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Lobe Sciences, Ltd. Announces the Acquisition of Altemia(TM) & Company

Lobe Sciences, Ltd. Announces the Acquisition of Altemia(TM) & Company

Lobe Sciences, Ltd. 宣佈收購 Altemia (TM) & Company
newsfile ·  2023/04/18 21:01
  • Move Affirms Lobe's Position as an Orphan/Rare Disease Drug Development Company and expands portfolio to include 4 Orphan Disease Programs
  • The Company expects to Launch Altemia, a Medical Food, and Generate Commercial Revenue in the Second Half of 2023
  • Acquisition also Includes an International License Agreement With Double Digit Royalty and Milestone Payments, Commercial Inventory and Intellectual Property.
  • Move 確認了 Lobe 作爲孤兒/罕見病藥物開發公司的地位,並將產品組合擴大到包括 4 個孤兒病項目
  • 該公司預計將在2023年下半年推出醫療食品Altemia併產生商業收入
  • 收購還包括一項包含兩位數特許權使用費和里程碑付款、商業庫存和知識產權的國際許可協議。

Vancouver, British Columbia--(Newsfile Corp. - April 18, 2023) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical Company committed to discovering and developing patient-focused medicines for Orphan and Rare diseases today announced that it has signed a share purchase agreement to acquire a 100% interest in Altemia & Company, LLC ("Seller") which includes all assets, know-how, intellectual property and commercial inventory of the Seller (the "Transaction") to manage patients suffering from Sickle Cell Disease ("SCD"). The Seller has no current or long-term liabilities.

不列顛哥倫比亞省溫哥華--(Newsfile Corp.——2023年4月18日)——致力於發現和開發以患者爲中心的孤兒和罕見病藥物的北美生物製藥公司Lobe Sciences Ltd.(CSE:LOBE)(OTCQB:LOBE)(“LOBE” 或 “公司”)今天宣佈,它已簽署股份購買協議,收購Altemia & Company, LLC的100%權益(“賣方”),包括賣方用於管理鐮狀細胞患者的所有資產、專有技術、知識產權和商業庫存(“交易”)疾病(“SCD”)。賣方沒有當前或長期負債。

Mr. Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "Starting in the second half of 2023 we will launch our first commercial product, a medical food called Altemia for the management of SCD. This product has been well studied in human clinical trials. It is a proprietary, patent pending formulation based on decades of research and will add commercial revenue this year and beyond. By targeting the 55 major SCD clinics in the United States we will be able to efficiently provide support and education for clinicians and other health care providers charged with treating this vulnerable population. As we prepare for launch and commercialization, I will be able to call upon my previous successes launching and selling Orphan Drugs in specialty markets. Altemia will be positioned as a cost-effective medical food option for patients and payers seeking alternatives to drug products with significant side effects. We will be announcing further information related to our commercial plans shortly. In addition to Altemia we have acquired a clinical stage asset, SAN100 which is being developed as a prescription drug alternative for the treatment of SCD uniquely in children. This indication may qualify for the Pediatric Priority Review Voucher."

公司董事長兼首席執行官Philip J. Young先生表示:“從2023年下半年開始,我們將推出我們的第一款商業產品,一種名爲Altemia的醫療食品,用於管理SCD。該產品已在人體臨牀試驗中得到充分研究。這是一種基於數十年研究的專有配方,正在申請專利,將在今年及以後增加商業收入。通過瞄準美國55家主要的SCD診所,我們將能夠有效地爲負責治療這些弱勢羣體的臨牀醫生和其他醫療保健提供者提供支持和教育。在我們爲上市和商業化做準備時,我將能夠回顧我之前在專業市場推出和銷售孤兒藥的成功經驗。Altemia將成爲尋求具有重大副作用的藥物替代品的患者和付款人的一種具有成本效益的醫療食品選擇。我們將很快宣佈與我們的商業計劃有關的更多信息。除了 Altemia 之外,我們還收購了臨牀階段資產 SAN100,該資產正在開發中,是專門用於治療兒童 SCD 的處方藥替代品。該適應症可能有資格獲得兒科優先審查券。”

Maghsoud Dariani, CSO of the Company added "SCD affects approximately 100,000 patients in the United States and millions more across the globe. ( 04102023) Altemia must be used under the direct care of medical professionals who are required to write a prescription for the product. Obtaining safe and effective treatments to lessen the debilitating effects of this disease is a constant struggle for patients globally. We believe that Altemia and our follow-on prescription product, SAN100, will become an important component in the daily lives of patients with SCD around the world."

