Dominari Holdings Inc (DOMH) 2011 Q4 法說會逐字稿

Welcome to the Spherix business update call. At this time all participants are in a listen-only mode. Following Management's prepared remarks, we'll hold a Q&A session.

歡迎致電 Spherix 業務更新。此時所有參與者都處於只聽模式。在管理層準備好的講話之後，我們將舉行問答會議。

(Operator Instructions)

（操作員說明）

As a reminder, this conference is being recorded, April 11, 2012. I would now like to turn the conference over to Kim Golodetz. Please go ahead.

謹此提醒，本次會議的錄製時間為 2012 年 4 月 11 日。我現在想把會議交給 Kim Golodetz。請繼續。

Thank you. This is Kim Golodetz with LHA. Thank you all for participating in today's call. Joining me this afternoon from Spherix are Dr. Claire Kruger, Chief Executive Officer; Robert Clayton, Chief Financial Officer; and Dr. Robert Lodder, the Company's President. On March 28, Spherix issued a press release reporting its 2011 financial results and business highlights. If you have not received this news release, or if you would like to be added to the Company's distribution list, please call LHA in New York at 212-838-3777 and speak with Carolyn Curran.

謝謝。我是 LHA 的 Kim Golodetz。感謝大家參加今天的電話會議。今天下午從 Spherix 來和我一起的是 Dr.克萊爾·克魯格，首席執行官；羅伯特·克萊頓，首席財務官；和博士。羅伯特·洛德，公司總裁。3 月 28 日，Spherix 發布新聞稿，報告其 2011 年財務業績和業務亮點。如果您還沒有收到本新聞稿，或者您希望被添加到公司的分發列表中，請致電紐約的 LHA，電話：212-838-3777，並與 Carolyn Curran 聯繫。

As we begin, I would like to caution that comments made during this conference call by Management will contain forward-looking statements regarding the operations and future results of Spherix. These forward-looking statements involve risks and uncertainties that include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, that Spherix may lack financial resources to complete development of SPX106 and/or D-tagatose, that the FDA may interpret the results of the studies differently than Management's interpretation, that competing products may be more successful, that demands for new pharmaceutical products may decrease, that the biopharmaceutical industry may experience negative market trends, that the Company's continuing efforts to develop SPX106 and/or D-tagatose may be unsuccessful, that its common stock could be delisted from the NASDAQ Capital Market, and other risks detailed in the Company's filings with the US Securities and Exchange Commission.

在我們開始之前，我想提醒大家，管理層在本次電話會議上發表的評論將包含有關 Spherix 的運營和未來業績的前瞻性陳述。這些前瞻性陳述涉及風險和不確定性，包括但不限於產品候選者可能在臨床中失敗或可能無法成功營銷或製造的風險，Spherix 可能缺乏財務資源來完成 SPX106 和/或 D-塔格糖的開發，FDA 對研究結果的解釋可能與管理層的解釋不同，競爭產品可能會更成功，對新藥品的需求可能會減少，生物製藥行業可能會經歷負面的市場趨勢，公司不斷努力開發SPX106 和/或 D-塔格糖可能會失敗，其普通股可能會從納斯達克資本市場退市，以及該公司向美國證券交易委員會提交的文件中詳述的其他風險。

I encourage you to review these filings, including the Company's Forms 10-K and 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Importantly, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live call, today, April 11, 2012. The Company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. With that, I would like to turn the call over to Claire Kruger, Dr. Kruger?

我鼓勵您查看這些文件，包括公司的 10-K 和 10-Q 表格，其中確定了可能導致實際結果或事件與前瞻性聲明中描述的結果或事件存在重大差異的具體因素。重要的是，本次電話會議的內容包含時間敏感信息，僅截至實時電話會議日期（即今天，即 2012 年 4 月 11 日）準確。公司不承擔修改或更新任何聲明以反映本次電話會議之後發生的事件或情況的義務。說到這裡，我想把電話轉給克萊爾·克魯格博士。克魯格？

Thank you, Kim, and my thanks to each of you for participating in our call today. My colleagues and I would like to use this forum to update you on the significant progress we've made to advance our dyslipidemia program, and the refinements to our growth strategy. We continue to gain valuable information about our compounds, SPX106 and SPX106T for the treatment of high triglycerides and other metabolic disorders. We have advanced SPX106T to the point where we are ready to begin clinical trials, and have requested a pre-IND meeting with the US Food and Drug Administration.

謝謝金，也感謝你們每個人參加我們今天的電話會議。我和我的同事想利用這個論壇向您介紹我們在推進血脂異常計劃方面取得的重大進展以及我們增長戰略的改進。我們不斷獲得有關我們的化合物 SPX106 和 SPX106T 用於治療高甘油三酯和其他代謝紊亂的寶貴信息。我們已將 SPX106T 推進到準備開始臨床試驗的階段，並已請求與美國食品和藥物管理局舉行 IND 前會議。

As you know, we licensed SPX106 from the University of Kentucky, and are testing it in combination with D-tagatose, which had a successful Phase III trial as a monotherapy in diabetics with mild disease. Importantly, in clinical testing there were no significant adverse events observed with D-tagatose administration. The combination of SPX106 and D-tagatose is called SPX106T. We continue to generate compelling data for this combination drug, and Robert Lodder will discuss these new promising data a little later in the call.

