INOVIO to Report Third Quarter 2022 Financial Results on November 8, 2022

On October 25, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and prevent infectious diseases, cancer, and diseases associated with HPV, reported that third quarter 2022 financial results will be released after the market close on November 8, 2022 (Press release, Inovio, OCT 25, 2022, View Source [SID1234622337]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

Immix Biopharma to Present Milestones Achieved to Enable Kick-Off of 2 IMX-110 Clinical Trials at the 2022 ThinkEquity Conference on October 26

On October 25, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported that Chief Executive Officer Ilya Rachman, MD, PhD, and Chief Financial Officer Gabriel Morris will present a company overview and milestones achieved to enable kick-off of 2 IMX-110 clinical trials at the ThinkEquity Conference at the Mandarin Oriental Hotel in New York, New York on Wednesday, October 26, 2022 at 2:00 PM ET (Press release, Immix Biopharma, OCT 25, 2022, View Source [SID1234622336]).

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Presentation date and time: October 26, 2022, 2:00 PM ET
View the live presentation: View Source
Presentation Topic: ImmixBio Milestones Achieved to Enable Kick-off of 2 IMX-110 Clinical Trials
A live webcast of the presentation will be available on the Events & Presentations page located within the Investor Relations section of the ImmixBio website at View Source for approximately 90 days following the presentation.

"I am pleased with the level of investor interest in Immix Biopharma after we announced in October that IMX-110 clinical trial data is expected to be released on a rolling basis beginning in Q1 2023," said Ilya Rachman, MD, PhD. "Since then, we have fielded additional inbound industry interest in ImmixBio. We are especially excited about our upcoming combination trial of IMX-110 with BeiGene / Novartis’ anti-PD-1, tislelizumab. I am looking forward to presenting milestones we have achieved to enable kick-off of 2 IMX-110 clinical trials at the upcoming ThinkEquity conference."

Cullinan Oncology Significantly Increases Ownership Stake in its MICA Subsidiary which Holds Worldwide Rights to Clinical-Stage Novel Monoclonal Antibody CLN-619

On October 25, 2022 Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology, reported that it has increased its ownership in its Cullinan MICA, Inc. (MICA) subsidiary from 54% to 92% (Press release, Cullinan Oncology, OCT 25, 2022, View Source [SID1234622335]). MICA holds the worldwide rights to CLN-619, an antibody that restores the MICA/MICB pathway to promote tumor cell lysis from both cytotoxic innate and adaptive immune cells. CLN-619 is being investigated as both monotherapy and in combination with checkpoint inhibitor therapy in an ongoing Phase I study in patients with advanced solid tumors. Cullinan increased its ownership by purchasing equity from two of MICA’s financial investors, Avalon Ventures and Bregua Corporation, for $30.7 million. The Myeloma Investment Fund, a venture philanthropy fund for the Multiple Myeloma Research Foundation (MMRF), maintained its ownership in the entity.

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"Cullinan Oncology has acquired additional ownership in the MICA subsidiary as part of our overall strategy to deploy our robust financial resources for pipeline investment, acceleration, and expansion," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "This investment recognizes the strategic importance of CLN-619 in our portfolio as a key asset with first-in-class potential and strong rationale for development in a broad range of cancer indications. We are excited by the potential of this unique approach to cancer treatment, and we remain committed to our mission to create new standards of care for patients with cancer."

"One of the hallmarks of cancer is the ability to avoid destruction by immune cells. CLN-619 is designed to overcome immune evasion by promoting NK cell-mediated tumor cell lysis and facilitating engagement of certain classes of T-cells. This differentiated mechanism activates both the innate and adaptive immune system, providing strong rationale to target the MICA/MICB pathway as a novel approach with potential to treat patients with cancer," said Jeff Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. "Given MICA/MICB are broadly expressed across tumor types, we are committed to investigating CLN-619 across a range of malignancies, and we look forward to reporting initial clinical data from our ongoing Phase I clinical study in mid-2023."

About CLN-619

CLN-619 is a humanized IgG1 monoclonal antibody that binds to MICA and MICB, ligands expressed on a wide variety of hematological and solid tumors that are recognized by both cytotoxic innate and adaptive immune cells via their NKG2D receptors. To evade lysis by these immune cells, tumor cells shed MICA/MICB from their cell surface. CLN-619 promotes an antitumor response through multiple potential mechanisms of action, including prevention of the proteolytic cleavage of MICA/MICB from cancer cells, antibody-dependent cell-mediated cytotoxicity (ADCC), and enhancement of MICA/MICB binding to NKG2D. Multiple studies evaluating serum samples from cancer patients have demonstrated that high serum levels of shed MICA correlate with poor prognosis. CLN-619 is being studied in an ongoing Phase I dose escalation and expansion trial both as a monotherapy and in combination with pembrolizumab. The study design allows dose level extensions as well as expansion in tumor specific cohorts. The trial was initiated in December 2021, and initial clinical data is anticipated in mid-2023.

