On November 12, 2020 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that Andrew Robbins, Chief Executive Officer and President, will present a corporate overview at the Jefferies 2020 Virtual London Healthcare Conference taking place November 17 – 19, 2020 (Press release, Cogent Biosciences, NOV 12, 2020, View Source [SID1234570804]).

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A recording of the presentation will be available to view after the conference under the "Events" tab on the investor relations section of the Cogent Biosciences website at: View Source

On November 12, 2020-Sun BioPharma, Inc. (Nasdaq: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported financial results for the quarter ended September 30, 2020 (Press release, Sun BioPharma, NOV 12, 2020, View Source;utm_medium=rss&utm_campaign=sbp-provides-business-update-and-reports-q3-2020-financial-results [SID1234570802]). Management is hosting an earnings call today at 4:30 p.m. ET.

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The third quarter of 2020 was marked by meaningful corporate, financial and clinical progress.
Highlights

• New CEO appointed on July 15, 2020
• Fast Track designation received for SBP-101
• Uplisted to Nasdaq Capital Market
• Closed $10.5 Million Public Offering

"During the third quarter we strengthened our leadership team, bolstered the balance sheet and broadened our potential investor audience by uplisting to Nasdaq," said Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Sun BioPharma. "These Q3 accomplishments lay the foundation to execute on near-term milestones. Those upcoming milestones include completing SBP-101’s enrollment in the current Phase 1b trial in Q4 2020, reporting data from our Phase 1 trial in 1H 2021, initiating a randomized Phase 2 study in 1H 2021 while evaluating additional opportunities for SBP-101. Looking ahead, we’re focused on rapidly advancing SBP-101’s clinical development to create significant shareholder value."

Based on interim data from our Phase I trial, SBP-101 demonstrated a 54% objective response rate in combination with gemcitabine & abraxane (G&A); more than double historical standard of care for metastatic pancreatic cancer with G&A.

We believe SBP-101 has the potential to expand into other cancers with known elevated levels of polyamine metabolism.

Upcoming Milestones
• Completion of enrollment in the expansion cohort targeting (Q4’20)
• Data from phase 1 trial (1H’21)
• Conference presentations (1H’21 or 2H’21)
• Initiation of randomized phase 2 study (1H’21)

Third Quarter ended September 30, 2020 Financial Results

General and administrative expenses increased to $1.2 million in the third quarter of 2020, up from $0.6 million in the third quarter of 2019. The change in the third quarter is due primarily to increased employee compensation expense.

Research and development expenses increased to $0.8 million in the third quarter of 2020, up from $0.7 million in the third quarter of 2019. The change in the third quarter is due to increased spending on the company’s clinical study.

Operating expenses in the third quarter of 2020 were partially offset by a foreign currency exchange gain on the intercompany receivable balance; for the same quarter in 2019 other expense, net was primarily a foreign currency exchange loss.

Net loss in the third quarter of 2020 was $1.7 million, or $0.21 per diluted share, compared to a net loss of $1.4 million, or $0.23 per diluted share, in the third quarter of 2019.

Total cash was $10.9 million as of September 30, 2020. Total current assets were $11.4 million and current liabilities were $1.9 million as of the same date.

Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

A replay of the call will be available from November 13, 2020 through November 26, 2020

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial. For more information, please visit View Source

On November 12, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported financial results for the quarter ended September 30, 2020 and provided a business update (Press release, Onconova, NOV 12, 2020, View Source [SID1234570798]).

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Management commentary

"During the third quarter, our product pipeline advanced while we pursued various licensing opportunities. We are particularly pleased that ON 123300, our proprietary, differentiated, first-in-class multi-kinase inhibitor, entered the clinic with HanX Biopharmaceuticals, our partner in China," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "The HanX Phase 1 dose-escalation study has enrolled three patients to date, and is expected to continue to enroll patients with advanced relapsed/refractory cancer at two sites until the recommended Phase 2 dose is identified.

"In parallel, we are preparing to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration by the end of this year, with patient enrollment expected to begin in the first quarter of 2021. We expect that our Phase 1 dose-escalation and dose-expansion study in the U.S. will differ from the HanX study in dose regimens and treatment cycles, and believe that data from these two studies will generate important information to inform anticipated later-stage studies. Our plan is to enroll patients with a variety of advanced solid tumors including an initial focus on HR+ HER2- postmenopausal metastatic breast cancer patients with resistance to approved second-generation CDK 4/6 inhibitors, as well as patients diagnosed with advanced non-Hodgkin’s lymphoma based on efficacy data from our preclinical models. We believe that, with its novel mechanism of action targeting both CDK4/6 and ARK5, ON 123300 presents an innovative approach for potentially treating HR+ HER2- metastatic breast cancer that is or has become resistant to the commercial CDK4/6 inhibitors, and potentially other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma."

