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Cue Biopharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights

On March 16, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported a business update for the fourth quarter and full year 2020 (Press release, Cue Biopharma, MAR 16, 2021, View Source [SID1234608282]).

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"We have executed on our stated corporate goals and objectives for 2020, enabling us to begin 2021 on track, despite the ongoing challenges of the global pandemic. Accordingly, we marked the beginning of 2021 by the dosing of the first patient in our CUE-101 Phase 1 combination trial with KEYTRUDA, which has the potential for significant mechanistic synergies to provide broader patient reach and enhancement of patient benefit," said Dan Passeri, chief executive officer of Cue Biopharma. Mr. Passeri added, "Importantly, we are now well-positioned to execute throughout 2021 with the aim of demonstrating the potential significance of our approach for treating debilitating diseases by restoring immune balance. In oncology, we have the ongoing Phase 1 studies of CUE-101 which aim to establish a potential registration path, as well as proof-of-principle and a mitigated risk profile for the entire CUE-100 series. For autoimmune disease, we remain on-track to demonstrate the potential of deploying our CUE-300 series (partnered with Merck for defined indications) where the autoantigens are known and well characterized, e.g., type 1 diabetes. For autoimmune diseases where the autoantigens are unknown, or not well characterized, we look forward to further progressing our novel CUE-400 series, a recent development that is based on our IL-2 variant and modified TGF-beta."

Ken Pienta, M.D., acting chief medical officer of Cue Biopharma, commented, "We are pleased with the progress and observations made to date in our monotherapy trial and with the initiation of our combination trial of our lead drug candidate CUE-101. We continue to generate supportive clinical datasets from the ongoing dose escalation and expansion portion of the monotherapy trial in preparation for the Phase 1b monotherapy expansion segment of the trial scheduled to begin in the second half of 2021. Furthermore, with the initiation of the combination trial in front-line therapy with KEYTRUDA, combined with the expectation of launching our neo-adjuvant study in newly diagnosed patients later this year, we have implemented a clinical development approach that we believe will enable us to broaden patient reach and maximize the potential for enhancing therapeutic benefit."

Fourth Quarter 2020 Financial Results

The Company reported collaboration revenue of approximately $0.5 million and $1.0 million for the three months ended December 31, 2020 and 2019, respectively. The decrease was primarily due to adjustments in the LG Chem, Ltd. and Merck collaboration budgets and full-time employee allocations.

Research and development expenses were $8.0 million and $7.0 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due to clinical trial activity for the CUE-101 monotherapy and combination clinical trials, hiring of research and development personnel in the fourth quarter of 2020, manufacturing costs for CUE-102 clinical material as well as development of the Neo-STAT cell line.

General and administrative expenses were $3.4 million and $3.1 million for the three months ended December 31, 2020 and 2019, respectively. The increase was due primarily to stock-based compensation and legal fees incurred during the fourth quarter of 2020.

Full Year 2020 Financial Results

The Company reported collaboration revenue of approximately $3.2 million and $3.5 million for the years ended December 31, 2020 and 2019, respectively. The decrease was primarily due to adjustments in the LG Chem Ltd., and Merck collaboration budgets and changes in the allocation of full-time employees to these programs during the year.

Research and development expenses were $33.5 million and $27.5 million for the years ended December 31, 2020 and 2019, respectively. The increase was due to clinical trial activity for the CUE-101 monotherapy and combination clinical trials, hiring of research and development personnel throughout 2020 and manufacturing costs related to CUE-101 and CUE-102 clinical material.

General and administrative expenses were $14.7 million and $12.7 million for the years ended December 31, 2020 and 2019, respectively. The increase in general and administrative expense was due primarily to stock-based compensation and legal fees offset by a decrease in travel expenses as the COVID-19 pandemic continued to hamper business travel throughout 2020.

As of December 31, 2020, the Company had approximately $84.9 million in cash and cash equivalents compared with $59.4 million as of December 31, 2019.

Cogent Biosciences Reports Fourth Quarter 2020 and Full Year 2020 Financial Results

On March 16, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the fourth quarter ended December 31, 2020 and provided several corporate updates (Press release, Cogent Biosciences, MAR 16, 2021, View Source [SID1234583736]).

