On March 27, 2020 Seneca Biopharma, Inc. (Nasdaq: SNCA), a biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, reported its financial results for the year ended December 31, 2019 (Press release, Seneca Biopharma, MAR 27, 2020, View Source [SID1234555956]).

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Business Highlights for the Year Ended December 31, 2019

In early 2019, the Company shifted its operating strategy and focus away from the development of our neural stem cell treatments and initiated an out-licensing effort to partner these programs, while seeking to in-license or acquire novel therapeutics that are complementary to our current technologies and could benefit from our development experience.

On July 17, 2019, we effected a 1-for-20 reverse stock split of our common stock;

In July of 2019, we completed an underwritten public offering of our securities resulting in gross proceeds of approximately $7.5 million;

On October 28, 2019, we changed our name from Neuralstem, Inc. to Seneca Biopharma, Inc.

Financial Results for the Year Ended December 31, 2019

Cash Position and Liquidity: At December 31, 2019, cash was approximately $5.1 million as compared to approximately $5.8 million at December 31, 2018. The $0.7 million decrease is due to cash used in operations of approximately $7.3 million partially offset by the proceeds from our July 2019 underwritten offering.

Operating Loss: Operating loss for the year ended December 31, 2019 was $8.6 million compared to a loss of $8.3 million for 2018. The increase in operating loss for the year was primarily due to the absence of revenue and a small increase in research and development expenses. General and administrative expenses totaled approximately $4.6 million during the two periods.

Net Loss: Net loss for the year ended December 31, 2019 was $8.4 million, or $3.80 per share, compared to a loss of $4.9 million, or $7.80 per share on a post-reverse stock-split basis, for 2018. The change in net loss was primarily attributed to non-cash related changes in the fair value of our liability classified stock purchase warrants.

R&D Expense: Research and development expense for the year ended December 31, 2019 was $4.1 million as compared to $4.0 million for the year ended December 31, 2018. The increase was primarily attributable to an increase in external consulting services engaged in the technical evaluation of our internal programs as well as the evaluation of certain potential assets we considered for acquisition. These costs were partially offset by lower clinical trial expenditures as we wound down clinical activates.

G&A Expense: General and administrative expense were approximately $4.6 million for both 2019 and 2018. As noted above, in early 2019, the Company shifted its operating strategy and initiated an out-licensing effort to partner our neural stem cell treatments while seeking to acquire novel therapeutics with the potential to be complementary to our current technologies and that could benefit from our development experience. Associated with this shift in strategic focus, our G&A expenses in 2019 reflect an enhanced internal management structure including individual consultants in key roles.

Liquidity: In January 2020, the Company entered into an agreement with certain accredited investors from our July 2019 underwritten offering. Under this agreement the exercise price of certain warrants issued in the July offering were reduced from $2.70 to $1.36 to induce the immediate cash exercise of such warrants. The Company received approximately $6.8 million in net proceeds. We believe that the proceeds from the warrant exercise, along with our cash as of December 31, 2019, will be sufficient to fund our planned operations for more than 12 months.

"With the proceeds from the January 2020 transaction, we have the capital to build out our management team and continue our initiative of evaluating new therapeutic products for development as well as seeking partners for our promising neural stem-cell therapeutic NSI-566" commented Dr. Kenneth Carter, Seneca’s Executive Chairman. "On this front, our China-based subsidiary is readying a new facility which will be utilized to complete activities for our China-based stroke trial from which we are expecting top line data by the end of this year. In addition, we recently held a discussion with the US FDA regarding a path forward for our ALS program. We will provide additional information on these programs when certain activities are concluded."

On March 27, 2020 Alphamab Oncology (stock code: 9966HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, has entered a clinical supply agreement with Pfizer Inc. ("Pfizer") to advance a clinical study to investigate KN026 in combination with Ibrance (palbociclib), an oral CDK4/6 inhibitor, in patients with previously-treated locally advanced and/or metastatic HER2-positive breast cancer (Press release, Alphamab, MAR 27, 2020, View Source [SID1234555955]). Jiangsu Alphamab, as the study sponsor, will oversee and run the trial, and Pfizer will supply palbociclib.

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Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "Through the collaboration with Pfizer, we are on the right track to investigate the combination of KN026 and a CDK4/6 inhibitor for patients with HER2-positive breast cancer as a chemo-free regimen. By combining KN026 with palbociclib, we believe it has the potential to provide more effective treatment options for patients with HER2‑positive breast cancer."

