On October 29, 2021 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug development company, reported an update on the ongoing development of its product candidates for the quarter ending 30 September 2021 (Press release, Kazia Therapeutics, OCT 29, 2021, View Source [SID1234592183]).

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Key Points

GBM AGILE study continues to make good progress, with activation of Canada expected in 4Q CY2021, and activation of Europe and China expected in CY2022.

EVT801 phase I study remains on track to commence recruitment by end of CY2021. Regulatory approval has been received from the French competent authority.

Final data from paxalisib phase II study in glioblastoma expected during 4Q CY2021.

Kazia CEO, Dr James Garner, commented, "We have continued to make good progress on all fronts during the third quarter. The last few months have been characterized by a focus on operational matters. As we move towards the end of CY2021, we expect to report a number of important data read-outs, and to commence recruitment to the phase I study of EVT801. Delivery of these milestones will neatly conclude a tremendously productive year for the company."

Good Progress in GBM AGILE Pivotal Study

Kazia previously provided an update on progress with the GBM AGILE pivotal study (NCT03970447) in June 2021. Since then, the study has continued to progress well, with almost thirty hospitals in the United States now recruiting to the paxalisib arm. The study is expected to open to the paxalisib arm in Canada during 4Q CY2021, and in Europe and China next year. The respective regulatory submissions in Europe and China have been submitted and are undergoing review by regulatory agencies.

Kazia has brought forward manufacture of an additional batch of paxalisib investigational product, and this is expected to become available for use in the study in 1Q CY2022.

EVT801 Phase I Study on Track to Commence in 4Q CY2021

On 2 September 2021, Kazia announced that the phase I study of EVT801 had received regulatory approval from L’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French regulatory agency. The study has since also received approval from the Committee for the Protection of Persons (CPP), which serves as a centralised ethics committee for both of the participating sites. Commencement of recruitment to the study is expected by the end of CY2021.

A team of Evotec scientists who led the early development of EVT801 have been working to compile their research into a scientific paper, which is expected to be submitted for publication in a peer-reviewed academic journal during 4Q CY2021.

Multiple Data Read-Outs from Paxalisib Program

The phase II study of paxalisib (NCT03522298) is moving towards completion, and Kazia expects to share top-line final data during 4Q CY2021, as previously indicated. In addition, the company expects to receive initial data from several ongoing investigator-initiated studies and will provide this to investors as soon as it is available.

Completion of Human ADME Study

Kazia indicated in its Appendix 4C for the June quarter that it had initiated a human ADME (absorption, distribution, metabolism, elimination) study to satisfy certain standard regulatory requirements for approval of a new pharmaceutical product (NCT05012670). This study has completed the in-life phase, and all results appear to lie within expected parameters. The company expects to conclude analysis of the study early in CY2022 and to share results with FDA shortly thereafter.

Impact of COVID-19

The company has no revisions to its prior guidance concerning COVID-19. At present, there is limited operational impact, but Kazia continues to monitor the situation closely.

Financial Update

As noted in the accompanying Appendix 4C, the company’s cash position as at 30 September 2021 was AU$ 19.6 million, versus AU$ 27.6 million at 30 June 2021. The company calculates our cash position will finance operations on a forward-looking basis through to 4Q CY2022.

On October 29, 2021 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 September 30, 2021 (Press release, ImmunoGen, OCT 29, 2021, View Source [SID1234592182]).

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"We look forward to announcing top-line data from our pivotal SORAYA trial this quarter, including data on the primary endpoint of overall response rate and key secondary endpoint of duration of response. With positive data, we will move quickly to complete the BLA, with the goal of submitting the filing in the first quarter of 2022," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In addition to SORAYA, we continue to advance a broad program to establish mirvetuximab as the standard of care for patients with FRα-positive ovarian cancer. Our confirmatory MIRASOL trial is enrolling at over 160 sites in 18 countries in North America, Europe, Asia, and Australia, and we have initiated the PICCOLO trial, which could support label expansion in recurrent platinum-sensitive ovarian cancer. Beyond mirvetuximab monotherapy, the first patients have been enrolled in the large investigator-sponsored studies evaluating mirvetuximab combined with carboplatin in both the neoadjuvant and recurrent platinum-sensitive settings to support our objective of making mirvetuximab the combination agent of choice in ovarian cancer, and we look forward to sharing our label-enabling combination strategy early next year."

