On July 29, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended June 30, 2022 (Press release, ImmunoGen, JUL 29, 2022, View Source [SID1234617125]).

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"With the BLA for MIRV accepted and receiving Priority Review designation from FDA, we have taken a significant step closer to bringing this important new therapy to ovarian cancer patients this year," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer, "We are pleased with the positive reception our data received at ASCO (Free ASCO Whitepaper) and are focused on building our commercial and medical infrastructure to support a successful launch to establish MIRV as the new standard of care for patients with folate receptor alpha positive disease."

Enyedy continued, "We have also completed accrual in MIRASOL and expect to report data from this confirmatory study early next year. In support of moving MIRV into broader patient populations, we are expanding our development program and are in the process of initiating the GLORIOSA and Trial 0420 studies. Turning to our second pivotal program, PVEK, we expect to report preliminary efficacy data from our pivotal CADENZA study in BPDCN this year and plan to present initial data from our triplet expansion cohort in AML at ASH (Free ASH Whitepaper). We have had a productive first half of the year, and with key regulatory and clinical milestones anticipated before year-end, we are well positioned to create meaningful value for both patients and shareholders."

RECENT PROGRESS

Announced that the U.S. Food and Drug Administration (FDA) accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with one to three prior systemic treatments with Priority Review designation.
Completed enrollment in the confirmatory MIRASOL study.
Presented additional efficacy data from the pivotal SORAYA study and an integrated safety summary of single-agent mirvetuximab across multiple studies enrolling almost 500 patients with FRα-positive recurrent ovarian cancer at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Advanced accrual in PICCOLO, a single-arm study of mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive ovarian cancer.
Supported investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Progressed the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Continued enrollment in expansion cohorts in the Phase 1b/2 study evaluating pivekimab, Vidaza (azacitidine), and Venclexta (venetoclax) in both R/R and frontline unfit acute myeloid leukemia (AML) patients.
Advanced dose escalation and opened additional sites in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed the generation of supplemental chemistry, manufacturing, and controls (CMC) information for submission to the FDA to support the investigational new drug (IND) application for IMGN151.
Announced a multi-year collaboration to research novel, first-in-class ADCs with Oxford BioTherapeutics (OBT) utilizing ImmunoGen’s proprietary linker-payload technology directed to novel targets identified via OBT’s proprietary OGAP discovery platform.
ANTICIPATED UPCOMING EVENTS

Potential FDA approval of mirvetuximab as a monotherapy in patients with FRα-high platinum-resistant ovarian cancer by the Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.
Generate top-line data for MIRASOL in early 2023.
Enroll the first patients in two combination studies for mirvetuximab in platinum-sensitive ovarian cancer: Trial 0420, a single-arm Phase 2 trial of mirvetuximab in combination with carboplatin followed by mirvetuximab continuation in FRα-low, medium, and high patients; and GLORIOSA, a randomized Phase 3 trial of mirvetuximab in combination with bevacizumab maintenance in FRα-high recurrent second-line platinum-sensitive ovarian cancer.
Present additional data from the mirvetuximab program at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and the 2022 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS) in September.
Report preliminary efficacy data from the pivotal CADENZA study of pivekimab in BPDCN before year-end.
Present pivekimab efficacy data for genetic sub-types of AML at the Society of Hematologic Oncology (SOHO) in September, and initial data from frontline and R/R AML expansion cohorts combining pivekimab, azacitidine, and venetoclax at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated before year-end.
Begin enrollment in the Phase 1 study of IMGN151 following the submission of supplemental CMC information to the FDA.
FINANCIAL RESULTS
Total revenues were $14.2 million for the quarter ended June 30, 2022 compared to $16.9 million for the quarter ended June 30, 2021. The decrease was driven by lower non-cash royalty revenue due to the completion of the first tranche of payments under the 2015 KADCYLA royalty agreement in the second quarter of 2021, partially offset by greater license and milestone fee revenue driven by the recognition of $6.9 million of fees previously received and deferred pursuant to the Company’s collaboration agreement with Huadong Medicine.

Operating expenses for the quarter ended June 30, 2022 were $75.2 million, compared with $44.3 million for the same quarter in 2021. Research and development expenses rose to $51.4 million for the quarter ended June 30, 2022 compared to $34.6 million for the quarter ended June 30, 2021, driven by increases in clinical trial costs, personnel and temporary staffing costs, and research expenses to further build our ADC pipeline, which includes a $7.5 million upfront fee paid to Oxford BioTherapeutics. Selling, general and administrative expenses increased to $23.8 million for the quarter ended June 30, 2022 compared to $9.7 million for the quarter ended June 30, 2021, due primarily to building commercial capabilities, including the hiring of personnel, in anticipation of a potential U.S. launch of mirvetuximab in the fourth quarter of 2022.

