On November 9, 2021 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported a single-site analysis of data from an ongoing Phase 2a clinical trial (NCT03077685) of intratumoral (IT) NanoPac (large surface area microparticle [LSAM] paclitaxel) suspension showed improved resection rates in locally advanced pancreatic cancer (LAPC) (Press release, NanOlogy, NOV 9, 2021, View Source;utm_medium=rss&utm_campaign=improved-resection-rates-in-locally-advanced-pancreatic-cancer-following-addition-of-intratumoral-nanopac-to-standard-of-care [SID1234594889]). The results were presented by Neil Sharma, MD (President, Parkview Cancer Institute, Chair, Upper GI Oncology Program, Assistant Professor, Indiana University School of Medicine) at the American College of Gastroenterology annual meeting (ACG 2021) at a plenary session on October 27, 2021.

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The presentation entitled Improved Resection Rates in Locally Advanced Pancreatic Cancer Following EUS-FNI of Large Surface Area Microparticle Paclitaxel described results from a single clinical site analysis of a subset of nonsurgical patients (n=13) treated with two monthly administrations of IT NanoPac via endoscopic ultrasound guided fine needle injection (EUS-FNI) together with neoadjuvant standard of care.

Highlights from the analysis:

7/13 (54%) of subjects considered nonsurgical at enrollment were restaged to surgical after addition of IT NanoPac to neoadjuvant standard of care (SOC) therapy.
Of 6 subjects who ultimately underwent surgery, 5 resulted in R0 resections (margin negative for tumor upon pathology examination) and 1 resulted in R1 resection (microscopic tumor remnants only).
A decrease in tumor size was seen in 5/6 subjects who underwent surgery. Mean decrease was 25% (range 4%-50%).
Mean time to surgery in the 6 subjects was 7 months (range 4 to 12) after initiation of IT NanoPac via EUS-FNI.
NanoPac (LSAM paclitaxel) suspension is composed of large surface area microparticles of pure paclitaxel designed for tumor entrapment and sustained drug release after local administration. The Phase 2a clinical trial was designed as a dose escalating and expansion study in 3 phases:

The first phase (n=10) was a single IT administration of escalating doses of NanoPac suspension to establish safety.
The second phase (n=22) expanded the highest dose to 2 monthly IT administrations. The presentation made at ACG was based on a 13-subject subset from this phase.
The third phase, which is currently underway, expands to up to 4 monthly IT administrations, and has enrolled 12 subjects as of this release.
NanoPac has been well tolerated in this trial to date with no confirmed drug-related systemic adverse events and transient mild/moderate abdominal pain as the primary local adverse event. No pancreatitis has been reported.

In addition to Dr. Sharma, clinical investigators in the trial include Simon Lo, MD (Cedars Sinai), Mohamed Othman, MD (Baylor College of Medicine), and Antonio Mendoza Ladd, MD (formerly Texas Tech University Health Sciences Center).

The American Cancer Society estimates nearly 58,000 new cases of pancreatic cancer in the United States for 2021 with more than 47,000 deaths. Pancreatic cancer is among the deadliest of cancers with no significant reduction in mortality despite decades of research. NanOlogy is planning to expand to a randomized clinical trial of neoadjuvant IT NanoPac in addition to SOC versus neoadjuvant SOC alone in LAPC to further evaluate safety and efficacy pending results from the current study.

In addition to this trial, NanOlogy clinical programs have advanced in lung, bladder, and other cancers. Data from preclinical and clinical studies in a variety of solid tumors have shown evidence of tumor kill, minimal local or systemic toxicity, and favorable antitumoral immune effects, which includes published preclinical research of LSAM-taxane synergy in combination with an immune checkpoint inhibitor.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts taxane API crystals into stable LSAMs of pure drug for tumor-directed therapy and sustained drug release. The taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, & US 10,993,927), Canada, Europe, Japan, China, Russia, and Australia all valid through June 2036, plus applications pending globally. These composition of matter patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, methods, and technology.

On November 9, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and nine months ended September 30, 2021 (Press release, Eagle Pharmaceuticals, NOV 9, 2021, View Source [SID1234594888]).