Enyedy continued, "In addition, our IMGN632, IMGC936, and IMGN151 programs are advancing as planned. We anticipate presenting data on IMGN632 in AML at ASH (Free ASH Whitepaper) in December, have escalated dosing in multiple solid tumors with our ADAM-9 targeting ADC, IMGC936, and expect to file the IND for IMGN151, our next-generation FRα-targeting ADC, by year-end. As we close out 2021, we remain focused on execution and look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for commercial launch next year."

RECENT PROGRESS

Further enrolled patients in the confirmatory MIRASOL study for mirvetuximab.
Initiated PICCOLO, a single-arm study of mirvetuximab monotherapy in high folate receptor alpha (FRα) recurrent platinum-sensitive ovarian cancer.
Enrolled the first patients in the 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.
Advanced accrual in the pivotal 801 Phase 2 study, now known as CADENZA, of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza (azacitidine) and Venclexta (venetoclax) in R/R acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
Escalated dosing in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed activities to support an investigational new drug (IND) application for IMGN151.
Appointed Helen M. Thackray, MD, to the Board of Directors.
ANTICIPATED UPCOMING EVENTS

Release top-line data from the pivotal SORAYA study this quarter, with the goal of submitting the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Submit the IND application for IMGN151 by the end of 2021.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in 2022.
Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022.
FINANCIAL RESULTS

Revenues for the quarter ended September 30, 2021 were $9.2 million, compared with $18.2 million for the quarter ended September 30, 2020. This decrease was driven by a reduction in non-cash royalty revenue due to the completion of the first tranche of payments under the 2015 transaction covering the sale of Kadcyla royalties. Revenues for the quarter ended September 30, 2021 also included recognition of an anticipated $2.5 million partner development milestone fee.

Operating expenses for the third quarter of 2021 were $43.4 million, compared with $34.9 million for the same quarter in 2020. Research and development expenses rose to $33.1 million for the third quarter of 2021, compared with $24.7 million for the third quarter of 2020, driven by increases in clinical trial expenses, personnel and temporary staffing costs, and third-party service fees in support of commercial readiness. General and administrative expenses were essentially flat at $10.3 million and $10.2 million for the third quarters of 2021 and 2020, respectively.

Net loss for the third quarter of 2021 was $37.3 million, or $0.18 per basic and diluted share, compared to a net loss of $22.4 million, or $0.13 per basic and diluted share, for the third quarter of 2020. Weighted average shares outstanding increased to 204.8 million for the 2021 period from 174.5 million in the prior year.

ImmunoGen had $245.8 million in cash and cash equivalents as of September 30, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding as of December 31, 2020. There was no convertible debt outstanding as of September 30, 2021. Cash used in operations was $123.5 million for the first nine months of 2021, compared with cash used in operations of $87.2 million for the same period in 2020. Capital expenditures were $(1.1) million for the first nine months of 2021, compared with net proceeds from the sale of equipment of $0.6 million for the first nine months of 2020.

During the quarter ended September 30, 2021, the Company sold 2.2 million shares of its common stock through its At-the-Market (ATM) facility, generating gross proceeds to the Company of approximately $13 million. In August 2021, the Company entered into a Securities Purchase Agreement pursuant to which the Company agreed to sell to an investor a warrant to purchase up to an aggregate of 5,434,782 shares of the Company’s common stock for a nominal value, generating additional gross proceeds of approximately $30 million.

FINANCIAL GUIDANCE

ImmunoGen has updated its financial guidance for 2021 and now expects:

revenues between $65 million and $75 million;
operating expenses between $190 million and $200 million; and
cash and cash equivalents at December 31, 2021 to be between $190 million and $200 million.
ImmunoGen expects that its current cash will fund operations into the fourth quarter of 2022.