"Cogent Biosciences was formed in July 2020, and we are extremely proud of the progress our team has made in such a short amount of time," said Andrew Robbins, President and CEO of Cogent Biosciences. "We remain on track and plan to initiate clinical trials of CGT9486 in advanced systemic mastocytosis in the first half of this year, and will follow in non-advanced systemic mastocytosis and GIST in the second half of this year. We are excited to demonstrate the role of this novel, potent, selective KIT-mutant inhibitor for these patient populations with significant remaining unmet medical need."

Recent Program and Corporate Highlights

Encouraging data from CGT9486 + sunitinib in Phase 1/2 combination study in heavily pre-treated patients with GIST support a randomized trial in 2H21
Data presented at the Connective Tissue Oncology Society (CTOS) 2020 virtual meeting demonstrated that treatment with a combination of CGT9486, a KIT inhibitor with activity against exon 17 mutations, and sunitinib, a KIT inhibitor with activity against exon 13 mutations, is associated with encouraging clinical activity in heavily pre-treated patients with GIST.
Data showed median progression free survival (PFS) of 12 months in a heavily pre-treated population of advanced GIST patients and an objective response rate (ORR) of 20%.
The combination was well-tolerated across three dose levels with no maximum tolerated dose level reached. The most common minor adverse events were anemia, hypophosphatemia, diarrhea, and lymphopenia.
Based on these encouraging data, Cogent plans to initiate a randomized trial in patients with imatinib-resistant GIST during the second half of 2021.
Upsized Public Offering with gross proceeds of approximately $115 million support advancement of CGT9486 into three clinical trials in 2021
On December 4, 2020, Cogent Biosciences announced the closing of its upsized underwritten public offering; net proceeds from which will be used for the continued clinical development of CGT9486 to treat patients with systemic mastocytosis and GIST.
Appointed new individuals to several key leadership positions
Todd E. Shegog to Board of Directors
Mr. Shegog currently serves as the Chief Financial Officer for Forma Therapeutics and brings more than 25 years of financial, operations, corporate strategy, and compliance expertise in the biotechnology and pharmaceutical industries to Cogent Biosciences’ Board. Todd has past experience as CFO at Synlogic, FORUM, and Millennium and received degrees in electrical engineering from Lafayette College and an MBA from the Tepper School of Management at Carnegie Mellon University.
Sara Saltzman as Senior Vice President, Regulatory Affairs
Ms. Saltzman has built extensive experience in Regulatory Affairs working for top-tier life sciences companies such as Genzyme, Takeda, and Alexion; most recently serving as the Vice President of Regulatory Affairs for Unum Therapeutics. Sara holds a degree in Biology from Colby College.
Ben Exter as Vice President, Pharmacovigilance and Risk Management
Dr. Exter spent several years in clinical development at Biogen and Takeda, culminating with his role as Global Head of Risk Management at Takeda. Most recently he was VP of Pharmacovigilance at Unum Therapeutics. Ben received his Doctorate of Pharmacy degree from Northeastern University.
Mark Lohman as Vice President, CGT9486 Program Team Leader
Mr. Lohman has spent over 20 years in program and alliance management and leadership roles at Array BioPharma and most recently at Pfizer as Executive Director, Alliance and Program Management for Oncology. Mark holds a degree in Chemistry from Kent State University and an MBA from the University of Colorado Denver.
Fourth Quarter and Year End 2020 Summarized Financial Results

R&D Expenses: Research and development expenses were $6.1 million for the fourth quarter of 2020 and $25.7 million for the year ended December 31, 2020, as compared to $10.4 million for the fourth quarter of 2019 and $43.7 million for the year ended December 31, 2019. This decrease is primarily related to the reduction in clinical activity of legacy cell therapy clinical trials.
G&A Expenses: General and administrative expenses were $5.3 million for the fourth quarter of 2020 and $17.4 million for the year ended December 31, 2020, as compared to $2.7 million for the fourth quarter of 2019 and $11.0 million for the year ended December 31, 2019. The increase is primarily related to higher professional fees and stock compensation.
Net Loss: Net loss was $11.3 million for the fourth quarter of 2020 and $74.8 million for the year ended December 31, 2020 as compared to a net income of $2.3 million for the fourth quarter of 2019 and a net loss of $31.8 million for the year ended December 31, 2019.
Cash and Cash Equivalents: As of December 31, 2020, Cogent Biosciences had cash and cash equivalents of $242.2 million. We believe our cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into 2024.

