On December 9, 2020 Athenex, Inc., (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 the presentation of updated Phase 3 PFS and OS data demonstrating clinical benefits in efficacy and tolerability of oral paclitaxel versus IVP in patients with metastatic breast cancer (MBC) (Press release, Athenex, DEC 9, 2020, View Source [SID1234573868]). The findings further support the superiority of increased ORR observed with oral paclitaxel. These data were presented today during a spotlight poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS).

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"Having previously presented superior efficacy on overall response rate and favorable tolerability versus IV paclitaxel at SABCS 2019, it is gratifying to report that our pivotal Phase 3 trial continues to show sustained efficacy and manageable adverse events with oral paclitaxel and encequidar," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "The updated Phase 3 PFS and OS data further support the clinical rationale for oral paclitaxel as an efficacious and tolerable treatment option for people living with metastatic breast cancer."

The spotlight poster presentation at SABCS featured an update on PFS and OS data from the Phase 3 trial. In the prespecified modified intent-to-treat (mITT) population (n = 360), the median PFS data showed a benefit for oral paclitaxel versus IVP (8.4 vs. 7.4 months, respectively; hazard ratio [HR] = 0.739; 95% confidence interval [CI]: 0.561, 0.974; p = 0.023). Median OS data also showed a benefit for oral paclitaxel versus IVP (23.3 months vs. 16.3 months, respectively; HR = 0.735; 95% CI: 0.556, 0.972; p = 0.026).

In the intent-to-treat (ITT) population, which included all 402 randomized patients, the median PFS showed a benefit for oral paclitaxel versus IVP (8.4 months vs. 7.4 months, respectively; HR = 0.768; 95% CI: 0.584, 1.01; p = 0.046). The median OS data demonstrated a trend favoring oral paclitaxel versus IVP (22.7 months vs. 16.5 months, respectively; HR = 0.794; 95% CI: 0.607, 1.037; p = 0.082).

Updated safety analyses of up to 112 weeks continue to demonstrate the reduction in incidence and severity of neuropathy favoring oral paclitaxel versus IVP: all grades of neuropathy were 22% vs. 64%, and grade 3 neuropathy was 2% vs. 15%.

Also presented were data on the effect of prophylactic treatments on the incidence and severity of gastrointestinal-related adverse events. After approximately 30% of patients were enrolled, the Phase 3 trial protocol was amended to allow patients randomized to the oral paclitaxel arm to receive prophylactic pre-medications for gastrointestinal side effects. Overall gastrointestinal (GI)-related adverse events (AEs) were less frequent in the IV paclitaxel arm. GI-related AEs improved in the oral paclitaxel arm following the amendment, as measured by lower incidences of grade 2 vomiting before and after amendment (24% vs. 7%) and grade 2 diarrhea before and after amendment (27% vs. 16%).

"The oral paclitaxel regimen appears to overcome some of the limitations of IV therapy, particularly in terms of reducing the risk of neuropathy," commented lead investigator Gerardo Antonio Umanzor Fúnez, M.D., a medical oncologist at Centro Oncologico Integral, working with DEMEDICA of San Pedro Sula, Honduras. "The lessened burden of neuropathy, the ability to manage GI side effects with prophylactic treatments, and the convenience of home-based administration, could be transformational in the treatment of metastatic breast cancer, especially in the current environment."

Oral paclitaxel has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic breast cancer with a PDUFA date of February 28, 2021.

About the Phase 3 Oral Paclitaxel and Encequidar Clinical Trial
The Phase 3 trial randomized 402 patients with any metastatic breast cancer subtypes in a 2:1 ratio to receive either the oral paclitaxel regimen (205 mg/m2 of oral paclitaxel plus 15 mg of encequidar) for three days a week or the approved IV paclitaxel regimen (175 mg/m2) as a three-hour infusion every three weeks. The primary efficacy endpoint was overall response rate (ORR) confirmed at two consecutive timepoints by a blinded, independent radiology review that used RECIST v1.1 criteria to evaluate patients’ tumors for response. The trial was designed to demonstrate superiority of oral paclitaxel over IVP on the primary end point of ORR. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). The trial was not powered to demonstrate superiority of oral paclitaxel versus IVP on the secondary survival endpoints of PFS and OS. These secondary endpoints were not controlled for multiplicity. P-values presented are nominal.