"Important investigator-initiated studies are also underway or planned with oral rigosertib," added Richard Woodman, M.D, Chief Medical Officer. "We are currently supporting a Phase 1 dose-escalation study at a leading medical center in New York City exploring the use of rigosertib in combination with the PD-1 inhibitor nivolumabin progressive K-RAS mutated non-small cell lung cancer (NSCLC). That study has enrolled five patients to date, and is designed to identify the recommended Phase 2 dose of the combination for future studies. Results are expected in 2021. In addition, an investigator-initiated phase 1b/2 study with rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa has opened, with first-patient-in expected 2021. Additional investigator-initiated preclinical studies with rigosertib are under consideration."

"Our focus is on advancing our pipeline, and while we believe ON 123300 and oral rigosertib have excellent prospects, we are also engaged in licensing discussions, both for geographic rights to certain of our assets, and evaluating the potential to in-license additional compounds to expand our product portfolio," Dr. Fruchtman concluded.

Third quarter financial results

Cash and cash equivalents as of September 30, 2020 were $24.2 million, compared with $22.7 million as of December 31, 2019. The Company expects that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the first quarter of 2022. During the third quarter of 2020, the Company received $2.7 million from the exercise of warrants.

Research and development expenses were $4.2 million for the third quarter of 2020, compared with $3.5 million for the third quarter of 2019. The increase was primarily related to higher consulting fees and manufacturing costs related to clinical supply for ON 123300, partially offset by lower expenses for the oral rigosertib combination program and the Phase 3 INSPIRE study.

General and administrative expenses were $2.1 million for the third quarter of 2020, compared with $1.6 million for the third quarter of 2019. The increase was due to higher pre-commercialization, insurance, and corporate legal and stockholder meeting expenses.

Net loss for the third quarter of 2020 was $6.2 million, compared with $4.6 million for the comparable prior-year quarter.

Conference call and webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern time, during which management will discuss financial results for the 2020 third quarter, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 8687160.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

On November 12, 2020 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule drugs that selectively destroys disease-causing proteins through degradation, reported financial results for the third quarter ended September 30, 2020, highlighted recent progress and provided a business update (Press release, C4 Therapeutics, NOV 12, 2020, View Source [SID1234570797]).

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"C4T’s recent IPO was a tremendous milestone for our team and an important accomplishment as the company advances our programs to the clinic. With a strong balance sheet and expanded senior team, we are well-positioned to execute against our pipeline and continue investing in our differentiated TORPEDO discovery platform," said Andrew Hirsch, chief executive officer at C4 Therapeutics. "Looking ahead, we expect to have four clinical-stage programs by the end of 2022, including our lead candidate, CFT7455, for hematological malignancies, which is on track for an IND submission by the end of this year. We believe targeted protein degraders represent a novel class of medicines with distinctive benefits over traditional inhibitor drugs and look forward to exploring their potential in patients."

THIRD QUARTER 2020 AND RECENT HIGHLIGHTS

Amended the Amended and Restated Roche Collaboration Agreement: In November 2020, C4T entered into the First Amendment to its 2018 Amended and Restated License Agreement with F. Hoffman-La Roche Ltd and Hoffman-La Roche Inc., which clarifies the rights and responsibilities of both parties in the event of a program termination. In addition, through this amendment, C4T and Roche mutually agreed to terminate the Amended and Restated Agreement with respect to the target epidermal growth factor receptor (EGFR). With this termination, C4T regains the right to pursue the target EGFR in products that use degradation as their mode of action.
Presented at Scientific Conferences on Protein Structure and Degradation: In October 2020, C4T participated in the 3rd Annual Targeted Protein Degradation Summit. Rhamy Zeid, Ph.D., Director of Target Biology at C4T, delivered a presentation highlighting CFT8634, a novel degrader of the protein BRD9. This case study showcased C4T’s TORPEDO platform’s capabilities to enable the development of novel, selective, orally bioavailable degraders. C4T’s Chief Scientific Officer, Stewart Fisher, Ph.D., also led a roundtable discussion on the pace of innovation in drug discovery and development. In November 2020, C4T participated in the 28th Annual Protein Structure Determination in Industry (PSDI) Conference. Joe Patel, Ph.D., C4T’s Senior Director of Biochemistry, Biophysics and Crystallography, delivered a presentation demonstrating how C4T’s TORPEDO platform leverages HDX data and computational methods to design novel degrader candidates with predictable ternary complexes.
Completed Upsized Initial Public Offering: In October 2020, C4T completed an upsized initial public offering of 11.0 million shares of common stock, including the full exercise of the underwriters’ over-allotment option, at a price of $19.00 per share. Net proceeds from the offering were $191.1 million.
Strengthened Leadership Team: In September 2020, C4T announced the appointment of Andrew Hirsch as Chief Executive Officer. Additionally, in July 2020, the Company announced the appointments of William McKee as Chief Financial Officer and Jolie M. Siegel as Chief Legal Officer.
KEY UPCOMING MILESTONES