Aravive Announces Approximately $41.5 Million Private Placement Financing

On October 25, 2022 Aravive, Inc. (Nasdaq: ARAV) ("Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that it has entered into definitive agreements with new biotechnology investors, existing investors, Company management and Company Directors for the issuance and sale of an aggregate of 45,178,811 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 45,178,811 shares of common stock in a private placement offering priced at-the-market under Nasdaq rules (Press release, Aravive, OCT 25, 2022, View Source [SID1234622334]). The purchase price per share and accompanying warrant was $0.9199 for all investors who participated in the deal (or $0.9198 per pre-funded warrant and accompanying warrant). Fifty percent of the warrants have an exercise price of $0.7949 per share and will expire on the date that is the later of: (i) 15 months from the date an increase in the number of authorized shares of common stock is effected, or (ii) one month after the public announcement of the topline Phase 3 platinum-resistant ovarian cancer (PROC) data. The remaining 50% of the warrants will have an exercise price of $0.7949 per share and will expire 30 months from the date an increase in the number of authorized shares of common stock is effected. All of the warrants other than the pre-funded warrants are exercisable for cash only.

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Investors in the transaction include new biotech-focused investors: BVF Partners L.P., and other institutions, as well as existing investors including Eshelman Ventures, LLC, Invus, and Company directors and senior management of the Company.

The private placement is expected to close on October 27th, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the "Minimum Price" requirement (as defined in the Nasdaq rules). In connection with the PIPE, the Company has agreed to convene a special meeting of its stockholders no later than 120 days following the closing to seek approval for an increase in the number of its authorized shares of common stock. The gross proceeds of approximately $41.5 million, before deducting placement agent fees and other expenses, will be used to provide funding to get beyond the topline readout of the pivotal Phase 3 trial in PROC, incremental data read outs from the Phase 1b/2 trial in clear cell renal cell cancer and expanded Phase 1b pancreatic adenocarcinoma studies anticipated in 2023.

Gail McIntyre, Ph.D., DABT, Chief Executive Officer, said, "We are honored to have the continued support from insiders, as well as new support from a strong and respected syndicate of leading biotech investors. Together, we will continue to advance batiraxcept towards our pivotal Phase 3 platinum-resistant ovarian cancer readout expected in mid-2023, as well as continued development of batiraxcept in clear cell renal cell cancer and pancreatic adenocarcinoma with the potential for the drug to be a first-in-class oncology agent with an accompanying predictive biomarker."

MTS Securities, LLC, an affiliate of MTS Health Partners L.P., acted as the exclusive placement agent in the financing.

The securities sold in this financing are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Aravive has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of its common stock underlying the pre-funded warrants and accompanying warrants sold in this financing.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Symeres acquires Exemplify BioPharma, further strengthening its strategic foothold in the US

On October 25, 2022 Symeres reported the acquisition of Exemplify BioPharma, a US based CRO that provides integrated drug development services in Process & Analytical Chemistry and Formulation Development to pharmaceutical and biotech partners (Press release, Symeres, OCT 25, 2022, View Source [SID1234622333]).

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Exemplify BioPharma, based in Cranbury, New Jersey (US), is a provider of high-quality integrated end-to-end small molecule Chemistry Manufacturing and Controls (CMC) services to pharmaceutical and biotech partners. The company offers functional expertise and consultancy services in Process Chemistry, Analytical Chemistry, and Formulation Development for a successful transition of programs from late-stage lead optimization through candidate selection to first-in-human. Exemplify employs 20 people, of which the majority are Ph.D-level scientists. The company will remain under the current management of co-founders: Yadan Chen, Chief Executive Officer, and Dr. Paul O’Shea, Chief Scientific Officer.

This acquisition further strengthens Symeres’ strategic foothold in the US, where the company already generates about 50% of its revenues. Exemplify operates from its new state-of-the-art 18,600 sq. ft. facility in New Jersey. Its functional expertise in Process & Analytical Chemistry and Formulation Development represents a highly synergistic combination with Symeres capabilities and service offering.
Exemplify BioPharma is Symeres’ second acquisition in the US this year, following the acquisition of Organix Inc., an organic chemistry services provider based in the Boston area specialized in lipids addressing the mRNA therapeutics and vaccines market.

Yadan Chen, CEO of Exemplify BioPharma, stated: "We are proud to see Exemplify BioPharma’s scientific expertise and strategic location in North America recognized and become part of the Symeres family. Symeres is a trusted partner that shares our values and business philosophy of strong customer focus. Exemplify BioPharma’s recent move to our new and larger state-of-the-art facility, and the combination with a global business like Symeres, will allow us to better serve our clients under one roof. We look forward to accelerating our growth together."

Dr. Eelco Ebbers, Co-founder and CEO of Symeres, stated: "We are pleased to welcome Exemplify BioPharma into the group. Exemplify has an excellent track record of supporting the development needs of North American biotech companies through their experience and outstanding laboratory-based science. This acquisition, following the addition of Organix earlier this year and our investment plans for all of our R&D facilities, is a further tangible demonstration of Symeres’ strategy of building a leading mid-sized transatlantic pharmaceutical R&D service provider for our clients around the world."

Amit Karna, Partner at Keensight Capital, added: "Following the recent acquisition of Organix in the Boston area, the addition of Exemplify BioPharma in New Jersey marks another milestone in Symeres’ strategy to build a truly transatlantic business, serving the biopharma industry globally. The scientific and cultural fit of Exemplify BioPharma within the group is excellent. Keensight Capital is delighted to support Symeres in this exciting acquisition."