On May 3, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that it has determined its first two indications in non-small cell lung cancer (NSCLC) in which to pursue Phase III clinical trials for its innovative, potential first-in-class bispecific antibody, ivonescimab (Press release, Summit Therapeutics, MAY 3, 2023, View Source [SID1234630955]).

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Summit has held multiple meetings with the US Food and Drug Administration (FDA) during the first quarter of 2023 regarding its planned Phase III clinical program and incorporated this feedback accordingly. We plan to initiate clinical studies in the following indications:

Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) ("HARMONi")
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients ("HARMONi-3")
For the HARMONi trial, Summit intends to dose its first patient during the current quarter (Q2 2023). We intend to dose our first patient in the HARMONi-3 trial in the second half of 2023.

Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. There is higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal, healthy tissue in the body. Ivonescimab’s tetravalent structure enables higher avidity (accumulated strength of multiple binding interactions) with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells.1 This tetravalent structure, the design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which are intended to improve side effects and safety concerns associated with these targets and have the potential to focus the antitumor activity of both targets.

Over 750 patients have been dosed with ivonescimab in clinical studies in China and Australia.

"I am immensely proud of the speed and efficiency of our team to enable clinical trials for SMT112," stated Robert W. Duggan, Chairman & Chief Executive Officer of Summit. "I am particularly enthusiastic about the potential of ivonescimab: this shared enthusiasm is the impetus behind Team Summit’s rapid development to enter into multiple Phase III clinical trials with SMT112. With our confidence in our ability to clinically develop, achieve regulatory approvals, and effectively commercialize a quality product, we believe that we have the opportunity to make a significant difference in the lives of those patients who could benefit from this innovative therapy."

"Our agreement to in-license ivonescimab from our high-achieving partner, Akeso, went effective this past January," added Dr. Maky Zanganeh, Co-CEO & President of Summit. "In just over three months’ time, we are preparing to enroll patients in our first Phase III clinical trial, while actively preparing to launch our second Phase III study later this year. The commitment, preparation, diligence, and vision of Team Summit is shining brightly today and reflects the work we have completed to maximize the opportunities for the success of ivonescimab."

Ivonescimab is an investigational product and is not approved for use by any health authority. Its efficacy and safety for the treatment of any indication have not been established.

1 Zhong et al, SITC (Free SITC Whitepaper) 2022

First Quarter 2023 Earnings Call

Summit will host an earnings call to announce its first quarter 2023 financial results and provide an operational update for the Company on Thursday, May 11, 2023, before the market opens. Summit will host a live webcast of the earnings conference call at 9:00am ET. It will be accessible through Summit’s website www.smmttx.com. An archived edition of the session will be available on our website.

On May 3, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported results for the first quarter of 2023 (Press release, MorphoSys, MAY 3, 2023, View Source [SID1234630954]).

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"We had a strong first quarter, marked by numerous achievements. Most importantly, we completed enrollment of our Phase 3 MANIFEST-2 study of pelabresib in first-line myelofibrosis ahead of schedule. As a result, the topline data from the trial are now expected by the end of 2023, months earlier than previously anticipated," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We continue to focus our work on our most-advanced clinical programs that have the potential to create near-term value for all stakeholders. We look forward to building on this great momentum in 2023 and the years ahead."

Monjuvi/Minjuvi Highlights:

Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 20.8 million (€ 19.4 million) for the first quarter 2023 (Q1 2022: US$ 18.7 million (€ 16.6 million)).

Minjuvi royalty revenue of € 0.7 million for sales outside of the U.S. in the first quarter 2023 (Q1 2022: € 0.7 million).

Corporate Developments:

On March 2, 2023, MorphoSys announced that it will stop work and operations on its pre-clinical research programs to optimize its cost structure. MorphoSys reduced its workforce at the company’s headquarters in Planegg, Germany, by approximately 17%. This action, along with other steps taken over the past year, enables MorphoSys to focus resources on its mid- to late-stage oncology pipeline.

On March 14, 2023, MorphoSys announced that Lucinda Crabtree, Ph.D., will join the company as its Chief Financial Officer and member of the Management Board in the third quarter of 2023 at the latest.

Charlotte Lohmann was appointed as Chief Legal Officer on March 1, 2023 and will serve as a member of MorphoSys’ Management Board ad interim.

On March 30, 2023, MorphoSys settled the repurchase of bonds in the value of € 62.9 million (approximately 19 % of the outstanding principal amount) resulting in an outstanding aggregate principal amount of the convertible bonds of € 262.1 million.

Significant Events After the End of the First Quarter of 2023:

Pelabresib:
On April 4, 2023, MorphoSys announced that enrollment is complete for MANIFEST-2, the ongoing Phase 3 study exploring the efficacy and safety of pelabresib, an investigational BET inhibitor, in combination with ruxolitinib versus ruxolitinib alone in patients with myelofibrosis who have not previously been treated with a JAK inhibitor (JAK inhibitor-naïve). More than 400 patients were enrolled in this study. The topline data are now expected by the end of 2023, earlier than previously anticipated.

