On October 29, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that it will report third quarter 2020 financial results before the open of U.S. financial markets on Thursday, November 5, 2020 (Press release, Kura Oncology, OCT 29, 2020, View Source [SID1234569334]). Kura’s management will host a webcast and conference call at 8 a.m. ET / 5 a.m. PT that day to discuss the financial results and provide a corporate update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 7456326. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On October 29, 2020 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will present its third quarter 2020 financial results and operational highlights in a conference call on November 5, 2020 at 8 a.m. ET (Press release, Intellia Therapeutics, OCT 29, 2020, View Source [SID1234569333]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To join the call:

U.S. callers should dial 1-877-317-6789 and international callers should dial 1-412-317-6789, approximately five minutes before the call.
All participants should ask to be connected to the Intellia Therapeutics conference call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com, beginning on November 5, 2020 at 12 p.m. ET.

On October 29, 2020 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 that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name REQORSA for its lead drug candidate in development for the treatment of non-small cell lung cancer, known previously by the laboratory designation GPX-001 (Press release, Genprex, OCT 29, 2020, View Source [SID1234569332]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The name REQORSA (pronounced "re-KORE-suh"), was developed in accordance with FDA’s guidance for the submission and evaluation of proprietary names. The Company selected the name based on comprehensive and disciplined review of name candidates, including a research study of healthcare practitioners across the U.S. to ensure accurate prescription and safety interpretation of the name.

"We are very pleased to receive FDA’s conditional acceptance of our proprietary name, REQORSA, which is a necessary step toward being able to market our lead drug candidate for non-small cell lung cancer," said Rodney Varner, President and Chief Executive Officer of Genprex. "This name approval also marks an important milestone in our overall branding strategy, giving us a unique, easily understood name people can associate with the Genprex brand and mission."

Genprex will resubmit its proprietary name for FDA final review upon completion of all required clinical trials and prior to the submission of a Biologics License Application. Final approval of the REQORSA brand name is conditional on FDA approval of the product candidate.

REQORSA uses the company’s unique, proprietary ONCOPREX nanoparticle delivery system, which delivers cancer-fighting genes by encapsulating them into nanoparticles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. In January 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso for the treatment of non-small cell lung cancer.

On October 29, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the third quarter ended September 30, 2020, and provided a business update on recent corporate and clinical developments (Press release, Protalix, OCT 29, 2020, View Source [SID1234569331]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"This quarter, we delivered on another important milestone for the Company with the FDA’s acceptance of, and grant of Priority Review designation to, the biologics license application (BLA) submitted for PRX-102 for the treatment of Fabry disease," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We continue to build-out our clinical data profile for PRX-102. The last patient has completed treatment in the BRIGHT study, and we expect to report top-line data from the study by the end of the first quarter, 2021. We remain focused on advancing our earlier stage pipeline as well. We are proud of our team’s continued dedication and collaboration in progressing on our corporate mission during these challenging times of the pandemic."

Recent Business Highlights

●Announced U.S. Food and Drug Administration (FDA) acceptance of the BLA submitted for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease and grant of Priority Review designation to the BLA. The BLA was submitted under the FDA’s accelerated approval pathway in collaboration with the Company’s development and commercialization partner, Chiesi Global Rare Diseases. The FDA indicated in its communications that it is not currently planning to hold an advisory committee meeting to discuss the application.
●The FDA set an action date of January 27, 2021 under the Prescription Drug User Fee Act (PDUFA) for the BLA. The FDA advised that, as part of its review of the BLA application, it requires an inspection of the Company’s manufacturing facility and that of a third party in Europe that performs fill and finish processes for PRX-102. Due to COVID-19 related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA date. Together with Chiesi, the Company is diligently exploring potential alternatives that would enable the FDA to meet its timeline. As part of such efforts, Chiesi submitted a request to the FDA for a Type A meeting. The

Company anticipates an FDA response to this request during the first week of November 2020.
● Disclosed the completion of the patient treatment period for the Company’s phase III BRIGHT clinical trial of PRX-102 for the treatment of Fabry disease. The trial was designed to evaluate the safety and efficacy of 2 mg/kg PRX-102 infused every four weeks, in Fabry patients. The Company expects to report top-line results from the trial by the end of the first quarter, 2021.
● Announced the launch of an Expanded Access Program in the United States for PRX-102 allowing a broader group of physicians and patients, beyond those in the Company’s phase III clinical program, access to PRX-102.
● Launched an at-the-market equity offering program with BofA Securities enabling the Company to sell up to $30 million shares of common stock according to the terms and conditions set forth in its agreement with BofA Securities. The program provides the Company with greater capital-raising flexibility as it executes on its commercialization and development plans.
Third Quarter 2020 Financial Highlights

The Company recorded revenues from selling goods of $3.3 million during the three months ended September 30, 2020, a decrease of $1.8 million, or 36%, compared to revenues of $5.1 million for the same period of 2019. The decrease resulted primarily from a timing difference in sales to Brazil in 2020 compared to 2019, which was partially offset by an increase in sales to Pfizer Inc.