About Oral Paclitaxel
Athenex’s oral paclitaxel and encequidar ("oral paclitaxel") is the first oral formulation of paclitaxel in late-stage development for the treatment of metastatic breast cancer (MBC), and is also in earlier stages of development for other malignancies. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of the transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the GI tract, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity, and low absorption of encequidar enables the oral administration of IV chemotherapies, several of which are under development by Athenex.

On December 9, 2020 Quirem Medical, a Terumo company, reported that it is awarded top 3 innovative medical device in the 2019 Belgian Galenus prize with the innovative Holmium-166 SIRT diagnostic scout dose product QuiremScout (Press release, Quirem Medical, DEC 9, 2020, View Source [SID1234573385]).

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The Galenus prize recognizes and rewards outstanding achievements that improve the global human condition through the development of innovative therapies1. It was created in France in 1970 by a pharmacist named Roland Mehl with the aim to advance pharmaceutical research. Recently, the Prix Galien award is also granted to innovative medical devices.2

The role of QuiremScout microspheres is to evaluate the expected safety and efficacy of the Selective Internal Radiation Therapy (SIRT). QuiremScout microspheres are based on the same Holmium-166 microspheres as the therapeutic treatment (QuiremSpheres). QuiremScout microspheres are intended to evaluate lung-shunt3 and extrahepatic deposition3 as part of the SIRT work-up. Moreover, they are intended for evaluation of the intrahepatic distribution3 during the work-up, which can be used to plan the SIRT treatment.4

Currently, 99mTc-MAA is most often used during the pre-treatment work-up of the SIRT treatment algorithm3.

However, QuiremScout has recently proven to be more accurate in terms of intrahepatic targeting5 and lung shunt assessment6 compared to 99mTc-MAA during the work-up. The usage of QuiremScout microspheres may allow physicians to improve their SIRT treatment planning.3

Recent clinical results continue to support the validation of QuiremScout microspheres in patient selection and planning as part of the Holmium Platform, such as the latest publication in the Lancet Oncology Journal from UMC Utrecht for the non-randomized HEPAR PLuS study7, which included Neuroendocrine tumor (NET) patients with liver metastasis after systemic radiation therapy with 177Lu-Dotatate.

The Holmium platform consists of three integrated products (QuiremScout, QuiremSpheres & Q-suite), which equips physicians with the necessary tools to optimize SIRT outcomes through more individualized treatment.

"QuiremScout is part of the Holmium platform that enables physicians to perform Selective intra-arterial radiation therapy. This technology uniquely allows a fine patient selection and individualized treatment for better outcomes. At Terumo, we are proud of this important recognition by the community.", said Laurent Domas, Vice President Global Interventional Oncology & Therapy Development, Terumo Interventional Systems.

On December 9, 2020 Enzo Biochem, Inc. (NYSE:ENZ), a leading biosciences and diagnostics company, reported financial results for the first quarter ended October 31, 2020 and provided a business update on recent corporate and operational developments (Press release, Enzo Biochem, DEC 9, 2020, sec.gov/Archives/edgar/data/316253/000121390020042554/ea131605ex99-1_enzobio.htm [SID1234572813]).

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"During this quarter we exceeded guidance and achieved profitability based on strong results that reflect our strategy to both streamline our operations and expand our product and platform capabilities as an integrated solutions provider of products and services in molecular diagnostics, immunoassays, cytology, and immunohistochemistry," said Elazar Rabbani, PhD., Chairman and Chief Executive Officer of Enzo. "The rapid application of our proprietary GenFlex platform in response to the COVID-19 pandemic is the most recent reflection of the strength and flexibility of our molecular diagnostic capabilities. We have also worked aggressively to expand our operations to focus on more advanced, higher margin market opportunities that reflect the core strengths of Enzo and our team. Our portable microplate reader brings new potential capabilities in point-of-care testing to researchers and healthcare providers while our GoTestMeNow.com online portal represents a major step forward in bringing access to diagnostic testing directly to people who need it conveniently and quickly."

