On January 5, 2021 Immuneering Corporation reported the completion of an oversubscribed $62 million Series B financing led by Cormorant Asset Management, with participation from Surveyor Capital (a Citadel company), Rock Springs Capital, funds and accounts advised by T. Rowe Price Associates, Inc., funds and accounts managed by BlackRock, Perceptive Advisors and LYFE Capital (Press release, Immuneering, JAN 5, 2021, View Source [SID1234574720]). Existing investors and senior management also participated in the financing.

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Immuneering will use proceeds from the financing to advance to clinical stage programs focused on targets in the RAS/MAPK pathway, a cellular signaling pathway commonly activated in many different tumor types and cancers. The company will also continue advancing additional programs in neuroscience and immuno-oncology, further develop its Disease Cancelling Technology (DCT) platform and enhance its computational biology services business.

"Our Disease Cancelling Technology platform has provided insights into therapies that can offer differentiated efficacy and safety with drugs targeting cancers driven by alterations that activate the RAS/MAPK pathway," said Ben Zeskind, Ph.D., MBA, co-founder and chief executive officer of Immuneering. "We are pleased to have such strong support from both our current and new investors as we begin our next phase of growth and advance our leading program targeting MEK into the clinic."

Andrew Phillips of Cormorant Asset Management stated, "With new treatments urgently needed for patients who have tumors dependent on MAPK signaling, we are thrilled to lead this Series B financing and bring together a syndicate to support Immuneering at a pivotal stage in the company’s growth. We are impressed by the biological insights that went into IMM-1-104 and its differentiated preclinical profile relative to other MEK inhibitors. IMM-1-104 is poised to potentially overcome limitations of current MEK inhibitors in providing deep pathway suppression alongside improved tolerability."

On January 5, 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 $68,500, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Geneva (Filing, 8-K, Propanc, JAN 5, 2021, View Source [SID1234573810]). The transaction contemplated by the Purchase Agreement closed on or about January 7, 2021. The Company intends to use the net proceeds ($65,000) from the Note for general working capital purposes.

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The maturity date of the Note is January 5, 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 July 5, 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 ("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 61 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 91 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 121 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 151 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 January 5, 2021 Researchers at Case Western Reserve University and partners in the United States and India reported that are applying the investigative and predictive capabilities of artificial intelligence (AI) to help physicians customize treatments for patients with oral squamous cell carcinomas (Press release, Case Western Reserve University, JAN 5, 2021, View Source [SID1234573758]).

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Research shows that oral squamous cell carcinomas is already the 8th most common cancer type worldwide and numbers are steadily increasing in the United States, India and other parts of Asia.

The National Cancer Institute awarded a five-year, $3.3 million grant to a group led by Anant Madabhushi, the Donnell Institute Professor of Biomedical Engineering at Case Western Reserve and head of the Center for Computational Imaging and Personalized Diagnostics (CCIPD), and James Lewis Jr., a Professor of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center.

The CCIPD has become a global leader in AI-driven precision medicine research. Madabhushi and his research team at the CCIPD hold more than 60 patents, many tied to their work in various cancers.

In this work, researchers will use advanced computer vision and machine learning techniques to identify cancer and immune cells on digitized images of oral squamous cell carcinoma tissue slides and then recognize spatial patterns among those cells.

This technology allows computerized vision to recognize patterns and quantify features that simply are beyond the human visual system but are powerful indicators of tumor biology. These algorithms will help oncologists and pathologists to then better determine which cancers are more versus less aggressive.

This, in turn, will then enable them to identify which patients with early stage disease could safely receive surgery alone, versus who might need postoperative radiation. In addition, it could help identify which patients with advanced stage disease might need chemotherapy with radiation after initial treatment versus who may be adequately treated with radiation alone.

Madabhushi and Lewis will work with a number of partners–Cleveland Clinic and University Hospitals in Cleveland, the San Francisco VA Health System, and Tata Memorial Centre in Mumbai, India–in a national and global endeavor to improve oral cavity squamous cell carcinoma patient care with advanced technology and data sharing.

The clinical partners will provide glass slides to be digitized or will directly provide digitally scanned whole slide images which will be used to train the AI algorithms for predicting outcomes as well as treatment benefit.

The team will also have access unique datasets from completed prospective, randomized, clinical trials of oral squamous cell carcinoma patients at the Tata Memorial Center as well as from the cancer clinical cooperative group NRG Oncology. The datasets that will allow for validation of the AI tools.

Seeking precise, personal predictions

Currently, physicians place oral carcinoma patients into one of three categories: those who require just surgery; those who should have surgery plus radiation therapy; or those who will need surgery, followed by radiation and chemotherapy.

"That’s the gold standard right now: a system that puts patients in those very broad categories," Madabhushi said. "For clinicians and pathologists, this is limiting because it relies on a limited number of parameters. But our machines are looking at the appearance of cells, their spatial architecture and interplay between different cell types, to parse out those patients who should actually be in another category."

For example, Madabhushi said, their AI research has already shown that there is a subset of early stage patients now placed in the first category–surgery alone–who are actually at a much higher risk and would do poorly with surgery alone.

"Instead, they should be offered radiation therapy as well, but under the current parameters, that is not called for," Madabhushi said.

The group will also look at anticipated differences in the appearance of oral cancer among patients of different races, a fast-developing aspect of Madabhushi’s AI-based investigations.