該公司首席科學官馬格蘇德·達里亞尼補充說:“SCD影響美國約10萬名患者,全球還有數百萬患者。(04102023)Altemia必須在醫療專業人員的直接護理下使用,他們需要爲該產品開處方。對於全球患者來說,要獲得安全有效的治療以減輕這種疾病的衰弱性影響是一項持續的鬥爭。我們相信,Altemia和我們的後續處方產品 SAN100 將成爲全球SCD患者日常生活中的重要組成部分。”

"I began research in the fundamentals of SCD over 12 years ago and believe that the disease has been misunderstood," said Dr. Sancilio, Founder and President of Altemia and Company, LLC. He went on to say that "During the last several years, our team began to realize that SCD could be managed with consumption of docosahexaenoic acid ethyl ester, but due to its lack of bioavailability, consumption of amounts that could affect SCD were nearly impossible. It would require a patient to consume up to 10 huge soft gelatin capsules of prescription products each day to match a single dose of Altemia. The search for a super-bioavailable form of this fatty acid led to a technology using a natural emulsification process that was adapted for this new product. By using this formulation and triglyceride esters instead of the ethyl ester, we can provide the equivalent of 10 or more soft gels in one packet of Altemia." Clinical trials were initiated in 2021 and completed recently showing Altemia to significantly reduce C-reactive protein in patients after the first month of intervention. C-reactive protein is a biomarker related to inflammation and when controlled may impart a positive effect for SCD sufferers. This led to patent filings and soon after, license agreements with distributors in Europe and elsewhere."

Altemia and Company, LLC的創始人兼總裁桑西里奧博士說:“我在12年前開始研究SCD的基礎知識,並認爲這種疾病被誤解了。”他接着說:“在過去的幾年中,我們的團隊開始意識到食用二十二碳六烯酸乙酯可以控制SCD,但由於其缺乏生物利用度,幾乎不可能食用可能影響SCD的量。這將需要患者每天服用多達10粒裝有處方產品的巨大軟明膠膠囊,才能與單劑量的Altemia相匹配。在尋找這種脂肪酸的超級生物利用形式的過程中,開發了一種採用天然乳化工藝的技術,該技術適用於這種新產品。通過使用這種配方和甘油三酯代替乙酯,我們可以在一包Altemia中提供相當於10種或更多的軟凝膠。”臨牀試驗於2021年啓動,最近完成,表明在干預的第一個月後,Altemia可以顯著降低患者的C反應蛋白。C反應蛋白是一種與炎症相關的生物標誌物,如果得到控制,可能會對SCD患者產生積極影響。這促成了專利申請,不久之後又與歐洲和其他地方的分銷商簽訂了許可協議。”

He went on to say "I am very happy to complete this transaction with Mr. Young and the Lobe team. Our group has invested a lot of time and several million dollars to bring us to the commercial launch phase of our first product. It's great to know that Mr. Young will be managing the sales and distribution of this product, allowing our development team to focus on its own strength." Altemia was designed with patented Natural Emulsion Technology (NET) allowing consistent and reliable fatty acid bioavailability. Altemia is simple to administer - a small daily packet of a great tasting cream is taken by mouth or mixed with food daily.

他接着說:“我很高興與楊先生和Lobe團隊完成這筆交易。我們的團隊投入了大量時間和數百萬美元,使我們進入了第一款產品的商業發佈階段。很高興得知楊先生將管理該產品的銷售和分銷,使我們的開發團隊能夠專注於自己的優勢。”Altemia 採用專利天然乳化技術 (NET) 設計,可實現穩定可靠的脂肪酸生物利用度。Altemia 易於服用——每天口服或與食物混合服用一小包美味的奶油。

Mr. Young concluded, "This transaction will transform our company into a revenue generating biotech company committed to treating Orphan Diseases and separating Lobe from the myriad of clinical stage companies in North America and Europe. We will be able to use the revenue from the SCD sales to fund ongoing and planned clinical activities with L-130 and L-131. I look forward to providing updates as we move forward with the planning and launch of Altemia for the treatment of Sickle Cell Disease."