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Business and Recent Highlights:

Entered into a worldwide licensing agreement for the commercial rights to CAL02, a novel first-in-class antitoxin agent ready for Phase 2b/3 development for the treatment of severe bacterial pneumonia in combination with traditional antibacterial drugs.
Vasopressin updates:
In August 2021, received favorable decision from the U.S. District Court for the District of Delaware that Eagle’s proposed vasopressin product does not infringe any of the patents Par Pharmaceutical, Inc. asserted against Eagle.
U.S. Food and Drug Administration ("FDA") maintained Priority Review for the Company’s ANDA with December 15, 2021 GDUFA date.
Received a 30-day information request from the FDA; Eagle fully responded to the request on September 20, 2021, and there are no other review requests outstanding.
Granted U.S. Patent No. 11,103,483, "Formulations of Bendamustine," which has been listed in the FDA Orange Book for BENDEKA and BELRAPZO.
Entered into a licensing agreement for the U.S. commercial rights to landiolol, a leading hospital emergency use product in Europe and Japan. Landiolol is currently approved in Europe for the treatment of non-compensatory sinus tachycardia and tachycardic supraventricular arrhythmias. Eagle will support the submission of a new drug application to the FDA seeking approval for landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
Financial Highlights

Third Quarter 2021

Total revenue for Q3 2021 was $39.9 million, compared to $49.9 million in Q3 2020, primarily reflecting lower product sales of BELRAPZO and BENDEKA, partially offset by higher product sales of TREAKISYM.
Q3 2021 net loss was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 diluted share in Q3 2020.
Q3 2021 adjusted non-GAAP net income was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million, or $1.19 per basic and $1.17 per diluted share, in Q3 2020.
Cash and cash equivalents were $99.7 million, net accounts receivable was $45.3 million, and debt was $28.0 million as of September 30, 2021.
"We are preparing for two significant product launches, vasopressin and PEMFEXY, expected within the next ninety days that we believe will meaningfully increase the revenue and profitability of Eagle. With the recent licensing of CAL02 and landiolol, our expectation going forward is that we will utilize our cash and possibly the balance sheet to further strengthen the pipeline and portfolio," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2021 Financial Results

Total revenue for the three months ended September 30, 2021 was $39.9 million, as compared to $49.9 million for the three months ended September 30, 2020.

Q3 2021 BELRAPZO product sales were $4.9 million, compared to $8.7 million in Q3 2020.

Q3 2021 RYANODEX product sales were $4.5 million, compared to $4.2 million in Q3 2020.

Royalty revenue was $27.7 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. BENDEKA royalties were $26.5 million in the third quarter of 2021, compared to $27.6 million in the third quarter of 2020. A summary of total revenue is outlined below:

Gross Margin was 79% during the third quarter of 2021, as compared to 76% in the third quarter of 2020. The increase in gross margin for the third quarter of 2021 was driven by revenue mix.

R&D expense was $23.3 million for the third quarter of 2021, compared to $4.8 million in the third quarter of 2020. The increase includes a $10.0 million upfront payment related to our license agreement with Combioxin for CAL02, a $5.0 million upfront expense related to our licensing agreement with AOP Orphan for landiolol, a $0.8 million increase in development and pre-launch inventory costs for vasopressin and a $1.1 million increase related to PEMFEXY. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2021 was $7.6 million.

SG&A expenses in the third quarter of 2021 totaled $18.5 million compared to $17.7 million in the third quarter of 2020. This increase is primarily related to higher external legal costs partially offset by a decrease in stock-based compensation expense. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2021 SG&A expense was $14.5 million.

Net loss for the third quarter of 2021 was $5.6 million, or $0.43 per basic and diluted share, compared to net income of $7.1 million, or $0.52 per basic and $0.51 per diluted share, in the third quarter of 2020, due to the factors discussed above.

