On November 8, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad pipeline targeting cancers and infectious disease, reported financial results for the third quarter of 2022 (Press release, Agenus, NOV 8, 2022, View Source [SID1234623371]).

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"Botensilimab has demonstrated impressive clinical responses in nine cold, treatment-resistant tumor types with strong durability, and we look forward to presenting expanded data in colorectal, ovarian, lung and sarcoma cohorts at a plenary session at SITC (Free SITC Whitepaper) followed by our R&D event this Saturday," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "In light of these compelling clinical data, we have expanded our leadership team to accelerate the development and seek registration of botensilimab with the aim of delivering this potentially transformative new therapy to patients across multiple tumor types."

Clinical update on botensilimab, Agenus’ innate and adaptive immune stimulator, to be presented in a plenary session of the SITC (Free SITC Whitepaper) Annual Meeting

New data on multiple expansion cohorts from the Phase 1 study of botensilimab in cold (immunotherapy-resistant) tumors will be presented at an oral plenary session on novel immunotherapies on Saturday, November 12th at 10:50am ET.
Two additional SITC (Free SITC Whitepaper) presentations will include new data on the mechanisms underpinning botensilimab’s differentiated and enhanced anti-tumor immunity.
Initiated Phase 2 ACTIVATE trials in advanced MSS colorectal cancer and melanoma

ACTIVATE-Colorectal is a global, randomized, open-label, dose-optimization study evaluating the safety and efficacy of botensilimab as monotherapy and in combination with balstilimab in advanced refractory MSS CRC patients.
ACTIVATE-Melanoma is a global, randomized, open-label, multi-cohort, dose-optimization study evaluating the safety and efficacy of botensilimab as a single agent in advanced refractory melanoma who have failed prior PD-1 +/- CTLA-4 therapy.
An additional Phase 2 study in pancreatic cancer is anticipated to begin later in 2022.
Expanded clinical and regulatory leadership team to accelerate botensilimab development

Patricia Carlos named Chief Regulatory, Quality, and Safety Officer. Patricia brings over 20 years of regulatory affairs leadership experience, directing programs from investigational new drug application to commercialization including prior regulatory and quality leadership roles at Arcus Biosciences, BeiGene, Medivation, Gilead Sciences, and Bayer.
Todd Yancey, MD named Senior Global Clinical Development, Medical Affairs and Commercial Advisor. Todd brings over 40 years of combined clinical and industry experience, including prior global clinical and commercial leadership roles at Beigene, BioMarin, Medivation, Onyx, Genentech, and Amgen.
Continued to advance clinical pipeline through company-led studies and corporate partnerships

Dosed first patient in Phase 1 study of AGEN1571 (ILT2 antagonist) as a monotherapy and in combination with botensilimab and/or balstilimab in participants with advanced solid tumors.
Combination study with AGEN2373 (CD137 agonist) and botensilimab in melanoma patients who have relapsed or are refractory to prior anti-PD-1 therapy continues to enroll.
Update on the Phase 2 trial of AGEN1423, an anti-CD73-TGFβ-trap bifunctional antibody in combination with balstilimab (anti-PD-1) in advanced pancreatic cancer will be presented at SITC (Free SITC Whitepaper).
BMS launched a Phase I/II study of BMS-986442 (a TIGIT bispecific discovered by Agenus, also known as AGEN1777) in combination with nivolumab +/- chemotherapy in patients with advanced solid tumors and non-small cell lung cancer.
Merck has initiated a randomized Phase II study evaluating MK-4830 (a candidate ILT4 antagonist discovered by Agenus) in combination with pembrolizumab and chemotherapy in ovarian cancer; additional Phase II studies are ongoing in NSCLC, small cell lung cancer, esophageal cancer, MSI-H colorectal cancer, renal cell carcinoma, and melanoma.
Incyte has initiated a randomized Phase II study evaluating INCAGN02385 (LAG-3) and INCAGN02390 (TIM-3), both discovered by Agenus, in combination with anti-PD-1 in 1L squamous cell carcinoma of the head and neck; additional Phase II studies are ongoing in melanoma, endometrial cancer, and urothelial carcinoma.
Third Quarter 2022 Financial Results
We ended our third quarter 2022 with a cash, cash equivalent, and short-term investment balance of $218.2 million as compared to $238.3 million and $306.9 million on June 30, 2022, and December 31, 2021, respectively. Cash used in operations was $32.2 million for the quarter ended September 30, 2022, and $128 million for the nine-months then ended.