如您所知，我們從肯塔基大學獲得了 SPX106 的許可，並正在將其與 D-塔格糖聯合進行測試，D-塔格糖作為輕度糖尿病患者的單一療法進行了成功的 III 期試驗。重要的是，在臨床測試中，D-塔格糖給藥沒有觀察到明顯的不良事件。SPX106 和 D-塔格糖的組合稱為 SPX106T。我們將繼續為這種組合藥物生成令人信服的數據，羅伯特·洛德將在稍後的電話會議中討論這些新的有希望的數據。

You may recall that Spherix consists of two subsidiaries, Spherix Consulting, as our health sciences consulting division, which is responsible for our revenue; Biospherics is our development subsidiary, which accounts for all of our R&D expense, and as we have been doing each quarter for the past year, we will provide our upcoming milestones, so that you can track our progress going forward. Let me start by updating you on our health science consulting business. We performed work on behalf of 20 clients in 2011, compared with 23 in the previous year. Our scientists regularly publish their work, and present at major trade shows and conferences. We disclose the major papers to you each quarter in our press releases.

您可能還記得，Spherix 由兩個子公司組成：Spherix Consulting，作為我們的健康科學諮詢部門，負責我們的收入；Spherix Consulting，作為我們的健康科學諮詢部門，負責我們的收入；Spherix Consulting，作為我們的健康科學諮詢部門，負責我們的收入。 Biospherics 是我們的開發子公司，負責我們所有的研發費用，正如我們去年每個季度所做的那樣，我們將提供即將到來的里程碑，以便您可以跟踪我們未來的進展。讓我首先向您介紹我們的健康科學諮詢業務的最新情況。2011 年，我們為 20 家客戶提供了服務，而上一年為 23 家。我們的科學家定期發表他們的研究成果，並出席主要的貿易展覽和會議。我們每個季度都會在新聞稿中向您披露主要論文。

The expertise that reside in this business is extremely important to the work at Biospherics, as our scientists oversee the work our CRO is performing, and ensure the necessary toxicology and mechanism of action work, among other studies, is performed with the scientific rigor required by the FDA. Before I discuss our plans to build our development pipeline and our expectations for SPX106 in the treatment of dyslipidemia alone and in combination with D-tagatose, I'll now turn the call over to Robert Clayton, who will review our 2011 financial results. Robert?

該業務的專業知識對於 Biospherics 的工作極其重要，因為我們的科學家監督我們的 CRO 正在執行的工作，並確保必要的毒理學和作用機制工作以及其他研究按照 Biospherics 所需的科學嚴謹性進行。 FDA。在我討論我們建立開發管線的計劃以及我們對 SPX106 單獨治療血脂異常以及與 D-塔格糖聯合治療的期望之前，我現在將電話轉給 Robert Clayton，他將審查我們 2011 年的財務業績。羅伯特？

Thanks, Claire. Our revenue for 2011 was $0.8 million. This compares with revenue of $1.5 million in 2010. As Claire mentioned, revenue is derived solely from our Spherix consulting business.

謝謝，克萊爾。我們 2011 年的收入為 80 萬美元。相比之下，2010 年的收入為 150 萬美元。正如克萊爾提到的，收入僅來自我們的 Spherix 諮詢業務。

R&D expense for 2011 was $1.6 million, and this represents a decrease of $3.2 million from R&D expenses in 2010 of $4.8 million. The decrease is attributed to lower spending, following the completion of a Phase III clinical trial, and a Phase II dose-ranging trial to develop D-tagatose for the treatment of Type II Diabetes in the prior year. 2011 R&D expense is related to the Company's pre-clinical trials for the use of both D-tagatose and SPX106 in lowering triglycerides.

2011年的研發費用為160萬美元，比2010年的480萬美元的研發費用減少了320萬美元。減少的原因是去年完成了一項 III 期臨床試驗和一項開發 D-塔格糖用於治療 II 型糖尿病的 II 期劑量範圍試驗後支出減少。2011年研發費用與公司使用D-塔格糖和SPX106降低甘油三酯的臨床前試驗有關。

The net loss for 2011 was $3.5 million or $1.32 per share, and this compares with a net loss of $7.7 million or $4.28 per share for 2010. Working capital was $4.6 million as of December 31, 2011, down slightly from working capital of $4.9 million as of December 31, 2010. The Company's cash and cash equivalents, as of December 31, 2011 were $1.9 million, and in February 2012, the Company raised an additional $1.15 million in a registered direct offering. With that, I'll turn the call back to Claire.

2011 年的淨虧損為 350 萬美元，即每股 1.32 美元，而 2010 年的淨虧損為 770 萬美元，即每股 4.28 美元。截至2011年12月31日，營運資本為460萬美元，略低於截至2010年12月31日的490萬美元營運資本。截至2011年12月31日，公司的現金和現金等價物為190萬美元，2012年2月，公司通過註冊直接發行額外籌集了115萬美元。說完，我會把電話轉回給克萊爾。

Thanks, Robert. As I've discussed in recent quarters, our growth strategy revolves around the development of pharmaceuticals in our Biospherics division. The strategy includes four components. First, utilizing our clinical development capabilities to manage and drive drug candidates through development and ultimately approval. Two, identifying and exploring licensing and partnership opportunities for drug candidates. Three, acquiring medically important drug candidates in early to mid-stage clinical development. And four, commercializing our drug candidates, either alone or more likely in partnership, which we believe can maximize stockholder value. This would extend to the outright sale of a drug candidate following our value add.

