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Clarity Pharmaceuticals closes $25m capital raising

On December 15, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has completed a capital raising of $25,000,410 (Press release, Clarity Pharmaceuticals, DEC 15, 2020, View Source [SID1234572891]).

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Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "It has been a pivotal year for Clarity with numerous critical milestones achieved in the development of our main products, advancement of our platform, as well as accelerated corporate and strategic activities despite facing an unprecedented global environment.

"The money raised will enable us to keep the momentum from 2020 going and provide financial resources to progress the following important initiatives:

– SARTATE

Progress the Cu-64/Cu-67 SARTATE Neuroblastoma trial at the Memorial Sloan Kettering Cancer Center in children with neuroblastoma;
Expand the Cu-64/Cu-67 SARTATE Neuroblastoma trial to additional clinical sites across the US with the ultimate goal of developing better treatment options for children with cancer; and
Commence patient recruitment in Phase II Cu-64 SARTATE Neuroendocrine trial.
– SAR-Bombesin

Progress and expand the Cu-64 BOmbesin in Breast CAncer Trial (C-BOBCAT) led by A/Prof Louise Emmett, Director of Theranostics and Nuclear Medicine, at St Vincent’s Hospital in Sydney with an aim of developing better treatment options to women with metastatic breast cancer, an area currently with a high unmet need;
Expand the C-BOBCAT trial to include prostate cancer patients; and
Seek US Food and Drug Administration’s (FDA) approval for an Investigational New Drug (IND) Application.
– SAR-bisPSMA

Commence a clinical trial in the US for Cu-64/Cu-67 SAR-bisPSMA (theranostic) and in Australia for Cu-64 SAR-bisPSMA (diagnostic) to build on the promising pre-clinical data with the help of an internationally recognised team of key opinion leaders in the prostate cancer field; and
Seek US FDA approval for an IND Application.
– Develop new targeted theranostic products for a broad range of cancer types, utilising Clarity’s SAR Technology Platform and the Cu-64/Cu-67 pairing."

Dr Taylor continued, "Clarity has a strong focus on getting its lead product SARTATE to market, supported by the US FDA granting both Cu-67 SARTATE and Cu-64 SARTATE Orphan Drug Designations and Rare Paediatric Disease Designations for the treatment and clinical management of neuroblastoma, as well as developing the copper platform in large and unmet clinical indications."

"It has been a very exciting year for Clarity" Dr Taylor added. "We would like to sincerely thank our long-term shareholders for their continued support of Clarity, as well as welcome and thank a broad range of new shareholders including institutions, family offices, high net-worth individuals and others who wanted to be part of the Clarity story. We would also like to thank Blue Ocean Equities for their contribution in assisting us with the capital raise."

Nevro to Present at 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021

On December 15, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that D. Keith Grossman, Nevro’s Chairman, CEO and President, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 4:30 pm Eastern Time / 1:30 pm Pacific Time (Press release, Nevro, DEC 15, 2020, View Source [SID1234572890]).

A live webcast of this event, as well as an archived recording, will be available in the Investors section of Nevro’s website at www.nevro.com.

Internet Posting of Information

Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

Protagonist Therapeutics, Inc. Announces Closing of $115 Million Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On December 15, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a clinical stage biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 5,476,189 shares of its common stock, including 714,285 shares sold pursuant to the underwriters’ exercise in full of their "green shoe" option to purchase additional shares, at a price to the public of $21.00 per share (Press release, Protagonist, DEC 15, 2020, View Source [SID1234572889]). Aggregate gross proceeds to Protagonist from the offering were approximately $115.0 million, before deducting underwriting discounts and commissions and offering expenses.

J.P. Morgan Securities LLC, SVB Leerink LLC, Piper Sandler & Co. and BMO Capital Markets Corp. are acting as joint book-running managers for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; from 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]; from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; or from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by email 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 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.

Rafael Holdings Reports First Quarter Fiscal Year 2021 Results

On December 15, 2020 Rafael Holdings, Inc., (NYSE: RFL), reported revenue of $1.1 million and a loss per share of $0.09 for the first quarter of its 2021 fiscal year, the three months ended October 31, 2020 (Press release, Rafael Holdings, DEC 15, 2020, View Source [SID1234572888]).

