Protagenic Therapeutics Announces Third Quarter 2021 Results and Business Update
Protagenic Therapeutics Announces Third Quarter 2021 Results and Business Update
NEW YORK, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Protagenic Therapeutics, Inc. (Nasdaq: PTIX) a biopharmaceutical company focused on developing therapies to treat stress-related neurologic disorders, today announced results for the third quarter ended September 30, 2021.
紐約，2021年11月16日(環球通訊社)--Protaggen治療公司(納斯達克市場代碼：PTIX)是一家專注於開發治療應激相關神經疾病療法的生物製藥公司，該公司今天公佈了截至2021年9月30日的第三季度業績。
Recent Highlights
最近的亮點
- Hosted a virtual science review to discuss the scientific rationale and evidence for PT00114 in the treatment of Depression, Anxiety, PTSD and Addiction. Replay available at www.protagenic.com.
- Hosted a key opinion leader (KOL) webinar focused on PT00114 for the regulation of stress in patients with Depression, PTSD, Anxiety and Addiction. Replay available at www.protagenic.com.
- Received FDA comment to provide clinical sites with ready-to-inject clinical vials of PT00114; to result in IND refiling in the fourth quarter
- 主持了一次虛擬科學評論，討論PT00114治療抑鬱症、焦慮症、創傷後應激障礙和成癮的科學依據和證據。重播可在www.protagenic.com上觀看。
- 主持了一次關鍵意見領袖(KOL)網絡研討會，重點關注PT00114，以調節抑鬱症、創傷後應激障礙、焦慮和成癮患者的壓力。重播可在www.protagenic.com上觀看。
- 收到FDA的意見，向臨牀地點提供隨時可以注射的PT00114臨牀小瓶；導致IND在第四季度重新申報
"During the third quarter and year to date, we made significant progress towards moving PT00114 into the clinic, in order to treat stress-related neuropsychiatric disorders which afflict a growing patient population," said Dr. Garo Armen, Executive Chairman of Protagenic Therapeutics. "We have a well-defined clinical path targeting psychiatric disorders like depression, anxiety, PTSD, and drug & alcohol addiction. We anticipate gathering efficacy and safety data readouts in the second half of 2022."
Protagen Treeutics公司執行主席加羅·阿爾門博士説：“在第三季度和今年到目前為止，我們在將PT00114移入臨牀方面取得了重大進展，以便治療與壓力有關的神經精神障礙，這些疾病困擾着越來越多的患者。”“針對抑鬱症、焦慮症、創傷後應激障礙以及藥物和酒精成癮等精神疾病，我們有一條明確的臨牀路徑。我們預計將在2022年下半年收集療效和安全性數據讀數。”
Anticipated Upcoming Milestones
預期即將到來的里程碑
- Q4 2021: Re-filing of IND application for PT00114
- Q1 2022: Initiation of Phase I/IIa study for PT00114
-
2H 2022: Initial Data Readout of Phase I/IIa study
- Q4 2021: 重新提交PT00114的IND申請
- Q1 2022: 展開PT00114第I/IIa期研究
-
2H 2022: 第I/IIa期研究的初步數據讀數
Financial Results for the Second Quarter Ended September 30, 2021:
截至第二季度的財務業績九月 30, 2021:
- Net loss attributable to common stockholders for the quarter ended September 30, 2021 was approximately $0.9 million, compared to approximately $1.0 million for the quarter ended September 30, 2020.
- Research and development expense totaled approximately $0.3 million for the quarter ended September 30, 2021, compared to approximately $0.5 million during the quarter ended September 30, 2020.
- General and administrative expense was approximately $0.5 million for the quarter ended September 30, 2021, compared to approximately $0.6 million during the quarter ended September 30, 2020.
- As of September 30, 2021, the Company had cash and cash equivalents of approximately $10.8 million.
- As of November 15, 2021, the Company had approximately 17.0 million common shares outstanding.