謝謝，羅伯特。正如我在最近幾個季度所討論的，我們的增長戰略圍繞著生物圈部門的藥品開發。該戰略包括四個組成部分。首先，利用我們的臨床開發能力來管理和推動候選藥物的開發和最終批准。第二，確定並探索候選藥物的許可和合作機會。第三，在早中期臨床開發中獲取具有醫學重要性的候選藥物。第四，將我們的候選藥物商業化，無論是單獨還是更有可能合作，我們相信這可以最大化股東價值。這將延伸到在我們增值後直接銷售候選藥物。

As you know, last year, Spherix embarked on an asset-centric growth strategy based on SPX106T. Now I'd like to give you a little more granularity on how we're approaching our strategy, and how we have refined and enhanced this approach with respect to our new development platform. We're launching a combination drug discovery platform based on a dynamic data-driven application simulation approach, or DDDAS.

如您所知，去年，Spherix 開始了基於 SPX106T 的以資產為中心的增長戰略。現在，我想向您詳細介紹一下我們如何實施我們的戰略，以及我們如何針對新的開發平台完善和增強這種方法。我們正在推出一個基於動態數據驅動的應用模擬方法（DDDAS）的組合藥物發現平台。

In addition to its own combination drug, Spherix is looking at Phase I and Phase II assets to roll up in its platform with an eye toward developing treatments for complex diseases that require more than one drug. To draw comparison to viral infection which is a disease category we're not working in, this combination drug or cocktail approach is well-established for treating diseases such as HIV and hepatitis C. Vytorin is an example of a combination drug in the dyslipidemia treatment category. Vytorin contains a combination of ezetimibe and simvastatin. These combination drugs are effective because they target more than one complementary pathway for treatment.

除了自己的組合藥物外，Spherix 還在尋找將一期和二期資產納入其平台的資產，著眼於開發針對需要多種藥物的複雜疾病的治療方法。為了與我們沒有研究的疾病類別病毒感染進行比較，這種組合藥物或雞尾酒方法對於治療艾滋病毒和丙型肝炎等疾病來說是行之有效的。Vytorin 是血脂異常治療類別中組合藥物的一個例子。Vytorin 含有依折麥布和辛伐他汀的組合。這些組合藥物之所以有效，是因為它們針對不止一種補充治療途徑。

This approach has been well-vetted. The DDDAS program began at the National Science Foundation. DDDAS is now being employed to model complex metabolic disease pathways, testing potential binary therapies in simulations at various combinations, at two points in the pathways, choosing the most effective pair-wise combinations. DDDAS is being used now in animal and human studies planned by Spherix. Recently, researchers at Stanford University have also begun to use the data-driven algorithmic approach to predict drug interaction.

這種方法已經過充分審查。DDDAS 項目始於美國國家科學基金會。DDDAS 現在被用來模擬複雜的代謝疾病途徑，在各種組合的模擬中測試潛在的二元療法，在途徑的兩個點上，選擇最有效的成對組合。DDDAS 目前正用於 Spherix 計劃的動物和人類研究中。最近，斯坦福大學的研究人員也開始使用數據驅動的算法方法來預測藥物相互作用。

DDDAS as a paradigm, through its simulations and measurements, become a symbiotic feedback control system. This paradigm entails the ability to dynamically incorporate additional data into an executing application, and in reverse, the ability of an application to dynamically steer the measurement process. Such capabilities promise more accurate analysis and prediction, more precise controls, and more reliable outcomes. The ability of an application simulation to control and guide the measurement process, and determine when, where, and how it is best to gather additional data has itself the potential of enabling more effective disease intervention, as well as diagnostic measurement methodologies. Furthermore, the incorporation of dynamic inputs into an executing simulation helps create application platforms that can more accurately describe real-world complex metabolic diseases.

DDDAS作為範例，通過其模擬和測量，成為一個共生反饋控制系統。這種範例需要動態地將附加數據合併到正在執行的應用程序中的能力，反過來，需要應用程序動態引導測量過程的能力。這些功能有望實現更準確的分析和預測、更精確的控制以及更可靠的結果。應用模擬能夠控制和指導測量過程，並確定何時、何地以及如何最好地收集額外數據，這本身就有可能實現更有效的疾病干預以及診斷測量方法。此外，將動態輸入納入執行模擬有助於創建可以更準確地描述現實世界複雜代謝疾病的應用程序平台。

The asset-centric growth strategy based on the combination drug SPX106T is a natural segue into a discovery platform strategy, designed to create new combination therapies for complex metabolic diseases. To be successful, an asset-centric growth strategy needs an experienced senior core team like the team at Spherix. This team must access the best of the scientific and business ecosystem around the assets, as Spherix is doing now with its orphan drug strategy. An asset-centric virtual business model relies on a broad network of strong academic collaborators, outstanding advisors and CRO partners.

