On April 29, 2022 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company will provide a corporate and financial update for the first quarter 2022 on Tuesday, May 10, 2022, before the market opens (Press release, Athenex, APR 29, 2022, View Source [SID1234613223]). Athenex’s management team will host a conference call and live audio webcast at 8:00 a.m. Eastern Time.

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To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source

On April 29, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, reported that it has entered into a securities purchase agreement with certain institutional investors to purchase 1,000,006 shares of Series A convertible redeemable preferred stock and 250,005 shares of Series B convertible redeemable preferred stock (Press release, Abeona Therapeutics, APR 29, 2022, View Source [SID1234613238]). Each share of Series A and Series B preferred stock has a purchase price of $19.00, representing an original issue discount of 5% of the $20.00 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of Abeona’s common stock at an initial conversion price of $0.45 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company’s receipt of stockholder approval for a reverse stock split of the Company’s common stock. Abeona will be permitted to redeem the Series A preferred stock at its option upon the fulfillment of certain conditions and subject to certain limitations. The Company and the holders of the Series A and Series B preferred stock will also enter into a registration rights agreement to register the resale of the shares of common stock issuable upon conversion of the Series A and Series B preferred stock. Total gross proceeds from the offerings, before deducting discounts, placement agent’s fees and other estimated offering expenses, is approximately $25 million.

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The Series A preferred stock permits the holders thereof to vote together with the holders of the Company’s common stock and any other shares of capital stock entitled to vote generally as a single class on all matters submitted to a vote of stockholders generally, including any proposal to effectuate a reverse stock split of the Company’s common stock at a special meeting of Company stockholders. The Series B preferred stock permits the holders thereof to vote on a proposal to effectuate a reverse stock split of the Company’s common stock at a special meeting of Company stockholders, together with the holders of common stock and Series A preferred stock. The Series B preferred stock permits the holder to cast 15,000 votes per share of Series B preferred stock on such proposal. Except as required by law or expressly provided by the certificate of designation, holders of the Series B preferred stock will not be permitted to vote on any other matters. The holders of the Series A and B preferred stock agreed not to transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of their shares of preferred stock until after the special meeting. The holders of the Series A preferred stock agreed to vote their shares in favor of the reverse stock split proposal and the holders of the Series B preferred stock agreed to vote their shares in the same proportions as the shares of common stock and Series A preferred stock are voted on that proposal. The holders of the Series A and Series B preferred stock have the right to require the Company to redeem their shares of preferred stock for cash at 105% of the stated value of such shares commencing after the earlier of the Company’s stockholders’ approval of the reverse stock split and 60 days after the closing of the issuances of the Series A and Series B preferred stock and until 90 days after such closing. The Company has the option to redeem the Series A preferred stock for cash at 105% of the stated value commencing 90 days after the closing of the issuance of the Series A preferred stock, subject to the holders’ rights to convert the shares prior to a redemption at the option of the Company.

The closing of the offerings is expected to occur on or about May 2, 2022, subject to the satisfaction of customary closing conditions. Additional information regarding the securities described above and the terms of the offering will be included in a Current Report on Form 8-K to be filed with the United States Securities and Exchange Commission ("SEC").

A.G.P./Alliance Global Partners is acting as the sole placement agent in connection with the offering.

The Series A and Series B preferred stock and shares of common stock into which these preferred shares are convertible are being issued in reliance upon the exemption from the securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act") and/or Rule 506 of Regulation D as promulgated by SEC under the 1933 Act.

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 April 29, 2022 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "We"), a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune diseases and infectious diseases, reported financial results for the fiscal year ended December 31, 2021, and provided an update on clinical and corporate developments (Press release, Aptorum, APR 29, 2022, View Source [SID1234613239]).

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Mr. Ian Huen, Chief Executive Officer and Executive Director of Aptorum Group, commented "Aptorum’s operational plans remain on track. In particular, our lead projects, ALS-4 (targeting infections caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA)) and SACT-1 (targeting neuroblastoma), have respectively completed their phase 1 clinical trials and we are working towards the commencement of the next stage of human clinical trials for further proof of concept of these 2 lead projects in the United States. We are also pleased with the progress of our other lead project, RPIDD, a liquid biopsy program targeting infectious disease diagnostics which is currently undergoing human clinical validations in Singapore. We are also excited about previously announced expanded oncology and autoimmune drug discovery programs targeting unmet mutations and novel biomarkers utilizing first-in-class drug molecules. Last but not least, we are excited about the near-future commercialization of our woman’s health supplement product NativusWell in Asia and Europe, which we hope to be followed by launch in the United States, subject to the successful completion of our registration process. Our team is currently focused on delivering the above milestones for our stakeholders and we believe 2022 will be an exciting year for the company."