Acepodia Completes $47 Million Series B Financing to Advance Pipeline of Allogeneic Cell Therapy Candidates

On March 16, 2021 Acepodia, a biotechnology company developing next generation solid tumor and hematologic cancer cell therapies, reported the closing of its $47 million Series B financing (Press release, Acepodia, MAR 16, 2021, View Source [SID1234579659]). The funding will be used to advance the company’s lead off-the-shelf natural killer (NK) cell therapy candidate, ACE1702, through clinical development in solid tumors, and to advance its preclinical NK and gamma delta T cell therapy pipeline into the clinic. Acepodia anticipates completing IND-enabling studies for two additional pipeline products in 2021.

The funding round was supported by new U.S. institutional investors, including Ridgeback Capital Investments, 8VC, and DEFTA Partners, and the Taiwan-based institutional investor-CDIB Capital Healthcare. Acepodia’s Series A investors also participated.

"This second capital raise for Acepodia represents a strong vote of confidence by our investors in our highly differentiated approach to cell therapy, particularly with NK cells, and in the Company’s potential to provide superior treatment options for patients with cancer," said Sonny Hsiao, Ph.D., founder and chief executive officer of Acepodia. "Accessible and effective allogeneic, off-the-shelf cell therapies will be an important part of next generation cancer therapy. With our discipline and capital efficiency, we are well-positioned to execute on our corporate objectives, including the continued clinical development of these therapies, including our lead candidate, ACE1702 for the treatment of solid tumors, and execution of future clinical trial initiations for our promising preclinical portfolio of NK and NK-like gamma delta T cell therapy candidates."

Wayne Holman, M.D., Chief Executive Officer and Founder of Ridgeback Capital, added, "We are excited to participate in this financing for Acepodia as we are believers in the foundational evidence suggesting cell therapies should play a significant role in the future of cancer therapy. We believe the prior success of Acepodia’s leadership group in cell therapies, and the unique Antibody-Cell Conjugation (ACC) technology when applied to allogeneic off-the-shelf cryopreserved NK cells could lead to enhanced and differentiated results."

Acepodia’s technology enables development of cell therapies with improved tumor engagement and targeting through optimized cell receptor selection, and seamless conjugation with antibody therapies. Utilizing its proprietary, patent-protected Antibody-Cell Conjugation (ACC) technology, Acepodia is able to directly conjugate and arm NK or gamma delta T cells with validated anti-tumor antibodies for cell therapies, a design which has demonstrated the ability to overcome traditionally resilient tumor defenses in preclinical trials. The company is currently conducting an ongoing Phase 1 clinical trial of ACE1702, the first antibody-conjugated NK cell therapy in clinical development for the treatment of HER2-expressing solid tumors.

Entry into a Material Definitive Agreement.

On March 16, 2021, Propanc Biopharma, Inc. (the "Company") reported that entered into a securities purchase agreement (the "Purchase Agreement") with Geneva Roth Remark Holdings, Inc. ("Geneva"), pursuant to which Geneva purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $63,500, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Geneva (Filing, 8-K, Propanc, MAR 16, 2021, View Source [SID1234576910]). The transaction contemplated by the Purchase Agreement closed on or about March 18, 2021. The Company intends to use the net proceeds ($60,000) from the Note for general working capital purposes.

