Protagenic Therapeutics Reports Fourth Quarter and Full Year 2023 Results
Protagenic Therapeutics Reports Fourth Quarter and Full Year 2023 Results
- Transitioned from Pre-Clinical to Clinical Stage company in FY 2023
- Phase 1/2a trial, designed to assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD or Generalized Anxiety Disorder, progressing through Phase 1 portion
- Plans to enroll final two out of five cohorts into the single dose portion of the Phase 1 trial within the next month
- 2023 財年從臨床前階段公司過渡到臨床階段
- 1/2a期試驗，旨在評估健康志願者和被診斷患有耐藥性抑鬱症、創傷後應激障礙或廣泛性焦慮症的患者，該試驗正在進行階段1階段
- 計劃在下個月內將五個隊列中的最後兩個隊列納入1期試驗的單劑量部分
NEW YORK, NY / ACCESSWIRE / April 1, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, today provided a corporate update and reported financial results for the fourth quarter and full year 2023.
紐約州紐約/ACCESSWIRE/2024年4月1日/生物製藥創新的領導者Protagenic Therapeutics, Inc.（納斯達克股票代碼：PTIX）今天提供了公司最新情況，並公佈了2023年第四季度和全年財務業績。
"In 2023, Protagenic Therapeutics achieved a significant milestone as we began enrolling patients for our neuropeptide drug candidate, PT00114," said Dr. Garo Armen, Executive Chairman. "Our primary focus lies in advancing this drug candidate, designed to address the substantial unmet needs across a spectrum of stress-related neuropsychiatric disorders, including Treatment-Resistant Depression, PTSD, Generalized Anxiety Disorder and Addiction withdrawal."
執行主席加羅·阿門博士說：“2023年，Protagenic Therapeutics實現了一個重要的里程碑，我們開始招募患者使用我們的神經肽候選藥物 PT00114。”“我們的主要重點是推進這種候選藥物，該候選藥物旨在解決一系列與壓力相關的神經精神疾病，包括耐藥性抑鬱症、創傷後應激障礙、廣泛性焦慮症和戒斷成癮的巨大需求。”
2023 Highlights about PT00114
2023 年關於 PT00114 的亮點
First Clinical Trial: PT00114, the company's synthetic version of the stress-regulating peptide TCAP, began the single ascending dose (S.A,D,) portion of a Phase 1 clinical trial. Notably, PT00114 has shown excellent tolerability with no adverse safety findings during these ongoing Phase 1 studies. With promising preclinical efficacy in anxiety, depression, PTSD, and addiction models, PT00114 is moving forward in clinical evaluation, representing a key step toward transformative therapies.
首次臨床試驗：PT00114 是該公司的壓力調節肽 TCAP 的合成版本，開始了 1 期臨床試驗的單一遞增劑量（S.A、D）部分。值得注意的是，在這些正在進行的 1 期研究中，PT00114 表現出良好的耐受性，沒有不良的安全性發現。PT00114 在焦慮、抑鬱、創傷後應激障礙和成癮模型中的臨床前療效令人鼓舞，臨床評估正在向前邁進，這是朝着變革性療法邁出的關鍵一步。
Safety Validation: Building on the low dose safety validation announced February 13th, as announced on March 27th, PT00114 has now demonstrated safety at a medium dose of 500 micrograms administered subcutaneously in the third of five planned cohorts of subjects in the single dose portion of the Phase I trial. No adverse reactions were observed among subjects, consistent with the two lower dose cohorts (125 micrograms and 250 micrograms), with no reported injection site reactions or tolerability issues in the week following dosing. Based on preclinical pharmacology, PT00114 is expected to be administered once weekly via subcutaneous injection.