Clinical Pipeline Update and Upcoming Milestones

In 2022, we announced a number of updates for our lead and other projects:

Our ALS-4 (a first in-class anti-virulence based small molecule drug targeting infections caused by Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus ("MRSA")) Phase 1 clinical trial is completed. Dosing and clinical evaluations of the Single Ascending Dose studies ("SAD") and Multiple Ascending Dose studies ("MAD") have been completed for a total of 72 healthy subjects, no subjects were dropped from the studies and no serious adverse events observed. With the encouraging safety data, we are on track to submit an IND application to the United States Food and Drug Administration ("US FDA") this year seeking to initiate a Phase 2 clinical study to assess the safety and efficacy of ALS-4 in patients.

Our SACT-1 (a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types) Phase 1 clinical trial for assessing relative bioavailability and food effect has been completed with no serious adverse events observed. Our first patent on SACT-1 has been granted by the US Patent and Trademark Office and the US FDA has also granted an Orphan Drug Designation for SACT-1 for the treatment of neuroblastoma. We plan to hold an end of Phase 1 meeting and submit a clinical protocol to the US FDA this year to initiate a Phase 1b/2a clinical study to assess the safety and efficacy of SACT-1 in patients.

Our first patent on the molecular based rapid pathogen diagnostics liquid biopsy technology ("RPIDD") has been granted by the US Patent and Trademark Office. We started the clinical validation of our RPIDD for the diagnosis of pathogens including viruses, bacteria, fungi and parasites. We have been enrolling patients with febrile neutropenia and sepsis for our clinical validation.. Various bacteria and viruses have been detected in these patient samples, including Escherichia coli, Klebsiella pneumoniae and Herpesviridae. The data have been cross-validated by standard of care diagnostics results such as blood culture technology. RPIDD achieved high analytical sensitivity and specificity of the clinical samples respectively at both low depth (60,000 reads) and high depth (1 million reads) sequencing and further clinical validation is ongoing.

We launched our oncology and autoimmune discovery and development platform. The platform will initially focus on non-small cell lung cancer ("NSCLC") and autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel diseases, etc. We are currently conducting optimization for selected candidates as part of its small molecule library for major targets including, but not limited to EGFR, ALK, KRAS, p53 mutations.

Fiscal Year End Financial Results

Aptorum Group reported a net loss of $27.1 million in 2021, as compared to net income of $4.9 million in 2020. The net income in 2020 was mainly driven by the gain on investments in marketable securities, net of $25.2 million, while there was a loss on investments in marketable securities, net of $8.0 million in 2021.

Research and development expenses were $10.9 million in 2021 as compared to $11.6 million in 2020. The decrease in research and development expenses in 2021 was primarily due to less sponsored research to universities in 2021, partly offset by the increase in contracted research organizations services and consultation due to the development progress of our lead projects.

General and administrative fees were $5.4 million in 2021 as compared to $4.9 million in 2020. The increase in general and administration fees was mainly due to increase in bonus expenses to our directors, employees, external consultants and advisors. The increase is partly offset by a significant decrease in travelling expenses due to the outbreak of COVID-19.

Legal and professional fees were $2.6 million in 2021 as compared to $2.9 million in 2020. The decrease in legal and professional fees was mainly due to less one-off professional services engaged during 2021.

Aptorum Group reported $8.3 million of cash and restricted cash as of December 31, 2021 compared to $3.6 million as of December 31, 2020. The increase in cash and restricted cash was mainly the result of the proceeds from sales of investment securities of $20.1 million and proceeds from issuance of Class A Ordinary Shares of $4.0 million in 2021, partly offset by the cash used in operating activities of $14.7 million, net repayment of loan from related parties of $2.0 million, and loan to a related party of $3.4 million in 2021.

On April 29, 2022 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers reported its audited annual consolidated 2021 financial statements (Press release, Theralase, APR 29, 2022, View Source [SID1234613460]).

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Financial Highlights:

For the years ended December 31st:

Total revenue decreased 16%, year over year, and is primarily attributed to the slower than anticipated Canadian and US economic recovery from the COVID-19 pandemic in 2021.

Cost of sales for the year ended December 31, 2021 was $470,698 or 60% of revenue resulting in a gross margin of $309,943 or 40% of revenue. In comparison, the cost of sales in 2020 was $659,442 or 71% of revenue resulting in a gross margin of $269,680 or 29% of revenue. The gross margin increase, as a percentage of sales, year over year, is primarily attributed to a decrease in labour and material costs.

Selling expenses for the year ended December 31, 2021, decreased to $363,886, from $447,882 in 2020, a 19% decrease. The decrease in selling expenses is primarily attributed to the COVID-19 pandemic, resulting in reduced advertising (43%), commissions (17%) and salaries (8%).