"During this very strong quarter for our company we also added two outstanding industry leaders to our Board of Directors. Drs. Mary Tagliaferri and Ian Walters significantly expand the operational and commercial expertise of our Company’s board, particularly concerning companion diagnostics and other therapeutic opportunities. We continue to execute on our strategy to position Enzo as a leading vertically integrated end–to-end diagnostic company capitalizing on our multi-platform technologies and products now and in a post-COVID-19 environment," said Barry Weiner, President of Enzo.

Operational Highlights:

The Company posted another successful quarter of progress in implementing its strategic plan as a fully integrated end-to-end diagnostic product and service provider while navigating through a range of operational issues during the COVID-19 pandemic. Our first responder staff’s response and commitment has been noteworthy in our achieving these goals.
Enzo rapidly expanded capacity in reagent and consumable supply manufacturing while broadening its menu of tests on its GenFlex molecular diagnostic platform.
The Company continued its strategic operational expansion program including plans to double its facility footprint in Farmingdale, NY.
Enzo completed the launch of the company’s new portable microplate reader for use with its ELISA and assay kits to simplify laboratory workflow and expand POC capabilities in molecular diagnostics.
In response to the continuing demand for improved access to molecular testing, Enzo introduced the GoTestMeNow online portal where consumers can directly order COVID-19 laboratory tests that are physician-approved, with plans to expand its use to other testing needs in 2021.
Customer interest for Enzo’s diagnostic platforms was strong following award of Emergency Use Authorization from the FDA highlighting the Company’s integrated in-house capabilities and ability to develop high throughput sensitive detection platforms. These platforms support rapid scalability of testing for COVID-19 in a model that can be applied to future testing needs in multiple areas including upper respiratory panels, STDs and expanded women’s health panels.
Corporate & Organizational Highlights:

Enzo added industry veterans Mary Tagliaferri, MD and Ian B. Walters, MD to the Company Board of Directors.
The Company planned and executed a range of operational and technological strategies to further its cost efficiencies.
The Company is in the process of evaluating various business opportunities concerning Enzo’s assets and capabilities for investment, partnerships, and commercial relationships.
Financial Highlights:

Following a slow-down of operations at the beginning of the COVID-19 pandemic as a result of a sharp industry-wide fall-off in medical visits and the closure of many customer facilities, Enzo monthly revenues have registered steady gains since April. Quarterly revenues advanced 47% sequentially and 42% year-over-year during the period.
The Company’s current annual revenue run-rate is approximately $115 million, representing more than 50% topline growth on an annualized basis.
Gross margins in the Enzo Clinical Labs division reached 39% in the first quarter.
1Q21 net income was $0.3 million compared to a net loss of $7.6 million in the previous year’s period, representing a $7.9 million improvement over the corresponding period a year ago and a $3.6 million improvement over the prior quarter.
First Quarter 2021 Financial Results

