On October 7, 2022 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported that it has obtained a $200 million non-dilutive term loan facility from Hercules Capital, Inc. (NYSE:HTGC), a leader in customized debt financing for companies in the life sciences and technology-related markets (Press release, Replimune, OCT 7, 2022, View Source [SID1234621835]). This non-dilutive capital extends cash runway into 2025 ahead of key catalysts from the Company’s registration-directed CERPASS and IGNYTE trials in cutaneous squamous cell carcinoma (CSCC) and anti-PD1 failed melanoma inclusive of the costs of funding commercial infrastructure and the running of a confirmatory study to support a potential BLA filing in anti-PD1 failed melanoma.

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"This non-dilutive financing option provides Replimune with significant flexibility as we prepare for key RP1 skin franchise data catalysts and related commercial preparations of our novel tumor-directed oncolytic immunotherapies as well as the advancement of RP2/3 into Phase 2 studies," said Jean Franchi, Chief Financial Officer of Replimune. "Not only does this non-dilutive financing strengthen what we believe to be an already strong financial position, it creates optionality in future capital formation and enables us to choose when, and to what extent, we access available funding in order to help manage future cost of capital and dilution."

"Hercules strives to align with some of the best and brightest companies in the life sciences industry to provide them with long-term capital commitments to help them achieve their ambitious goals. We are excited to collaborate with Replimune and their team ahead of numerous data, regulatory, and commercial milestones," said Bryan Jadot, Senior Managing Director and Group Head at Hercules Capital.

The loan facility consists of up to six tranches, five of which can be drawn at Replimune’s option and each maturing in October 2027. The loan facility provides for at least 48-months of interest-only at close, which interest-only period can be extended up to 60 months upon satisfaction of certain milestones. An initial $30 million tranche was funded at closing with an additional $30 million available to be drawn at Replimune’s option prior to September 30, 2023. An additional $115 million is available subject to the Company’s achievement of specified performance milestones relating to clinical, regulatory, and commercial events. The final $25 million tranche is available for draw, at Replimune’s option and subject to Hercules consent during the interest-only period.

Armentum Partners acted as the Company’s exclusive financial advisor on this transaction.

On October 7, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company’s participation in the following upcoming investor and industry conferences to be held in October 2022 (Press release, Genprex, OCT 7, 2022, View Source [SID1234621834]).

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Event: Dawson James Securities Annual Small Cap Growth Conference

Event: Immuno-Oncology Summit

Event: BIO Europe

Event: LD Micro Main Event XV

Live Webcast Link: https://bit.ly/3EgC5af

For those interested in meeting Genprex management at LD Micro’s Main event, please request a meeting through LD Micro or reach out to Kalyn Dabbs at [email protected].

On October 7, 2022 Bristol Myers Squibb (NYSE:BMY) reported that it has changed the dial-in and replay information of its previously announced third quarter 2022 earnings conference call scheduled for Wednesday, October 26, 2022 (Press release, Bristol-Myers Squibb, OCT 7, 2022, View Source [SID1234621833]). Company executives will review financial results and address inquiries from investors and analysts during a conference call at 8:00 a.m. ET that same day.

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The new dial-in and replay information are as follows:

Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source Investors and the public can also access the live webcast by dialing in the U.S. toll free 888-330-2388 or international +1 240-789-2707, confirmation code: 24168. Dial-in participants can register for the conference call here and once registration is complete, will not require operator assistance to connect. Materials related to the call will be available at View Source prior to the start of the conference call.

A replay of the webcast will be available on View Source approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on October 26 through 11:30 a.m. ET on November 9, 2022, by dialing in the U.S. toll free 800-770-2030 or international +1 647-362-9199, confirmation code: 24168.

On October 7, 2022 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that preclinical data for its two lead RAS programs – a next-generation KRAS G12C dual inhibitor program and a PI3Kα:RAS breaker program – will be featured in an oral presentation on Monday, October 17th at the Fourth RAS Initiative Symposium (Press release, BridgeBio, OCT 7, 2022, View Source [SID1234621832]). The Symposium will take place in Frederick, MD on October 17-19, 2022. Details about the oral presentation and the investor call and webcast are listed below.

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KRAS G12C dual inhibitor:
BridgeBio has selected a next-generation KRAS G12C dual inhibitor development candidate and plans to enter the clinic in 2023. The Company’s development candidate is the first-known small molecule that directly binds and inhibits KRAS G12C in both its active (GTP bound) and inactive (GDP bound) conformations. BridgeBio believes this could lead to differentiated activity in cancer patients with KRAS G12C driven disease, as all other known clinical stage direct KRAS G12C inhibitors do not inhibit the active oncogenic form of the protein (GTP-bound KRAS G12C).