Q1 FY 2021 Consolidated Financial Highlights

Revenue of $1.1 million in Q1 FY 2021, generated by Rafael Holdings’ real estate portfolio, decreased from $1.2 million in the year-ago quarter.
Loss per share of $0.09, a decrease from $0.10 in the year ago quarter largely due to a gains on the sale of the Company’s commercial real estate property in Piscataway, New Jersey and other investments which more than offset the increased research and development expense.
On December 7, 2020, the Company acquired the economic rights related to an additional 33.33% membership interest in Altira, a company which owns the rights to a receive a royalty on sales of certain Rafael Pharmaceuticals products. The acquisition added to the 33.33% interest purchased in fiscal 2020 As in the first such agreement, the Company purchased the potential right to receive a 1% royalty on Net Sales on these products.
On December 7, 2020, Rafael Holdings entered into a Securities Purchase Agreement for the sale of 567,437 shares of the Company’s Class B common stock at a price per share of $22.91 (the closing price of Class B common stock on the prior trading day) for an aggregate purchase price of $13 million. In connection with the purchases, each purchaser was granted warrants to purchase 20% of the shares of Class B common stock purchased by such purchaser exercisable at $22.91. A majority of the proceeds received are expected to be used by the Company to exercise an additional portion of the warrant held by the Company’s subsidiary to purchase equity securities of Rafael Pharmaceuticals. The remaining proceeds are expected to be used to fund the operations of Rafael Holdings’ drug development programs including its Barer Institute subsidiary and for general corporate purposes.
Rafael Pharmaceuticals
At October 31, 2020, the Company and its subsidiaries collectively owned securities representing 51% of the outstanding capital stock of Rafael Pharmaceuticals and approximately 37% on a fully diluted basis. Recent developments announced by Rafael Pharmaceuticals include:

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s lead compound, CPI-613 (devimistat), for the treatment of both metastatic pancreatic cancer and acute myeloid leukemia (AML).
Rafael Pharmaceuticals announced that it will initiate a Phase 2 clinical trial of CPI-613(devimistat) in combination with hydroxychloroquine in patients with clear cell sarcoma of soft tissue. The Company will begin enrolling patients in partnership with Sara’s Cure and Sarcoma Alliance for Research through Collaboration (SARC).
The FDA has granted Orphan Drug Designation for CPI-613 (devimistat) for the treatment of soft tissue sarcoma. Rafael Pharmaceuticals’ clinical trial will focus on the treatment of relapsed or refractory clear cell sarcoma.
Rafael Pharmaceuticals announced that it had crossed the enrollment of 100 patients in its Phase 3 clinical trial (Armada 2000) for patients with relapsed or refractory acute myeloid leukemia (AML). The multi-center, open-label, randomized pivotal trial is assessing the efficacy and safety of Rafael’s lead compound CPI-613 (devimistat) in combination with high dose cytarabine and mitoxantrone (CHAM) compared to high dose cytarabine and mitoxantrone (HAM) therapy in older patients.
LipoMedix
At October 31, 2020, Rafael Holdings held 68% of the issued and outstanding ordinary shares of LipoMedix, a development-stage Israeli company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery.

Barer Institute
The Barer Institute has identified and begun to develop new therapeutic compounds, including compounds to regulate cancer metabolism, through internal development and in-licensing. It is working to validate newly discovered biomarkers for resistance and sensitivity within its portfolio compounds and to identify certain novel targetable mechanisms of action.

Remarks by Howard Jonas, Chairman and CEO of Rafael Holdings
"Rafael Holdings’continued to pursue the strategic goal of creating value in the pharmaceutical field including through its investments in Rafael Pharmaceuticals and its wholly owned Barer Institute. In that regard, I am pleased that, among other milestones achieved, Rafael Pharmaceuticals’ lead compound, CPI-613 (devimistat), received U.S. Food and Drug Administration granted Fast Track designation for the treatment of metastatic pancreatic cancer and, as Rafael Pharmaceuticals announced earlier today, for acute myeloid leukemia (AML). The Barer Institute continues to make meaningful progress on its drug development programs."

ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Fourth Quarter and Year Ended September 30, 2020

On December 15, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported a corporate update and reported financial results for the fiscal year ended September 30, 2020 (Press release, ESSA, DEC 15, 2020, View Source [SID1234572887]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

"In 2020, ESSA made significant progress towards the development of EPI-7386, our highly-selective, oral, small molecule inhibitor that targets the N-terminal domain of the androgen receptor for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC)," stated David Parkinson, MD, President and CEO of ESSA. "In July, we initiated a Phase 1 monotherapy dose escalation clinical study with EPI-7386 and the study is progressing as planned. Additionally, with the $48.9 million raised in a public offering in July, we believe we are well-positioned financially to advance the development of EPI-7386 in the current Phase 1 study as well as to initiate one or more combination studies with approved anti-androgen treatments."