Total first quarter revenue was $28.7 million, compared to $20.2 million in the first quarter last year, an increase of 42%, reflecting continuing expansion of operations and revenue following the slow-down associated with the impact of COVID-19 on the diagnostic testing sector. Consolidated gross margin was 42% compared to 28% a year ago.
Enzo Clinical Lab revenue increased 66% to $21.2 million from $12.8 million in the first quarter 2020 and more than 55% sequentially. The year over year improvement was driven by volume growth to 300,000 accessions in the period versus approximately 200,000 in the previous year’s first quarter. Net revenue per accession increased to more than $69 per accession vs. $62 in the previous year’s period. Clinical services gross margin amounted to 39% up from 14% in the first quarter 2020, primarily due to testing mix as well as from ongoing cost-saving initiatives.
Enzo Life Sciences revenue of $7.4 million increased 27% from $5.8 million in the previous quarter reflecting the beginning of a recovery from the impact of COVID-19 pandemic globally. Gross margin was 49%, compared to 52% in the previous year’s quarter and 46% in the fourth quarter due to product mix and the impact of the COVID-19 pandemic.
Research and development expenses decreased 29% to $0.8 million (3% of total revenues) from $1.1 million, (5% of total revenues), in the year ago period. Selling, general and administrative expenses of $10.0 million (down to 35% of total revenue) declined from $11.1 million (55% of total revenue) in year ago period, 10% lower.
GAAP net income was $0.3 million or $0.01 per share versus a net loss of $3.3 million or ($0.07) per share last quarter and a loss of $7.7 million, or ($0.16) per share, in the year-ago quarter. Adjusted EBITDA in the quarter was $1.0 million compared to an adjusted EBITDA loss of $5.7 million in the previous year’s first quarter. The year-over-year improvement was driven mainly by an increase in gross margin (from COVID-19 testing and lower reagent costs) and lower SG&A expenses from headcount efficiencies, as well as reduced intangibles amortization and travel.
Cash and cash equivalents totaled $46 million at the end of the first quarter, slightly lower than the $48 at the end of the fiscal year due to increases in accounts receivable, inventory, and capital expenditures. Working capital improved to $37 million from $36 million at the end of the fiscal year. As of October 31, 2020, the Company had 47.9 million shares outstanding.
Conference Call and Webcast Information

The Company will host a conference call on Wednesday, December 9, 2020, at 4:30 pm, Eastern Standard Time, to review the operational, corporate, and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call or click the webcast link below to participate over the internet:

Domestic: 877-407-0792
International: 201-689-8263
Conference ID: 13713236
Webcast: View Source

A replay of the call will be available via webcast for on-demand listening shortly after completion of the call on the Investor Relations section of the Company’s website, View Source, and will remain available for approximately 90 days. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

Adjusted Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the investor relations section of the Company’s website (View Source) any reconciliation of differences between GAAP and Adjusted financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release, which includes reconciliation tables of GAAP to Adjusted net income (loss) and EBITDA to Adjusted EBITDA.

On December 9, 2020 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, reported the pricing of an underwritten public offering of 1,460,027 shares of its common stock at a public offering price of $13.25 per share (Press release, 8-K, Delcath Systems, DEC 9, 2020, sec.gov/Archives/edgar/data/872912/000119312520316013/d64437dex991.htm [SID1234572677]). The gross proceeds of the offering to the Company are expected to be approximately $19.3 million, before deducting the underwriting discounts and commissions and other estimated offering expenses.

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The closing of the offering is expected to occur on or about December 11, 2020, subject to the satisfaction of customary closing conditions.

Delcath intends to use the net proceeds from this offering for (i) the completion of its FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the "Focus Trial"), a global registration clinical trial that is investigating the primary endpoint of objective response rate, as well as other secondary and exploratory endpoints, in metastatic ocular melanoma, or mOM; (ii) preparation of the federal regulatory application for the HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system), or HEPZATO, a drug/device combination product regulated as a drug, designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects; (iii) preparation for the commercial launch of HEPZATO; (iv) continued clinical development, including additional indications and expanded access trials in metastatic ocular melanoma; and (v) general corporate purposes, which may include capital expenditures and other operating expenses.

Canaccord Genuity and Roth Capital Partners are acting as joint book-running managers for the proposed offering.

A shelf registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on December 21, 2018. A preliminary prospectus supplement relating to the offering was filed with the SEC on December 8, 2020 and is available on the SEC’s website at View Source The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read the prospectus supplement and the accompanying prospectus in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, which provide more information about the Company and the offering. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Canaccord Genuity LLC, Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, by telephone at (617) 371-3900 or by email at [email protected] or Roth Capital Partners, LLC, 888 San Clemente, Newport Beach, CA 92660, Attention: Prospectus Department, or by telephone at (800) 678-9147.

This press release shall not constitute an offer to sell or a 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.

On December 9, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 8,888,889 shares of common stock of the Company, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 9, 2020, View Source [SID1234572613]). The closing of the offering is expected to occur on or about December 14, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 1,333,333 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $40.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary 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].

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.