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, dial (877) 621-5803; the conference ID is 1587202. 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 October 29, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the quarter and the half year ended September 30, 2021 (Press release, Dr Reddy’s, OCT 29, 2021, View Source [SID1234592180]).

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The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS). COVID portfolio We continue to play our role in the fight against Covid-19 by acting proactively to bring multiple preventive and curative treatment options, including a vaccine. Our major Covid-19 products launched till now include Sputnik V vaccine, Remdesivir, Avigan (Favipiravir) and 2-deoxy-D-glucose (2-DG). We have commercialized all these products in India and some of these products in overseas markets.

Currently, we are conducting clinical trials for Sputnik Light, Molnupiravir and are also developing several other covid drugs for treatment ranging from mild to severe conditions. Revenue Analysis Global Generics (GG) Revenues from GG segment at Rs. 47.4 billion:

 Year-on-year growth of 19% and sequential quarter growth of 15% was driven by covid portfolio, new product launches and base business volume traction across key markets. However, this was offset partly by price erosion in some of our products. North America Revenues from North America at Rs. 18.9 billion:
 Year-on-year growth of 3% and sequential quarter growth of 9%, driven by launch and scale up of new products and increase in volumes of certain of our existing products, which was offset by price erosion in some molecules. 

During this quarter, we launched 4 new products. These were Chlordiazepoxide Hydrochloride + Clidinium Bromide Capsules in the US and Lenalidomide capsules, Ertapenem injection and Dasatinib tablets in Canada.  We filed two new ANDAs during the quarter. As of 30th September 2021, cumulatively 93 generic filings are pending for approval with the USFDA (90 ANDAs and 3 NDAs under 505(b)(2) route). Out of these 93 pending filings, 46 are Para IVs and we believe 23 have ‘First to File’ status. Europe Revenues from Europe at Rs. 4.1 billion. Year-on-year growth of 10% and sequential quarter growth of 4% was primarily on account of volume traction in base business and new product launches across our markets, which was partially offset by price erosion. India Revenues from India at Rs. 11.4 billion:

 Year-on-year growth of 25% and sequential quarter growth of 8% was primarily driven by increase in sales volumes of our existing products, including from our Covid portfolio, contribution from new product launches and increase in sales price of our existing products.
 We launched two new products during the quarter. These were Melotryp and Baricax. 5 Emerging Markets Revenues from Emerging Markets at Rs. 13.0 billion. Year-on-year growth of 50% and sequential quarter growth of 42%:  Revenues for Russia at Rs. 5.7 billion. Year-on-year growth of 44% and sequential quarter growth of 63% was on account of increase in volumes and sales prices in our existing products and new products launches. We have launched biosimilar bevacizumab in Russia during the quarter.
 Revenues from other CIS countries and Romania at Rs. 2.2 billion. Year-on-year growth of 9% and sequential quarter growth of 51% was driven by primarily by new product launches. While sequential quarter growth was supported by increase in sales volumes and prices of certain of our existing products, year-on-year growth was offset partly on account of reduction in volumes and price erosion in some of our existing products.

 Revenues from Rest of World (RoW) territories at Rs. 5.1 billion. Year-on-year growth of 90% and sequential growth of 22% was driven by covid portfolio, new products and volume traction in our base business, partially offset by a reduction in sales price of some of our products. Pharmaceutical Services and Active Ingredients (PSAI) Revenues from PSAI at Rs. 8.4 billion with a year-on-year decline of 2% and sequential quarter growth of 11%.  While there has been growth from covid portfolio, there was a decline in some of our other products due to lower traction in the volumes and further there has been decrease in sales price for some of our products.