楊先生總結說:“這筆交易將把我們公司轉變爲一家創收的生物技術公司,致力於治療孤兒病,並將Lobe與北美和歐洲的衆多臨牀階段公司分開。我們將能夠使用 SCD 銷售收入爲正在進行和計劃中的 L-130 和 L-131 臨牀活動提供資金。在我們推進用於治療鐮狀細胞病的Altemia的規劃和推出過程中,我期待提供最新信息。”

Terms of the Agreement

協議條款

Pursuant to the Agreement, Altemia shareholders will receive total consideration of $3,800,000 through the issuance on a pro-rata basis of an aggregate of 76,000,000 common shares of Lobe (each a "Lobe Share") at a deemed issue price of $0.05 per Lobe Share. All Lobe Shares to be issued will be subject to contractual restrictions on transfer, pursuant to which 25% of the Lobe Shares issued will be transferable on the closing of the Transaction and further 25% on delivery of inventory to a Lobe designated storage facility; 25% on the first commercial sale allowing the trademark validation; and 25% on successful completion of SAN100 Tech Transfer Documentation (batch records for R&D batch) and Samples of SAN100 are delivered to Lobe.

根據該協議,Altemia股東將通過按比例發行總計7600,000股Lobe普通股(每股爲 “Lobe Share”),獲得380萬美元的總對價,總對價爲380萬美元,每股Lobe的認定發行價爲0.05美元。所有即將發行的Lobe股票都將受到合同的轉讓限制,根據該限制,已發行的Lobe股票中有25%可在交易完成時轉讓,另外25%在向Lobe指定的存儲設施交付庫存時可轉讓;在允許商標驗證的首次商業銷售中,有25%可轉讓;在成功完成 SAN100 技術轉讓文檔(研發批次的批量記錄)和 SAN100 樣品後可轉讓25%。

Lobe will pay a tiered royalty of up to 10% on annual net sales of $125,000,000 or more and issue 3,000,000 warrants upon the first achievement of $20,000,000 in annual sales. The transaction also provides a 5% payment on the net sales revenue received for the sale of a Pediatric Priority Review Voucher for the approval of our SCD prescription drug for the Pediatric Orphan indication.

Lobe將對年淨銷售額1.25億美元或以上的分級特許權使用費支付高達10%的分級特許權使用費,並在首次實現2000萬美元的年銷售額時發行300萬份認股權證。該交易還爲出售兒科優先審查券所獲得的淨銷售收入支付5%,用於批准我們的用於兒科孤兒適應症的SCD處方藥。

The Transaction will be completed pursuant to exemptions from the prospectus and registration requirements under applicable securities laws. None of the Lobe Shares issued to Altemia shareholders in connection with the Transaction will be registered under the United States Securities Act of 1933, as amended, and none may be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any Lobe Shares, nor shall there be any distribution of Lobe Shares in any jurisdiction in which such offer, solicitation or sale would be unlawful.

該交易將根據適用的證券法規定的招股說明書和註冊要求的豁免完成。根據經修訂的1933年《美國證券法》,向Altemia股東發行的與交易相關的Lobe股票均不予註冊,如果沒有註冊或此類註冊要求的適用豁免,則不得在美國發行或出售任何股票。本新聞稿不構成出售要約或徵求購買任何Lobe Shares的要約,也不得在任何非法的司法管轄區進行Lobe Shares的分配。

Shares for Debt

以股票換債務

The Company also announced that on April 14, 2023, pursuant to the January 23, 2023 press release, it issued 2,166,000 common shares at a deemed price of $0.05 per common share to the Company's directors as settlement of directors fees payable of $108,300.