- 截至2021年9月30日的季度，普通股股東的淨虧損約為90萬美元，而截至2020年9月30日的季度約為100萬美元。
- 截至2021年9月30日的季度，研發支出總額約為30萬美元，而截至2020年9月30日的季度約為50萬美元。
- 截至2021年9月30日的季度，一般和行政費用約為50萬美元，而截至2020年9月30日的季度約為60萬美元。
- 截至2021年9月30日，該公司的現金和現金等價物約為1080萬美元。
- 截至2021年11月15日，該公司約有1700萬股已發行普通股。
Select Financial Information
選擇財務信息
Protagenic Therapeutics, Inc., and Subsidiary
Balance Sheet
(In U.S. Dollars)
(Unaudited)
Protaggen Treateutics，Inc.及其子公司資產負債表(美元)(未經審計)
| September 30, 2021 | December 31, 2020 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 460,115 | $ | 671,091 | ||||
| Marketable securities | 10,394,573 | - | ||||||
| Prepaid expenses | 802,417 | 208,156 | ||||||
| TOTAL CURRENT ASSETS | 11,657,105 | 879,247 | ||||||
| TOTAL ASSETS | $ | 11,657,105 | $ | 879,247 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued expenses | $ | 724,417 | $ | 571,517 | ||||
| Derivative liability | - | 83,670 | ||||||
| TOTAL CURRENT LIABILITIES | 724,417 | 655,187 | ||||||
| PIK convertible notes payable, net of debt discount | 441,435 | 1,081,384 | ||||||
| PIK convertible notes payable, net of debt discount - related parties | 120,654 | 292,412 | ||||||
| TOTAL LIABILITIES | 1,286,506 | 2,028,983 | ||||||
| STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Preferred stock, $0.000001 par value; 20,000,000 shares authorized; 872,766 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 872,766 shares issued and outstanding at September 30, 2021, and December 31, 2020 | - | 1 | ||||||
| Common stock, $.0001 par value, 100,000,000 shares authorized, 16,955,817 and 10,360,480 shares issued and outstanding at September 30, 2021, and December 31, 2020 | 1,697 | 1,036 | ||||||
| Additional paid-in-capital | 31,872,763 | 16,719,749 | ||||||
| Accumulated deficit | (21,331,483 | ) | (17,698,936 | ) | ||||
| Accumulated other comprehensive loss | (172,378 | ) | (171,586 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | 10,370,599 | (1,149,736 | ) | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 11,657,105 | $ | 879,247 | ||||
| 2021年9月30日 | 2020年12月31日 | |||||||
| 資產 | ||||||||
| 流動資產 | ||||||||
| 現金 | $ | 460,115 | $ | 671,091 | ||||
| 有價證券 | 10,394,573 | - | ||||||
| 預付費用 | 802,417 | 208,156 | ||||||
| 流動資產總額 | 11,657,105 | 879,247 | ||||||
| 總資產 | $ | 11,657,105 | $ | 879,247 | ||||
| 負債和股東權益(赤字) | ||||||||
| 流動負債 | ||||||||
| 應付賬款和應計費用 | $ | 724,417 | $ | 571,517 | ||||
| 衍生負債 | - | 83,670 | ||||||
| 流動負債總額 | 724,417 | 655,187 | ||||||
| 應付PIK可轉換票據，扣除債務貼現 | 441,435 | 1,081,384 | ||||||
| 應付PIK可轉換票據，扣除債務貼現相關各方 | 120,654 | 292,412 | ||||||
| 總負債 | 1,286,506 | 2,028,983 | ||||||
| 股東權益(虧損) | ||||||||
| 優先股，面值0.000001美元；授權股份2000萬股；以下類別的已發行和流通股872,766股： | ||||||||
| 優先股；面值0.000001美元；授權發行2,000,000股；無已發行和已發行股票 | - | - | ||||||
| B系列可轉換優先股，面值0.000001美元；授權發行1800萬股；在2021年9月30日和2020年12月31日發行和發行的股票分別為0和872,766股 | - | 1 | ||||||
| 普通股，面值0.0001美元，授權發行1億股，2021年9月30日和2020年12月31日發行和發行的普通股分別為16,955,817股和10,360,480股 | 1,697 | 1,036 | ||||||