Adjusted non-GAAP net income for the third quarter of 2021 was $7.5 million, or $0.57 per basic and $0.56 per diluted share, compared to adjusted non-GAAP net income of $16.1 million or $1.19 per basic and $1.17 per diluted share in the third quarter of 2020. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2021 Expense Guidance

R&D spend in 2021, on a non-GAAP basis, is expected to be $34-$38 million, as compared to $27.8 million in 2020.
SG&A spend in 2021, on a non-GAAP basis, is expected to be $52-$56 million, as compared to $50.9 million in 2020.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.
Liquidity

As of September 30, 2021, the Company had $99.7 million in cash and cash equivalents plus $45.3 million in net accounts receivable. The Company had $28.0 million in outstanding debt. Therefore, as of September 30, 2021, the Company had net cash plus receivables of $117.0 million.

In the third quarter of 2021, the Company purchased $8.3 million of its common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through September 30, 2021, the Company has repurchased $219.4 million of its common stock.

Conference Call

As previously announced, Eagle management will host its third quarter 2021 conference call as follows:

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-8292 (US) or 402-220-6069 (International) and entering conference call ID EGRXQ321. The webcast will be archived for 30 days at the aforementioned URL.

On November 9, 2021 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported that additional results from its Phase 2 trial HERACLES (NCT03359980) and extended results from its compassionate use (EAP) program for lead microbiome therapeutic MaaT013 will be discussed in an oral presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held from December 11-14, 2021 (Press release, MaaT Pharma, NOV 9, 2021, View Source [SID1234594887]). With these additional data from its MaaT013 Phase 2 trial and from MaaT013 early access program, this is the second year that results from the Company are selected for an oral presentation, and the fifth year in a row that the Company presents data at the ASH (Free ASH Whitepaper) conference.

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The HERACLES results include data from 24 patients with grade III-IV, steroid-resistant, gastrointestinal (GI)-predominant, acute Graft-versus-Host-Disease (aGvHD) that were treated with MaaT013 as second line therapy. The EAP results include data from 52 patients treated with MaaT013, with steroid-resistant or steroid-dependent aGvHD with GI involvement, who had previously failed 1 to 6 lines (median: 3) lines of systemic therapy; MaaT Pharma provided the product to hospitals under a compassionate access program in France ("accès compassionnel"- EAP). MaaT013 is a high-richness, high-diversity Microbiome Ecosystem Therapy (MET) derived from pooled donations from strictly vetted healthy individuals and is presented as an enema.

The data will be presented by Prof. Mohamad Mohty, professor and head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University.

Oral Presentation details:

Title: Pooled Allogenic Fecal Microbiotherapy MaaT013 for the Treatment of Steroid-Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Phase IIa Heracles Study and Expanded Access Program

Abstract No: 262

Session Name: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Treatment of acute and chronic graft vs. host disease

Date/Time: Saturday, December 11, 2021; 2:45 PM EST

Room: Georgia World Congress Center, B304-B305

MaaT Pharma will announce the results through a press release on Monday, December 13, 2021.

On November 9, 2021 Aadi Bioscience, Inc. ("Aadi"), clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that management will be participating in the upcoming Jefferies London Healthcare Conference and the Piper Sandler Virtual Healthcare Conference (Press release, Aadi Bioscience, NOV 9, 2021, View Source [SID1234594886]).

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Conference details can be found below.

Jefferies London Healthcare Conference
Format: Pre-recorded presentation and one-on-one investor meetings
Presentation accessible on demand starting: Thursday, November 18 3:00 am ET / 12:00 am PT
Webcast link: View Source

A live webcast of this presentation will also be accessible in the Events & Presentations section of the company’s website at View Source Replay will also be available at this link for 90 days.

Piper Sandler Virtual Healthcare Conference
Format: Pre-recorded presentation and one-on-one investor meetings
Presentation accessible on demand for conference registrants starting: Monday, November 22 10:00 am ET / 7:00 am PT

On November 9, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported its financial results for the third quarter ended September 30, 2021, and recent business highlights (Press release, Achilles Therapeutics, NOV 9, 2021, View Source [SID1234594885]).