Tafasitamab:
On April 4, 2023, MorphoSys announced that enrollment of the Phase 3 frontMIND study is also complete, with more than 880 patients enrolled in the trial. frontMIND is a global, multicenter, randomized, double-blind, placebo-controlled trial exploring tafasitamab, marketed in the U.S. as Monjuvi and outside the U.S. by Incyte as Minjuvi, plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP alone as a first-line treatment for high-intermediate and high-risk patients with diffuse large B-cell lymphoma (DLBCL). The topline data from this study are expected in the second half of 2025.

Conference Data Highlight:
On April 16, 2023, MorphoSys and Incyte announced final five-year follow-up data from the Phase 2 L-MIND study showing that Monjuvi (tafasitamab-cxix) plus lenalidomide followed by Monjuvi monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory DLBCL. These data were featured as a late-breaking oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023.

New data on pelabresib in essential thrombocythemia and tulmimetostat in a broad array of advanced tumors will be featured in two poster presentations during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Financial Results for the First Quarter of 2023 (IFRS):

Total revenues for the first quarter 2023 were € 62.3 million compared to € 41.5 million for the same period in 2022. This increase resulted mainly from higher revenues from the sale of clinical vials.

in € million*

Q1 2023

Q4 2022

Q1 2022

Q-Q Δ

Y-Y Δ

Total revenues

62.3

81.6

41.5

(24) %

50 %

Monjuvi product sales

19.4

24.7

16.6

(21) %

17 %

Royalties

21.6

29.1

19.0

(26) %

14 %

Licenses, milestones and other

21.3

27.9

5.8

(24) %

> 100%

* Differences due to rounding.

Cost of Sales: Cost of sales in the first quarter of 2023 amounted to € 21.0 million (Q1 2022: € 7.9 million). The year-on-year increase resulted primarily from expenses related to vial sales to Incyte. Cost of sales related to Monjuvi U.S. product sales amounted to € 3.1 million in the first quarter of 2023. The gross margin of Monjuvi U.S. net product sales amounted to 84% (Q1 2022: 79%).

Research and Development (R&D) Expenses: In the first quarter 2023, R&D expenses were € 83.1 million (Q1 2022: € 65.0 million). The increase mainly resulted from additional costs incurred due to the positive development of the patient recruitment in the major ongoing clinical studies of MorphoSys. Additionally, the first quarter of 2023 included a one-time effect resulting from severances in connection with the restructuring of the research area.

Selling, General and Administrative (SG&A) Expenses: Selling expenses in the first quarter 2023 were € 16.9 million (Q1 2022: € 21.9 million). The decrease was driven by streamlining and focusing of selling efforts. General and administrative (G&A) expenses amounted to € 10.9 million (Q1 2022: € 14.6 million).

Operating Loss: Operating loss amounted to € 69.5 million in the first quarter 2023 (Q1 2022: operating loss of € 68.0 million).

Consolidated Net Loss: For the first quarter 2023, consolidated net loss was € 44.4 million (Q1 2022: consolidated net loss of € 122.7 million).

Full Year 2023 Financial Guidance:

Amounts in million

2023 Financial Guidance

2023 Guidance Insights

Monjuvi U.S. net
product sales

US$ 80m to 95m

100% of Monjuvi U.S. net product sales are recorded
on MorphoSys’ income statement and
related profit/loss is split 50/50 between
MorphoSys and Incyte.

Gross margin for
Monjuvi U.S. net
product sales

75% to 80%

100% of Monjuvi U.S. product cost of sales are
recorded on MorphoSys’ income statement and
related profit/loss is split 50/50 between
MorphoSys and Incyte.

R&D expenses

€ 290m to 315m

2023 anticipated to be incrementally higher than
2022 due to the expansion of the pelabresib
development program.

SG&A expenses

€ 140m to 155m

45% to 50% of mid-point of SG&A expenses
represent Monjuvi U.S. selling costs of which
100% are recorded in MorphoSys’ income
statement. Incyte reimburses MorphoSys for half
of these selling expenses.