基於組合藥物 SPX106T 的以資產為中心的增長戰略是發現平台戰略的自然延續，旨在為複雜的代謝疾病創造新的聯合療法。為了取得成功，以資產為中心的增長戰略需要像 Spherix 團隊這樣經驗豐富的高級核心團隊。該團隊必須利用資產周圍最好的科學和商業生態系統，正如 Spherix 現在通過其孤兒藥戰略所做的那樣。以資產為中心的虛擬商業模式依賴於強大的學術合作者、傑出顧問和 CRO 合作夥伴組成的廣泛網絡。

Frequently, the single asset development model realizes its value creation through an acquisition by a larger company. Only occasionally does a single asset model company bring a product all the way to market. The transition to a discovery platform model requires efficient deployment of resources, including the resources Spherix already has. Importantly, our scientists at Spherix Consulting, and our access to the University of Kentucky's laboratories provides significant information that allows us better understanding of the path to product candidates.

通常，單一資產開發模式通過被大公司收購來實現其價值創造。只有偶爾，單一資產模型公司才會將產品一路推向市場。向發現平台模式的過渡需要高效部署資源，包括 Spherix 已有的資源。重要的是，我們 Spherix Consulting 的科學家以及我們對肯塔基大學實驗室的訪問提供了重要的信息，使我們能夠更好地了解候選產品的路徑。

A key emphasis over the next few years will be validating that the platform generates repeatable advances. Discovery platform model focuses resources on core expertise, and mitigates risk through diversification. Combination drugs may be the best therapies for complex multi-factorial diseases and these diseases are notoriously difficult to treat. The discovery platform model offers ongoing value creation through licensing one or more drugs in its pipeline, and through revenue from sales as well as through acquisition by another company. For these reasons and more, the adoption of the DDDAS approach to combination drug development is a good strategic move for Spherix.

未來幾年的重點將是驗證該平台是否能產生可重複的進步。發現平台模式將資源集中在核心專業知識上，並通過多元化降低風險。聯合藥物可能是治療複雜的多因素疾病的最佳療法，而這些疾病是出了名的難以治療。發現平台模型通過許可其管道中的一種或多種藥物、通過銷售收入以及被另一家公司收購來提供持續的價值創造。出於這些原因以及其他原因，採用 DDDAS 方法進行組合藥物開發對於 Spherix 來說是一個很好的戰略舉措。

With this development platform in mind, we continue to be actively engaged in pursuing an in-licensing strategy to bolster and diversify our pipeline. We also are currently evaluating numerous additional opportunities, including those in the orphan drug space, as exciting and achievable targets. Our objective remains the same, to choose the opportunities best suited to our business goals based on financial considerations, achievable clinical milestones, and development potential that will enhance shareholder value. Our financial advisor continues to bring us developments, potential development candidates for review, and there's several under active consideration.

考慮到這個開發平台，我們將繼續積極推行引進許可戰略，以加強我們的產品線並使其多樣化。我們目前還在評估許多其他機會，包括孤兒藥領域的機會，作為令人興奮和可實現的目標。我們的目標保持不變，即根據財務考慮、可實現的臨床里程碑以及可提高股東價值的發展潛力，選擇最適合我們業務目標的機會。我們的財務顧問繼續為我們帶來進展、潛在的發展候選者以供審查，並且有幾個正在積極考慮中。

Orphan indications fall under this umbrella. As we've discussed before, our attention to the orphan drug market is important because the benefits of orphan drugs for the developer and marketer are numerous. First, the pathway to approval tends to be shorter, because by definition, these patients have unmet medical needs, and the regulatory authorities are anxious to provide solutions. Orphan drugs are granted seven years of market exclusivity to encourage their development, by providing a commercial incentive. In addition, these drugs typically are premium-priced and are marketed by a smaller sales force.

孤兒藥適應症屬於這一範疇。正如我們之前討論的，我們對孤兒藥市場的關注很重要，因為孤兒藥為開發商和營銷人員帶來的好處很多。首先，批准的途徑往往較短，因為根據定義，這些患者的醫療需求未得到滿足，而監管機構急於提供解決方案。孤兒藥被授予七年的市場獨占權，通過提供商業激勵來鼓勵其開發。此外，這些藥物通常價格昂貴，並且由較小的銷售人員銷售。

With that overview of our strategy, I'd like to turn the call over to Dr. Robert Lodder, who will go over the most recent development progress with SPX106 and SPX106T. Rob?

概述了我們的策略後，我想將電話轉給 Dr.Robert Lodder 將介紹 SPX106 和 SPX106T 的最新開發進展。搶？

Thanks, Claire. I'm excited to apply my expertise in DDDAS approaches to our drug development platform. Previously, I was involved in an academic project to reduce medication errors in hospitals and nursing homes, using DDDAS techniques. As you mentioned, SPX106 is in pre-clinical development, in combination with other agents, including D-tagatose for the prevention and treatment of atherosclerosis, hypertriglyceridemia, and related dyslipidemias.