安全驗證：在3月27日宣佈的2月13日宣佈的低劑量安全驗證的基礎上第四，在I期試驗的單劑量部分中，在五組計劃受試者中，PT00114 現已證明皮下給藥的中等劑量爲500微克是安全的。受試者中未觀察到不良反應，這與兩個較低劑量的隊列（125微克和250微克）一致，在給藥後的一週內沒有報告注射部位反應或耐受性問題。根據臨床前藥理學，PT00114 預計將通過皮下注射每週給藥一次。
Clinical Protocol Progress: This marks progress in the ongoing Phase 1/2a trial, designed to assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder. The company plans to enroll the final two cohorts into the single dose portion of the Phase 1 trial within the next month.
臨床方案進展：這標誌着正在進行的1/2a期試驗的進展，該試驗旨在評估健康志願者和被診斷患有耐藥性抑鬱症、創傷後應激障礙或廣泛性焦慮症的患者。該公司計劃在下個月內將最後兩個隊列納入1期試驗的單劑量部分。
Comprehensive Approach: In addition to monitoring disease status, the trial incorporates biomarker assessments, including circulating cortisol levels, to measure initial treatment response. Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital, serves as the Principal Investigator in Protagenic's Phase 1/2a clinical trial with a basket design.
綜合方法：除了監測疾病狀況外，該試驗還包括生物標誌物評估，包括循環皮質醇水平，以衡量初始治療反應。麻省總醫院首席精神科醫生毛裏齊奧·法瓦博士是Protagenic採用籃子設計的1/2a期臨床試驗的首席研究員。
Strategic Collaboration: Axiom Real-Time Metrics, a CRO/Data Analytics firm, manages the clinical program.
戰略合作：首席投資官/數據分析公司Axiom Real-time Metrics負責管理臨床項目。
Fourth Quarter and Full Year 2023 Financial Results
2023 年第四季度和全年財務業績
Our financial results reflect an increase in research & development spending to pursue our primary objective of developing and commercializing PT00114 during FY 2023, particularly during the fourth quarter. In the fourth quarter of 2023, we spent $1.0 million on R&D, an increase of 301% over our $258,000 R&D spend in the fourth quarter of 2022. This significant increase in R&D expenditures was entirely due to the clinical trial that is now in progress for PT00114, which commenced just as Q4 was starting. Our G&A spend for the fourth quarter of 2023 was just $201,000, down 50% from our G&A spend in the comparable quarter a year ago. Our net loss for Q4 was $1.2 million, compared to a net loss of $656,000 in the year-ago quarter.
我們的財務業績反映了研發支出的增加，以實現我們在2023財年，特別是在第四季度開發和商業化 PT00114 的主要目標。2023年第四季度，我們在研發上的支出爲100萬美元，比2022年第四季度的25.8萬美元研發支出增長了301％。研發支出的顯著增長完全歸因於目前正在進行的 PT00114 臨床試驗，該試驗是在第四季度開始時開始的。我們在2023年第四季度的併購支出僅爲201,000美元，比去年同期的併購支出下降了50％。我們第四季度的淨虧損爲120萬美元，而去年同期的淨虧損爲65.6萬美元。
For the full year 2023, we spent $3.3 million on R&D, up 109% from the $1.6 million we spent on R&D for the full year 2022. Our full-year G&A of $1.2 million was, similar to the quarter, down almost 40% from the amount spent in the year-ago period.
2023年全年，我們在研發上的支出爲330萬美元，較2022年全年的160萬美元研發支出增長了109％。與本季度類似，我們的全年併購額爲120萬美元，比去年同期下降了近40％。
For full year net income, we lost $4.5 million, which is 27% more loss than we had in 2022, driven primarily by our higher R&D spend because of our clinical trial activities.
就全年淨收入而言，我們損失了450萬美元，比2022年的虧損增加了27％，這主要是由臨床試驗活動導致的研發支出增加所致。
For cash, we ended the year with $4.1 million in cash and cash equivalents, down from the $8.0 million we had as of Dec 31, 2022. We believe that our current cash reserves are sufficient to fund all of our Phase I clinical trial.