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"We have continued to make good progress during the third quarter and will share an update from the first eight patients across our CHIRON (non-small cell lung cancer, or NSCLC) and THETIS (melanoma) studies at the upcoming SITC (Free SITC Whitepaper) meeting. Our unique ability to accurately quantify the tumor reactive component of each product and to track clonal neoantigen reactive T cells (cNeT) in the patients post-dosing is possible through the detailed genomic analysis of the tumor and prospective clonal neoantigen targeting afforded by our proprietary bioinformatics platform. We believe this best-in-class analytical capability will be critical for the successful development of TIL-based therapies," said Dr Iraj Ali, Chief Executive Officer of Achilles. "At SITC (Free SITC Whitepaper), we will also share details of our VELOS Process 2 manufacturing, which is able to routinely generate significantly higher doses of cNeT than our current Process 1. We will present further GMP scale data from VELOS Process 2 at the upcoming ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress taking place December 8-11, 2021."

Business Highlights

Two abstracts for the SITC (Free SITC Whitepaper) 36th Annual Meeting were published today – Poster 543, underscoring the ability to sensitively detect, quantify and track patient-specific cNeT during manufacture and post dosing, and Poster 193, highlighting our ability to generate increased doses of reactive cNeT from VELOS Process 2
Delivered an oral presentation at the 2021 European Society for Gene and Cell Therapy (ESGCT) Congress entitled, "Multicentre, prospective research protocol for development of a clonal neoantigen-reactive T cell therapy pipeline across multiple tumour types" highlighting the Company’s Material Acquisition Platform (MAP)​ and supporting the potential use of cNeT in a broad range of solid tumor indications
Granted US patent US 11,098,121 and European patent EP3347039B covering a method of identifying cancer patients that are likely to respond to a checkpoint inhibitor (CPI) by determining the total number of clonal neoantigens or the ratio of clonal to sub-clonal neoantigens in patients’ cancer cells
Enrolled the first patient in the United States at the Moffitt Cancer Center in the Phase I/IIa CHIRON clinical trial
In-licensed from Secarna Pharmaceuticals GmbH & Co antisense oligonucleotide technology and intellectual property for the ex vivo manufacture of a T cell pharmaceutical product
Financial Highlights

Cash and cash equivalents: Cash and cash equivalents were $281.9 million as of September 30, 2021, as compared to $177.8 million as of December 31, 2020. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations into the second half of 2023, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials
Research and development (R&D) expenses: R&D expenses were $10.7 million for the third quarter ended September 30, 2021, an increase of $5.4 million compared to $5.3 million for the third quarter ended September 30, 2020. R&D expenses were $30.4 million for the nine months ended September 30, 2021, an increase of $16.7 million compared to $13.7 million for the nine months ended September 30, 2020. The increase was primarily driven by increased activity related to our ongoing clinical trials and overall R&D
General and administrative (G&A) expenses: G&A expenses were $5.0 million for the third quarter ended September 30, 2021, an increase of $2.0 million compared to $3.0 million for the third quarter ended September 30, 2020. G&A expenses were $15.3 million for the nine months ended September 30, 2021, an increase of $8.2 million compared to the $7.1 million for the nine months ended September 30, 2020. The increase was primarily driven by fees associated with the Company’s public company obligations, and an increase in headcount and related personnel costs
Net loss: Net loss for the third quarter ended September 30, 2021 was $12.9 million or $0.34 per share compared to $8.2 million or $7.50 per share for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021 was $42.9 million or $1.69 per share compared to $20.3 million or $21.16 per share for the nine months ended September 30, 2020. The decrease in loss per share is due in part to the increased number of shares following the conversion and issuance of shares from the IPO
Upcoming Events

Achilles will present at the following medical and investor conferences in November and December 2021. Additional details will be available in the Events & Presentations section of the Company’s website:

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting: November 10 – 14, 2021
Piper Sandler Annual Healthcare Conference: November 29 – December 2, 2021
ESMO Immuno-Oncology Congress 2021: December 8 – 11, 2021
In addition, the Company will host a live webcast and conference call on Friday, November 12, 2021 at 8:30am ET / 1:30pm UK to review the SITC (Free SITC Whitepaper) presentations and provide a corporate update. The live webcast can be accessed in the Events & Presentations section of the Company’s website. The conference call dial-in numbers for investors and analysts are (833) 732-1204 (toll free within the USA), 0800 0288438 (toll free within the United Kingdom) or (720) 405-2169 (outside the USA) with the access code 4795875.