Previous research by the lab used AI to reveal apparent tissue level cellular distinctions between Black and white men with prostate cancer, enabling the development of population-specific risk prediction models.

Oral cancers rising

Oral carcinomas include cancers of the mouth, tongue, gums, and lips. According to the National Institutes of Health (NIH), these cancers can develop on the mobile tongue, the tissue lining the gums and hard palate, and on the underside of the tongue and floor of the mouth,

Oral carcinoma accounts for roughly 3% of all cancers diagnosed annually in the United States, with nearly 400,000 new cases being diagnosed annually worldwide.

Oral carcinoma most often occurs in people over age 40 and affects more than twice as many men as women. Most oral cancers are related to tobacco use, alcohol use, or both. Infection by the human papillomavirus (HPV), which is very common in oropharyngeal carcinomas, is a less common cause of oral carcinomas.

Other members of the research team include: Drs. Shlomo Koyfman, David Adelstein, and Deborah Chute at the Taussig Cancer Center, Cleveland Clinic; Dr. Ted Teknos, president of Seidman Cancer Center, University Hospitals; Dr. Stephen Connelly, San Francisco VA Health System; and Drs Sarbani Ghosh-Laskar and Swapnil Rane, Tata Cancer Center.

Case Western Reserve University is one of the country’s leading private research institutions. Located in Cleveland, we offer a unique combination of forward-thinking educational opportunities in an inspiring cultural setting. Our leading-edge faculty engage in teaching and research in a collaborative, hands-on environment. Our nationally recognized programs include arts and sciences, dental medicine, engineering, law, management, medicine, nursing and social work. About 5,100 undergraduate and 6,200 graduate students comprise our student body. Visit case.edu to see how Case Western Reserve thinks beyond the possible.

On January 5, 2021 Pharma Two B Ltd., a privately held company developing innovative therapeutics based on previously approved drugs for Parkinson disease, reported that Sheila Oren, M.D., M.B.A., was appointed Chief Executive Officer of Pharma Two B, effective January 1, 2021 (Press release, Pharma Two B, JAN 5, 2021, View Source [SID1234573533]). Dr. Oren brings more than 25 years of demonstrated success as a biomedical industry executive with experience in global strategy, clinical and regulatory development, and medical affairs. She has specific expertise in Parkinson’s disease, having led all global clinical research and development of rasagiline (AZILECT) from Phase 1 to market. Dr. Oren will replace David Tierney M.D. who has agreed to act as a strategic consultant to the Company for a transition period.

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"This is an exciting time for Pharma Two B, with the Company’s main product candidate P2B001 having the potential to become a much needed and important therapeutic option for early-stage Parkinson’s Disease," stated Dr. Oren. "My immediate priority will be to leverage the necessary resources to complete the ongoing Phase 3 trial and advance P2B001 towards NDA submission. In tandem, I look forward to exploring new opportunities to expand Pharma Two B’s pipeline—delivering on the Company’s mission to develop innovative therapeutics for patients."

Dr. Oren was previously a biopharma consultant at Soren Medical Consulting. Prior to that she was Chief Medical Officer at NeuroDerm Ltd. She joined NeuroDerm when it was a small startup company and was instrumental in building it into a successful company that went through a successful IPO on NASDAQ. NeuroDerm was later acquired by Mitsubishi Tanabe Pharma Corporation for $1.1 billion.

Prior to NeuroDerm, Dr. Oren held leadership roles at Teva Pharmaceutical Industries. As a Clinical and Medical Director, she led global clinical development and marketing plans for new CNS drugs. She had a major role in the development, approval, and launch of Azilect, a worldwide-approved drug used to treat Parkinson’s disease. She played a critical role in designing the Azilect delayed-start "neuroprotection" study and is one of the co-inventors recognized in the patent application. The report of this study was published in the New England Journal of Medicine in 2009. Dr. Oren received an MD degree from the Sackler School of Medicine, Tel Aviv University, Israel and an MBA from the Interdisciplinary Center, Herzliya, Israel.

On January 5, 2021 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported the pricing of an underwritten public offering of 4,421,053 shares of its common stock at a public offering price of $85.50 per share. In addition, in lieu of common stock to certain investors, the Company announced the pricing of an underwritten public offering of pre-funded warrants to purchase 257,310 shares of its common stock at a purchase price of $85.499 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant. This represents an aggregate offering of approximately $400 million. Fate Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 701,754 shares of its common stock. The proceeds to Fate Therapeutics from this offering are expected to be approximately $376 million after deducting underwriting discounts and commissions and other estimated offering expenses but excluding any exercise of the underwriters’ option. Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies of its product candidates, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes. All shares of common stock and pre-funded warrants to be sold in the offering are being offered by Fate Therapeutics. The offering is expected to close on or about January 8, 2021, subject to customary closing conditions.

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Jefferies, BofA Securities, SVB Leerink and Barclays are acting as joint book-running managers for the offering. Wells Fargo Securities is acting as lead manager for the offering, and Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. are acting as co-managers for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-228513) that was previously filed by Fate Therapeutics with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on November 21, 2018. The securities may be offered only by means of a prospectus.

A preliminary prospectus supplement and a free writing prospectus related to the offering were filed with the SEC on January 4, 2021 and January 5, 2021, respectively, and are available on the SEC’s website at View Source and a final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at View Source. Copies of the final prospectus supplement and the accompanying prospectus for the securities being offered may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at [email protected].

This press release does 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.