公司還宣佈,根據2023年1月23日的新聞稿,它於2023年4月14日以每股普通股0.05美元的認定價格向公司董事發行了2166,000股普通股,作爲應付董事費108,300美元的結算。

About Altemia

關於 Altemia

Altemia is a trademark registered to Altemia and Company, LLC of Stuart Florida. Altemia is the brand name of a patent pending oral emulsion consisting of a proprietary mixture of polyunsaturated fatty acid triglyceride esters clinically evaluated to reduce inflammation associated in adults with SCD. The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." SCD is among a few inborn errors of metabolism specifically named in legislation that qualifies as treatable with medical foods. More information is available at . This product should not be confused with a previous product development program with a similar name. That program also called Altemia (SC411) was the project name used during the development of a drug product to treat SCD in children.

Altemia 是佛羅里達州斯圖爾特的 Altemia and Company, LLC 註冊的商標。Altemia 是一種正在申請專利的口服乳液的品牌名稱,該乳液由多不飽和脂肪酸甘油三酯的專有混合物組成,經過臨牀評估,可減少成人患有 SCD 的炎症。根據《孤兒藥法》(21 U.S.C. 360ee (b) (3))第5(b)條的定義,醫療食品一詞是 “一種配製爲在醫生監督下食用的食品,旨在對根據公認的科學原理通過醫學評估確定特殊營養要求的疾病或病症進行特定飲食管理。”SCD 是立法中特別提及的少數幾種有資格用醫療食品治療的先天代謝錯誤之一。更多信息可在以下網址獲得 不應將本產品與以前具有相似名稱的產品開發程序混淆。該項目也被稱爲Altemia(SC411),是開發治療兒童SCD的藥物產品時使用的項目名稱。

About Sickle Cell Disease

關於鐮狀細胞病

SCD is a group of hereditary red blood cell disorders. Healthy red blood cells are round, and they move through small blood vessels to carry oxygen to all parts of the body. In someone who has SCD, the red blood cells (RBC) become inflamed under certain stress conditions resulting in among other symptoms, an increase of C-Reactive Protein (a biomarker for SCD). Inflammation causes the RBC's membrane to become hard and sticky, and this tends to slow or even block blood flow in the blood vessels (capillaries) of the limbs and organs. This slowing of the blood cells causes a cascade of events that results in pain and vaso-occlusive event (VOC). The sickle cells also die earlier than normal red blood cells and the bone marrow cannot make enough new red blood cells to replenish the dying ones, which causes a constant shortage of red blood cells called anemia. Blocked blood flow may cause pain and other serious problems such as infection, acute chest syndrome and stroke. Populations that suffer from SCD have a shortened life span. According to the CDC, it is estimated that SCD affects approximately 100,000 individuals in the United States, occurring among approximately 1 out of every 500 Black or African American births and 1 out of every 36,000 Hispanic American births. A similar number of patients are affected in Europe. There are millions of patients in the Middle East, Africa and India. Lobe plans to sell the product globally, either directly or through partners.

SCD 是一組遺傳性紅細胞疾病。健康的紅細胞是圓形的,它們通過小血管移動,將氧氣輸送到身體的各個部位。在患有 SCD 的人中,紅細胞(RBC)在某些壓力條件下會發炎,從而導致除其他症狀外,還會增加 C 反應蛋白(SCD 的生物標誌物)。炎症會導致紅細胞膜變硬變粘,這往往會減緩甚至阻塞四肢和器官血管(毛細血管)中的血液流動。血細胞的這種減慢會導致一系列事件,從而導致疼痛和血管閉塞事件 (VOC)。鐮狀細胞的死亡時間也比正常的紅細胞早,骨髓無法產生足夠的新紅細胞來補充即將死亡的紅細胞,這會導致紅細胞持續短缺,稱爲貧血。血流阻塞可能導致疼痛和其他嚴重問題,例如感染、急性胸部綜合症和中風。患有 SCD 的人羣壽命縮短。根據美國疾病預防控制中心的數據,據估計,在美國,大約每500名黑人或非裔美國人新生兒中就有1人患有SCD,每36,000名西班牙裔美國人新生兒中就有1人患有SCD。在歐洲,也有類似數量的患者受到影響。中東、非洲和印度有數百萬患者。Lobe計劃直接或通過合作伙伴在全球銷售該產品。

About Lobe Sciences Ltd.