Revenues from license and R&D services for the three months ended September 30, 2020 were $7.5 million, a decrease of $1.6 million, or 18%, compared to $9.1 million for the same period of 2019. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 as well as lower costs related to the Company’s phase III BALANCE clinical trial of PRX-102 for the treatment of Fabry disease.

Cost of goods sold for the three months ended September 30, 2020 was $2.9 million, a decrease of $0.3 million, or 11%, compared to $3.2 million for the same period of 2019. The decrease is primarily due to a change in the cost structure as well as lower royalties paid to the Israeli Innovation Authority.

Research and development expenses for the three months ended September 30, 2020 were $7.7 million, a decrease of $2.3 million, or 23%, compared to $10.0 million for the same period of 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the BALANCE study as well as a decrease in costs

related to manufacturing of the Company’s drug in development as some of the manufactured drug product and related costs have been recorded as inventory.

Selling, general and administrative expenses for the three months ended September 30, 2020 were $2.8 million, an increase of $0.2 million, or 9%, compared to $2.6 million for the same period of 2019.

Financial expenses net for the three months ended September 30, 2020 were $1.9 million, a decrease of $0.1 million, or 8%, compared to $2.0 million for the same period of 2019.

Cash, cash equivalents and short-term bank deposits were approximately $41.3 million at September 30, 2020.

Conference Call and Webcast Information:

The Company will host a conference call on Thursday, October 29, 2020 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Company Link: View Source

Webcast Link: View Source

Conference ID: 13711708

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

On October 29, 2020 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported its operating and financial results for the third quarter ended September 30, 2020 (Press release, Genocea Biosciences, OCT 29, 2020, View Source [SID1234569329]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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GEN-011 Phase 1/2a clinical trial initiation
Genocea recently announced the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) Application for GEN-011, an adoptive neoantigen T cell therapy designed to improve upon the limitations of TIL and TCR therapies. The company initiated a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy to evaluate safety, T cell proliferation and persistence as well as clinical activity. Genocea plans to enroll up to 24 patients across several tumor types in the trial.

Scientific and clinical presentations: ESMO (Free ESMO Whitepaper) Congress, upcoming SITC (Free SITC Whitepaper) meeting and conference call
Genocea presented clinical response and immunogenicity data on the first five patients from Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020. The incremental follow-up findings demonstrated tumor reductions or stable outcomes for all five patients, suggesting GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100% of patients demonstrated immune responses to ATLAS-identified neoantigens.

Genocea will report additional clinical and immunogenicity data from the remaining GEN-009 Part B patients during the 2020 virtual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting from November 9-14. The company will also provide a detailed introduction to GEN-011 and will share new insights on the utility of ATLAS-identified Inhibigens to inform future immunotherapy development.

Genocea will host a conference call on Monday, November 9 at 8:30 a.m. EST to discuss the new GEN-009 clinical and immunogenicity data reported at SITC (Free SITC Whitepaper).

Private placement
In July, Genocea completed a private placement with $74.5 million in net proceeds. The proceeds will be used to fund continued development of GEN-009, GEN-011 and ATLAS.

"In the third quarter, our team achieved important clinical, scientific and financial progress. We provided what we believe to be differentiated immunogenicity and efficacy data from an initial look at our GEN-009 Part B clinical trial and secured critical fresh capital", said Chip Clark, president and chief executive officer Genocea. "Using these proceeds to advance GEN-011 into the clinic and to further our investigation into ATLAS and its applications represents an exciting opportunity."

Third Quarter 2020 Financial Results

Cash position: As of September 30, 2020, cash and cash equivalents were $87.6 million versus $40.1 million as of December 31, 2019.
Research and Development (R&D) expenses: R&D expenses were $7.5 million for the quarter ended September 30, 2020, compared to $6.8 million for the same period in 2019.
General and Administrative (G&A) expenses: G&A expenses were $3.6 million for the quarter ended September 30, 2020, compared to $2.8 million for the same period in 2019.
Net loss: Net loss was $4.6 million for the quarter ended September 30, 2020, compared to $7.5 million for the same period in 2019.
Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations to mid-2022.

Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. EDT. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 5951388. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.