PI3Kα:RAS breaker:
BridgeBio is also pursuing PI3Kα:RAS breakers, small molecules that block RAS driven PI3Kα activation. Inhibiting PI3Kα activity by preventing its interaction with RAS can provide a "tumor selective" mechanism that spares glucose metabolism. This novel approach could, if successful, potentially have broad utility against oncogene-driven tumors as both a monotherapy and in combination with other agents.

Oral presentation details:

Webcast Information
BridgeBio will host an investor call and simultaneous webcast to discuss preclinical data from both lead RAS programs and the selection of the KRAS G12C dual inhibitor development candidate on October 17, 2022 at 1:30 pm ET. To access this call via phone, participants will need to register using the following link where they will be provided a phone number and access code: (https://register.vevent.com/register/BIbd4d7a752dcc4ade970571556d4060e5). The webcast and presentation slides can be viewed during the time of the call via a link on the event calendar page of BridgeBio’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event.

On October 7, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on stimulating the immune system to transform outcomes for cancer patients, reported the publication of preclinical data in Nature Communications highlighting the potential of its viral RNA (vRNA)/lipid nanoparticle (LNP) platform as a novel approach to treating cancer by enabling repeat intravenous (IV) administration of viral immunotherapies (Press release, Oncorus, OCT 7, 2022, View Source [SID1234621828]). Data published today demonstrate vRNA/LNP delivery and selective replication, virus assembly, spread and lysis of tumor cells, leading to potent anti-tumor efficacy even in the presence of virus neutralizing antibodies in the bloodstream.

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The article describes the design and development of Oncorus’ synthetic RNA viruses for the systemic treatment of cancer. The IV delivery of viral RNA genomes for two picornaviruses, Coxsackievirus A21 (CVA21) and Seneca Valley Virus (SVV), were formulated in LNPs. By encapsulating vRNA in LNPs, Oncorus was able to cause reductions in tumor growth and avoid neutralizing antibodies. The vRNA/LNP constructs were well tolerated and elicited tumor-specific in situ production of oncolytic virions, immune cell recruitment and tumor destruction. Efficacy was observed across multiple cancer models, including xenografts, PDX, GEMM and syngeneic models, with survival benefit observed in an orthotopic small cell lung cancer (SCLC) tumor model. Overall, synthetic RNA viruses were well tolerated after a single or multiple IV dose in mice and non-human primates. These results support the potential of this modality to expose all tumor lesions within a patient to a potently living drug that can both kill tumor cells and stimulate the immune system to fight cancer more effectively.

"Oncorus has made great strides in the development of viral RNA encapsulated within LNPs, and this publication is an important first step in realizing the potential of our platform as we progress this highly innovated approach into the clinic. We are focused on overcoming the neutralizing antibodies seen in previous studies involving the IV-administration of RNA-based oncolytic therapeutics which has likely limited their effectiveness today and believe that our data supports the ability our self-amplifying vRNA/LNP constructs to overcome these challenges," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "As demonstrated in animal models outlined here, we’ve established a way to simultaneously cause direct tumor cell killing in addition to broad immune stimulation in multiple tumors through an IV-administered self-amplifying RNA encapsulated within an LNP. We look forward to progressing our first candidate from this platform, ONCR-021, in patients with non-small cell lung cancer, renal cell carcinoma, melanoma and hepatocellular carcinoma. We plan to submit an IND with the U.S. FDA for this program in mid-2023," said Matthew Kennedy, Ph.D., Vice President of Research at Oncorus and the lead author on this paper.

Oncorus has built a pioneering platform addressing significant unmet needs in cancer immunotherapy treatment. This novel IV-administered approach involves encapsulating the RNA genomes of viruses known to kill cancer cells in an LNP, resulting in a vRNA/LNP immunotherapy. Oncorus’ LNP delivery strategy is intended to be less immunogenic than a natural viral capsid and is designed to overcome the challenges caused by neutralizing antibodies. Using its platform, Oncorus has developed two vRNA/LNP immunotherapy programs, ONCR-021 and ONCR-788, which are based on CVA21 and SVV, respectively. The Company plans to submit an investigational new drug (IND) application with the U.S Food and Drug Administration (FDA) for ONCR-021 in mid-2023.