Durvalumab

WESTLAKE VILLAGE, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the third quarter of 2024 and provided general business updates. The Company initiated its second lung cancer trial, a US-based, Phase 2 trial (VIRO-25) treating patients with recurrent advanced or metastatic non-small cell lung cancer (NSCLC) with Olvi-Vec, followed by platinum-doublet chemotherapy + immune checkpoint inhibitor. Additionally, a Phase 1b/2 lung cancer trial is ongoing in recurrent small cell lung cancer (SCLC) in China which is co-sponsored with Newsoara BioPharma Co., Ltd. Both trials utilize Olvi-Vec delivered intravenously to treat patients who have previously failed platinum-based chemotherapy. The trials are designed based on earlier clinical results, including Olvi-Vec demonstrating (i) positive outcomes in patients with primary or metastatic lung cancer when delivered intravenously and (ii) clinical reversal of platinum resistance and refractoriness in a Phase 2 trial in platinum-resistant/refractory ovarian cancer (PRROC). "Over the past quarter, we marked another important step forward in our efforts to advance the systemic delivery of Olvi-Vec and to demonstrate the re-sensitization to platinum-based chemotherapy in multiple tumor types," said Thomas Zindrick, President, CEO and Chairman of Genelux. "With interim data from our SCLC trial anticipated by the end of 2024 and data releases from our Phase 3 registration trial in PRROC and Phase 2 trial in NSCLC anticipated in 2025, we are confident that Genelux is positioned to make a meaningful impact in the lives of cancer patients." Pipeline Highlights The Company’s clinical program is designed to position Olvi-Vec as an ideal backbone of combination cancer therapy due to its unique mechanism of action to modify the tumor immune microenvironment. Building on the promising results from our previous clinical trials, we see the potential of Olvi-Vec to induce platinum re-sensitization as a strategy to enhance patient response and extend survival in platinum-resistant populations. In addition, the VIRO-25 trial expands the program to include combination therapies with immune checkpoint inhibitors as we aim to unlock synergistic activity that amplify the immune response against tumors. Patient enrollment continues to progress in the Phase 3 OnPrime/GOG-3076 trial for PRROC, now active at over 25 sites (NCT05281471). Topline results are anticipated in the latter half of 2025. Phase 2 VIRO-25 is actively enrolling recurrent NSCLC patients (NCT06463665), with interim data expected by mid-2025. Interim results from the Phase 1b portion of a Phase 1b/2 SCLC trial projected by end of 2024. Third Quarter 2024 Financial Results Cash and cash equivalents, and short and long-term investments were $35.1 million as of September 30, 2024. The Company expects its existing cash and cash equivalents, and short and long-term investments will provide runway into the first quarter of 2026. Research and development (R&D) expenses $4.1 million and $2.8 million for the three months ended September 30, 2024 and 2023, respectively, an increase of $1.2 million. Significant variations between periods are primarily a result of a $0.4 million increase in stock-related compensation in 2024, relating to the increased cost of stock options and restricted stock units in 2024; and a $0.9 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with our Phase 3 OnPrime Registration trial in 2024. General and administrative (G&A) expenses were $2.9 million and $2.5 million for the three months ended September 30, 2024 and 2023, respectively, an increase of $0.4 million. Significant variations between periods are primarily a result of a $0.7 million increase in stock compensation expense in 2024, due to the increase in the cost of stock options and restricted stock units in 2024; offset by a $0.3 million decrease in professional service expenses in 2024, primarily resulting from decreased corporate legal costs. Net loss was $6.5 million for the third quarter of 2024 or a net loss per share of $0.19, as compared to net loss of $5.3 million for the third quarter of 2023, or a net loss per share of $0.20. About Genelux Corporation Genelux is a late-stage clinical biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus. Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux's discovery and development efforts revolves around its’ proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. For more information, please visit www.genelux.com and follow us on Twitter @Genelux_Corp and on LinkedIn. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, Genelux’s anticipated cash runway and the sufficiency of its resources to support its planned operations, the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, and the potential capabilities and advantages of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. Investor and Media Contacts Ankit Bhargava, MDAllele Communications, LLCgenelux@allelecomms.com Source: Genelux Corporation Genelux CorporationCondensed Balance Sheets(in thousands, except for share amounts and par value data) September 30, December 31, 2024 2023 ASSETS(Unaudited)Current Assets Cash and cash equivalents$6,102 $9,418 Short-term investments 27,955 13,773 Prepaid expenses and other current assets 1,910 1,012 Total Current Assets 35,967 24,203 Property and equipment, net 1,278 1,170 Right of use assets 1,930 2,428 Long-term investments 1,003 - Other assets 92 92 Total Other Assets 4,303 3,690 TOTAL ASSETS$40,270 $27,893 LIABILITIES AND SHAREHOLDERS' EQUITY Current Liabilities Accounts payable and accrued expenses$4,454 $3,784 Accrued payroll and payroll taxes 686 2,117 Lease liabilities, current portion 415 653 Total Current Liabilities 5,555 6,554 Lease liabilities, long-term portion 1,624 1,866 Total Liabilities 7,179 8,420 Shareholders' Equity Preferred stock, par value $0.001, 10,000,000 shares authorized; no shares issued and outstanding, respectively; - - Common stock, par value $0.001, 200,000,000 shares authorized; 34,538,185 and 26,788,986 shares issued and outstanding 35 27 Treasury stock, 433,333 shares, at cost (433) (433)Additional paid-in capital 275,782 241,389 Accumulated other comprehensive income 124 14 Accumulated deficit (242,417) (221,524)Total Shareholders' Equity 33,091 19,473 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$40,270 $27,893 The accompanying notes are an integral part of these condensed financial statements. Genelux CorporationCondensed Statements of Operations(in thousands, except for share amounts and per share data) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 (Unaudited) (Unaudited) Revenues$- $- $8 $170 Operating expenses: Research and development 4,051 2,819 12,478 8,607 General and administrative 2,890 2,488 9,478 8,727 Total operating expenses 6,941 5,307 21,956 17,334 Loss from operations (6,941) (5,307) (21,948) (17,164) Other income (expenses): Interest income 474 4 1,055 4 Interest expense - - - (167)Debt discount amortization - - - (649)Financing costs - (42) - (3,152)Debt extinguishment costs - (402)Total other income (expenses), net 474 (38) 1,055 (4,366) NET LOSS$(6,467) $(5,345) $(20,893) $(21,530) LOSS PER COMMON SHARE - BASIC AND DILUTED$(0.19) $(0.20) $(0.69) $(0.91) WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED 34,532,355 26,210,068 30,405,615 23,640,995 The accompanying notes are an integral part of these condensed financial statements. Genelux CorporationCondensed Statements of Comprehensive Loss(in thousands) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 (Unaudited) (Unaudited) Net loss$(6,467) $(5,345) $(20,893) $(21,530) Other comprehensive loss: Net unrealized gain on short and long-term investments 135 - 110 - Comprehensive loss$(6,332) $(5,345) $(20,783) $(21,530) The accompanying notes are an integral part of these condensed financial statements.

