On August 8, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the second quarter 2022 and provided an update on the company’s recent developments (Press release, FibroGen, AUG 8, 2022, View Source [SID1234617770]).

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"We continue making excellent progress with pamrevlumab across all our high value indications and are pleased to have recently completed enrollment of the LELANTOS-2 Phase 3 study in ambulatory patients with Duchenne muscular dystrophy. We now expect topline data from three pivotal pamrevlumab Phase 3 trials in 2023: the ZEPHYRUS-1 trial in idiopathic pulmonary fibrosis, and the LELANTOS-1 and LELANTOS-2 trials in non-ambulatory and ambulatory Duchenne muscular dystrophy, respectively," said Enrique Conterno, Chief Executive Officer, FibroGen. "We are delighted with our roxadustat sales in China, showing significant year-over-year volume growth. In Europe, our partner Astellas continues with additional roxadustat launches."

Recent Developments:

Completed enrollment of the LELANTOS-2 Phase 3 clinical trial of pamrevlumab in ambulatory patients with Duchenne muscular dystrophy (DMD).
Completed interim analysis of event free survival in the LAPIS Phase 3 study of pamrevlumab in locally advanced pancreatic cancer (LAPC), and the study will continue to its primary endpoint of overall survival.
Roxadustat continues to be approved in additional countries, most recently in Mexico and South Africa. It is now approved in China, Europe, Japan, and numerous other territories for the treatment of CKD patients on dialysis and patients not on dialysis.
China Performance:

FibroGen’s net product revenue under U.S. GAAP from sale of roxadustat in China was $23.3 million compared to $13.4 million in the second quarter of 2021.
Second quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca was $53.1 million, compared to $52.8 million in the second quarter of 2021. This result was driven by an increase in volume of over 80% benefitting from the National Reimbursement Drug List (NRDL) price reduction.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.
Upcoming Milestones:

Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab in non-ambulatory DMD patients expected 1H 2023.
Topline data from the MATTERHORN Phase 3 study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2023.
Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in IPF expected mid-2023.
Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory DMD patients expected 2H 2023.
Topline data from the LAPIS Phase 3 study of pamrevlumab in LAPC expected 1H 2024.
Financial:

Total revenue for the second quarter of 2022 was $29.8 million, as compared to $24.4 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $72.6 million, or $0.78 net loss per basic and diluted share, compared to a net loss of $134.0 million, or $1.45 net loss per basic and diluted share one year ago.
At June 30, 2022, FibroGen had $517.6 million in cash – defined as cash, cash equivalents, investments, and accounts receivable.
Based on our latest forecast, we estimate a 2022 ending cash balance of $330-$360 million.
_____________________________
1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, August 8, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the Company’s website, www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).

About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD), and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD), and Fast Track designation to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. The U.S. Food and Drug Administration has also granted Rare Pediatric Disease Designation to pamrevlumab for the treatment of patients with DMD. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in IPF, LAPC, and DMD. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets not licensed to Astellas.

On August 8, 2022 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended June 30, 2022 (Press release, MacroGenics, AUG 8, 2022, View Source [SID1234617769]).

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"We made important progress in the second quarter, during which we completed enrollment in a Phase 1/2 dose expansion study of lorigerlimab, a PD-1 × CTLA-4 DART molecule. In addition, we recently dosed the first patient in a Phase 1 study of MGD024, our next-generation CD123 × CD3 DART molecule, in patients with CD123-positive hematologic malignancies," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are also pleased with continued progress made to operationalize TAMARACK, our Phase 2/3 study of MGC018, a B7-H3-directed antibody-drug conjugate (ADC), in patients with metastatic castration-resistant prostate cancer (mCRPC). We expect to start this study by year-end."

Updates on Proprietary Investigational Programs

Recent progress and anticipated events in 2022 related to MacroGenics’ investigational product candidates in clinical development are highlighted below.