| 額外實收資本 | 31,872,763 | 16,719,749 | ||||||
| 累計赤字 | (21,331,483 | ) | (17,698,936 | ) | ||||
| 累計其他綜合損失 | (172,378 | ) | (171,586 | ) | ||||
| 股東權益合計(虧損) | 10,370,599 | (1,149,736 | ) | |||||
| 總負債和股東權益(赤字) | $ | 11,657,105 | $ | 879,247 | ||||
Consolidated Statements of Operations
(In U.S. Dollars)
(Unaudited)
合併業務報表(美元)(未經審計)
|
For the three months ended September 30, |
For the nine months ended September 30, |
||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||
| OPERATING AND ADMINISTRATIVE EXPENSES | |||||||||||||||||||||
| Research and development | 257,279 | 539,770 | 990,222 | 657,737 | |||||||||||||||||
| General and administrative | 506,892 | 552,246 | 2,288,972 | 1,356,990 | |||||||||||||||||
| TOTAL OPERATING AND ADMINISTRATIVE EXPENSES | 764,171 | 1,092,016 | 3,279,194 | 2,014,727 | |||||||||||||||||
| LOSS FROM OPERATIONS | (764,171 | ) | (1,092,016 | ) | (3,279,194 | ) | (2,014,727 | ) | |||||||||||||
| OTHER (EXPENSE) INCOME | |||||||||||||||||||||
| Interest income | 336 | 17 | 568 | 494 | |||||||||||||||||
| Interest expense | (114,464 | ) | (58,827 | ) | (437,591 | ) | (152,757 | ) | |||||||||||||
| Change in fair value of derivative liability | - | 104,718 | 83,670 | 141,907 | |||||||||||||||||
| TOTAL OTHER INCOME (EXPENSES) | (114,128 | ) | 45,908 | (353,353 | ) | (10,356 | ) | ||||||||||||||
| LOSS BEFORE TAX | (878,299 | ) | (1,046,108 | ) | (3,632,547 | ) | (2,025,083 | ) | |||||||||||||
| INCOME TAX EXPENSE | - | - | - | - | |||||||||||||||||
| NET LOSS | $ | (878,299 | ) | $ | (1,046,108 | ) | $ | (3,632,547 | ) | $ | (2,025,083 | ) | |||||||||
| COMPREHENSIVE LOSS | |||||||||||||||||||||
| Other Comprehensive Loss - net of tax | |||||||||||||||||||||
| Net unrealized loss on marketable securities | (974 | ) | - | (974 | ) | - | |||||||||||||||
| Foreign exchange translation income (loss) | (791 | ) | 736 | 182 | (599 | ) | |||||||||||||||
| TOTAL COMPREHENSIVE LOSS | $ | (880,064 | ) | $ | (1,045,372 | ) | $ | (3,633,339 | ) | $ | (2,025,682 | ) | |||||||||
| Net loss per common share - Basic and Diluted | $ | (0.05 | ) | $ | (0.10 | ) | $ | (0.26 | ) | $ | (0.20 | ) | |||||||||
| Weighted average common shares - Basic and Diluted | 16,521,882 | 10,275,758 | 13,939,400 | 10,274,005 | |||||||||||||||||
|
在截至的三個月內 9月30日， |
在過去的九個月裏 9月30日， |
||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||
| 運營和行政費用 | |||||||||||||||||||||
| 研發 | 257,279 | 539,770 | 990,222 | 657,737 | |||||||||||||||||
| 一般事務和行政事務 | 506,892 | 552,246 | 2,288,972 | 1,356,990 | |||||||||||||||||
| 運營和行政費用總額 | 764,171 | 1,092,016 | 3,279,194 | 2,014,727 | |||||||||||||||||
| 運營虧損 | (764,171 | ) | (1,092,016 | ) | (3,279,194 | ) | (2,014,727 | ) | |||||||||||||
| 其他(費用)收入 | |||||||||||||||||||||
| 利息收入 | 336 | 17 | 568 | 494 | |||||||||||||||||
| 利息支出 | (114,464 | ) | (58,827 | ) | (437,591 | ) | (152,757 | ) | |||||||||||||
| 衍生負債公允價值變動 | - | 104,718 | 83,670 | 141,907 | |||||||||||||||||