大多数非小细胞肺癌确诊的时候处于晚期，无法进行手术治疗。如果患者没有靶向药的治疗机会，那么唯一的机会就是免疫检查点抑制剂，如果不是PD-L1高表达，则还需要将PD-1联合铂类化疗进行组合，总体来说免疫治疗的出现改善了患者的生存期。对于没有EGFR或ALK基因突变的肺癌，PD-1抑制剂联合培美曲塞和铂类化疗是晚期非小细胞肺癌的一线标准治疗。而且患者使用这些药物组合起效，则生存期超过5年的概率更大。 奥拉帕利是一种PARP抑制剂，对于乳腺癌和卵巢癌表现出较好的治疗活性。临床前的研究表明，PARP抑制剂可以通过激活干扰素通路和促进免疫细胞浸润肿瘤微环境，来诱导免疫原反应。PARP抑制剂还可以上调PD-L1表达，所以就有了将PARP抑制剂和PD-1抑制剂联合使用的思路。下面就是一项三期临床试验，研究PD-1抑制剂帕博利珠单抗联合奥拉帕利，或帕博利珠单抗联合培美曲塞进行维持治疗，以判断联合治疗的思路。 1、PD-1和PARP抑制剂联合的疗效 这是一项三期临床试验，入组的患者为晚期非鳞状非小细胞肺癌，这些患者没有驱动性基因突变且没有经过系统治疗。这些患者首先使用PD-1抑制剂帕博利珠单抗联合培美曲塞和卡铂或顺铂治疗4个周期，对于治疗产生完全缓解、部分缓解或病情稳定的患者分为两组。一组患者每天两次口服奥拉帕利（每次300毫克），每3周使用PD-1抑制剂帕博利珠单抗。另外一组患者属于对照组，则是每3周使用帕博利珠单抗联合培美曲塞。也就是两组患者的治疗区别是维持治疗的药物。 这项临床试验入组的患者很多，1003名患者选出了672名患者分为了两组。中位随访时间达到了39.9个月，结果如上面的图示，奥拉帕利联合PD-1的中位无进展生存时间是7.1个月，PD-1联合培美曲塞的中位无进展生存时间是8.3个月，没有显著区别。 两组患者的中位总生存时间分别是20.7个月和23个月，也是没有显著区别。也就是这个研究的结论是没有达到预期的终点。安全性方面，3级以上治疗相关不良事件的发生率分别是26.1%和30%。 2、启发和讨论 这个研究属于耗资比较大的三期临床试验，但是很遗憾没有达到预期的结果。也就是在临床前探索的PARP抑制剂与PD-1的组合没有达到更好的预期，当然如果能达到预期则患者可以不需要打化疗了，可能这是比较具有吸引力的。但研究结果如此可能也确实没有更好的办法了。不过后面关于这两种药物的组合是否有新的思路或数据我们拭目以待。但是上面的研究结论请大家注意，避免不必要的联合用药错误。欢迎关注癌度，了解全球肿瘤诊疗的最新进展！ 癌度与吉因加启动的“基因检测人人可及”计划里，仅需要3000元就能检测36个基因，大家可以联系癌度或扫描上面的二维码咨询癌度医学顾问，了解基因检测的相关问题。 参考文献： Gray JE, et al., The Phase 3 KEYLYNK-006 Study of Pembrolizumab plus Olaparib versus Pembrolizumab plus Pemetrexed as Maintenance Therapy for Metastatic Nonsquamous Non–Small-Cell Lung Cancer, Journal of Thoracic Oncology (2024),  往期推荐  抗癌新药SY-5007首次人体临床试验数据报道，治疗多种肿瘤产生积极疗效！ 抗癌病毒治疗在脑瘤试验中显示出希望，有患者可见病灶消失！ 遗憾！免疫治疗药物度伐利尤单抗治疗PD-L1高表达肺癌，未能改善总生存时间！ 最新临床研究：强效新疗法使晚期乳腺癌的无进展生存期翻倍！