謝謝，克萊爾。我很高興能夠將我在 DDDAS 方法方面的專業知識應用於我們的藥物開發平台。此前，我參與了一個學術項目，旨在使用 DDDAS 技術減少醫院和療養院的用藥錯誤。正如您提到的，SPX106正處於臨床前開發階段，與其他藥物（包括D-塔格糖）聯合用於預防和治療動脈粥樣硬化、高甘油三酯血症和相關血脂異常。

We recently reported two important developments with SPX106T. One concerns safety and the other potential efficacy. In March, we announced the SPX106T arrested development and reduced atherosclerotic plaque area in the aortic arch, thoracic aorta, and sinus of Valsalva in mice genetically predisposed to cardiovascular disease. Atherosclerosis can lead to myocardial infarction and stroke. Each year about 770,000 people in the US experience their first MI, and about one-third of these events are fatal.

我們最近報導了 SPX106T 的兩項重要進展。一個涉及安全性，另一個涉及潛在功效。今年 3 月，我們宣布 SPX106T 可以抑制遺傳易患心血管疾病的小鼠主動脈弓、胸主動脈和 Valsalva 竇的動脈粥樣硬化斑塊面積，並阻止其發育。動脈粥樣硬化可導致心肌梗塞和中風。美國每年約有 77 萬人經歷首次心梗，其中約三分之一是致命的。

Two groups of apolipoprotein E-deficient mice, including a control group and an SPX106T group were fed a western diet, high in fat and carbohydrates for eight weeks. In the SPX106T group, the sucrose portion of the dietary carbohydrates was replaced with D-tagatose, and SPX106 was added at 0.1%. Plaque area was quantified at three locations, the sinus of Valsalva on top of the heart, the aortic arch, and thoracic aorta.

兩組載脂蛋白E缺陷小鼠（包括對照組和SPX106T組）被餵食高脂肪和碳水化合物的西方飲食八週。在SPX106T組中，膳食碳水化合物中的蔗糖部分被D-塔格糖替代，並添加0.1%的SPX106。對三個位置的斑塊面積進行量化：心臟頂部的瓦爾薩爾瓦竇、主動脈弓和胸主動脈。

SPX106T reduced atherosclerotic plaque areas almost 5-fold in all locations, with a statistically significant P-value of less than 0.05 in the thoracic aorta and less than 0.01 in the aortic arch and sinus of Valsalva, where the disease is always more severe. These results expand on previous work done by Spherix, which was presented at the American Association of Pharmaceutical Scientists' 2011 national meeting in October, showing that SPX106T significantly reduced serum cholesterol, the amount of subcutaneous, retroperitoneal, and epididymal body fat, and prevented weight gain.

SPX106T 將所有位置的動脈粥樣硬化斑塊面積減少了近 5 倍，胸主動脈的 P 值具有統計學意義，小於 0.05，主動脈弓和 Valsalva 竇的 P 值小於 0.01，而這些地方的疾病總是更嚴重。這些結果擴展了 Spherix 之前所做的工作，該工作於 10 月份在美國藥學科學家協會 2011 年全國會議上發表，表明 SPX106T 顯著降低血清膽固醇、皮下、腹膜後和附睾體脂肪量，並預防體重增加獲得。

These data also supports Spherix's other findings that SPX106T reduced atherosclerotic lesion areas in the aortic arches of LDL-receptor deficient mice fed fructose and glucose. LDL cholesterol is a known risk factor for the development of atherosclerosis in humans. Spherix has previously shown that LDL cholesterol is reduced in LDL-receptor deficient mice, treated with SPX106T.

這些數據還支持 Spherix 的其他發現，即 SPX106T 減少了餵食果糖和葡萄糖的 LDL 受體缺陷小鼠主動脈弓內的動脈粥樣硬化病變區域。低密度脂蛋白膽固醇是人類動脈粥樣硬化發展的已知危險因素。Spherix 此前已表明，經 SPX106T 治療後，LDL 受體缺陷小鼠的 LDL 膽固醇有所降低。

We also successfully completed a 28-day rat toxicology study with SPX106. Results demonstrated an ample margin of safety with the dosing plan for the first in human study. The study also established that SPX106 does not accumulate, and is rapidly secreted after multiple days of dosing. This study, in conjunction with earlier efficacy studies, continues to support SPX106 as a component of a combination therapy for dyslipidemia, which tends to be a complex metabolic disease.

我們還成功完成了 SPX106 為期 28 天的大鼠毒理學研究。結果表明，首次人體研究的給藥方案具有足夠的安全邊際。該研究還確定 SPX106 不會蓄積，並且在給藥多天后會迅速分泌。這項研究與早期的療效研究相結合，繼續支持 SPX106 作為血脂異常聯合療法的組成部分，血脂異常往往是一種複雜的代謝性疾病。

Earlier tests have shown reduced dyslipidemia in apolipoprotein E-deficient mice, and Syrian Golden hamsters, as well as in LDL-receptor deficient mice. As a combination drug, SPX106T is thought to treat dyslipidemia by simultaneously blocking carbohydrate conversion to lipids, and promoting lipid catabolism or lipid break down. The toxicology report will be included in our IND application, which we expect to submit to FDA following our pre-IND meeting. We've already requested the pre-IND meeting and expect that the date will be provided in the coming weeks, paving the way for SPX106T human clinical trials to begin this year.