MGC018 is an ADC that targets B7-H3, an antigen with broad expression across multiple solid tumor types and a member of the B7 family of molecules involved in immune regulation.
Following constructive interactions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency, MacroGenics expects to start the TAMARACK Phase 2/3 study of MGC018 in patients with mCRPC by year-end. The Company believes that this should enable the delivery of interim data from the Phase 2 portion of the study by the end of 2024.
Patient recruitment continues in a Phase 1/2 dose escalation study of MGC018 in combination with lorigerlimab in patients with various advanced solid tumors.
Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule. MacroGenics completed enrollment of a Phase 1/2 dose expansion study with lorigerlimab as monotherapy in cohorts of patients with microsatellite stable colorectal cancer, mCRPC, melanoma and checkpoint-naïve non-small cell lung cancer. The Company expects to provide a data update from this study by early 2023.
MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. MacroGenics recently dosed the first patient in a Phase 1 study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.
Enoblituzumab is an Fc‐engineered, monoclonal antibody (mAb) that targets B7‐H3.
As previously announced in July 2022, MacroGenics closed the Phase 2 study evaluating enoblituzumab in combination with either retifanlimab (anti-PD-1 mAb) or tebotelimab (PD-1 × LAG-3 bispecific antibody), each an investigational agent, in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The decision to discontinue this study was based on an internal review of safety data and a risk benefit analysis in front-line SCCHN patients. The Company does not believe this decision has any impact on its other B7-H3-directed programs or its ability to potentially develop enoblituzumab in other indications.
At the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, investigators at Johns Hopkins University presented encouraging clinical and safety data from their ongoing, investigator-sponsored Phase 2 trial of enoblituzumab in patients with localized prostate cancer in the neoadjuvant setting. In the 32-patient, single-arm study, enoblituzumab showed a favorable safety profile and encouraging activity with 66% of patients having PSA 0 at one-year post-surgical resection, which correlated with peripheral expansion of tumor associated T-cell clones. This published data from the ongoing investigator-sponsored trial to date provide rationale for further evaluation of enoblituzumab in prostate cancer.
Other Program Updates:

Teplizumab is an investigational, anti-CD3 mAb acquired from MacroGenics by Provention Bio, Inc. (Provention) under an asset purchase agreement in 2018. Provention is developing teplizumab for the treatment of type 1 diabetes. On June 30, 2022, Provention announced that the FDA had extended its review period by three months for the biologics license application (BLA) for teplizumab. The extended Prescription Drug User Fee Act (PDUFA) target date is November 17, 2022. MacroGenics is eligible to receive royalties on net sales of teplizumab, if approved, in addition to milestone payments, including $60 million upon approval of a BLA in the United States.
Retifanlimab is an investigational anti-PD-1 mAb that has been exclusively licensed to Incyte Corporation. MacroGenics is eligible to receive royalties on net sales of retifanlimab, if approved, in addition to milestone payments. In July 2022, MacroGenics received $30 million in milestone payments from Incyte as part of its collaboration agreement. Retifanlimab is currently being studied as monotherapy or in combination with other agents across multiple studies.
Corporate Restructuring

MacroGenics today initiated cost-saving measures to focus on key clinical programs and to extend its cash runway with the goal of delivering value-creating data with its existing and anticipated financial resources. These planned measures include an approximate 15% workforce reduction in employees and closure of two of its satellite facilities, including a Brisbane, California-based research site and a smaller-scale, non-commercial GMP manufacturing site in Rockville, Maryland. The Company believes these measures will provide resources to advance its pipeline of innovative product candidates.

The reduction in workforce announced today will be implemented immediately in some areas and completed over time as certain projects are wound down and sites are closed. MacroGenics expects to incur additional costs as the Company recognizes one-time employee termination-related charges.

"In an effort to prioritize our pipeline of product candidates and reduce our spending, we have previously announced the termination of multiple studies. Today, we are taking additional decisive action to extend our cash runway and put MacroGenics in a stronger position to execute on our prioritized programs. The decision to reduce our workforce and close two sites was not taken lightly, and we are grateful to every MacroGenics employee who has helped advance our Company," said Scott Koenig, M.D., Ph.D. "With these actions, we believe our updated cash runway should enable the delivery of interim data from the Phase 2 portion of the TAMARACK study of MGC018 by the end of 2024, data from the Phase 1 dose expansion of lorigerlimab by early 2023 and data from the dose escalation of MGD024 in AML patients, as well as execution of the Company’s other ongoing clinical and preclinical studies."

Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2022, were $133.7 million, compared to $243.6 million as of December 31, 2021. The June 30, 2022 balance did not include $34.5 million in payments subsequently received from collaboration partners in July 2022.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $26.0 million for the quarter ended June 30, 2022, compared to total revenue of $30.8 million for the quarter ended June 30, 2021. Revenue for the quarter ended June 30, 2022 included MARGENZA net sales of $4.7 million, compared to $3.2 million for the quarter ended June 30, 2021.
R&D Expenses: Research and development expenses were $51.7 million for the quarter ended June 30, 2022, compared to $55.8 million for the quarter ended June 30, 2021. The decrease was primarily related to decreased retifanlimab manufacturing costs for Incyte and decreased costs related to discontinued studies. These decreases were partially offset by increased development of discovery projects and preclinical molecules, increased clinical expenses related to lorigerlimab, and increased costs related to MGC018.
SG&A Expenses: Selling, general and administrative expenses were $13.7 million for the quarter ended June 30, 2022, compared to $15.2 million for the quarter ended June 30, 2021. The decrease was primarily related to decreased selling costs for MARGENZA, which launched in March 2021, as well as decreased consulting expenses.
Net Loss: Net loss was $41.3 million for the quarter ended June 30, 2022, compared to net loss of $39.9 million for the quarter ended June 30, 2021.
Shares Outstanding: Shares of common stock outstanding as of June 30, 2022 were 61,458,790.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $133.7 million as of June 30, 2022, combined with $34.5 million in payments subsequently received from collaboration partners, anticipated and potential collaboration payments, product revenues and savings from the execution of the Company’s restructuring plan should extend its cash runway into 2024. This cash runway guidance reflects anticipated expenditures related to the planned Phase 2 portion of the MGC018 TAMARACK study as well as continuation of MacroGenics’ other ongoing preclinical and clinical studies.
Conference Call Information

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.

On August 8, 2022 Amgen (NASDAQ: AMGN) reported new data from the DeLLphi300 clinical trial, a Phase 1 dose exploration and expansion study evaluating the safety and efficacy of investigational tarlatamab, a potential first-in-class half-life extended bispecific T-cell engager (HLE BiTE) molecule targeting delta-like ligand 3 (DLL3), in small cell lung cancer (SCLC) (Press release, Amgen, AUG 8, 2022, View Source [SID1234617768]). Updated data from the ongoing Phase 1 study were presented at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) in Vienna, Austria.

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"Small cell lung cancer is one of the most devastating and aggressive solid tumor cancers. The disease has lacked effective treatments with no therapies specifically approved to treat patients in the third-line setting," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Our Phase 1 data for tarlatamab presented earlier today at WCLC continues to demonstrate exciting antitumor activity with remarkable response durability in heavily pre-treated patients. We are encouraged by the overall survival of 13.2 months."

In heavily pretreated patients with SCLC (n=106), a population with few treatment options beyond first-line, investigational tarlatamab demonstrated encouraging antitumor activity with notable response durability. Tarlatamab delivered a confirmed ORR of 23% (confirmed and unconfirmed responses), a median duration of response of 13.0 months and a median overall survival (OS) of 13.2 months. Treatment-related adverse events (TRAEs) of any grade occurred in 97 patients (92%), and TRAEs grade ≥ 3 occurred in 33 patients (31%). Cytokine release syndrome (CRS) was primarily grade 1/2, mostly occurred in Cycle 1, rarely occurred in subsequent cycles and was generally manageable. Overall, treatment discontinuation due to treatment-related AEs was low (4%).

Based on these data, a potentially registrational Phase 2 study of tarlatamab in the third-line treatment of SCLC is currently enrolling patients. Additional studies investigating tarlatamab are underway, including DeLLphi-303, a Phase 1b study testing tarlatamab in combination with standard of care in first-line SCLC and a Phase 1b study in de novo or treatment-emergent neuroendocrine prostate cancer.

About Tarlatamab
Tarlatamab is an investigational potential first-in-class half-life extended bispecific T-cell engager (BiTE) molecule that is uniquely designed to target delta-like ligand 3 (DLL3) in neuroendocrine cancers, such as small cell lung cancer (SCLC) and neuroendocrine prostate cancer – both of which have high unmet medical needs.1,2 DLL3 is highly upregulated on the cell surface of neuroendocrine tumors and rarely expressed on nonmalignant cells, making it a novel target for investigating a BiTE immuno-oncology molecule.2,3,4

Tarlatamab is being investigated in multiple studies, including DeLLphi-301, a potentially registrational Phase 2 study in relapsed/refractory SCLC; DeLLphi-303, a Phase 1b study testing tarlatamab in combination with standard of care therapies in first-line SCLC; DeLLphi-302, a Phase 1b combination study with AMG 404 in second-line or later SCLC; and DeLLpro-300, a Phase 1b study in de novo or treatment-emergent neuroendocrine prostate cancer.

