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.

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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.

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.

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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.

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.

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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.

On March 16, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a business update (Press release, Merus, MAR 16, 2021, View Source [SID1234576814]).

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"We have made significant progress in 2020, advancing our clinical programs, further developing our discovery and research pipeline and strengthening our financial position," said Bill Lundberg, M.D., Chief Executive Officer of Merus. "Our most advanced program zenocutuzumab remains on track for a clinical update on more than 30 patients with NRG1 fusion cancers in 2Q21, and we plan to bring our next program, MCLA-129, into the clinic in the US this year. In addition, our best-in-class Biclonics, bispecific antibody technology platform has been further validated by the significant collaboration with Loxo Oncology at Lilly, as we announced earlier this year. We look forward to a productive year across our entire portfolio of innovative cancer therapeutic candidates."

Clinical Programs and Business Update

Zenocutuzumab, or "Zeno" (MCLA-128: HER3 x HER2 Biclonics)
NRG1 gene fusion (NRG1+) Cancers: Phase 1/2 eNRGy trial clinical data and program update planned for Q2 2021

We plan to present efficacy and safety data from the eNRGy trial and Early Access Program (EAP) at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting with results on more than 30 patients with NRG1+ pancreatic, non-small cell lung and other cancers across the eNRGy trial and EAP with the opportunity for four or more months of follow up. At that time, we plan to also discuss details of the program and overall strategy.

Zeno is currently in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. We believe that Zeno continues to demonstrate encouraging single agent activity in NRG1+ cancers and has been observed to be well tolerated, consistent with previously reported safety data in the overall patient population treated with Zeno monotherapy.

In August 2020, Zeno was granted Orphan Drug Designation by the U.S. Food and Drug Administration for pancreatic cancer and in January 2021, Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions that have progressed on standard-of-care therapy.

Over the course of 2020 we have engaged in a series of agreements and collaborations with companies and medical organizations worldwide with the goals of raising awareness of the eNRGy trial and providing molecular screening opportunities for eligible patients with cancers that may have NRG1 fusions.

Details of the eNRGy trial, including current trial sites, can be found at clinicaltrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

MCLA-158 (Lgr5 x EGFR Biclonics): Solid Tumors
Phase 1 trial continues: dose expansion in patients with gastro-esophageal and head-and-neck cancers

We are developing MCLA-158 for the potential treatment of solid tumors. Our phase 1 clinical trial of MCLA-158 is ongoing in the dose expansion phase.

On January 15, 2021, we presented in a poster session interim clinical data from the phase 1 dose escalation study of MCLA-158 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Gastrointestinal Cancers Symposium. As of a data cut-off of September 2020, MCLA-158 was administered to 33 patients over 11 dose levels (5-1500 mg, flat dose), a heavily pretreated population having received a median of four lines of prior therapy. As of the cut-off date, MCLA-158 was observed to be well tolerated, and no dose limiting toxicities occurred. The recommended phase 2 dose was established at 1500 mg administered intravenously once every two weeks. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues at this dose in the expansion phase of the open-label, multicenter trial, and preliminary evidence of antitumor activity has been observed.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors
Phase 1 trial advancing with clinical update planned for 2H 2021

MCLA-145 is currently being evaluated in a phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase, in patients with solid tumors. MCLA-145 is the first drug candidate co-developed under our global collaboration and license agreement with Incyte Corporation (Incyte), which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from our Biclonics platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States, and Incyte is responsible for its development and commercialization outside the United States. We plan to present a clinical update at a major medical conference in the second half of 2021.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
First patient planned to be dosed in 2021

We plan to evaluate MCLA-129 in a phase 1 open-label, multicenter dose escalation study, including a safety dose expansion phase, for the treatment of various solid tumors, with a plan to dose a first patient in the United States in 2021. MCLA-129 is subject to collaboration and license agreement, which permits Betta Pharmaceuticals Co. Ltd. (Betta) to exclusively develop MCLA-129 in China, while Merus retains full ex-China rights.

In January 2021, Betta announced that the Chinese National Medical Products Administration had accepted its Investigational New Drug application of MCLA-129 injection.