早期的測試表明，載脂蛋白 E 缺陷型小鼠、敘利亞金倉鼠以及 LDL 受體缺陷型小鼠的血脂異常有所減輕。作為一種組合藥物，SPX106T被認為通過同時阻止碳水化合物轉化為脂質並促進脂質分解代謝或脂質分解來治療血脂異常。毒理學報告將包含在我們的 IND 申請中，我們預計將在 IND 前會議後向 FDA 提交該申請。我們已經請求召開 IND 前會議，並預計將在未來幾週內提供日期，為今年開始的 SPX106T 人體臨床試驗鋪平道路。

With that, I'll turn the call back to Claire. Claire?

說完，我會把電話轉回給克萊爾。克萊爾？

Thanks, Rob. We're very excited about the opportunities in front of us to provide treatment to the enormous and growing patient population with metabolic syndrome, while creating value for our shareholders. The market for triglyceride lowering and cholesterol lowering drugs is large and under served, with an estimated worldwide treatment market of $26 billion annually, including more than $3 billion in the US alone. With fully one-third of Americans classified as overweight or obese, the market for pharmaceutical products to treat the metabolic syndrome is enormous, and a host of drugs has been fraught with safety problems and denied approval by the FDA.

謝謝，羅布。我們對眼前的機會感到非常興奮，可以為數量龐大且不斷增長的代謝綜合徵患者群體提供治療，同時為我們的股東創造價值。降低甘油三酯和降低膽固醇藥物的市場規模巨大且服務不足，估計全球治療市場每年達 260 億美元，其中僅美國就超過 30 億美元。由於有三分之一的美國人屬於超重或肥胖，治療代謝綜合徵的藥品市場巨大，許多藥物存在安全問題，被 FDA 拒絕批准。

We hope that SPX106T will prove to be safe and effective, and ultimately garner very meaningful sales. We also recognize that the growth of Spherix can't rest upon one drug, and we are diligently working to broaden our pipeline of later-stage products, while being mindful of our resources. We look forward to updating you in the coming months. With that, we'll open up the call for questions. Operator?

我們希望 SPX106T 能夠被證明是安全有效的，並最終獲得非常有意義的銷售。我們還認識到 Spherix 的增長不能依賴於一種藥物，我們正在努力擴大後期產品的管道，同時注意我們的資源。我們期待在未來幾個月內向您通報最新情況。至此，我們將開始提問。操作員？

(Operator Instructions). Your first question comes from the line of Jason Napodano of Zacks.

（操作員說明）。你的第一個問題來自 Zacks 的 Jason Napodano。

So, a question about the data presented in March. You showed arrested development and reduced atherosclerotic plaque in mice fed the western diet, when substituted, or when treated with SPX106T. Just a question on the design of the study. The control mice received the western chow, but the test mice received the western chow less sucrose plus tagatose plus SPX106. Why was the study run that way? Why wasn't the mice given a standardized chow, where either all mice were given sucrose or given the standard chow, or the sucrose was taken away? And the reason I ask that question is because it's difficult to tell if the reductions that you saw in the plaque was a factor of the addition of tagatose, the addition of 106 or simply the lack of sucrose in the test mice.

那麼，關於三月份提供的數據的問題。您發現，在用西方飲食餵養、替代飲食或用 SPX106T 治療的小鼠中，小鼠的發育受到抑制，動脈粥樣硬化斑塊減少。只是關於研究設計的問題。對照小鼠接受西方食物，但測試小鼠接受較少蔗糖加塔格糖加SPX106的西方食物。為什麼研究要這樣進行？為什麼不給小鼠提供標準化的食物，要么給所有小鼠餵食蔗糖，要么給它們標準的食物，要么把蔗糖拿走？我問這個問題的原因是因為很難判斷你在斑塊中看到的減少是否是添加塔格糖、添加 106 或僅僅是測試小鼠中缺乏蔗糖的一個因素。

So the question is about standard diet, you're talking about laboratory chow like TD2014 or TD2016 as an alternative?

所以問題是關於標準飲食，您是在談論像 TD2014 或 TD2016 這樣的實驗室食物作為替代嗎？

That's the chow?

這就是周公？

Yes.

是的。

Yes, so I mean my question is, if you're going to do the test to show that SPX106 reduces plaque or arrested development, then why weren't the two groups of mice given the same exact chow? Why take out the sucrose in the mice that were given tagatose and 106? And again, the reason I ask that is, if you had done a study where you had just given 50% of the mice western chow and the other 50% of the mice western chow with no sucrose added, with the sucrose removed, what would those results have been? You might have shown a reduction in plaque in simply those mice.

是的，所以我的意思是，我的問題是，如果您要進行測試來證明 SPX106 減少斑塊或阻止發育，那麼為什麼不給兩組小鼠提供完全相同的食物？為什麼要取出給予塔格糖和106的小鼠體內的蔗糖？再說一次，我問這個問題的原因是，如果你做了一項研究，你剛剛給 50% 的老鼠餵西方食物，另外 50% 的老鼠餵不添加蔗糖的西方食物，去掉蔗糖，結果會怎樣？那些結果得到了？您可能已經發現這些小鼠的斑塊減少了。

Well but it wouldn't be western chow without the sucrose, unless you added some other carbohydrate. In our case, that carbohydrate was tagatose, so western diet has to be high in fat and has to be high in carbs. So, I mean that's why I asked about TD2014, which is not high in fat or carbs, and the mice don't get atherosclerosis on that. So what we're trying to do is design an intervention for the diet that people eat, and if people would eat healthy, we wouldn't have any market for our drug maybe, except for the orphan cases, the familial hypercholesterolemia, that wouldn't be nearly the market, but we're trying to create a situation that parallels what humans in the US are really like, not what we would like them to be like.