We recognized revenue of $22.8 million and incurred a net loss of $56.7 million, or $0.19 per share, for the third quarter ended September 30, 2022. For the nine-months ended September 30, 2022, we recognized revenue of $69.6 million and incurred a net loss of $156.6 million, or $0.54 per share.

Non-cash operating expenses for the third quarter and nine-months ended September 30, 2022, were $22.2 million and $62.8 million respectively.

Webcast
A webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

"The Road Taken" R&D Event
Agenus will host an in-person and virtual R&D event ("The Road Taken") on Saturday, November 12th from 2:00 p.m. to 5:00 p.m. ET at the Prudential Tower in Boston, MA. The event will feature insights from leading cancer immunologists who will share their collective and individual expertise on the current and future state of cancer immunotherapy, including a deep dive into the botensilimab data presented at SITC (Free SITC Whitepaper). Institutional investors, research analysts, and key opinion leaders are invited to attend the event in-person and can RSVP by emailing [email protected]. To register for the live webcast, please click here.

On November 8, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported that it will report financial results for the third quarter ended September 30, 2022 on Monday, November 14, 2022, after the close of U.S. markets (Press release, Inhibikase Therapeutics, NOV 8, 2022, View Source [SID1234623370]). Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET on Tuesday, November 15, 2022 to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 1-844-825-9789 (United States) or 1-412-317-5180 (International) with the conference code 10172407. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On November 8, 2022 MannKind Corporation (Nasdaq: MNKD) reported financial results for the third quarter and nine months ended September 30, 2022 (Press release, Mannkind, NOV 8, 2022, View Source [SID1234623369]).

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"In the third quarter, we grew total revenues by 48% over 2021 as our collaboration with United Therapeutics had its first full quarter during which we recognized both manufacturing revenue and royalties associated with the launch of Tyvaso DPI," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "In addition, our Endocrine Business Unit grew revenues 67% over 2021 as we integrated the V-Go acquisition and continued to grow Afrezza demand."

Third Quarter 2022 Results

Total revenues were $32.8 million for the third quarter of 2022, reflecting Afrezza net revenue of $10.8 million, V-Go net revenue of $5.4 million, collaborations and services revenue of $10.3 million, and royalties of $6.2 million. Afrezza net revenue increased 11% compared to $9.8 million in the third quarter of 2021 as a result of price (including a more favorable gross-to-net adjustment) and higher patient demand, partially offset by wholesaler inventory ordering patterns which resulted in lower inventory levels for the third quarter of 2022. Collaborations and services revenue decreased $2.1 million compared to the third quarter of 2021 primarily due to the completion of the research and development ("R&D") services associated with our collaboration with United Therapeutics ("UT"), which was mostly offset by manufacturing revenue from sales of Tyvaso DPI to UT following the launch of Tyvaso DPI in June 2022.

Afrezza gross profit for the third quarter of 2022 was $8.7 million compared to $5.9 million in the same period of 2021, an increase of $2.8 million, or 47%, which was driven by an increase in Afrezza sales and a decrease in cost of goods sold. Afrezza’s cost of goods sold decreased by $1.7 million, or 45%, compared to the same period in 2021, primarily due to a $2.0 million decrease in excess capacity costs. Afrezza gross margin in the third quarter of 2022 was 81% compared to 61% for the same period in 2021. V-Go gross profit for the third quarter of 2022 was $2.5 million with a gross margin of 46%.

Cost of revenue – collaborations and services in the third quarter of 2022 was $12.4 million compared to $6.1 million for the same period in 2021, an increase of $6.4 million, primarily due to an increase in manufacturing activities for the production of Tyvaso DPI.

R&D expenses for the third quarter of 2022 were $4.1 million compared to $3.6 million for the third quarter of 2021. This $0.5 million increase was mainly related to personnel costs for headcount hired in the second half of 2021, partially offset by a decrease in the Afrezza pediatrics clinical study (INHALE-1) due to study startup costs incurred in the third quarter of 2021.

Selling, general and administrative ("SG&A") expenses for the third quarter of 2022 were $22.6 million compared to $17.2 million for the third quarter of 2021. This $5.4 million increase was primarily attributable to V-Go promotional efforts, the elimination of a co-promotion collaboration (which permitted some expenses associated with the sales force to be recognized as cost of revenue for collaborations and services in the third quarter of 2021), higher stock-based compensation, the net impact of personnel-related costs due to Afrezza sales force restructuring and increased professional fees.