Expanding collaborations

In January 2021 Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement that will leverage Merus’ proprietary Biclonics platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies. Merus received an upfront cash payment of $40 million, as well as an equity investment by Lilly of $20 million in Merus common shares. Merus is also eligible to receive up to $540 million in potential development and commercialization milestones per product, for a total of up to approximately $1.6 billion for three products, as well as tiered royalties ranging from the mid-single to low-double digits on product sales should Lilly successfully commercialize a therapy from the collaboration. Under the terms of the agreement, Merus will lead the discovery and early-stage research and Loxo Oncology at Lilly will be responsible for additional research, development and commercialization activities.

Runway extended to at least 2H 2024

Based on the Company’s current operating plan, we expect our existing cash, cash equivalents and marketable securities inclusive of the proceeds of $60.0 million from the collaboration with and equity investment by Lilly in January 2021 and aggregate net proceeds from a follow-on offering of $129.7 million in January 2021, will fund Merus’ operations at least into the second half of 2024.

Full Year 2020 Financial Results

Collaboration revenue for the year ended December 31, 2020 decreased $1.4 million as compared to the year ended December 31, 2019, primarily as a result of a decrease of $4.1 million in Ono Pharmaceutical milestone revenue due to the achievement of milestones in 2019 that did not recur in 2020, partially offset by an increase in Betta milestone revenue due to a $2.0 million earned in the fourth quarter. The change in exchange rates did not materially impact collaboration revenue.

Research and development expense for the year ended December 31, 2020 increased $14.4 million as compared to the year ended December 31, 2019, primarily as a result of an increase in manufacturing related costs, and higher research and development-related costs related to our programs, particularly increases in costs for zenocutuzumab, and a $2.0 million milestone earned by Betta incurred in the fourth quarter, offset by decreases in costs for MCLA-145.

General and administrative expense for the year ended December 31, 2020 increased $1.7 million as compared to the year ended December 31, 2019, primarily as a result increases in stock-based compensation, insurance, facilities, intellectual property related costs and other items, partially offset by a decrease in consulting and personnel costs.

Other income, net consists of interest earned on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange gains or losses on our foreign denominated cash, cash equivalents and marketable securities.

Merus ended 2020 with cash, cash equivalents and marketable securities of $207.8 million as compared to $241.8 million at December 31, 2019. The decrease was primarily the result of cash used in operations and the effect of exchange rate changes, offset by the net proceeds received from the issuance of common shares through at the market offerings under an August 2020 Open Market Sale Agreement, between us and Jefferies LLC ("Jefferies"), under which Jefferies acted as sales agent.

Financial Outlook

Based on Merus’ current operating plan, Merus expects that its existing cash, cash equivalents and marketable securities of $207.8 million as of December 31, 2020, combined with the aggregate immediate proceeds from the closing of the collaboration license agreement and a share purchase agreement with Lilly in January 2021 of $60.0 million and the aggregate net proceeds from a January 2021 follow-on offering of $129.7 million in January 2021, will fund Merus’ operations at least into the second half of 2024.

On March 16, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported the closing of its previously announced underwritten public offering of 2,078,214 shares of its common stock, offered at a price of $7.00 to the public, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares (Press release, Cyclacel, MAR 16, 2021, View Source [SID1234576813]). The gross proceeds to the Company from this offering are approximately $14.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. Existing and new institutional investors participated in the offering.

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Cyclacel intends to use the net proceeds from this offering to support the Company’s growth strategy and for working capital and general corporate purposes, including research and development expenses, and capital expenditures.

Oppenheimer & Co. Inc. acted as the sole book-running manager, and Ladenburg Thalmann & Co. Inc., Roth Capital Partners, and Brookline Capital Markets, a division of Arcadia Securities, LLC acted as co-managers for the public offering.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (No. 333-231923) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on June 21, 2019. A preliminary prospectus supplement relating to the offering was filed with the SEC on March 11, 2021 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s web site at www.sec.gov. Before investing in the offering, you should read the prospectus supplement and the accompanying prospectus in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering. Copies of the final prospectus supplement and accompanying prospectus may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.