好吧，但是沒有蔗糖就不是西方食物了，除非你添加一些其他碳水化合物。在我們的例子中，碳水化合物是塔格糖，所以西方飲食必須含有高脂肪和高碳水化合物。所以，我的意思是，這就是為什麼我詢問 TD2014，它的脂肪或碳水化合物含量不高，而且小鼠不會因此而患上動脈粥樣硬化。因此，我們正在嘗試做的是針對人們的飲食設計一種干預措施，如果人們飲食健康，我們的藥物可能就沒有任何市場，除了孤兒病例，家族性高膽固醇血症，這不會我們不會接近市場，但我們正在努力創造一種與美國人的真實情況相似的情況，而不是我們希望他們是什麼樣的情況。

Okay, so once you get into human trials, obviously, like you said, controlling that food intake or call it chow is impossible, so what would happen in the average--?

好吧，一旦你進入人體試驗，顯然，就像你說的那樣，控制食物攝入量或稱其為食物是不可能的，那麼平均會發生什麼——？

Well the average human in the US that you enroll is not going to be vegetarian. They are going to be eating a high fat, high carb diet.

那麼，你所登記的美國普通人不會是素食主義者。他們將吃高脂肪、高碳水化合物的飲食。

Right, so would you have seen the significant reductions if those mice or humans were eating a high carb, high fat diet that included sucrose but then also given tagatose and SPX106?

是的，那麼，如果這些小鼠或人類吃的是包含蔗糖的高碳水化合物、高脂肪飲食，但同時又添加了塔格糖和 SPX106，您是否會看到顯著的減少？

So I guess you're asking are we going to have to supplement?

所以我猜你會問我們是否需要補充？

Well I think he's asking, we've actually done some studies, we're looking into the mechanism by which tagatose actually competes with other sugars at the level of the gut and the liver. To demonstrate that in combination, it would have an efficacious result, because it's going to reduce your body's ability to use those other sugars to create lipids.

嗯，我認為他是在問，我們實際上已經做了一些研究，我們正在研究塔格糖在腸道和肝髒水平上與其他糖實際競爭的機制。為了證明這一點，結合起來，它會產生有效的結果，因為它會降低你的身體利用其他糖來產生脂質的能力。

We announced that, right? About one third, so if you give fructose for example, versus tagatose, you can displace about one third of the other sugar, uptake of the other sugar with tagatose.

我們宣布了這一點，對嗎？大約三分之一，所以如果你給予果糖，而不是塔格糖，你可以用塔格糖取代大約三分之一的其他糖，即其他糖的吸收。

Okay that was essentially the hypothesis before testing tagatose in the treatment of diabetes.

好吧，這本質上是在測試塔格糖治療糖尿病之前的假設。

Yes, basically the same hypothesis, except now we're going past the carbohydrate part and to the part where triglycerides are formed and MTP forms, via LDL down to the fat pathway.

是的，基本上是相同的假設，只是現在我們要越過碳水化合物部分，進入甘油三酯形成和 MTP 形成的部分，通過 LDL 進入脂肪途徑。

Okay. And so now that you've got this data that shows a reduction in plaque, you've got data from last year showing reduced cholesterol, both the LDL, VDL, you've got reductions in subcutaneous fat, and you've got good safety data, at least certainly we know the safety of tagatose, so two questions I guess. Can you give us a sense of the safety profile of 106? I know, I can't remember if you said it's been tested in humans. What kind of Phase I essentially Phase I pure safety study would you need to do to test before you kind of advanced into proof of concept stuff with 106 or 106T, and then when you do enter human trials, given all of the data that you've got so far, what is the proposed indication or what are you looking to show when you demonstrate that proof of concept?

好的。現在，您已經獲得了顯示斑塊減少的數據，您還獲得了去年的數據，顯示膽固醇（LDL、VDL）減少，皮下脂肪減少，並且您的身體狀況良好安全數據，至少我們肯定知道塔格糖的安全性，所以我猜有兩個問題。您能給我們介紹一下106的安全性嗎？我知道，我不記得你是否說過它已經過人體測試。在你進入 106 或 106T 的概念驗證之前，你需要進行什麼樣的第一階段本質上的第一階段純安全性研究來測試，然後當你進入人體試驗時，考慮到你的所有數據到目前為止，建議的指示是什麼，或者當您演示概念驗證時您希望展示什麼？

Well the safety of SPX106 from our research so far is quite good. It is something that humans are exposed to, in albeit small quantities, because it is present in the food supply, a very, very small quantity. There is information we would be able to glean from the literature that helps support the safety profile that we understand, and our 28-day study was done at exaggerated doses that gives us what we believe is really an ample margin of safety to go into humans. As Rob indicated, we did not only toxicology but we had a pharmacokinetic arm, so we looked at the body's ability to ingest it and excrete it very, very rapidly, so we don't believe we have any undue adverse effects over the long term by virtue of the fact that it would be stored. It's rapidly excreted, so this is going to allow us to go into what we would like to do in our first study is a pharmacokinetic profile, to show its handling in humans to confirm that it is the same as the information that we have. It speaks to the pharmacokinetic handling in animal models.