Net loss for the second quarter of 2022 was $62.0 million, or $0.24 per basic and diluted share, compared to a net loss of $30.7 million, or $0.15 per basic and diluted share, for the second quarter of 2021. Weighted average shares outstanding increased to 253.3 million for the 2022 period from 199.9 million in the prior year.

ImmunoGen had $373.9 million in cash and cash equivalents as of June 30, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $105.4 million for the first six months of 2022, compared with cash used in operations of $88.5 million for the same period in 2021, with the current period benefiting from a $13.0 million upfront license payment received from Lilly. Capital expenditures were $0.5 million and $0.9 million for the first six months of 2022 and 2021, respectively.

FINANCIAL GUIDANCE
ImmunoGen’s financial guidance for 2022 remains unchanged; the Company continues to expect:

revenues between $75 million and $85 million;
operating expenses between $285 million and $295 million; and
cash and cash equivalents at December 31, 2022 to be between $245 million and $255 million.
Given the range in timing for potential approval, revenue guidance does not reflect potential product sales from mirvetuximab.

ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.

CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

On July 29, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its Quarterly Activities Report and Appendix 4C for the period ended 30 June 2022 (Press release, Starpharma, JUL 29, 2022, View Source;mc_eid=bf52dd3418 [SID1234617144])

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Starpharma’s closing cash balance as at 30 June 2022 was $49.9 million. The net cash burn for the financial year was $10.6 million. Receipts from customers and grants for FY22 totaled $13.0 million, including receipts from customers of $4.8 million (FY21: $2.4 million).

Commenting on the quarter, Dr Jackie Fairley, Starpharma CEO, said:

"Starpharma continues to attract and deepen our partnerships with industry leading pharma companies, reaffirming the broad applicability of our DEP technology which has the potential to be applied to a vast number of therapeutic products under multiple, independent commercial agreements. During the quarter, existing DEP partner AstraZeneca, expanded the clinical program for their DEP product, AZD0466. This expanded program includes an additional indication (non-Hodgkin’s lymphoma) as well as a significant increase in the number of recruitment sites globally to accelerate patient enrolment in the planned expansion phase of the ongoing leukemia trial. In parallel, our three clinical stage DEP products and our preclinical candidates have continued to make good progress.

"Marking an important milestone, VIRALEZE was relaunched this quarter in the UK through our commercial partner, LloydsPharmacy, with promotional activities underway. We were delighted to also report new results from our collaboration with The Scripps Research Institute, demonstrating the highly protective effects of VIRALEZE against the Omicron variant of SARS-CoV-2 in an in vivo viral challenge model. Importantly, these findings showed that VIRALEZE could provide significant benefit when used either before and after exposure to virus, or when used only after exposure to virus. VIRALEZE is now registered in over 30 countries and available in pharmacies, retail outlets and online."

Partnered DEP Programs

Starpharma recently signed an expanded DEP Research Agreement with Genentech. During the quarter, Starpharma has commenced work on this new program, which involves the design and synthesis of DEP dendrimer conjugates incorporating a Genentech proprietary molecule.

Under Starpharma’s DEP licence with AstraZeneca, the international clinical program for AZD0466 continued to advance with multiple new sites opening and commencement of a new clinical trial in an additional indication – non-Hodgkin’s lymphoma (NHL), one of the most commonly occurring cancers. The new NHL Phase 1/2 trial of AZD0466 is now recruiting at sites in the US and Korea. AstraZeneca plans to further expand recruitment for this trial, with more than 20 additional sites expected to open across the US, Canada, Europe, Australia, and Asia.

In the Phase 1/2 leukemia trial of AZD0466 in patients with advanced haematological malignancies additional sites were also opened. This trial is now recruiting at sites in the US, Australia, Italy, Germany, and Korea.

A further new DEP agreement with a leading pharmaceutical company is well advanced. Active commercial discussions continue in other areas including DEP radiopharmaceuticals.

Internal DEP Programs

Starpharma’s Phase 2 clinical trial of DEP cabazitaxel continues to recruit well with 68 patients enrolled to date, including a number of advanced refractory ovarian cancer and gastro-oesophageal cancer patients. Patients in this trial continue to show encouraging efficacy signals, including prolonged stable disease, significant tumour shrinkage, and reductions in tumour markers.

DEP cabazitaxel has been selected for a poster presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in early September. The poster will focus on a summary of the clinical data on DEP cabazitaxel in prostate cancer. ESMO (Free ESMO Whitepaper) is considered one of the largest international oncology conferences and is attended by clinicians, researchers, and healthcare industry representatives from all over the world, representing an excellent platform for presenting these results.