For the third quarter of 2022, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $1.8 million compared to $2.1 million for the third quarter of 2021. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest income, consisting of interest on investments net of amortization, increased $0.6 million for the third quarter of 2022 to $0.7 million primarily due to higher yields on our marketable securities and money market funds.

Interest expense on the financing liability was $2.5 million for the third quarter of 2022, representing interest incurred on the November 2021 sale and lease-back of our manufacturing facility in Danbury, CT.

The net loss for the third quarter of 2022 was $14.4 million, or $0.06 per share, compared to $4.4 million in the third quarter of 2021, or $0.02 per share. The $10.0 million increase in net loss was primarily due to an increase in selling, general and administrative expense, interest on the financing liability, and the $4.9 million gain on extinguishment of debt in the third quarter of 2021.

Nine Months September 30, 2022

Total revenues were $63.7 million for the nine months ended September 30, 2022, reflecting Afrezza net revenue of $31.3 million, V-Go net revenue of $7.5 million, collaborations and services revenue of $18.4 million and royalties of $6.5 million. Afrezza net revenue increased 13% compared to $27.8 million in the nine months ended September 30, 2021 as a result of price (including a more favorable gross-to-net adjustment) higher product demand and a more favorable cartridge mix. Collaborations and services revenue for the nine months ended September 30, 2022 decreased $16.7 million compared to the same period in the prior year, primarily due to the completion of the R&D services associated with our collaboration with UT, which was partially offset by revenues associated with Tyvaso DPI of $15.8 million. As of September 30, 2022, $32.2 million of revenue associated with UT remains deferred and will be recognized as commercial product is sold to UT.

Afrezza gross profit for the nine months ended September 30, 2022 was $23.6 million, compared to $15.3 million in the same period of 2021, an increase of $8.3 million, or 54%, which was driven by an increase in Afrezza sales and a decrease in cost of goods sold. Afrezza’s cost of goods sold for the nine months ended September 30, 2022 decreased by $4.8 million, or 38%, compared to the same period in 2021, primarily due to a $3.8 million decrease in excess capacity costs and a $2.0 million fee incurred for the amendment of the Insulin Supply Agreement in the prior year period. Afrezza gross margin for the nine months ended September 30, 2022 was 75% compared to 55% for the same period in 2021. V-Go gross profit for the nine months ended September 30, 2022 was $3.3 million with a gross margin of 44%.

Cost of revenue – collaborations and services for the nine months ended September 30, 2022 was $29.5 million compared to $14.9 million for the same period in 2021, an increase of $14.6 million, primarily due to an increase in manufacturing activities for the production of Tyvaso DPI.

R&D expenses for the nine months ended September 30, 2022 were $12.6 million compared to $8.4 million for the same period in 2021. This $4.2 million increase was primarily attributable to personnel costs for headcount hired in the second half of 2021, development activities on our product pipeline, and the Afrezza pediatrics clinical study (INHALE-1).

SG&A expenses for the nine months ended September 30, 2022 were $69.4 million compared to $54.7 million for the same period in 2021. This $14.7 million increase was primarily attributable to a pilot promotional effort aimed at primary care physicians that began in Q4 2021, elimination of a co-promotion collaboration (which permitted some expenses associated with the sales force to be recognized as cost of revenue from collaborations and services in the same period of 2021), promotional expenses to support V-Go, higher stock-based compensation and increased professional and consulting fees.

For the nine months ended September 30, 2022, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $8.3 million compared to $5.0 million for the same period of 2021. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest income, consisting of interest on investments net of amortization, increased $1.5 million for the nine months ended September 30, 2022 to $1.6 million primarily due to higher yields on our marketable securities and money market funds.

Interest expense on the financing liability was $7.3 million for the nine months ended September 30, 2022, representing interest incurred on the November 2021 sale and lease-back of our manufacturing facility in Danbury, CT.

The net loss for the nine months ended September 30, 2022 was $69.5 million, or $0.27 per share, compared to $52.9 million in the same period of 2021, or $0.21 per share. The $16.6 million increase in the net loss was primarily due to higher cost of revenue for collaborations and services due to increased manufacturing activities for Tyvaso DPI, higher selling, general and administrative expenses, interest on the financing liability and increased research and development expenses, offset by a $17.2 million loss on the extinguishment of debt in 2021.

As of September 30, 2022, cash and cash equivalents and investments were $177.8 million.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.

On November 8, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported business highlights and financial results for the third quarter ended September 30, 2022 (Press release, Delcath Systems, NOV 8, 2022, View Source [SID1234623368]).

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Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. (PRNewsfoto/Delcath Systems, Inc.)