Clinical and Corporate Highlights for 2020 Fiscal Year

On September 14, 2020, the Company announced that Fast Track Designation had been granted by the FDA to EPI-7386 for the treatment of mCRPC.
On July 31, 2020, the Company closed a public offering of common shares, led by Jefferies, as sole book-running manager, for gross proceeds of $48.9 million. Certain existing investors participated in the financing along with new investors: Pfizer Inc. (NYSE: PFE), Avidity Partners, CAM Capital, Point72, Ridgeback Capital, Sphera Healthcare, Vivo Capital, and others.
On July 15, 2020, the Company announced that the first patient had been dosed in a Phase 1 clinical trial designed to evaluate the safety and tolerability of EPI-7386 in mCRPC patients who failed standard of care treatments, including second generation anti-androgens. The trial is being conducted at five sites in the United States and Canada and is expected to enroll approximately 18 patients in a standard 3+3 trial design with an approximate 10 additional patients enrolled in the dose expansion cohort.
Throughout the year, at multiple scientific conferences, the Company presented preclinical data characterizing the preclinical profile of EPI-7386 in various prostate cancer preclinical models, including studies evaluating androgen receptor binding, gene expression analyses and the toxicologic profile were presented, in addition to data related to the binding and utility of EPI-7386 against AR-V7 splice-variant driven prostate cancer models.
In October 2019, the Company paid off the balance of its $3.6M debt facility, leaving the Company with no outstanding debt.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $23.4 million ($1.04 loss per common share based on 22,443,893 weighted average common shares outstanding) for the year ended September 30, 2020, compared to a net loss of $12.8 million ($1.51 loss per common share based on 8,433,441 weighted average common shares outstanding) for the year ended September 30, 2019. For the year ended September 30, 2020, this included non-cash share-based payments of $7.5 million compared to $1.1 million for the prior year, recognized for stock options granted and vesting. The net loss for the fourth quarter ended September 30, 2020 was $4.5 million compared to a net loss of $3.3 million for the fourth quarter ended September 30, 2019.
Research and Development ("R&D") expenditures. R&D expenditures for the year ended September 30, 2020 were $12.1 million compared to $6.7 million for the year ended September 30, 2019 and includes non-cash costs related to share-based payments ($1.9M for year ended 2020 compared to $304,786 for year ended 2019). For the fourth quarter ended September 30, 2020, R&D expenditures were $2.2 million (net and gross), as compared to $2.0 million (net and gross) for the fourth quarter ended September 30, 2019. The increase in R&D expenditures for the full year and fourth quarter were primarily related to preclinical work leading to the filing of the IND for EPI-7386 in March 2020, and the increased expenditure on chemistry and manufacturing of drug product, and clinical costs related to the Phase 1 clinical trial of EPI-7386 which commenced with the dosing of the first patient in July 2020.
General and administration ("G&A") expenditures. G&A expenditures for the year ended September 30, 2020 were $11.4 million compared to $5.5 million for the year ended September 30, 2019 and include non-cash costs related to share-based payments of $5.6M for the year ended 2020 compared to $841,921 for the year ended 2019. For the fourth quarter ended September 30, 2020, G&A expenditures were $2.2 million, compared to $1.2 million for the fourth quarter ended September 30, 2019. The increase in the full year and fourth quarter is the result of increased professional fees related to transitioning to be a domestic filer, higher salaries and benefits, as well as the non-cash share-based payments.
Liquidity and Outstanding Share Capital
At September 30, 2020, the Company had available cash reserves and short-term investments of $78,332,100, reflecting the gross proceeds of the July 2020 financing of $48.9 million, less operating expenses in the intervening period.

As of September 30, 2020, the Company had 32,064,411 common shares issued and outstanding.

In addition, as of September 30, 2020 there were 9,272,977 common shares issuable upon the exercise of warrants and broker warrants. This includes 8,863,504 prefunded warrants at an exercise price of $0.0001, and 409,473 warrants at a weighted average exercise price of $39.12. There are 5,309,584 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.42 per common share.

Transition to US GAAP reporting
As noted in prior quarters, ESSA began reporting its results in accordance with US GAAP effective for the fiscal 2020 results. This transition is a result of the fact that the Company is no longer a foreign private issuer ("FPI") as defined under the rules of the United States Securities and Exchange Commission ("SEC"). As a domestic filer, the Company prepares consolidated financial statements in accordance with US GAAP, reports with the SEC on domestic forms, and complies with SEC rules and regulations applicable to domestic issuers.

All prior reporting periods for 2020 have been converted to US GAAP, with the first, second, and third quarter 2020 unaudited condensed consolidated interim financial statements re-filed in accordance with US GAAP.

About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial ((NCT04421222) in men with metastatic castration-resistant prostate cancer ("mCRPC") whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of the IND and Health Canada acceptance. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.