| 其他收入(費用)合計 | (114,128 | ) | 45,908 | (353,353 | ) | (10,356 | ) | ||||||||||||||
| 税前虧損 | (878,299 | ) | (1,046,108 | ) | (3,632,547 | ) | (2,025,083 | ) | |||||||||||||
| 所得税費用 | - | - | - | - | |||||||||||||||||
| 淨虧損 | $ | (878,299 | ) | $ | (1,046,108 | ) | $ | (3,632,547 | ) | $ | (2,025,083 | ) | |||||||||
| 綜合損失 | |||||||||||||||||||||
| 其他綜合虧損-税後淨額 | |||||||||||||||||||||
| 有價證券未實現淨虧損 | (974 | ) | - | (974 | ) | - | |||||||||||||||
| 外匯折算收入(損失) | (791 | ) | 736 | 182 | (599 | ) | |||||||||||||||
| 全面損失總額 | $ | (880,064 | ) | $ | (1,045,372 | ) | $ | (3,633,339 | ) | $ | (2,025,682 | ) | |||||||||
| 普通股每股淨虧損-基本虧損和攤薄虧損 | $ | (0.05 | ) | $ | (0.10 | ) | $ | (0.26 | ) | $ | (0.20 | ) | |||||||||
| 加權平均普通股-基本普通股和稀釋普通股 | 16,521,882 | 10,275,758 | 13,939,400 | 10,274,005 | |||||||||||||||||
See accompanying notes to these unaudited consolidated financial statements in our Form 10-Q filed with the SEC November 15, 2021
請參閲我們提交給美國證券交易委員會2021年11月15日的10-Q表格中這些未經審計的合併財務報表的附註
About Protagenic Therapeutics, Inc.
普羅泰根治療公司簡介
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is a pre-clinical biopharmaceutical company endeavoring to develop first-in-class neuro-active peptides into human therapeutics to treat several stress related disorders. For more information, visit http://www.protagenic.com.
Protaggen Treateutics公司(納斯達克市場代碼：PTIX)是一家臨牀前生物製藥公司，致力於將一流的神經活性多肽開發成人類療法，用於治療幾種與壓力有關的疾病。欲瞭解更多信息，請訪問http://www.protagenic.com.。
Forward-Looking Statements
前瞻性陳述
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Protagenic Therapeutics' product candidates and pre-clinical development and clinical trial plans and activities. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the pre-clinical testing and eventual clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in pre-clinical and clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors described under the Risk Factors section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission.. Protagenic Therapeutics cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Protagenic undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
本新聞稿包含根據聯邦證券法的安全港條款作出的前瞻性陳述，包括有關Protaggen Treeutics的候選產品以及臨牀前開發和臨牀試驗計劃和活動的陳述。前瞻性表述包括“預期”、“預期”、“打算”、“計劃”、“可能”、“相信”、“估計”以及類似的表述。這些前瞻性陳述會受到風險和不確定因素的影響，這些風險和不確定因素可能會導致實際結果大不相同。這些風險和不確定因素包括，除其他外，我們能否以可接受的條件獲得額外資本以滿足我們的流動性需求，甚至包括完成我們候選產品的臨牀前測試和最終臨牀試驗所需的額外資本；我們成功完成候選產品的研究、進一步開發和商業化的能力；臨牀前和臨牀測試中固有的不確定性；獲得監管部門批准的時間、成本和不確定性；我們保護公司知識產權的能力；任何高管或關鍵人員或顧問的流失；競爭；監管格局的變化或實施影響公司產品的法規；以及在我們提交給美國證券交易委員會(SEC)的最新10-K表格年度報告的風險因素部分中描述的其他因素。普羅泰根治療公司告誡投資者不要過分依賴本新聞稿中包含的前瞻性陳述。這些聲明僅在本新聞稿發佈之日發表，普羅泰吉公司不承擔更新或修改聲明的義務, 未達到法律要求的程度。所有前瞻性陳述都明確地受到本警告性聲明的全部限制。
Analyst Contact:
Alexander K. Arrow, MD, CFA
Chief Financial Officer
213-260-4342
alex.arrow@protagenic.com
分析員聯繫方式：亞歷山大·K·阿羅，醫學博士，CFA首席財務官213-260-4342郵箱：alex.row@protagenic.com
Media Contact:
James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com
媒體聯繫人：詹姆斯·卡博納拉海登紅外光譜(646)-755-7412郵箱：james@haydenir.com
譯文內容由第三人軟體翻譯。