Performance.

羅伯特史密斯，表演中心。

Hi. Good afternoon, everyone. Thanks for taking my question. So, Mark or Joe, can you speak to the current state of the Janssen arrangement and what's been happening there? Thanks.

你好。大家下午好。感謝您提出我的問題。那麼，馬克或喬，您能談談詹森安排的現狀以及那裡發生了什麼嗎？謝謝。

Yeah. I mean, we're moving and advancing forward with Janssen. We're working on two different proteins. One's a monoclonal antibody and one's a bispecific. I can't actually tell you what the disease state is because that's confidential. And we've made very good progress. And we're in discussions with Janssen to potentially accelerate that program and even provide more resources so that we can get that done sooner and potentially hit our milestones faster and then they can get the platform embedded into Janssen sooner.

是的。我的意思是，我們正在與詹森一起前進。我們正在研究兩種不同的蛋白質。一個是單株抗體，一個是雙特異性抗體。我實際上無法告訴你疾病狀態是什麼，因為這是保密的。我們已經取得了很好的進展。我們正在與楊森討論，以可能加速該計劃，甚至提供更多資源，以便我們可以更快地完成該計劃，並可能更快地達到我們的里程碑，然後他們可以更快地將平台嵌入到楊森中。

So, I guess the key word is patience, but as the months go into quarters and years, what is your first shot at really some substantial breakthrough as far as a production item? What's your best guess?

所以，我想關鍵字是耐心，但隨著時間的流逝，進入季度和年份，就生產項目而言，您第一次嘗試真正取得實質突破的機會是什麼？你最好的猜測是什麼？

Well, first of all, I think we've had a substantial breakthrough and major milestone where a human being showing safety and immunogenicity with an antigen for the first time produced from C1. That's a gate-opening item for big pharma, for governments, academia. It's driving more and more input, driving more and more program opportunities. So, I think we've already hit one of those points. Now, the question is, how are we going to monetize that?

嗯，首先，我認為我們已經取得了重大突破和重大里程碑，人類首次以 C1 產生的抗原表現出安全性和免疫原性。對於大型製藥公司、政府和學術界來說，這是一個開門計畫。它推動了越來越多的投入，推動了越來越多的專案機會。所以，我認為我們已經達到了其中一點。現在的問題是，我們要如何將其貨幣化？

Yeah, that's what I meant, yeah.

是的，這就是我的意思，是的。

Yeah, what you have to recognize is, to be honest with you, we've excelled on the science. We've exceeded even our own expectations of the transformation of the technology, the C1 technology for pharmaceutical use in recombinant protein vaccines. We're light years ahead of people like Novavax and Sanofi, baculovirus, or [N6L] platforms.

是的，你必須承認的是，老實說，我們在科學方面表現出色。我們對這項技術的改造，即重組蛋白疫苗的藥用C1技術，甚至超出了我們自己的預期。我們比 Novavax 和賽諾菲、桿狀病毒或 [N6L] 平台等公司領先數光年。

So, now the question is, now that we're in human beings getting data, and by the end of the last quarter this year, we should have the final report and the final data complete. And, you know, right now people are seeing the data within the industry, the 29-day data. We have 90-day data coming up soon. I mean, we're already through 180 days with patients on the low-dose and almost any day on the high-dose.

所以，現在的問題是，現在我們正在人類取得數據，到今年最後一個季度末，我們應該會完成最終報告和最終數據。而且，你知道，現在人們看到的是產業內的數據，29天的數據。我們即將推出 90 天的數據。我的意思是，我們已經度過了 180 天，患者接受低劑量治療，幾乎每天都接受高劑量治療。

So, the safety of the platform is being proven for the first time ever. So, now it's going to be who wants to step up and get their hands on this for what rights, what access, what fields, what applications, what areas, in addition to the many things we already have going on all over the world. So, if you think about it, between Rino Rappuoli, which if you look him up, and he's now, let's say, helping us, not just for his own use, but to approach the industry in general to solve the problem of human health and human equity. Because there is no human health inequity outside the, let's say, the developed countries.

