On March 31, 2020 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company, reported that it has entered into a loan and security agreement with Silicon Valley Bank ("SVB") pursuant to which Aclaris has borrowed $11.0 million (Press release, Aclaris Therapeutics, MAR 31, 2020, View Source [SID1234556042]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This financing allows us to strengthen our financial position by extending our cash runway and to continue to execute on our refocused business strategy as planned," said Dr. Neal Walker, President and CEO of Aclaris. Aclaris believes the proceeds from the loan, in combination with its existing cash, cash equivalents, and marketable securities, will be sufficient to fund its operations into the first quarter of 2022.

Terms of Financing

The term loan requires interest only payments beginning April 1, 2020 and continuing through March 1, 2022, followed by monthly installments of principal, plus monthly payments of accrued interest, starting on April 1, 2022 and continuing through March 1, 2024. The loan is secured by substantially all of Aclaris’ assets, other than intellectual property. In connection with the term loan, Aclaris issued SVB a warrant to purchase up to 460,251 shares of Aclaris’ common stock at an initial exercise price of $0.956 per share. The warrant became immediately exercisable in full upon the funding of the loan. Other material terms related to the term loan and the warrant can be found in Aclaris’ Current Report on Form 8-K, which will be filed with the U.S. Securities and Exchange Commission.

On March 31, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that it has entered into definitive agreements with several institutional investors for the purchase and sale of 1,713,064 shares of Phio’s common stock, at a purchase price of $2.335 per share, for gross proceeds of approximately $4.0 million in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, MAR 31, 2020, View Source [SID1234556040]). Phio has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 1,713,064 shares of common stock. The closing of the offering is expected to occur on or about April 2, 2020, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

The warrants have an exercise price of $2.21 per share of common stock, will be exercisable immediately following the date of issuance and will expire 5.5 years following the date of issuance.

Phio currently intends to use the net proceeds from the offering for the development of its immuno-oncology programs, other research and development activities and for general working capital needs.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Phio pursuant to a "shelf" registration statement on Form S-3 (File No. 333-224031) previously filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. The offering of the shares of common stock will be 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 will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, 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].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 31, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the company is entering into a financing of up to $3 million with an institutional investor, with an initial $450,000 of securities purchased at closing (Press release, Propanc, MAR 31, 2020, View Source [SID1234556039]). Funds raised will be used to undertake an engineering run and full scale GMP manufacture of PRP, the Company’s lead product candidate, as well as validation of the pharmacokinetics method to analyze the distribution of the drug in advanced cancer patients for a FIH study, which the Company intends to undertake at the Peter Mac Center in Melbourne, Australia.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To complete the transaction, the Company entered into a Securities Purchase Agreement for the purchase of 11,250,000 shares of common stock and prefunded warrants issued at closing and 11,250,000 Series A warrants to purchase common stock at $0.20 per share. At closing, the investor was also issued 63,750,000 Series B warrants to purchase common stock at $0.04 per share (for an aggregate maximum exercise price of $2,550,000), and 63,750,000 Series C warrants to purchase common stock at $0.20 per share, which vest upon exercise of the Series B warrants on a ratable basis. Such warrants contain cashless exercise and other cashless conversion provisions. The Company has agreed to register for resale all shares of common stock issued, or underlying securities issued. The Company will provide further information regarding this financing in a Current Report on Form 8-K to be filed with the U.S. Securities and Exchange Commission.

"The completion of this transaction is at a pivotal point for the Company, as we move towards commencing a FIH study for PRP," said James Nathanielsz, Propanc’s Chief Executive Officer. "Given the unique and challenging situation for humankind due to recent global events, the need to improve our standard of healthcare is ever more urgent. During this time, I am especially thinking of cancer sufferers, who may be exposed to standard treatments like radiation or chemotherapy, having a suppressed immune system and therefore exposure to infection like COVID-19 becomes an extremely high risk. Our goal is to improve quality of life, reduce side effects compared to standard treatments and extend life meaningfully. We are grateful to have a strategic institutional investor on board with us who is willing to support our vision."