The maturity date of the Note is March 16, 2022 (the "Maturity Date"). The Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to Geneva in shares of common stock, but shall not be payable until the Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. Geneva has the option to convert all or any amount of the principal face amount of the Note, starting on September 12, 2021 and ending on the later of the Maturity Date and the date of payment of the Default Amount (as defined below) is paid if an event of default occurs, for shares of the Company’s common stock at the then-applicable conversion price. The conversion price for the Note shall be equal to the Variable Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Variable Conversion Price" shall mean 65% multiplied by the Market Price (as defined herein) (representing a discount rate of 35%). "Market Price" means the average of the lowest three (3) Trading Prices (as defined below) for the Common Stock during the ten (10) Trading Day period ending on the latest complete Trading Day prior to the Conversion Date. "Trading Price" means, for any security as of any date, the closing bid price on the OTCQB, OTCQX, Pink Sheets electronic quotation system or applicable trading market (the "OTC") as reported by a reliable reporting service designated by Geneva (i.e. Bloomberg) or, if the OTC is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the "pink sheets". Notwithstanding the foregoing, Geneva shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Geneva and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 91 days from the issuance date, then the prepayment premium shall be 115% of the face amount plus any accrued interest, if prepaid after 90 days from the issuance date, but less than 121 days from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, but less than 151 days from the issuance date, then the prepayment premium shall be 125% of the face amount plus any accrued interest, and if prepaid after 150 days from the issuance date, but less than 181 days from the issuance date, then the prepayment premium shall be 129% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from Geneva, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144. Pursuant to the terms of the Purchase Agreement, the Company paid Geneva’s fees and expenses in the aggregate amount of $3,500.

Other than as described above, the Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the Note. Additional events of default shall include, among others: (i) failure to reserve at least five times the number of shares issuable upon full conversion of the Note; (ii) bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for relief under any bankruptcy law or any law for the relief of debtors shall be instituted by or against the Company or any subsidiary of the Company; provided, that in the event such event is triggered without the Company’s consent, the Company shall have sixty (60) days after such event is triggered to discharge such event, (iii) the Company’s failure to maintain the listing of the common stock on at least one of the OTC markets (which specifically includes the quotation platforms maintained by the OTC Markets Group) or an equivalent replacement exchange, the Nasdaq National Market, the Nasdaq Small Cap Market, the New York Stock Exchange, or the American Stock Exchange, (iv) The restatement of any financial statements filed by the Company with the SEC at any time after 180 days after the issuance date for any date or period until this note is no longer outstanding, if the result of such restatement would, by comparison to the un-restated financial statement, have reasonably constituted a material adverse effect on the rights of Geneva with respect to this note or the Purchase Agreement, and (v) the Company’s failure to comply with its reporting requirements of the Securities and Exchange Act of 1934 (the "Exchange Act"), and/or the Company ceases to be subject to the reporting requirements of the Exchange Act.

In the event that the Company fails to deliver to Geneva shares of common stock issuable upon conversion of principal or interest under the Note within three business days of a notice of conversion by Geneva, the Company shall incur a penalty of $1,000, provided, however, that such fee shall not be due if the failure to deliver the shares is a result of a third party such as the transfer agent.

Upon the occurrence and during the continuation of certain events of default, the Note will become immediately due and payable and the Company will pay Geneva, in full satisfaction of its obligations in the Note an amount equal to 150% of an amount equal to the then outstanding principal amount of the Note plus any interest accrued upon such event of default or prior events of default (the "Default Amount").

The Note was issued, and any shares to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

Hackensack Meridian Health Launches Anthology Diagnostics Laboratories for State-of-the-Art Lab Genomic Profiling of Cancers

On March 16, 2021 Hackensack Meridian Health and Genomic Testing Cooperative (GTC) in Irvine, California, reported that they have teamed up to establish the first-of-its-kind genomic profiling laboratory called Anthology Diagnostics, to generate more personalized, precise, and real-time insights for cancer patients, oncologists and hospitals (Press release, Genomic Testing Cooperative, MAR 16, 2021, View Source [SID1234576771]). The reference laboratory located at Hackensack Meridian JFK University Medical Center in Edison, New Jersey will offer next generation sequencing data of DNA and RNA that is useful to clinicians in treatment decision-making for their patients as well as to researchers seeking to identify innovative biomarkers that can further improve the understanding and management of blood cancers and solid tumors.

