On July 26, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported preliminary fourth quarter 2022 Vyleesi product sales (Press release, Palatin Technologies, JUL 26, 2022, View Source [SID1234616946]). Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

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"We are pleased with Vyleesi’s momentum and our preliminary product sales results for the quarter ended June 30, 2022," stated Carl Spana, Ph.D., President and CEO of Palatin. "Our operating results, which includes significant increases across all sales and distribution value metrics, compared to both the prior quarter and the comparable quarter in 2021, continue to demonstrate Vyleesi’s potential within the female sexual healthcare market."

Preliminary fourth quarter ended June 30, 2022 Vyleesi results:

Net product revenue increased 225% over the prior quarter;
increased 600% over the comparable quarter in 2021.
Gross product sales increased 75% over the prior quarter;
increased 90% over the comparable quarter in 2021.
Total prescriptions dispensed increased 45% over the prior quarter;
increased 50% over the comparable quarter in 2021.
Preliminary Financial Information
The Vyleesi related financial and operating data for the fourth quarter of fiscal 2022 is preliminary and may change. This preliminary data has been prepared by, and is the responsibility of, Palatin’s management and no independent accounting firm has audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial data. There can be no assurance that Palatin’s actual results for this quarterly period will not differ from the preliminary financial and operating data and such changes could be material. In addition, Palatin’s estimate of Vyleesi product sales for the fourth quarter of 2022 should not be viewed as a substitute for full financial statements for the fourth quarter and full year of fiscal 2022 prepared in accordance with U.S. generally accepted accounting standards. Additional information that will be material to investors will be provided in the financial statements for the three and twelve months ended June 30, 2022, and, accordingly, investors should not place undue reliance on the limited preliminary information being provided herein.

About Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD.

Palatin is actively seeking Vyleesi collaborations for North America and for territories outside the currently licensed territories of China and Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea.

Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com.

On July 26, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported an update of its financial guidance for 2022, after preliminary completion of the latest evaluation of MorphoSys’ half year 2022 financial performance (Press release, MorphoSys, JUL 26, 2022, View Source [SID1234616945]).

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MorphoSys updates its financial guidance based on the preliminary unaudited consolidated results for the first six months 2022 and following the recent licensing agreements with Human Immunology Biosciences, Inc. (HIBio) for felzartamab and MOR210. Preliminary Monjuvi (tafasitamab-cxix) U.S. Net Product Sales are US$ 23.3 million (€ 21.7 million) for the second quarter of 2022 and US$ 41.9 million (€ 38.3 million) for the first half year 2022. For the full year of 2022, MorphoSys now expects Monjuvi U.S. Net Product Sales in the range of US$ 90 to US$ 110 million (previously: US$ 110 to US$ 135 million). Further, MorphoSys now expects R&D expenses in the range of € 275 to € 300 million (previously: € 300 to € 325 million) and SG&A expenses in the range of € 150 to € 165 million (previously: € 155 to € 170 million). The previous financial guidance for 2022 was provided by MorphoSys on January 7, 2022 and reiterated on March 16 2022 and May 4, 2022 and can be found at www.morphosys.com. Guidance for Gross Margin for Monjuvi U.S. Net Product Sales remains unchanged.

On July 26, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the fourth quarter of 2022 (Press release, Merck & Co, JUL 26, 2022, View Source [SID1234616944]). Payment will be made on Oct. 7, 2022, to shareholders of record at the close of business on Sept. 15, 2022.

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On July 26, 2022 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on developing lenzilumab, a first-in class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), reported a strategic realignment of its pipeline and resources to achieve key clinical milestones (Press release, Humanigen, JUL 26, 2022, View Source [SID1234616941]). The Company plans to accelerate the development of lenzilumab in chronic myelomonocytic leukemia ("CMML"), a rare blood cancer, for which the PREACH-M study is already underway. Humanigen will also advance its plan to study lenzilumab in acute graft versus host disease ("aGvHD") that occurs in patients undergoing bone marrow transplant, which will be the focus of the RATinG study that is expected to enroll its first patient in 3Q22. These studies are majority funded by our clinical partners.

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As part of this realignment, Humanigen expects to significantly reduce its go-forward, cash-based operating expenses including elimination of ongoing lenzilumab manufacturing, significant reduction in other R&D costs, and some reduction in general and administrative expenses through headcount reduction as well as other initiatives.

Key elements of the strategic realignment plan include:

·Advancing and expanding the ongoing PREACH-M study of lenzilumab for the treatment of high-risk chronic myelomonocytic leukemia ("CMML") in patients with NRAS, KRAS, and CBL genetic mutations to more rapidly reach the initial clinical assessment of this open-label study once sufficient patients have received three cycles of treatment with lenzilumab in addition to azacitidine. Three patients have been enrolled in the study and followed for multiple cycles, all with encouraging results.

oThe current standard of care for CMML are hypomethylating agents such azacitidine and decitabine, which historically have a complete response rate of 11%-22% according to the International Working Group Criteria.1,2,3

oAustralian clinical partners plan to open additional sites in Australia and may also expand the study to centers in New Zealand.

oHumanigen plans to support expansion of the study to U.S. sites and has received approval from the Principal Investigator to share the protocol and provide monitoring to those additional sites.