The DEP irinotecan Phase 2 clinical trial continues to progress well, with 82 patients now enrolled. Efficacy signals such as prolonged tumour shrinkage and reductions in tumour markers have been observed in multiple tumour types, including colorectal, breast, ovarian, pancreatic, lung, and oesophageal cancers. Starpharma is finalising preparations for the commencement of a combination arm for DEP irinotecan in combination with 5-FU + Leucovorin (‘FOLFIRI’, a commonly used combination treatment regimen in colorectal cancer) to run in parallel with the ongoing monotherapy study. The combination arm is expected to commence shortly at sites in the UK and Australia.

The clinical program for DEP docetaxel has enrolled 71 patients across the monotherapy and combination arms, with additional patients in screening. Encouraging efficacy signals such as prolonged stable disease and significant tumour shrinkage have been observed in heavily pre-treated patients with lung, pancreatic, oesophageal, cholangiocarcinoma and gastric cancers.

Manufacture of DEP gemcitabine product is now complete in readiness for Starpharma to commence a Phase 1/2 clinical trial, with planned clinical trial sites in the UK and Australia. Preparations for trial commencement are well advanced, with the clinical research organisation (CRO) and site selection processes, regulatory and ethics preparations nearing completion.

In parallel with progressing these clinical candidates, Starpharma continues to undertake discussions with potential licensing partners. Starpharma continues to deepen its pipeline of DEP assets by actively progressing a number of its own internal programs in areas including DEP radiotheranostics and DEP antibody drug conjugates (ADCs).

Marketed Products

During the quarter, VIRALEZE nasal spray was relaunched in the UK through LloydsPharmacy, with a number of promotional activities underway. LloydsPharmacy is one of the largest pharmacy groups in the UK with ~1400 stores, and its affiliated wholesale arm AAH, is also one of the largest pharmaceutical wholesalers in the UK, supplying over 14,000 independent pharmacies.

VIRALEZE recently demonstrated excellent protection against infection with the highly transmissible SARS-CoV-2 Omicron variant in a stringent in vivo viral challenge model. The findings are important because they indicate, even when VIRALEZE is only used after exposure to virus (e.g., if you forget to use the spray before exposure to a high-risk situation), it has potential to provide significant benefit.

The broad-spectrum activity of VIRALEZE was further highlighted with impressive results for SPL7013, in VIRALEZE, against influenza A and B. SPL7013 achieved more than 90% reduction in viral infectivity of both influenza A and B viruses within one minute. These influenza viruses are responsible for seasonal epidemics of influenza, with influenza A being known to cause flu pandemics. SPL7013 also demonstrated irreversible virucidal properties against both types of influenza virus. In addition, testing at Scripps Research assessed the activity of two antiviral agents used in marketed nasal sprays – hydroxypropyl methyl cellulose (HPMC) and iota-carrageenan. In contrast to the potent and rapid effect of SPL7013, seen within one minute, HPMC and iota-carrageenan did not exhibit virucidal effect in this experiment, even after 30 minutes.

VIRALEZE is registered in more than 30 countries and is available in pharmacies, retail outlets and online in a number of countries. Starpharma continues to pursue registration and commercialisation for VIRALEZE in multiple other countries, with active commercial discussions underway. In Australia, the review by the TGA for the nasal spray application as a medical device is ongoing.

Regulatory approvals for VivaGel BV were achieved in Bahrain and Qatar and pre-launch marketing activities have commenced. Starpharma’s marketing partner, Mundipharma is also progressing further launches of VivaGel BV in Asia as well as undertaking joint regulatory activities across a number of countries.

Other Business Development Activities

In an endorsement of interest in Starpharma’s DEP technology, the company was invited to present DEP at the Novel Format Conjugates Summit, an industry conference focusing on next generation non-traditional ADCs, which took place in Boston in April. The conference participants included senior representatives from AstraZeneca, Merck, and Sanofi. An abridged version of Starpharma’s presentation is available on our website.

During the quarter, Starpharma also participated in major industry conferences, including American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and BIO International. The company also met with a number of existing DEP partners and potential new partners during these meetings.

Cash Flows

Starpharma’s closing cash balance as at 30 June 2022 was $49.9 million. Receipts from customers and grants for FY22 totaled $13.0 million, including receipts from customers of $4.8 million (FY21: $2.4 million) and total grants of $8.2 million, including $7.7 million R&D tax incentive.

During the quarter, Starpharma continued to invest in research and development (R&D) for its three clinical stage DEP programs as well as a number of preclinical programs, including in DEP antibody drug conjugates and DEP radiotheranostics. Net operating cash outflows for the quarter were $4.9 million, including R&D outflows of $2.2 million and product manufacturing and operating costs of $1.2 million for VIRALEZE, VivaGel BV and key raw material inventory. Staffing costs of $2.0 million include non-executive and executive directors’ fees of $258,000. Other related party transactions required for disclosure were $3,479 for consulting services.