在現金方面，我們在年底的現金及現金等價物爲410萬美元，低於截至2022年12月31日的800萬美元。我們認爲，我們目前的現金儲備足以資助我們所有的I期臨床試驗。
Profit and Loss Statements
損益表
| For the years ended December 31, | ||||||||
| 2023 | 2022 | |||||||
OPERATING AND ADMINISTRATIVE EXPENSES |
||||||||
Research and development |
$ | 3,319,867 | $ | 1,589,239 | ||||
General and administrative |
1,207,107 | 1,968,549 | ||||||
TOTAL OPERATING AND ADMINISTRATIVE EXPENSES |
4,526,974 | 3,557,788 | ||||||
LOSS FROM OPERATIONS |
(4,526,974) | (3,557,788) | ||||||
OTHER INCOME |
||||||||
Interest income |
264,476 | 185,790 | ||||||
Interest expense |
(107,682) | (137,456) | ||||||
Realized loss on marketable securities |
(630,317) | (46,051) | ||||||
TOTAL OTHER INCOME |
(473,523) | 2,283 | ||||||
LOSS BEFORE TAX |
(5,000,497) | (3,555,505) | ||||||
INCOME TAX EXPENSE |
- | - | ||||||
NET LOSS |
$ | (5,000,497) | $ | (3,555,505) | ||||
COMPREHENSIVE LOSS |
- | - | ||||||
Other Comprehensive Loss - net of tax |
||||||||
Net unrealized gain (loss) on marketable securities |
16,848 | (421,738) | ||||||
Reclassification of realized losses on debt securities |
489,120 | - | ||||||
Foreign exchange translation income (loss) |
57,393 | (6,820) | ||||||
TOTAL COMPREHENSIVE LOSS |
$ | (4,437,136) | $ | (3,984,063) | ||||
Net loss per common share - Basic and Diluted |
$ | (1.15) | $ | (0.82) | ||||
Weighted average common shares - Basic and Diluted |
4,344,580 | 4,317,875 | ||||||
| 在截至12月31日的年度中， | ||||||||
| 2023 | 2022 | |||||||
運營和管理費用 |
||||||||
研究和開發 |
$ | 3,319,867 | $ | 1,589,239 | ||||
一般和行政 |
1,207,107 | 1,968,549 | ||||||
運營和管理費用總額 |
4,526,974 | 3,557,788 | ||||||
運營損失 |
(4,526,974) | (3,557,788) | ||||||
其他收入 |
||||||||
利息收入 |
264,476 | 185,790 | ||||||
利息支出 |
(107,682) | (137,456) | ||||||
有價證券的已實現虧損 |
(630,317) | (46,051) | ||||||
其他收入總額 |
(473,523) | 2,283 | ||||||
稅前虧損 |
(5,000,497) | (3,555,505) | ||||||
所得稅支出 |
- | - | ||||||
淨虧損 |
$ | (5,000,497) | $ | (3,555,505) | ||||
綜合損失 |
- | - | ||||||
其他綜合虧損——扣除稅款 |
||||||||
有價證券的未實現淨收益（虧損） |
16,848 | (421,738) | ||||||
債務證券已實現虧損的重新分類 |
489,120 | - | ||||||
外匯折算收入（虧損） |
57,393 | (6,820) | ||||||
綜合損失總額 |
$ | (4,437,136) | $ | (3,984,063) | ||||
普通股每股淨虧損——基本虧損和攤薄虧損 |
$ | (1.15) | $ | (0.82) | ||||
加權平均普通股——基本股和攤薄後普通股 |
4,344,580 | 4,317,875 | ||||||
Balance Sheet
資產負債表
| December 31, 2023 | December 31, 2022 | |||||||
ASSETS |
||||||||
CURRENT ASSETS |
||||||||
Cash |
$ | 1,287,893 | $ | 215,189 | ||||
Marketable securities |
2,768,119 | 7,763,517 | ||||||
Prepaid expenses |
144,025 | 56,939 | ||||||
TOTAL CURRENT ASSETS |
4,200,037 | 8,035,645 | ||||||
Equipment - net |
123,332 | 1,775 | ||||||
TOTAL ASSETS |
$ | 4,323,369 | $ | 8,037,420 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable and accrued expenses |