On March 31, 2020 Driven by its Intelligent Cancer Care approach in developing new solutions that use advanced technologies like machine learning, Varian (NYSE: VAR), reported the newest release of its treatment planning system, Eclipse v16 (Press release, Varian Medical Systems, MAR 31, 2020, View Source [SID1234556038]). This new release includes intelligent features such as RapidPlan PT, the first clinical application of machine learning in proton treatment planning, and RT Peer Review, which is a collaborative workspace designed to streamline and accelerate the peer review process for radiotherapy treatment plans.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Previously only available for photon-based radiotherapy treatment planning, RapidPlan is knowledge-based treatment planning software that enables clinicians to leverage knowledge and data from similar prior treatment plans to quickly develop high-quality personalized plans for patients. This knowledge-based planning software is now available for proton treatment planning with RapidPlan PT. The software also allows dose prediction with machine learning models that can be used as a decision support tool to determine which patients would be appropriate for proton or photon therapy. Varian is the first vendor in the industry to offer machine learning capability in both proton and photon treatment planning.

"With the number of operational proton treatment rooms continuing to increase, there is a need for experienced proton therapy clinicians," said Kolleen Kennedy, chief growth officer, president, Proton Solutions, Varian. "RapidPlan PT helps bridge the learning curve, allowing established centers to share their models and clinical experience. The machine learning in RapidPlan PT has the potential to reduce proton treatment plan optimization from a one to eight hour process, as reported by clinical proton centers, to less than 10 minutes, while also potentially improving plan quality."

In many radiotherapy departments, radiation therapy peer review meetings have been routinely integrated into the clinical QA process for safer healthcare delivery for the patient. Although the relevant patient information is manually retrievable from the clinical database, there is currently no efficient and effective platform to support these peer reviews. The RT Peer Review feature in Eclipse v16 is designed for the oncology community to seamlessly integrate this review process into their normal clinical workflow by automatically presenting the necessary information that is required for peer review.

On March 31, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that the U.S. Food and Drug Administration (FDA ) granted Fast Track designation to ME-401, MEI’s investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta for the treatment of adult Patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies (Press release, MEI Pharma, MAR 31, 2020, View Source [SID1234556035]). MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), a Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to report that we have received Fast Track designation for ME-401. This designation holds several important advantages to expedite the development and regulatory review of ME-401 as we work diligently to deliver it as a new potential treatment option for patients and their physicians," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We remain very encouraged by the maturing body of ME-401 clinical data, and we are excited to continue expanding the opportunity that ME-401 holds to provide a meaningful impact in the treatment of B-cell malignances."

About Fast Track

Fast Track is an FDA program intended to facilitate the development and review of new drugs to address unmet medical needs for the treatment of serious or life-threatening conditions so that a product may get approved and therefore can reach the market expeditiously.

To qualify for Fast Track designation, a drug must address an unmet medical need, demonstrated by nonclinical or clinical data, in a serious condition, and show some advantage over any available therapy, such as:

Having an improved effect on serious outcome(s) of the condition
Providing comparable efficacy while avoiding serious toxicity that occurs with the available therapy or avoiding less serious toxicity that is common and causes discontinuation of treatment of the serious condition
Features of fast track designation include:

Actions to expedite a drug’s development and review by frequent interactions with FDA
A rolling review process in which a Sponsor, in agreement with FDA, may submit portions of its New Drug Application (NDA) in advance of submission of a complete application. However, actual review of submitted portions may not commence until an application is complete. The FDA review clock starts upon receipt of a complete application.
Fast track designated products are eligible for consideration of priority review if supported by clinical data at the time of NDA submission.

About ME-401

ME-401 is an oral, once-daily, selective phosphatidylinositol 3-kinase (PI3K) delta inhibitor in clinical development for the treatment of B-cell malignancies. MEI owns worldwide rights in all geographies except Japan, which we licensed to Kyowa Kirin Company in 2018.

MEI is currently conducting TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), a Phase 2 clinical trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma ("FL") after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. Subject to the results, upon completion of the Phase 2 clinical trial, we are planning a submission with the FDA to support an accelerated approval of a marketing application under 21 CFR Part 314.500, Subpart H.

In addition to TIDAL, MEI is also conducting a multi-arm, open-label, Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies such as Rituxan or agents such as Zanubrutinib in patients with relapsed or refractory B-cell malignancies.