On July 29, 2022 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease (SCD), prostate cancer and other rare hematologic diseases and cancers, reported that it will release second quarter 2022 financial results Friday, August 5, 2022 (Press release, Forma Therapeutics, JUL 29, 2022, View Source [SID1234617146]). Forma management will host an investment community conference call at 8 a.m. Eastern Daylight Time (EDT) on August 5, 2022 to discuss these financial results and provide a business update.

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Investors may participate in the call by using the registration link here. Once registered, participants will receive a dial-in number as well as a PIN to enter the event. A live webcast of the conference call will be available in the "News & Investors" section of Forma’s website at www.formatherapeutics.com.

On July 29, 2022 Nippon Kayaku reported that (Press release, Nippon Kayaku, JUL 29, 2022, View Source [SID1234617328])

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1. Consolidated Business Results for the First Quarter of Fiscal Year Ending March 31, 2023 (April 1, 2022– June 30, 2022) (Figures shown are rounded down to the nearest million yen.)
(1) Consolidated Operating Results
(2) Consolidated Financial Position

2. Status of Dividends

3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2023 (April 1, 2022– March 31, 2023)

1. Qualitative Information Concerning Results for the First Quarter
(1) Analysis of Operating Results During the first quarter of this consolidated fiscal year (April 1 to June 30, 2022), the global economy saw a return to normalcy from the COVID-19 pandemic, mainly in Europe and the U.S. However, the sense of uncertainty increased even more as a result of the zero COVID policy in China, the Russian invasion of Ukraine, and increasing global inflation caused by high fuel and raw material prices.

The Nippon Kayaku Group launched KAYAKU Vision 2025, the new mid-term business plan beginning this fiscal year, amid such conditions. We are working to implement the roadmap to the vision specified for each business while advancing initiatives to address key company-wide issues aimed at achieving the vision. As a result, net sales for the first quarter of this consolidated fiscal year totaled 48,296 million yen, an increase of 1,849 million yen (4.0%) year-on-year. Sales in the pharmaceuticals and other businesses underperformed while the functional chemicals and safety systems businesses outperformed the first quarter of the previous fiscal year. Operating income totaled 6,380 million yen, an increase of 493 million yen (8.4%) year-on-year. Ordinary income totaled 8,634 million yen, an increase of 2,285 million yen (36.0%) year-on-year.

Profit attributable to owners of parent was 5,957 million yen, an increase of 691 million yen (13.1%) year-on-year. The figures in the provisional accounting for a business combination in the second quarter of the previous consolidated fiscal year have been confirmed. The content confirmed in the provisional accounting is reflected in the figures for the first quarter of the previous consolidated fiscal yearPerformance by business segment is as described below. [Functional Chemicals Business] Sales rose to 21,117 million yen, an increase of 1,027 million yen (5.1%) year-on-year. The functional materials business as a whole outperformed the first quarter of the previous fiscal year. The outperformance resulted from strong sales of semiconductor materials such as epoxy resins, MEMS, and other resin composites.

These materials are used in high-speed (5G) communication devices and IoT, which are proliferating, and IT equipment, where demand increased due to increasingly sophisticated electronic equipment in vehicles. The color materials business as a whole outperformed the first quarter of the previous fiscal year. This outperformance resulted from strong sales of colorants for inkjet printers for consumer use, which more than compensated for the underperformance of colorants for inkjet printers in industrial applications compared to the first quarter of the previous fiscal year. The catalyst business underperformed the first quarter of the previous fiscal year despite strong orders both in Japan and exports overseas. The underperformance resulted from delays in freight reaching customer plants due to the lock-downs and logistics chaos that accompanied China’s zero COVID policy. In the Polatechno business, demand for dye-type polarizing films declined due to a shortage of semiconductors at customer plants.

This decline exceeded the strong sales of components for X-ray analysis systems and resulted in underperformance of the Polatechno business as a whole, compared with the first quarter of the previous fiscal year. Segment profit totaled 3,760 million yen, an increase of 361 million yen (10.6%) year-on-year. This increase resulted from growth in sales in the functional materials and color materials businesses.

On July 29, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that it will release its second quarter 2022 financial results on Tuesday, August 2, 2022 after the markets close (Press release, Lexicon Pharmaceuticals, JUL 29, 2022, View Source [SID1234617127]). Management will conduct a conference call and live webcast at 5:00 p.m. ET / 4:00 p.m. CT that day to discuss its financial and operating results and to provide a general business update.

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The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.