$ | 439,757 | $ | 669,704 | ||||
Accounts payable and accrued expenses - related party |
215,495 | 105,928 | ||||||
PIK convertible notes payable, net of debt discount |
- | 150,591 | ||||||
PIK convertible notes payable, net of debt discount - related parties |
- | 193,639 | ||||||
TOTAL CURRENT LIABILITIES |
655,252 | 1,119,862 | ||||||
TOTAL LIABILITIES |
655,252 | 1,119,862 | ||||||
STOCKHOLDERS' EQUITY |
||||||||
Preferred stock, $0.000001 par value; 20,000,000 shares authorized; none shares issued and outstanding in the following classes: |
- | - | ||||||
Preferred stock; par value $0.000001; 2,000,000 shares authorized; none issued and outstanding |
- | - | ||||||
Series B convertible preferred stock, $0.000001 par value;18,000,000 shares authorized; 0 and 0 shares issued and outstanding at December 31, 2023, and December 31, 2022 |
- | - | ||||||
Preferred stock value |
- | - | ||||||
Common stock, $.0001 par value, 100,000,000 shares authorized, 4,435,132 and 4,321,315 shares issued and outstanding at December 31, 2023, and December 31, 2022 |
444 | 434 | ||||||
Additional paid-in-capital |
34,559,091 | 33,371,406 | ||||||
Accumulated deficit |
(30,777,872) | (25,777,375) | ||||||
Accumulated other comprehensive loss |
(113,546) | (676,907) | ||||||
TOTAL STOCKHOLDERS' EQUITY |
3,668,117 | 6,917,558 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
$ | 4,323,369 | $ | 8,037,420 | ||||
| 2023年12月31日 | 2022年12月31日 | |||||||
資產 |
||||||||
流動資產 |
||||||||
現金 |
$ | 1,287,893 | $ | 215,189 | ||||
有價證券 |
2,768,119 | 7,763,517 | ||||||
預付費用 |
144,025 | 56,939 | ||||||
流動資產總額 |
4,200,037 | 8,035,645 | ||||||
設備-網絡 |
123,332 | 1,775 | ||||||
總資產 |
$ | 4,323,369 | $ | 8,037,420 | ||||
負債和股東權益 |
||||||||
流動負債 |
||||||||
應付賬款和應計費用 |
$ | 439,757 | $ | 669,704 | ||||
應付賬款和應計費用-關聯方 |
215,495 | 105,928 | ||||||
扣除債務折扣後的PIK可轉換票據 |
- | 150,591 | ||||||
扣除債務折扣後的PIK可轉換票據——關聯方 |
- | 193,639 | ||||||
流動負債總額 |
655,252 | 1,119,862 | ||||||
負債總額 |
655,252 | 1,119,862 | ||||||
股東權益 |
||||||||
優先股，面值0.000001美元；已授權20,000,000股；以下類別的未發行和流通股票： |
- | - | ||||||
優先股；面值0.000001美元；授權2,000,000股；未發行和流通 |
- | - | ||||||
B系列可轉換優先股，面值0.000001美元；已授權1800萬股；截至2023年12月31日和2022年12月31日已發行和流通的0股和0股 |
- | - | ||||||
優先股價值 |
- | - | ||||||
普通股，面值0.0001美元，已授權1億股，截至2023年12月31日和2022年12月31日已發行和流通的4,435,132股和4,321,315股股票 |
444 | 434 | ||||||
額外的實收資本 |
34,559,091 | 33,371,406 | ||||||
累計赤字 |
(30,777,872) | (25,777,375) | ||||||
累計其他綜合虧損 |
(113,546) | (676,907) | ||||||
股東權益總額 |
3,668,117 | 6,917,558 | ||||||
負債總額和股東權益 |
$ | 4,323,369 | $ | 8,037,420 | ||||
See accompanying notes to the consolidated financial statements in the company's Form 10-K, filed concurrently.