This Phase Ib/II clinical trial is a multicenter, open-label study, aiming to evaluate efficacy, safety and tolerability of KN026 in combination with palbociclib in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

KN026 received IND approval from the National Medical Products Administration of China and U.S. Food and Drug Administration in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trials in the United States, targeting HER2 expression solid tumors cancers, such as breast cancer, gastric cancer, urothelial cancer and gynecological cancers.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab w/o combination with Pertuzumab. KN026 has increased binding capacity as well as better inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. KN026 phase I trials have shown good safety and preliminary efficacy.

On March 27, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported that it closed its previously announced registered direct offering for the purchase and sale of 1,000,002 shares of the Company’s common stock, at a purchase price of $3.50 per share, which has been priced at-the-market under Nasdaq rules (Press release, Thermogenesis, MAR 27, 2020, View Source [SID1234555954]).

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to ThermoGenesis from this offering were approximately $3.5 million, before deducting the placement agent’s fees and other offering expenses payable by ThermoGenesis. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The shares of common stock were offered by ThermoGenesis pursuant to a "shelf" registration statement on Form S-3 (File No. 333-235509) previously filed with the Securities and Exchange Commission (the "SEC") on December 13, 2019 and declared effective by the SEC on January 3, 2020. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered has been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

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

On March 27, 2020 AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. reported the discontinuation of their CyFi-2 study, a randomized Phase 2 clinical study evaluating ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with high-dose cytarabine vs. high-dose cytarabine alone in patients with relapsed and refractory acute myeloid leukemia (AML) (Press release, AVEO, MAR 27, 2020, View Source [SID1234555953]). This decision is being taken due to the urgent shift among clinical sites toward efforts to combat the COVID-19 pandemic, which has impacted the feasibility of completing the study within the shelf-life of the current ficlatuzumab clinical trial supply. The study has not yet begun patient enrollment.

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"While this is a difficult decision, as we remain optimistic about the potential of ficlatuzumab in AML, we believe it is necessary in light of the COVID-19 pandemic and its effect on the states where the CyFi-2 study was to take place," said Michael Bailey, president and chief executive officer of AVEO. "Our investigators have been informed of the closure, and we greatly appreciate their enthusiasm for the study. We remain committed to the practice of scientific discovery and will focus our resources and efforts on our ongoing initiatives."

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in a clinical study of patients with squamous cell carcinoma of the head and neck (HNSCC).

On March 27, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin and eye cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported to its website results from a survey performed by the Collaborative Ocular Oncology Group (COOG) for the purpose of providing a current practices survey for clinicians regarding management of patients diagnosed with uveal melanoma and other ocular tumors during the COVID-19 pandemic (Press release, Castle Biosciences, MAR 27, 2020, View Source [SID1234555952]).

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The Collaborative Ocular Oncology Group (COOG) represents most major ocular oncology centers in North America who manage patients with uveal melanoma and other ocular tumors. Twenty-three of twenty-five COOG members were able to complete the survey.

The COOG conducted an on-line survey study between March 25-26, 2020, in order to survey current management practices for patients with a range of eye tumors, including uveal melanoma, high risk choroidal nevus, retinoblastoma, intraocular metastasis, vitreoretinal lymphoma, benign intraocular tumors, conjunctival melanoma, conjunctival squamous cell carcinoma/ocular surface squamous neoplasia (OSSN), and conjunctival lymphoma.

"Telemedicine is of limited value in patients with active intraocular cancers, due to the need for specialized ophthalmic imaging, whereas it may be of more benefit in patients with treated inactive tumors, and those with ocular surface conjunctival tumors, in which the patient can take photos of the eye with their smartphone," said J. William Harbour, M.D., the Mark J. Daily Endowed Professor of Ophthalmology, Vice Chairman for Translational Research, and Director of Ocular Oncology at Bascom Palmer Eye Institute, Associate Director for Basic Research at Sylvester Comprehensive Cancer Center, and chair of the COOG. "Given these challenges, we conducted a survey of COOG investigators across North America to obtain a snapshot of current practices during the COVID-19 pandemic. Currently, most ocular oncology experts continue to promptly see new patients with eye cancers, such as uveal melanoma, retinoblastoma, intraocular metastasis and vitreoretinal lymphoma. In contrast, many experts would delay by at least a few weeks the return of established eye cancer patients who have been treated and are stable, and those with benign or low-grade tumors."

Summary results are attached, and detailed results are available on the Castle Biosciences DecisionDx-UM page: View Source The attached results were prepared by the COOG, and Castle Biosciences makes no representation or warranty as to their accuracy or completeness.

About DecisionDx-UM

DecisionDx-UM is a 15-gene expression profiling (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is considered to be standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies and it has been shown to be a superior predictor of metastasis compared to other prognostic factors such as chromosome 3 status, mutational status, AJCC stage, and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their initial diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.