從我們目前的研究來看，SPX106 的安全性是相當好的。它是人類接觸到的東西，儘管數量很少，因為它存在於食物供應中，數量非常非常少。我們可以從文獻中收集到一些信息，這些信息有助於支持我們所理解的安全性概況，而且我們為期 28 天的研究是在誇大的劑量下進行的，這為我們提供了我們認為確實有足夠的安全裕度用於人體。正如羅布指出的那樣，我們不僅進行了毒理學研究，而且還建立了藥代動力學臂，因此我們研究了身體攝入它並非常快速地排泄它的能力，因此我們認為從長遠來看，我們不會產生任何不當的副作用因為它將被存儲。它會迅速排出體外，因此這將使我們能夠在第一項研究中進行藥代動力學分析，以顯示其在人體中的處理情況，以確認它與我們所掌握的信息相同。它涉及動物模型中的藥代動力學處理。

We're looking at basically a single ascending dose study for the first one, with safety evaluated at each step.

我們基本上正在研究第一個單一劑量遞增研究，並在每個步驟中評估安全性。

Got you, okay. And then as far as when you look to move into a Phase II study to show proof of concept, what are your initial thoughts on what kind of indication you would be looking at? Because like your pre-clinical data looks great so far but you've got four or five different potential indications there between cholesterol, dyslipidemia, plaque, fat, it's a broad range. I'm wondering what your first shot on goal will be.

明白你了，好吧。然後，當您希望進入第二階段研究以展示概念驗證時，您對您將關注哪種適應症的初步想法是什麼？因為到目前為止，您的臨床前數據看起來不錯，但在膽固醇、血脂異常、斑塊、脂肪之間有四到五種不同的潛在跡象，這是一個廣泛的範圍。我想知道你的第一次射門會是什麼。

Well we are looking to define an orphan population for use of this combination, and as you alluded to, yes, we do have some information from animal studies that may be something that we would look at over the long term, but our first shot on goal, as you say, would really be to look at the more immediate effects on the dyslipidemic endpoints, for example, triglycerides and cholesterol as our first proof of concept in humans.

好吧，我們正在尋求定義使用這種組合的孤兒群體，正如您所提到的，是的，我們確實從動物研究中獲得了一些信息，這些信息可能是我們長期關注的內容，但我們的第一次嘗試正如你所說，目標實際上是研究對血脂異常終點的更直接影響，例如甘油三酯和膽固醇，作為我們在人類中的第一個概念證明。

And that's an orphan? I mean those aren't orphan indications, I guess, unless you go into what Rob said which is a familial hypercholesterolemia?

而且還是個孤兒？我的意思是，我想這些都不是孤兒適應症，除非你深入了解羅布所說的家族性高膽固醇血症？

Right. Genetic subtypes is what we're looking at.

正確的。我們正在研究的是遺傳亞型。

And you would do that because it's what, cheaper and quicker to get to market than because those clearly by definition, the orphan market is a smaller market compared to the general population.

你會這樣做，因為它比一般人群更便宜、更快地進入市場，因為根據定義，孤兒市場是一個較小的市場。

Yes, absolutely. It's a good first step for our Company to do something in a much more manageable size, faster, and then that of course that once we get that information, one could always broaden--

是的，一點沒錯。對於我們公司來說，以更易於管理的規模、更快地做一些事情是一個很好的第一步，當然，一旦我們獲得了這些信息，我們就可以隨時擴大範圍——

And then you have some revenue and you could do bigger studies with a different broader population.

然後你就有了一些收入，你可以對更廣泛的不同人群進行更大規模的研究。

Got you. Okay. Makes perfect sense. Thank you.

明白你了。好的。很有道理。謝謝。

(Operator Instructions). There are no further questions at this time. Please proceed with your presentation, or any closing remarks.

（操作員說明）。目前沒有其他問題。請繼續您的演講或任何結束語。

Thank you, Operator. We believe that we've made excellent progress in rebuilding our product pipeline following the FDA's change in requirements for diabetes drug approvals, that impacted our plans for D-tagatose, despite its clean safety profile and efficacious Phase III results. As we broaden our pipeline, we're mindful of choosing projects with a dependable path to commercialization. I wish you all a good day.

謝謝你，接線員。我們相信，在 FDA 改變糖尿病藥物審批要求之後，我們在重建產品管道方面取得了巨大進展，這影響了我們的 D-塔格糖計劃，儘管它具有良好的安全性和有效的 III 期結果。當我們擴大管道時，我們會注意選擇具有可靠商業化途徑的項目。祝大家有美好的一天。

Ladies and gentlemen, that concludes your conference call for today. We thank you for your participation, and ask that you please disconnect your lines.

女士們、先生們，今天的電話會議到此結束。我們感謝您的參與，並請您斷開線路。