About Small Cell Lung Cancer
Small cell lung cancer (SCLC) is a particularly aggressive form of the disease that accounts for about 10% to 15% of all lung cancers.5 SCLC tends to spread faster than NSCLC, with nearly 70% of people with SCLC having metastatic disease at the time of diagnosis.5

The five-year survival rate for advanced SCLC remains low at 3% and unfortunately treatment options have not changed much in several decades.6,7 Delta-like ligand 3 (DLL3) is an emerging treatment target that is expressed in greater than 80% of SCLC tumors with minimal expression in normal cells.8

About BiTE Technology
BiTE (bispecific T-cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens.

The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T-cell treatment available to all providers when their patients need it. Amgen is advancing a number of BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That’s why we’re relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

For more information, follow us on www.twitter.com/amgenoncology.

On August 8, 2022 Applied DNA Sciences, Inc., (NASDAQ: APDN) (the "Company" or "Applied DNA"), a leader in polymerase chain reaction ("PCR")-based technologies, reported the closing of its previously announced public offering of 3,000,000 shares of its common stock (or common stock equivalents in lieu thereof), together with Series A warrants to purchase up to 3,000,000 shares of its common stock and Series B warrants to purchase up to 3,000,000 shares of its common stock at a combined offering price to the public of $4.00 per share (or common stock equivalent) and associated warrants, priced at a premium to market under Nasdaq rules (Press release, Applied DNA Sciences, AUG 8, 2022, View Source [SID1234617767]). The gross proceeds to the Company from the offering were $12 million before deducting the placement agent’s fees and other offering expenses payable by the Company.

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The Series A warrants have an exercise price of $4.00 per share, are exercisable immediately upon issuance, and expire five years following the date of issuance. The Series B warrants have an exercise price of $4.00 per share, are exercisable immediately upon issuance and expire thirteen months following the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The offering was conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-266223) previously filed with the Securities and Exchange Commission (SEC), which became effective on August 4, 2022, and an additional registration statement filed pursuant to Rule 462(b) which became automatically effective on August 4, 2022. The offering was made only by means of a prospectus, which is part of the effective registration statements. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On August 8, 2022 Genmab A/S (Nasdaq: GMAB) reported that it is improving its 2022 financial guidance published on May 11, 2022 (Press release, Genmab, AUG 8, 2022, View Source,by%20the%20items%20described%20above.&text=Genmab’s%20financial%20results%20for%20the,published%20on%20August%2010%2C%202022. [SID1234617766]). The improved guidance is driven primarily by increased royalty revenue due to higher net sales of DARZALEX and the positive net foreign exchange impact of the strong U.S. Dollar.

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Genmab expects its 2022 revenue to be in the range of DKK 12,000 – 13,000 million, an increase to the previous guidance of DKK 11,000 – 12,000 million, driven primarily by the continued strong growth of DARZALEX net sales as well as the positive impact of the strong U.S. Dollar. Genmab’s projected revenue for 2022 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2022 net sales of USD 7.8 – 8.2 billion compared to Genmab’s previous estimate of USD 7.5 – 8.0 billion.

Genmab anticipates its 2022 operating expenses to be in the range of DKK 7,600 – 8,200 million, an increase to the previous guidance of DKK 7,200 – 7,800 million, driven by increased investment related to pipeline progression and epcoritamab launch readiness activities as well as the negative impact of the strong U.S. Dollar.

Genmab now expects its 2022 operating profit to be in the range of DKK 3,800 – 5,400 million, an increase to the previous guidance of DKK 3,200 – 4,800 million, driven primarily by the items described above.

Genmab’s financial results for the first half of 2022 will be published on August 10, 2022.

The above expectations are based on assumptions including those described on pages 5 and 6 of the Interim Report for the First Quarter of 2022 (Company Announcement No. 17/2022) as well as an updated USD/DKK exchange rate of 6.8, compared to the previous exchange rate of 6.4.