GTC has developed highly validated tests for DNA as well as RNA profiling. DNA is the blueprint for all genetic information in the body; RNA converts genetic information from DNA to build proteins. Often in cancer, mutations in genes lead to defective proteins that can trigger cancer development, cause cancers to become resistant to treatment, or make them spread. Profiling both DNA and RNA in a patient with cancer can provide more information than DNA testing alone regarding the cancer origin, biology, and clinical behavior as well as the response of the immune system of the patient to the cancer.

"We are thrilled with the launch of Anthology Diagnostics Laboratory as it demonstrates the commitment of Hackensack Meridian Health to enhance the diagnosis and treatment of cancer, which is one of the country’s most common illnesses and a leading cause of death in the United States," noted Robert C. Garrett, FACHE, chief executive officer, Hackensack Meridian Health. "The technologies we are spearheading with the laboratory puts us on the forefront of cancer care and research."

"Paired DNA and RNA profiling is increasingly recognized as the new standard in precision medicine, and GTC is leading the way in the development of clinical applications for this approach. Although we are currently using genomic information for diagnostic and therapeutic decision-making, we have only touched the surface in terms of how this technology can be applied," said Andre Goy, M.D., physician-in-chief for Oncology at Hackensack Meridian Health. "The collaboration between Hackensack Meridian Health and GTC will facilitate the translation of this technology to everyday patient care more quickly — not only at our institution, but along the entire East Coast."

The results of next-generation genetic sequencing of DNA and RNA have enormous value for:

Confirming a diagnosis and understanding the molecular subtype of a cancer — not just what it looks like under a microscope
Identifying drivers of cancer growth, including genetic mutations such as chromosomal translocations or fusions, that may guide the choice of targeted cancer therapies — an approach called "precision medicine" that may not only help in the selection of the most effective therapies, but avoid the use of less effective treatments. RNA profiling also yields more information than DNA sequencing if multiple molecular pathways are driving a cancer’s growth, enabling clinicians to take aim at the cancer from a variety of angles by using a combination of targeted therapies
Understanding the aggressiveness of a patient’s cancer so doctors know how intensively they need to treat it, or if it needs to be treated at all (some can just be monitored)
Predicting a patient’s prognosis and generating volumes of data on patient outcomes
Monitoring response to therapy, allowing physicians to change to a different treatment if genomic testing shows another approach is not working
Detecting signs of relapse earlier, before it can be seen on an imaging exam or causes symptoms
Refining the selection of patients for clinical trials which require participants to have certain molecular features in their cancers
The lab will also be able to perform "liquid biopsies," the analysis of cell-free DNA (cfDNA) released by cancer cells in the bloodstream. Doctors can look for very early evidence of cancer just by taking a blood sample from a patient, avoiding the need for repeat invasive tissue biopsies in patients with solid tumors and bone marrow biopsies in those with hematologic (blood) cancers, such as leukemia.

"We look forward to collaborating with Hackensack Meridian Health through this reference laboratory, which offers sophisticated high-quality molecular testing to strengthen the practice of precision medicine and drive innovation through research and development," explained Maher Albitar, M.D., chief executive officer and chief medical officer at GTC. "This collaboration will allow GTC to co-develop new tests with Hackensack Meridian Health utilizing real world clinical and outcomes data."

The Anthology Diagnostics Laboratories at JFK University Medical Center complements the previously announced next-generation sequencing laboratory operated by Regional Cancer Care Associates (RCCA) in their practice at John Theurer Cancer Center at Hackensack University Medical Center, which provides services for RCCA physicians.

Physicians and hospitals interested in utilizing the services of the reference laboratory at Hackensack Meridian JFK University Medical Center may contact 732-321-7240.

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Cue Biopharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights

Cogent Biosciences Reports Fourth Quarter 2020 and Full Year 2020 Financial Results

Acepodia Completes $47 Million Series B Financing to Advance Pipeline of Allogeneic Cell Therapy Candidates

Entry into a Material Definitive Agreement.

Hackensack Meridian Health Launches Anthology Diagnostics Laboratories for State-of-the-Art Lab Genomic Profiling of Cancers