附錄99.1
Talphera宣布2024年第二季度財務業績並提供企業更新。
NEPHRO CRRt研究患者篩選已在多個臨床站點啟動
nafamostat的安全性和有效性正在NEPHRO CRRt的註冊性研究中評估，在最多14個臨床研究站點中，共有166名患者參與。
2024年6月30日的現金與投資總額為1400萬美元
將於2024年8月14日（星期三）下午4:30（美東時間）舉行電話會議和網絡直播。
2024年8月14日，加州聖馬特奧 - 鈹公司（納斯達克股票代號：TLPH）（「鈹公司」），一家專注於醫療監督環境中開發和推廣創新療法的特殊藥品公司，宣佈了2024年第二季度財務業績並提供了企業更新。
「我們很高興已在多個臨床研究機構展開NEPHRO CRRt登記研究的患者篩選。我們現已與八家大型學術機構敲定了臨床試驗協議條款，其中包括我們潛在招募量最高的研究機構。我們還獲得了FDA批准，將研究地點的最大數量從10增加到14，我們相信這將有助於加快完成研究，」Talphera的首席執行官Vince Angotti表示。「NEPHRO研究應該能夠高效完成，因為主要終點的測量在24小時後進行，患者在72小時後完成研究。此外，獲得FDA的突破性設備指定有望為明年產品候選者的及時批准提供優勢。Nafamostat有潛力補充目前美國可用抗凝劑產品已知的不足之處，在日本和韓國已經作為標準護理使用超過30年。如果獲批，我們期待將nafamostat提供給美國的醫療保健提供者，」Angotti繼續說。
塔爾斐拉公司的首席研發官Shakil Aslam博士自加入公司以來一直領導NEPHRO CRRt研究。Aslam博士在腎臟病學方面的專業知識以及在學術界和藥物和器械研發領域的20年經驗已被證明是一個資產。NEPHRO研究的監督工作從首席醫學官Palmer博士轉交給Aslam博士，Palmer博士在此職位上任近兩個十年後將在十月養老。在Palmer博士退休之後，Aslam博士將接替她擔任塔爾斐拉公司的首席醫學官，而Palmer博士將繼續作為該公司的顧問，直至NEPHRO研究完成。
藉著董事會和整個組織的名義，我想感謝Pam在公司服務多年以來的領導和奉獻。我們祝她在共同創立Talphera並在過去19年在董事會和首席醫療官的職務上付出後，養老生活盡如人意。Pam一直是公司背後的科學和醫療推動力，成功獲得美國的藥品批准以及兩個歐洲的藥品批准。能與Palmer博士一起工作是一種榮幸，我很感激Pam同意留任顧問，直到NEPHRO研究完成。此外，我們很高興有Aslam博士加入。Shakil已為Talphera做出重大貢獻，包括加快NEPHRO研究進度。Vince Angotti表示。
2024年第二季度及最近要聞
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NEPHRO CRRt註冊研究已在多個臨床研究站點啟動篩選。NEPHRO CRRt研究將招募166名正在美國境內最多14家臨床研究站點接受連續腎臟替代治療（CRRT）的患者。該研究的主要終點是對比於安慰劑的nafamostat在首24小時內對充注有滑膜激活成活時間的平均後過濾器。 |
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已最終敲定與八家大型學術機構的臨床試驗協議條款，其中最初八家機構的最後四家啟動拜訪預計將在本月完成。 |
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Shakil Aslam博士於2024年5月20日加入Talphera，擔任首席開發官。Aslam博士在廣泛的治療領域擁有超過20年的臨床和研究經驗，包括腎臟和血管疾病以及急性腎損傷。他從biocryst製藥公司加入Talphera，擔任臨床開發、腎臟學和罕見疾病副總裁。Aslam博士先前在Angion Biomedica、費森尤斯醫療和安進擔任職位，並在喬治城大學醫院擔任助理教授十二年，專注於急性和慢性腎臟疾病、高血壓、腎臟移植和其他腎臟疾病。 |
2024年第二季財務信息
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現金，現金等價物和投資餘額截至2024年6月30日為1400萬美元。 |
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2024年第二季的研發和S＆A費用總額為430萬美元，較2023年第二季的420萬美元有所增加。在不包括非現金股票酬勞費用的情況下，2024年第二季的金額為400萬美元，較2023年第二季的380萬美元有所增加。2024年第二季結合研發和S＆A費用的增加主要是由於與Niyad開發相關的成本增加。 |
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在2024年第二季，公司認列持續業務淨虧損380萬美元，相較於2023年第二季的淨虧損440萬美元，主要是由於公司認股權負債公允價值變動所致。 DSUVIA的出售代表了已停止的操作；因此，所有業務的歷史營運結果均反映在已停止的業務內。在2024年第二季並沒有與DSUVIA相關的費用。 |
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2024年第二季度歸屬於普通股股東的淨虧損為380萬美元，每股基本和稀釋份額為0.15美元，較2023年第二季度的440萬美元淨損，每股基本和稀釋份額為0.40美元。 |
會議看漲和網路轉播資訊
Talphera將在東部日光節約時間下午4:30 / 太平洋日光節約時間下午1:30進行電話會議和網絡直播，討論業績並提供有關公司業務的最新消息。
希望參加公司的投資者可以撥打1-800-836-8184與北美的投資者看漲，或是撥打1-646-357-8785（適用收費）與加拿大以外的國際投資者看漲。會議ID為28132。網路直播可以透過 點此 造訪公司網站的投資者部門 www.talphera.com ，並在投資者/資訊與活動/即將舉行活動部分中點擊網路直播的鏈結。網路直播將包括幻燈片展示，活動結束後將於Talphera網站提供90天的回放。
關於Talphera, Inc.
Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA).
This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com.
About Niyad and nafamostat
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera’s registrational study of Niyad™ is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets.
About the NEPHRO CRRT Study
The NEPHRO Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.
Forward-looking statements
This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as “believe,” “expect,” “finalize,” “may,” “if,” “intends,” “plans,” “potential,” ”projected,” “will,” or the negative of these words or other comparable terminology, and include: Talphera’s expectation that the NEPHRO study will enroll and complete efficiently, the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, and the potential advantage of having Breakthrough Device Designation and potential FDA approval of the nafamostat product candidate. Talphera’s discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera’s developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera’s ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption “Risk Factors” and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the “Investors” tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
Investor Contacts:
Talphera
Raffi Asadorian, CFO
650-216-3500
investors@talphera.com
LifeSci Advisors
Kevin Gardner
617-283-2856
kgardner@lifesciadvisors.com
Chris Calabrese
917-680-5608
ccalabrese@lifesciadvisors.com
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Selected Financial Data |
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(in thousands, except per share data) |
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(unaudited) |
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Three Months Ended |
Six Months Ended |
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June 30 |
June 30 |
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2024 |
2023 |
2024 |
2023 |
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Statement of Operations Data |
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Revenue |
$ | - | $ | 253 | $ | - | $ | 253 | ||||||||
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Operating costs and expenses: |
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Research and development (1) |
1,909 | 1,552 | 3,342 | 2,599 | ||||||||||||
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Selling, general and administrative (1) |
2,361 | 2,670 | 5,165 | 6,951 | ||||||||||||
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Total operating costs and expenses |
4,270 | 4,222 | 8,507 | 9,550 | ||||||||||||
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Loss from operations |
(4,270 | ) | (3,969 | ) | (8,507 | ) | (9,297 | ) | ||||||||
| - | ||||||||||||||||
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Other income: |
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Interest expense |
- | (15 | ) | - | (134 | ) | ||||||||||
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Interest income and other income, net |
201 | 858 | 421 | 1,058 | ||||||||||||
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Gain on sale of future payments |
- | - | 1,246 | - | ||||||||||||
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Change in fair value of warrant liability |
455 | (1,299 | ) | (547 | ) | 4,012 | ||||||||||
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Non-cash interest expense on liability related to sale of future payments |
(213 | ) | - | (394 | ) | - | ||||||||||
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Total other income (expense) |
443 | (456 | ) | 726 | 4,936 | |||||||||||
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Net loss before income taxes |
(3,827 | ) | (4,425 | ) | (7,781 | ) | (4,361 | ) | ||||||||
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Provision for income taxes |
- | (3 | ) | - | (3 | ) | ||||||||||
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Net loss from continuing operations |
(3,827 | ) | (4,428 | ) | (7,781 | ) | (4,364 | ) | ||||||||
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Net income (loss) from discontinued operations |
- | 57 | - | (8,159 | ) | |||||||||||
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Net loss |
$ | (3,827 | ) | $ | (4,371 | ) | (7,781 | ) | (12,523 | ) | ||||||
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Net (loss) income per share attributable to stockholders: |
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Basic and diluted, continuing operations |
$ | (0.15 | ) | $ | (0.41 | ) | $ | (0.31 | ) | $ | (0.40 | ) | ||||
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Basic and diluted, discontinued operations |
$ | - | $ | 0.01 | $ | - | $ | (0.75 | ) | |||||||
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Basic and diluted loss per share |
$ | (0.15 | ) | $ | (0.40 | ) | $ | (0.31 | ) | $ | (1.15 | ) | ||||
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Shares used in computing net (loss) income per share of common stock, basic and diluted |
26,202 | 10,924 | 25,462 | 10,909 | ||||||||||||
| $ | - | |||||||||||||||
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(1) Includes the following non-cash stock-based compensation expense: |
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| 0 | ||||||||||||||||
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Research and development |
$ | 85 | $ | 80 | $ | 192 | $ | 173 | ||||||||
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Selling, general and administrative |
138 | 391 | 333 | 848 | ||||||||||||
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Discontinued operations |
- | - | - | 19 | ||||||||||||
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Total |
$ | 223 | $ | 471 | $ | 525 | $ | 1,040 | ||||||||
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Selected Balance Sheet Data |
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(in thousands) |
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June 30, 2024 |
December 31, 2023(1) |
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(Unaudited) |
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Cash, cash equivalents and investments |
$ | 14,023 | $ | 9,381 | ||||
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Total assets |
24,856 | 20,395 | ||||||
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Total liabilities |
12,126 | 6,290 | ||||||
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Total stockholders' equity |
12,730 | 14,105 | ||||||
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(1) Derived from the audited financial statements as of that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. |
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Reconciliation of Non-GAAP Financial Measures |
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(Operating Expenses less stock-based compensation expense) |
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Three Months Ended |
Twelve Months Ended |
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June 30 |
June 30 |
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2024 |
2023 |
2024 |
2023 |
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Operating expenses (GAAP): |
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Research and development |
$ | 1,909 | $ | 1,552 | $ | 3,342 | $ | 2,599 | ||||||||
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Selling, general and administrative |
2,361 | 2,670 | 5,165 | 6,951 | ||||||||||||
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Total operating expenses |
4,270 | 4,222 | 8,507 | 9,550 | ||||||||||||
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Less stock-based compensation expense |
223 | 471 | 525 | 1,021 | ||||||||||||
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Operating expenses (non-GAAP) |
$ | 4,047 | $ | 3,751 | $ | 7,982 | $ | 8,529 | ||||||||