Administrative expenses for the year ended December 31, 2021, decreased to $1,562,867 from $2,070,261 in 2020, a 25% decrease. The decrease in administrative expenses is primarily attributed to decreased spending on director and advisory fees (37%) and general and administrative expenses (21%). Stock based compensation expense decreased 63% in 2021 due to a reduction in stock options granted.

Net research and development expenses for the year ended December 31, 2021, decreased to $2,924,733 from $3,448,243 in 2020, a 15% decrease. The decrease in research and development expenses for the year ended December 31, 2021, is primarily attributed to the significant delay in patient enrollment and treatment in the Phase II NMIBC clinical study ("Study II") due to the COVID-19 pandemic. Research and development expenses represented 62% of the Company’s operating expenses and represents investment primarily into the research and development of the Company’s ACT technology.

The net loss for the year ended December 31, 2021 was $4,411,061 which included $618,586 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss).

This compared to a net loss in 2020 of $5,598,540 which included $1,202,017 of net non-cash expenses. The ACT division represented $3,426,488 of this loss (78%) for the year ended December 31, 2021.

The decrease in net loss is primarily attributed to the following:

Significant delay in patient enrollment and treatment due to the COVID-19 pandemic, resulting in decreased research and development expenses in Study II.
Decreased salaries due to the COVID-19 pandemic, resulting in the resignation or termination of certain non-essential administrative, research and production personnel.
Operational Highlights:

1. Break Through Designation Update. In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.

In 2021, Theralase completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites ("CSS") availability to complete all required assessments.

2. COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.

In the CLT division, the Company continues to experience variations in sales and the timing of these sales due to the ongoing COVID-19 pandemic and has taken actions to minimize expenses by eliminating non-essential personnel and imposing a temporary hiring freeze commencing in March 2020. The Company lifted the temporary hiring freeze in 4Q2021, now that the Canadian and United States ("US") economies have started to demonstrate a sustainable business and economic recovery from COVID-19.

3. Clinical study site status and update. The Company has successfully launched five CSS in Canada and seven CSSs in the US that are open for patient enrollment and treatment for a total of 12 CSSs.

To date, the phase II NMIBC clinical study has enrolled and provided the primary study treatment for 35 patients (including three patients from Phase Ib study treated at the Therapeutic Dose) for a total of 38 patients.

The interim analysis of the Study II Evaluable Patient clinical data (with 3 patients from Study Ib) supports the following provisional conclusions:

Note: Evaluable Patients are defined as patients who have evaluable data; hence, have been evaluated by the principal investigator and thus excludes patients who have clinical data pending.

For evaluable patients, who completed Study II, who achieved a CR at 90 days, 78% continue to demonstrate that CR at 180 and 270 days, while 56% continue to demonstrate that CR at 360 and 450 days.

Note: The current interim analysis presented above, should be read with caution, as the reported clinical data is extremely interim in its presentation, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trends.

Note: The data analysis is only a representation of the data accrued to date with and does not intend to represent a tendency or portray any conclusion as to the effectiveness, duration or safety of the investigational treatment. A significant number of treated patients are still pending assessments.

For a more comprehensive analysis of the interim data please refer to Managements Discussion and Analysis ("MD&A") for the year ended December 31, 2021.

4. Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). The Company has commenced Non – Good Laboratory Practices ("GLP") toxicology studies with Rutherrin in animals to help determine the maximum recommended human dose of the drug, when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.

5. COVID-19 Research Update. In April 2021, Theralase executed a Collaborative Research Agreement ("CRA") with the National Microbiology Laboratory, Public Health Agency of Canada ("PHAC") for the research and development of a Canadian-based SARS-CoV-2 ("COVID-19") vaccine. Under the terms of the agreement, Theralase and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase’s patented PDC and then light activating it with Theralase’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus would then be purified and used to inoculate naive animals followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, "Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine" and commenced in mid-April 2021.

In February, 2022 Theralase reported that PHAC had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.

These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022.

Note: The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus.

About Study II

Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About TLD-1433

TLD-1433 is a patented PDC with over 10 years of published peer reviewed preclinical research and is currently under investigation in Study II.

On April 29, 2022 Portage Biotech Inc., NCI, and Stimunity reported that it entered a Cooperative Research and Development Agreement, under which they will collaborate with NCI’s Center for Cancer Research to advance preclinical and potential clinical development of STING agonists and anti-Receptor for Advanced Glycation End products (RAGE) agents to enhance the efficacy of cancer vaccines developed in the NCI CCR Vaccine Branch (Press release, Portage Biotech, APR 29, 2022, View Source [SID1234616275]).

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