參見同時提交的公司10-K表中合併財務報表的附註。
Conference Call
電話會議
Date: April 1 , 2024, 4:30 p.m. ET
日期：美國東部時間 2024 年 4 月 1 日下午 4:30
To access dial-in numbers, please register here.
要訪問撥入號碼，請在此處註冊。
Participant link (for all regular participants):
Or by phone: 888-506-0062
International: 973-528-0011
Participant Access Code: 628544
參與者鏈接（適用於所有普通參與者）：
或者通過電話：888-506-0062
國際：973-528-0011
參與者訪問碼：628544
Webcast
A live webcast and replay of the conference call will be accessible on the company's website at:
網絡直播
電話會議的網絡直播和重播將在該公司的網站上觀看，網址爲：
About Protagenic Therapeutics, Inc.:
Protagenic Therapeutics, Inc. (Nasdaq:PTIX) is dedicated to pioneering therapeutics based on neuro-active peptides to alleviate the negative effects of stress and treat stress-related disorders such as anxiety, depression, PTSD, and addiction. For more information, visit .
關於 Protagenic Therapeutics, Inc.：
Protagenic Therapeutics, Inc.（納斯達克股票代碼：PTIX）致力於開發基於神經活性肽的開創性療法，以減輕壓力的負面影響，治療焦慮、抑鬱、創傷後應激障礙和成癮等與壓力相關的疾病。欲了解更多信息，請訪問。
About PT00114:
PT00114, a 41-amino-acid residue synthetic peptide, shows promise as a novel treatment for serious neuro-psychiatric conditions, including depression, anxiety, and PTSD. It is a synthetic form of the naturally occurring brain peptide TCAP, which counters the negative biochemical and behavioral effects of stress-induced brain hormones Corticotropin Releasing Factor and Arginine-Vasopressin. Among its benefits is the reduction of excessive circulating levels of cortisol often associated with various stressors.
關於 PT00114：
PT00114 是一種 41 氨基酸殘留的合成肽，有望成爲嚴重神經精神疾病（包括抑鬱、焦慮和創傷後應激障礙）的新療法。它是天然存在的大腦肽 TCAP 的合成形式，可抵消壓力誘導的大腦激素促腎上腺激素促腎上腺皮質激素釋放因子和精氨酸加壓素的負面生化和行爲影響。它的好處之一是降低了皮質醇的過高循環水平，通常與各種壓力有關。
Forward-Looking Statements:
This press release contains forward-looking statements concerning Protagenic Therapeutics' product candidates and clinical trial plans. These statements are subject to various risks and uncertainties. Investors are urged to exercise caution and not place undue reliance on these forward-looking statements.
前瞻性陳述：
本新聞稿包含有關Protagenic Therapeutics候選產品和臨床試驗計劃的前瞻性陳述。這些陳述受各種風險和不確定性的影響。敦促投資者謹慎行事，不要過分依賴這些前瞻性陳述。
Company Contact:
Alexander K. Arrow, MD, CFA
Chief Financial Officer
Protagenic Therapeutics, Inc. 149 Fifth Ave, Suite 500, New York, NY 10010. Tel: 213-260-4342
Email: alex.arrow@protagenic.com
公司聯繫人：
亞歷山大·阿羅，醫學博士，特許金融分析師
首席財務官
Protagenic Therapeutics, Inc. 第五大道 149 號，套房 500，紐約，紐約州 10010。電話：213-260-4342
電子郵件：alex.arrow@protagenic.com
Investor Relations Contact:
Kirin M. Smith, President, PCG Advisory, Inc. 950 Third Avenue, Suite #2700, New York, NY 10022. Tel: 646-823-8656 Email: ksmith@pcgadvisory.com
投資者關係聯繫人：
Kirin M. Smith，PCG Advisory, Inc. 總裁。第三大道950號，套房 #2700，紐約，紐約州，10022。電話：646-823-8656 電子郵件：ksmith@pcgadvisory.com
SOURCE: Protagenic Therapeutics, Inc.
來源：Protagenic Therapeutics, Inc.
譯文內容由第三人軟體翻譯。