Investigational New Drug (IND) submission planned for Q4 2020 for CFT7455, an orally bioavailable MonoDAC (Monofunctional Degradation Activating Compound) targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas (NHLs), including peripheral T cell lymphoma (PTCL) and mantle cell lymphoma (MCL). C4T anticipates initiating a Phase 1/2 clinical trial for this program in 1H 2021.
IND submission expected in 2H 2021 for CFT8634, an orally bioavailable BiDAC (Bifunctional Degradation Activating Compound) targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors. C4T anticipates initiating a Phase 1/2 clinical trial for this program by 2H 2021.
UPCOMING INVESTOR EVENTS

November 19, 2020 – C4T will present at the Jefferies Virtual London Healthcare Conference
December 3, 2020 – C4T will hold a Fireside Chat/Panel discussion at the 3rd Annual Evercore ISI HealthCONx Conference
THIRD QUARTER 2020 FINANCIAL RESULTS

Revenues: Total revenues for the third quarter of 2020 were $8.4 million, compared to $5.4 million for the third quarter of 2019. Total revenues reflect revenues recognized under our collaboration agreements with Roche, Biogen and Calico and increased by $3 million compared to the same period of 2019 primarily due to increased reimbursements from Biogen reflecting increase activities on collaboration projects and related activities.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2020 were $23.9 million, compared to $12.9 million for the third quarter of 2019. The increase in R&D expense was primarily attributable to increased third-party chemistry and biology costs, higher preclinical costs related to our lead programs and increased workforce expenses to support our growing clinical development activities.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2020 were $2.9 million, compared to $2.4 million for the third quarter of 2019. The increase in G&A expense was primarily attributable to higher legal and professional costs supporting the company’s growth.

Net Loss: Net loss for the third quarter of 2020 was $21.8 million, compared to $10.1 million for the third quarter of 2019.

Cash Position and Financial Guidance: Cash, cash equivalents and short-term investments as of September 30, 2020, were $199.4 million, compared to $90.5 million as of December 31, 2019. The September 30th balance does not include $191.1 million in net proceeds from our initial public offering, which was completed on October 6, 2020. We expect our cash, cash equivalents and short-term investments, including the net proceeds from our initial public offering and payments to be received under our existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures into the second half of 2023.

On November 12, 2020 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported an operational update and financial results for the quarter ended September 30, 2020 (Press release, Poseida Therapeutics, NOV 12, 2020, View Source [SID1234570795]).

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"During our first quarter as a publicly traded company, we continued to maintain our focus on research innovation and advancement of our clinical programs, while also building new strategic collaborations," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida. "In `early September, we released data demonstrating new manufacturing technology that has the potential to create more efficacious cell therapies and have now implemented that technology across our entire CAR-T pipeline. In October, we announced a research collaboration with TScan Therapeutics to evaluate the feasibility of producing a novel cell-based therapeutic for the treatment of COVID-19. This collaboration will expand our platforms to include T cell receptor-engineered T cell (TCR-T) therapies and further expand the indications we can potentially treat beyond oncology."

Program Updates

P-PSMA-101

P-PSMA-101 is a solid tumor autologous CAR-T product candidate being developed to treat patients with metastatic castrate resistant prostate cancer. The program started enrollment in May 2020. On November 2, 2020, the Company announced that a clinical hold placed on the trial was lifted by the FDA. The trial has now resumed with minor protocol modifications to increase patient compliance and safety. The protocol changes are specific to the P-PSMA-101 program and do not affect the ongoing P-BCMA-101 clinical trial. The Company now expects to provide an initial data update in mid-2021.