 During the quarter we filed two DMFs in the US. Proprietary Products (PP) & Others Revenues from PP & Others at Rs. 1.8 billion. Year-on-year growth of 195% and sequential quarter growth of 238% was primarily on account of recognition of a license fee associated with the sale of our U.S. and Canada territory rights for ELYXYB (celecoxib oral solution) 25 mg/ml, to BioDelivery Sciences International, Inc.Income Statement Highlights:  Gross profit margin for the quarter at 53.4%:-Decreased by ~50 bps over previous year majorly on account of price erosion and lower export benefits partially offset by leverage benefit on manufacturing overheads.-Increased by ~120 bps sequentially, driven majorly by leverage benefit on manufacturing overheads partially offset by price erosion.-Gross profit margin for GG and PSAI business segments are at 56.9% and 25.9% respectively.

 Selling, general & administrative (SG&A) expenses at Rs. 16.0 billion, increased by 22% on a yearon-year basis and by 6% sequentially. This increase was in line with the business growth and primarily attributable to royalty on sales, annual increments, investments in sales & marketing of our key brands and investments in digitalization.  Research & development (R&D) expenses at Rs. 4.5 billion. As % to revenues – Q2 FY22: 7.7% | Q1 FY22: 9.2% | Q2 FY21: 8.9%. We continue our focus on investing in R&D to build a healthy pipeline of new products across our markets including development of products in our biosimilars and generics businesses.

 Other operating income at Rs. 1.7 billion compared to Rs. 149 million in Q2 FY21. The increase was on account of recognition of income towards sale of all of our rights relating to our anti-cancer agent E7777 (denileukin diftitox) to Citius Pharmaceuticals, Inc.  Net Finance income at Rs. 319 million compared to Rs. 237 million in Q2 FY21.  Profit before Tax at Rs. 12.7 billion, increased by 47% year-on-year and by 71% sequentially.  Profit after Tax at Rs. 9.9 billion. The effective tax rate is 21.8% for the quarter.  Diluted earnings per share is at Rs. 59.65. Other Highlights:  EBITDA is at Rs. 15.6 billion and the EBITDA margin is 27.0%.  Capital expenditure is at Rs. 3.6 billion.  Free cash flow is at Rs. 830 million.  Net debt for the company is at Rs. 2.7 billion as on September 30, 2021

. Consequently, net debt to equity ratio is 0.015. 7 Earnings Call Details (05:30 pm IST, 08:00 am EDT, Oct 29, 2021) The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

On October 29, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that its third quarter 2021 financial results will be released after market close on Monday, November 8, 2021 (Press release, Coherus Biosciences, OCT 29, 2021, View Source [SID1234592179]). Starting at 5 p.m. ET, Coherus’ management team will host a conference call and webcast to discuss financial results and provide a general business update.

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After releasing third quarter financial results, the Company will post them on the Coherus website at View Source

Conference Call Information

Webcast: View Source

Please dial-in 15 minutes early to ensure a timely connection to the call.

On October 29, 2021 Alphamab Oncology (stock code: 9966.HK) reported, a pivotal clinical study of PD-L1/CTLA-4 bispecific antibody KN046 in China (ENREACH-LUNG-02) recently completed the first drug administration (Press release, Alphamab, OCT 29, 2021, View Source [SID1234592178]).

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ENREACH-LUNG-02 is a multi-center, open-label, randomized-controlled phase II/III clinical study. Phase III study is planned to be carried out in about 50 research centers, recruiting about 486 patients, with OS and PFS as co-primary endpoints. To evaluate the efficacy of KN046 combined with lenvatinib versus docetaxel in patients with advanced NSCLC who have progressed on anti-PD-(L)1 treatment.

The principal investigator Professor Caicun Zhou, Director of the Department of Oncology from Shanghai Pulmonary Hospital Affiliated to Tongji University, commented, "In recent years, major progress has been made in lung cancer treatment, especially immunotherapies have brought significant clinical benefits to patients. However, there is still no effective option for PD-(L)1 refractory NSCLC patients. Through ENREACH-LUNG-02 study, we look forward to bringing new treatment options to these patients with huge unmet needs."

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism CTLA-4 domain fused with a PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg（suppress tumor immunity） clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown promising data in terms of survival for patients. Alphamab Oncology has received FDA clearance to enter later stage trials of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.