On November 9, 2021 Asgard Therapeutics AB ("Asgard"), a private biotech company pioneering in vivo cell reprogramming approaches to elicit potent anti-cancer immune responses, reported the completion of a EUR 6 million seed financing round (Press release, Asgard Therapeutics, NOV 9, 2021, View Source [SID1234594891]). The financing was co-led by Novo Holdings, Boehringer Ingelheim Venture Fund and Industrifonden.

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Asgard is developing a paradigm-shifting cancer immunotherapy approach, based on its proprietary TrojanDC technology, to reinstate cancer immunogenicity. TrojanDC is a gene therapy that reprograms cancer cells into type-1 conventional dendritic cells, allowing the presentation of their own antigens to the immune system, thereby eliciting potent anti-cancer immune responses. Designed as an off-the-shelf gene therapy, TrojanDC induces a personalized immune response, and overcomes many of the logistic and manufacturing hurdles of conventional cell-based therapies.

The Company originated from Lund University’s Cell Reprogramming and Immunity lab, led by Professor Filipe Pereira PhD, who is also Asgard’s Co-Founder and Head of Innovation. Cristiana Pires PhD and Fábio Rosa PhD established the seminal work describing direct reprogramming of somatic cells published in the prestigious science journal Science Immunology .

Cristiana Pires, PhD, Co-Founder and Chief Executive Officer of Asgard Therapeutics, said: "At Asgard, we are committed to surpassing the challenges of current cancer immunotherapies, making them available for every patient. The support we have received from such a strong syndicate of life science investors, is a strong endorsement to the potential of our TrojanDC technology. The financing will enable us to expand our pipeline of preclinical assets and build on our commitment to making personalized cancer immunotherapies optimized to each unique patient."

João Ribas from Novo Seeds commented: "We are very pleased to co-lead this financing and support the translation of the founders’ scientific research at Lund University. While reprogramming approaches have been mainly restricted to regenerative medicine, the work of Filipe, Cristiana and their team opens exciting opportunities to merge the fields of cell reprogramming and cancer immunotherapy that can be applied to several cancers, representing a platform technology with enormous potential. We look forward to working with the Asgard team as they pioneer a new generation of cancer immunotherapy".

Philipp Müller from Boehringer Ingelheim Venture Fund commented: "We are excited to support Asgard Therapeutics and its founder team as co-lead of this seed investment. The seminal work conducted at Lund University by Cristiana Pires, Filipe Pereira, and Fábio Rosa enables the direct conversion of non-related somatic cells into antigen presenting cells with a completely novel cellular identity. We believe this approach holds the potential to significantly impact the way cancer immunotherapy will evolve in the future and to bring new treatment options with true breakthrough potential to cancer patients in need."

Bita Sehat from Industrifonden said: "Asgard’s novel gene therapy approach to reprogram cancer cells into antigen-presenting cells holds great promise to open up new avenues within the immune-oncology space. We are pleased to co-lead this round and look forward to partnering with this strong group of investors and distinguished scientists as the co-founding team to advance what we believe will be a broadly applicable new cancer treatment platform."

Asgard Therapeutics has received support from LU Innovation and several translational grants, including from the Novo Nordisk Foundation, the European Commission’s Horizon 2020 and the Swedish Innovation Agency Vinnova. Asgard Therapeutics is also supported by the BioInnovation Institute in Copenhagen, and a member of the Nordic Mentor Network for Entrepreneurship (NOME) mentoring program. Being a SmiLe incubator company, Asgard is now setting up a new lab at SmiLe, Medicon Village, and will be expanding its research and drug development teams.

As part of the transaction, Søren Møller (Novo Holdings), Philipp Müller (BIVF) and Jonas Jendi (Industrifonden) join current Board Members Filipe Pereira and Lars Hedbys. João Ribas (Novo Holdings) and Fábio Rosa (Asgard Therapeutics) will also join as Board Observers.

On November 9, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Wolfe Research Virtual Healthcare Conference on Thursday, Nov. 18, 2021 (Press release, Eli Lilly, NOV 9, 2021, View Source [SID1234594890]). Jacob Van Naarden, CEO of Loxo Oncology at Lilly and president, Lilly Oncology; Mark Mintun, senior vice president, research and development – neuroscience, and president, Avid Radiopharmaceuticals; and David Hyman, M.D., chief medical officer, Lilly Oncology, will participate in a fireside chat at 10:30 a.m., Eastern time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

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.