The incidence of CMML in the US, UK, and Australia is about 1,700 patients annually.4 As a rare disease, lenzilumab may qualify for certain regulatory and commercial advantages that may accelerate development and approval. Humanigen and the Principal Investigator are assessing regulatory pathways that may enable early results to support a regulatory submission and potential approval by the Therapeutic Goods Administration in Australia, which could be expanded through Project Orbis to the United States and the United Kingdom.

There have been no new therapeutic agents for patients with high-risk CMML in 30 years5 and independent publications have demonstrated the key role of GM-CSF and RAS pathway mutations in this and other cancers, including juvenile myelomonocytic leukemia ("JMML"), myelodysplastic syndromes, myeloproliferative neoplasms, and acute myeloid leukemia.6,7,8

oA clinical protocol is also being developed for JMML with NRAS, KRAS, PTPN11 and/or NF1 genetic mutations

·Continuing to execute the RATinG study for lenzilumab for the early treatment of aGvHD with the goal of reporting a planned interim assessment of the first 20 patients in 2Q23

oThe study is being run and funded primarily by the IMPACT partnership; a group of transplant centers located in the UK.

oLenzilumab will be administered to patients that are identified as having markers for high-risk steroid refractory aGvHD, a population known to have four-fold higher mortality than those identified as low-risk using the same biomarkers.9

·Identifying and supporting further clinical assessment of lenzilumab for prevention of CAR-T therapy related toxicities through an investigator-initiated trial

oPhase 1 ZUMA-19 study completed and target dose defined for further study.

oHumanigen to provide lenzilumab to investigators free of charge to support investigator-initiated trials.

·Seeking potential inclusion of lenzilumab in international, large-scale COVID-19 platform studies through partnerships

·Planning to continue the development of ifabotuzumab, an EphA-3 targeted monoclonal antibody currently in phase 1 development, as part of an antibody drug conjugate, for certain solid tumors.

·Eliminating long-term debt on the balance sheet by fully retiring the Company’s senior secured term loan, reducing interest expense, and enhancing our ability to generate additional liquidity from our intellectual property by freeing it from the loan’s collateral requirements

"We remain committed to advancing the scientific effort to prove the clinical benefits of neutralizing GM-CSF in life-threatening conditions for patients and have had to take difficult though necessary measures to do so," said Cameron Durrant, Chairman and CEO, Humanigen. "Sharpening our in-house pipeline focus and partnering other resource-intensive programs may enable Humanigen and its clinical partners to rapidly derive important data in these indications. Our CMML, aGvHD programs are already primarily funded by partners and we hope to utilize a similar approach with our other programs, reducing our cash-based R&D expenses. We believe this strategic plan offers an opportunity to return value to our stockholders while providing hope to patients with serious and life-threatening conditions for improved outcomes."

On July 26, 2022 Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, reported that it has entered into a collaboration and exclusive license agreement with MSD (the tradename of Merck & Co., Inc Rahway NJ USA), to develop an investigational antibody drug conjugate (ADC) for the treatment of solid tumors (Press release, Merck & Co, JUL 26, 2022, View Source [SID1234616940]).

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Under the terms of the agreement, Kelun-Biotech has granted MSD global, exclusive rights to develop, manufacture and commercialize an investigational ADC. Kelun-Biotech and MSD will also collaborate on the early clinical development of the investigational ADC. In return, Kelun-Biotech will receive an upfront payment of $35mm and is eligible to receive future development, approval and commercial milestone payments totaling up to $901mm, plus tiered royalties on net sales.

This latest transaction follows MSD’s decision earlier this year to exercise an option for worldwide rights, except for the Greater China region (including Mainland China, Hong Kong, Macau, and Taiwan), to SKB-264, an investigational TROP2 targeting ADC. SKB-264 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic triple-negative breast cancer and in Phase 2 trials for non-small cell lung cancer and advanced solid tumors. Kelun-Biotech and MSD will collaborate on certain early clinical development plans, including evaluating the potential of SKB-264 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) for advanced solid tumors.

"These collaborations with MSD underscore the sophistication and capabilities of Kelun-Biotech’s ADC platform and the potential of our ADC therapeutics," said Dr. Junyou Ge, Chief Executive Officer of Kelun-Biotech. "Incorporating MSD’s deep and broad global expertise with Kelun-Biotech’s innovation power has the potential to generate great development synergy, significantly accelerating the development and commercialization of the collaboration programs. These collaborations will also strengthen our strategic position in building a global, innovative, fully-integrated biopharmaceutical company."

"The collaboration with Kelun-Biotech strengthens and diversifies MSD’s oncology pipeline as we seek to further the potential of ADCs to provide more treatment options and improve outcomes for people with cancer," commented Dr. Eric H. Rubin, senior vice president, oncology early development, MSD Research Laboratories. "We look forward to advancing this collaboration with the Kelun-Biotech team."