因此，該平台的安全性首次得到證明。因此，現在的問題是，除了我們在世界各地已經開展的許多事情之外，誰想要站出來並獲得哪些權利、哪些存取權限、哪些領域、哪些應用程式、哪些領域。所以，如果你想一想，如果你查一下 Rino Rappuoli，你會發現他現在正在幫助我們，不僅是為了他自己，而是為了整個產業解決人類健康問題和人類平等。因為除了已開發國家之外，不存在人類健康不平等問題。

And so, we're getting the people in the world that are the experts who've taken things through the clinic multiple times with big pharma now jumping in and saying, we want to help. And including some of the major pharmaceutical companies we're in discussions with, like the top five pharma company we're working on a vaccine with, that they're fully funded.

因此，我們讓世界上的專家多次透過大型製藥公司的診所進行治療，現在他們介入並表示，我們想提供協助。包括我們正在討論的一些主要製藥公司，例如我們正在合作開發疫苗的前五家製藥公司，他們都有充足的資金。

That could be the major breakthrough. Because if we can develop that and show that that is functionally equal or better and can produce faster and larger amounts at lower cost, as Joe pointed out earlier, there's a commercialization back into that already baked into the agreement. So, that might be the first one that cracks the egg open. But there's a variety of other ones that could happen in between.

這可能是重大突破。因為如果我們能夠開發它，並證明它在功能上相同或更好，並且可以以更低的成本更快地生產更多數量的產品，正如喬早些時候指出的那樣，那麼就可以將商業化重新納入協議中。所以，這可能是第一個打開雞蛋的人。但其間還可能發生各種其他情況。

Tony Bowers, Intro-Act.

東尼鮑爾斯，序幕。

Hi, Mark. I think with COVID now not so much in the news. I mean, that was a huge distraction, but a lot of pharma companies got very fat and happy off of the money they made on that program. You've talked to people for a lot of years about the advantages of C1. Do you think that there's urgency or complacency versus a year or so ago? And is there funding? And do you think that it's going to be overseas where somebody gets ahead of the pack and then everybody else has to get on board? So, whether it's the South Africans or the Italians, somebody will move, show that they believe, show that there's economic advantages, and then the rest of the industry will wake up. Is that how you see this playing?

嗨，馬克。我認為現在關於新冠肺炎的新聞報導已經不多了。我的意思是，這是一個巨大的干擾，但許多製藥公司從該計劃中賺到的錢中獲得了巨大的財富和快樂。您多年來一直與人們談論 C1 的優勢。您認為與一年前相比，現在是緊迫還是自滿？還有資金嗎？你是否認為在海外會出現有人走在前面，然後其他人都必須加入的情況？因此，無論是南非人還是義大利人，總是會有人採取行動，表明他們相信，表明存在經濟優勢，然後該行業的其他公司就會覺醒。你是這樣看待這場比賽的嗎？

Yeah, but I don't think it's just economic advantage. I think it's life and death. I think that the people are missing here is -- quite frankly, I won't tell you who, but I had a call this week, a Zoom call with five or six people, senior people at one of the big, let's say, biopharmaceutical supply houses. And they said the same thing. They're like shaking their head saying, this is just incredible what we've accomplished to date with the science.

是的，但我不認為這只是經濟優勢。我認為這是生與死。我認為這裡缺少的人是 - 坦率地說，我不會告訴你是誰，但是這週我接到了一個電話，一個有五六個人的 Zoom 電話，其中一個大公司的高級人員，比方說，生物製藥供應廠。他們也說了同樣的話。他們搖著頭說，迄今為止我們在科學上的成就真是令人難以置信。

And we're talking to them about helping expand the market access. We need, obviously, the horsepower of one of these big players to come in and help us accelerate adoption and use. And we have that now with the foundation, Biotecnopolo in Italy, that memorandum of understanding, and we're in discussions and contracts have been shared back and forth on drafts, providing we get that sign, which we're pretty confident we will. You know, that group and that gentleman, he has contacts into everybody. I'm not going to name names, but you can go from the top to the bottom and everywhere in between in every country, virtually on the planet, and he has to reach into there.