P-BCMA-101

P-BCMA-101 is an autologous CAR-T product candidate for the treatment of patients with relapsed/refractory multiple myeloma. The program is currently enrolling in an expanded Phase 1 clinical trial to inform the potentially registrational Phase 2 clinical trial. Phase 1 dose expansion enrollment continues, although at a slower pace than planned due in part to the COVID-19 pandemic. Further, the Company expects to make a Phase 2 dosing decision on P-BCMA-101 by early 2021.

At the CAR-TCR Digital Week meeting on September 16, 2020, the Company presented data related to CAR-T manufacturing optimizations and also illustrated the impact of these optimizations with preliminary clinical analysis of the first patients dosed in the P-BCMA-101 Phase 1 expansion trial.

P-BCMA-ALLO1

The Company’s first allogeneic CAR-T product candidate, P-BCMA-ALLO1, is in development for the treatment of relapsed/refractory multiple myeloma and is designed to be fully allogeneic, with

genetic edits designed to reduce or eliminate both host-vs-graft and graft-vs-host alloreactivity. The program is proceeding toward an IND filing which is expected in the first half 2021.

P-MUC1C-ALLO1

This allogeneic CAR-T product candidate is in preclinical development with the potential to treat a wide range of solid tumors, including breast and ovarian cancers. The program is proceeding with an expected IND filing in 2021.

P-OTC-101 Gene Therapy Program

P-OTC-101 is the Company’s first liver-directed gene therapy program for in vivo treatment of urea cycle disease caused by congenital mutations in the OTC gene, a condition characterized by high unmet medical need. The Company now expects to submit an IND in 2022 due to pandemic related factors, including longer timelines due to COVID-19 vaccine-related capacity constraints at certain vendors.

Early Stage Development Programs

For programs in early development, including the fully allogeneic Dual CAR programs, P-PSMA-ALLO1 and P-MMUT-101, the Company expects to update specific guidance at a later date, as it gains further clarity on the timelines and any impacts of the COVID-19 pandemic.

Other Operational Updates and Upcoming Events

Collaboration agreement with TScan Therapeutics to explore developing allogeneic T cell receptor therapies for the treatment of COVID-19

In October, the Company and TScan Therapeutics announced a research collaboration and license agreement to explore the use of the Company’s fully allogeneic stem cell memory T cell platform in combination with TScan’s proprietary TCR platform and findings related to SARS-CoV-2. The collaboration will allow the Company to explore platform and T cell technology utilizing one or more TCRs in allogeneic cell therapy applications.

Piper Sandler 32nd Annual Virtual Healthcare Conference

The Company is participating in a virtual conference that will be made available at 10 am ET on November 23, 2020, ahead of the conference start scheduled for December 1, 2020. The audio recording of the presentation, formatted as a fireside chat, will be available through the conference coordinators and posted on the Company’s website.

62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition

The Company plans to provide an update on the P-BCMA-101 Phase 1 expansion trial in early December with an oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition scheduled for Saturday, December 5, 2020.

Financial Results

Research and Development Expenses

Research and development expenses were $27.0 million for the three months ended September 30, 2020, compared to $15.7 million for the same period in 2019. For the nine months ended September 30, 2020, research and development expenses were $75.6 million, compared to $41.2 million for the same period in 2019. The increase in both periods was primarily due to increased headcount, external costs related to preclinical programs and clinical stage programs, including the ongoing P-BCMA-101 and P-PSMA-101 clinical trials, and internal costs related to facilities development.

General and Administrative Expenses

General and administrative expenses were $6.5 million for the three months ended September 30, 2020, compared to $4.0 million for the same period in 2019. General and administrative expenses were $15.6 million for the nine months ended September 30, 2020, compared to $14.4 million for the same period in 2019. The increase in both periods was primarily due to increased headcount and professional fees associated with becoming a publicly traded company.

Net Losses

Net losses were $34.4 million and $93.6 million for the three and nine months ended September 30, 2020, respectively, and $21.0 million and $62.9 million for the three and nine months ended September 30, 2019, respectively.

Cash Position

As of September 30, 2020, cash, cash equivalents and marketable securities were $341.5 million. Net proceeds from the Company’s initial public offering, which closed in July 2020, were $205.7 million.