關於洛博科學有限公司

Lobe Sciences is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness. Each of our New Chemical Entities, L-130 and L-131, are being developed to address unmet medical needs in neurological therapeutic applications.

Lobe Sciences 是一家生物製藥公司,專注於開發對患者友好、實用的迷幻藥物。該公司通過與行業領先的合作伙伴合作,使用亞幻覺劑量的迷幻化合物進行藥物研發,並開發改善心理健康和健康的創新設備和遞送機制。我們的每種新化學實體,L-130 和 L-131,都是爲了滿足神經治療應用中未得到滿足的醫療需求而開發的。

For further information please contact:

欲瞭解更多信息,請聯繫:

Lobe Sciences Ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

洛博科學有限公司
首席執行官菲利普·楊
info@lobesciences.com
電話:(949) 505-5623

NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

CSE 及其監管服務提供商均未審查本新聞稿的準確性或充分性或承擔責任。

This does not constitute an offer to sell or a solicitation of offers to buy any securities.

這不構成賣出要約或徵求購買任何證券的要約。

Forward Looking Statements

前瞻性陳述

This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at . As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.

本新聞稿包含與公司未來運營有關的前瞻性陳述以及其他非歷史事實的陳述。前瞻性陳述通常由 “意願”、“可能”、“應該”、“預期”、“期望” 等術語和類似表達方式來識別。除本新聞稿中包含的歷史事實陳述(包括但不限於有關公司未來計劃和目標、迷幻化合物的研發以及改善心理健康和福祉的創新設備和交付機制的開發的陳述)以外的所有陳述均爲涉及風險和不確定性的前瞻性陳述。無法保證此類陳述會被證明是準確的,實際結果和未來事件可能與此類陳述中的預期存在重大差異。提醒讀者,在準備前瞻性陳述時使用的假設可能不正確。由於許多已知和未知的風險、不確定性和其他因素,事件或情況可能導致實際業績與預測存在重大差異,其中許多因素是公司無法控制的,包括監管環境的變化;公司的藥物研發活動可能不成功;由公司或代表公司生產的藥物和醫療器械可能無法按預期或根本無法按預期的方式運作,並可能使公司受到影響產品責任或其他責任索賠;公司可能無法實現公司的公司目標和目標;以及公司不時提交的持續披露文件中詳述的其他風險因素,如公司簡介所示 。因此,公司無法保證任何前瞻性陳述都能兌現,並提醒讀者不要過分依賴任何前瞻性信息。本警示聲明明確限制了本新聞稿中包含的前瞻性陳述。本新聞稿中包含的前瞻性陳述僅在本新聞稿發佈之日作出,除非適用的加拿大證券法明確要求,否則公司不打算更新所包含的任何前瞻性陳述。

Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This news release may contain certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company's development efforts to date. In addition to the risk factors set out above and those detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at , other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Lobe has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements.

藥物開發需要很長的準備時間,非常昂貴,並且涉及許多不確定性變量。藥物開發的預期時間表基於合理的假設,這些假設是根據公司當前的知識和信息得出的。未來研究中接受治療的每位患者都可以積極改變這些假設(表明新藥申請和其他批准的時間更短),也可以消極地改變這些假設(表明新藥申請和其他批准的時間較短)。本新聞稿可能包含有關預期或可能的藥物開發時間表的某些前瞻性陳述。除其他外,此類聲明以開發藥物的監管指導方針爲依據,包括安全性研究、概念驗證研究以及新藥申請提交和批准的關鍵研究,並假設此類研究在指導方針、其他行業示例以及公司迄今爲止的開發努力所規定的時間表內成功實施和取得成果。除了上面列出的風險因素以及公司不時提交的持續披露文件中詳述的風險因素外,公司概況載於以下網址 ,其他目前不被視爲實質性的因素可能導致實際業績與前瞻性陳述中描述的結果存在重大差異。儘管洛伯試圖確定可能導致實際行爲、事件或結果與前瞻性陳述中描述的存在重大差異的重要風險和因素,但可能還有其他因素和風險導致行動、事件或結果無法預期、估計或預期。因此,讀者不應過分依賴前瞻性陳述。

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譯文內容由第三人軟體翻譯。


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