我們正在與他們討論幫助擴大市場准入的問題。顯然，我們需要這些大公司之一的力量來幫助我們加速採用和使用。我們現在與義大利的 Biotecnopolo 基金會簽署了諒解備忘錄，我們正在討論，合約已經在草稿上來回共享，只要我們得到這個標誌，我們非常有信心我們會得到這個標誌。你知道，那個團體和那位先生，他與每個人都有聯繫。我不會點名，但你可以從上到下，甚至在每個國家，幾乎在地球上的任何地方，他都必須觸及那裡。

So he's going to bring industrial credibility because he wants to do the same thing we do. He wants to make sure people have access. It's affordable. This technology can be used in countries for distribution. You don't need the cold chain storage. You can produce it at a price that actually you cannot bankrupt the countries by doing it.

因此，他將帶來行業信譽，因為他想做我們所做的同樣的事情。他希望確保人們能夠訪問。這是負擔得起的。該技術可在各國使用並進行分發。您不需要冷鏈儲存。你可以以一個實際上不會讓國家破產的價格來生產它。

And so I think we've got a lot of momentum going. We've got momentum with the FDA, with BARDA. We've got in Europe, in Bangladesh, in India. So I'm not quite sure. There's a few other continents, you know, South America we're working on. That might be the last frontier. I don't know. But there's things happening everywhere. And I would say that we're excited about where we are. We're excited about where we're going. But we're more excited about what we have. And the next step is perfecting the antibody program because the vaccine platform, as Joe pointed out, it's prime time, ready to go, and it's being applied.

所以我認為我們有很大的動力。我們與 FDA 和 BARDA 保持著良好的合作關係。我們在歐洲、孟加拉、印度都有。所以我不太確定。還有其他一些大陸，你知道，我們正在研究南美洲。那可能是最後的邊界。我不知道。但到處都有事情發生。我想說，我們對我們所處的位置感到興奮。我們對我們要去的地方感到興奮。但我們對我們所擁有的更感到興奮。下一步是完善抗體計劃，因為疫苗平台，正如喬指出的那樣，現在是黃金時間，準備就緒，並且正在應用。

Thank you. I will now turn the call over to Dyadic CEO, Mr. Emalfarb, for closing remarks.

謝謝。現在，我將把電話轉交給 Dyadic 執行長 Emalfarb 先生，他將致閉幕詞。

Thank you, Stacey. In 2023, we're seeing the impact of our Phase 1 further validate the C1 platform for pharmaceutical use in human and animal health. We're also beginning to realize the investment in the Dapibus platform and alternative proteins. We remain focused on improving the value of Dyadic for the life science industry, which will in turn improve value for shareholders and improve access to affordable vaccines and therapeutics globally.

謝謝你，史黛西。 2023 年，我們將看到第一階段的影響，進一步驗證 C1 平台在人類和動物健康領域的藥物用途。我們也開始實現對 Dapibus 平台和替代蛋白質的投資。我們仍然專注於提高 Dyadic 對生命科學產業的價值，這反過來又會提高股東的價值，並改善全球獲得負擔得起的疫苗和治療方法的機會。

We've refined our focus and revised our business strategies to exploit existing and new commercialization opportunities in the near term, while enabling us to fulfill our mission as a global biotechnology company to improve the way we feed, fuel, and heal the world.

我們已經調整了重點並修改了業務策略，以在短期內利用現有和新的商業化機會，同時使我們能夠履行作為全球生物技術公司的使命，改善我們為世界提供食物、燃料和治癒的方式。

I want to thank you for joining us in today's Q2 2023 conference call, and we look forward to keeping you updated as we advance our commercial and scientific initiatives on the next call. And I would say please keep an eye out for other periodic updates.

我要感謝您參加今天的 2023 年第二季電話會議，我們期待在下次電話會議上推進我們的商業和科學計劃時向您通報最新情況。我想說，請留意其他定期更新。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.

會議現已結束。感謝您參加今天的演講。此時您可以斷開線路。