Recent Business Highlights

During and since the third quarter, Delcath:

Confirmed the pending resubmission of the NDA for the Hepzato Kit (melphalan hydrochloride for injection/Hepatic Delivery System) to the FDA by the end of the year,

Attracted a growing number of sites to our Expanded Access Program (EAP),

Strengthened its balance sheet by raising $5 million in a private placement priced at market,

Reached terms of settlement to end its dispute with medac, its former distributor in Europe, and

Announced that independent investigators published Predictive Parameters in Patients Undergoing Percutaneous Hepatic Perfusion with Melphalan for Unresectable Liver Metastases from Uveal Melanoma: A Retrospective Pooled Analysis in the journal Cardiovascular and Interventional Radiology
"We are excited by the level of clinician interest in Hepzato and have enrolled three EAP sites with an additional four sites in process" said Gerard Michel, Chief Executive Officer of Delcath. Mr. Michel added, "We continue to make progress toward the resubmission of the Hepzato Kit NDA by the end of this year, and assuming a six-month review, we consequently would expect a PDUFA date by the end of June 2023."

Third Quarter 2022 Results

Income Statement Highlights.

Total revenue for the three months ended September 30, 2022, was approximately $0.9 million, compared to $0.5 million for the prior year period, from our sales of CHEMOSAT in Europe. This increase in product revenue is primarily due to direct product sales for the third quarter of 2022 compared to the revenue share arrangement with our distribution partner in Europe during the third quarter of 2021.

Research and development expenses for the quarter were $4.0 million, compared to $3.0 million in the prior year quarter. The growth in R&D expense is primarily due to increased activity related to the expenses incurred in preparation for our NDA filing by the end of the year. Selling, general and administrative expenses for the quarter were approximately $4.5 million, compared to $4.0 million in the prior year quarter. The increase in general and administrative expenses was primarily due to the settlement of the medac litigation offset by lower share-based compensation expense.

The Company recorded a net loss for the three months ended September 30, 2022 of $8.5 million, $0.92 per share (basic and diluted), compared to a net loss of $7.1 million, $0.94 per share (basic and diluted), for the same period in 2021.

Balance Sheet Highlights

On September 30, 2022, the Company had cash, cash equivalents and restricted cash totaling $14.0 million, as compared to cash, cash equivalents and restricted cash totaling $27.0 million on December 31, 2021. During the three months ended September 30, 2022, and September 30, 2021, we used $5.2 million and $4.9 million, respectively, of cash in our operating activities.

On July 20, 2022, we closed a private placement for the issuance and sale of 690,954 shares of common stock and 566,751 pre-funded warrants to purchase Common Stock (the "Pre-Funded Warrants") to certain investors. Each share of common stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a price of $3.97 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $0.01 per share of common stock and are immediately exercisable. We received gross proceeds from the Private Placement of approximately $5.0 million before deducting offering expenses.

On November 8, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. has received investigational new drug (IND) approval from China’s National Medical Products Administration (NMPA) for a Phase 2 clinical trial of AC101 (HLX22), a monoclonal HER2 antibody, in combination with anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab), HANQUYOU (trastuzumab) and chemotherapy as a 1st line treatment for HER2-positive locally advanced/metastatic gastric cancer patients (Press release, Alligator Bioscience, NOV 8, 2022, View Source [SID1234623365]).

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Alligator out-licensed AC101 (HLX22) to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China. Alligator retains an ownership interest entitling the company to 35% of AbClon’s income from the agreement with Henlius.
In September 2022, Henlius announced the completion of the Phase 1 trial of AC101 (HLX22) in patients with HER2 overexpressing advanced solid tumors, in which it demonstrated a good safety and tolerability profile.

"Henlius is making very encouraging progress in its clinical development of AC101 (HLX22) in gastric cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "Following the good safety and tolerability results from the Phase 1 study in September, this is now the second Phase 2 study the company has initiated with this candidate in this indication. It is a further boost to the potential of our AC101 (HLX22) asset, and we are particularly looking forward to seeing what results this new combination setting yields, especially as it includes the addition of the anti-PD-1 monoclonal antibody serplulimab."

Henlius initiated a prior Phase 2 clinical trial to evaluate AC101 (HLX22) in combination with HANQUYOU (trastuzumab) and chemotherapy as a first-line treatment for HER2-positive locally advanced/metastatic gastric cancer patients in September 2021. The estimated primary completion date is April 2023, and the study completion date is expected in September 2024.

The information was submitted for publication, through the agency of the contact persons set out below, at 9.30 a.m. CET on November 8, 2022.