Additional information related to 2023 Financial Guidance:

Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys, as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2023.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. MorphoSys does not provide guidance for these sales.
Operational Outlook:

The following events and development activities planned for 2023 and beyond include the following:

topline results for the pivotal Phase 3 study (MANIFEST-2) of pelabresib in myelofibrosis (MF) by the end of 2023;
primary analysis data from the Phase 3 study (inMIND) of tafasitamab in patients with indolent lymphoma (r/r FL/MZL) in 2024;
primary analysis data from the pivotal Phase 3 study (frontMIND) of tafasitamab in previously untreated DLBCL in the second half of 2025.
MorphoSys Group Key Figures (IFRS, end of the first quarter: March 31, 2023)

in € million

Q1 2023

Q1 2022

Δ

Revenues

62.3

41.5

50 %

Product Sales

19.4

16.6

17 %

Royalties

21.6

19.0

14 %

Licenses, Milestones and Other

21.3

5.8

>100%

Cost of Sales

(21.0)

(7.9)

>100%

Gross Profit

41.3

33.6

23 %

Total Operating Expenses

(110.8)

(101.5)

9 %

Research and Development

(83.1)

(65.0)

28 %

Selling

(16.9)

(21.9)

(23) %

General and Administrative

(10.9)

(14.6)

(25) %

Operating Profit / (Loss)

(69.5)

(68.0)

2 %

Other Income

2.1

1.4

50 %

Other Expenses

(1.8)

(3.7)

(51) %

Finance Income

55.0

10.6

>100%

Finance Expenses

(28.3)

(62.8)

(55) %

Income from Reversals of Impairment Losses / (Impairment Losses) on
Financial Assets

0.5

(0.1)

>(100)%

Share of Loss of Associates accounted for using the Equity Method

(2.5)

—

n/a

Income Tax Benefit / (Expenses)

0.0

0.0

n/a

Consolidated Net Profit / (Loss)

(44.4)

(122.7)

(64) %

Earnings per Share, Basic and Diluted (in €)

(1.30)

(3.59)

(64) %

Cash and other financial assets (end of period)

791.5

907.2 *

(13) %

* Value as of December 31, 2022

MorphoSys will hold its conference call and webcast tomorrow, May 04, 2023, at 2:00pm CEST (1:00pm GMT/8:00am EST) to present the results for the first quarter 2023.

Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call:

View Source;linkSecurityString=77dbe4aa2

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at the Investors section under "Events & Conferences" on MorphoSys’ website, View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The statement for the first quarter 2023 (IFRS) is available for download at:

View Source/en/investors/financial-information

On May 3, 2023 Foundation Medicine, Inc., a leader in molecular profiling for cancer, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for EXKIVITY (mobocertinib), which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Press release, Foundation Medicine, MAY 3, 2023, View Source [SID1234630953]). For full Indication, Important Safety Information and link to the Prescribing Information, please see ‘About Exkivity’ below. FoundationOne Liquid CDx is the only blood-based comprehensive genomic profiling (CGP) test that is FDA-approved to detect EGFR exon 20 insertion mutations to identify patients who may be appropriate for treatment with EXKIVITY.

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Non Small cell Lung cancer is the most common form of lung cancer, accounting for 80-85% of lung cancer diagnoses.1 Approximately 1-2% of patients with NSCLC have EGFR exon 20 insertion mutations, which are more common in Asian populations compared to Western populations.2-6

"EGFR exon 20 insertion-positive NSCLC is a rare and historically underdiagnosed disease that requires a targeted treatment approach at the molecular level due to its unique mutation," said Stefanie Granado, head, U.S. Oncology Business Unit, Takeda. "The approval of this indication for Foundation Medicine’s blood-based companion diagnostic test is another important step forward to expand the identification of patients in the U.S. with this rare cancer and improve access for people who may benefit from treatment with EXKIVITY, including those unable to undergo tumor biopsy."

Foundation Medicine’s two FDA-approved tests meet rigorous analytical and clinical validation standards. From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes for genomic alterations that cause cancer to grow.

"Cancer is an incredibly complex disease, so it’s critical that oncologists leverage companion diagnostics, which are high-quality, well-validated genomic tests, to inform treatment decisions for their patients," said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "We’re proud of the work we’ve done with Takeda to develop blood and tissue-based companion diagnostics for therapies in their precision oncology pipeline, including this recent approval for EXKIVITY."

"People living with rare forms of lung cancer like EGFR exon 20 insertion mutated NSCLC often face limited treatment options," said Danielle Hicks, chief patient officer at GO2 for Lung Cancer. "It’s encouraging to see continued progress toward improving access to new treatment options for patients living with advanced non-small cell lung cancer."

On May 3, 2023 Photocure ASA (Photocure) (PHO: OSE) reported that it will announce the first quarter 2023 financial results on Wednesday 10 May 2023 at 08:00 CEST and will present a live webcast at 14:00 CEST the same day (Press release, PhotoCure, MAY 3, 2023, View Source [SID1234630952]).

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The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com.

The investor presentation will be streamed live and be hosted by Dan Schneider, CEO and Erik Dahl, CFO. The presentation will be held in English and questions can be submitted throughout the event. The presentation is scheduled to conclude at 14:45 CEST.

The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20230510_9/.

On May 3, 2023 KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-therapeutic oncolytic viral immunotherapy programs, reported that its Director of Immunology, Ravikumar Muthuswamy, Ph.D., will present "Novel Oncolytic therapy VET3-TGI restricts TGFβ1 and augments Type-1 immune response in TME, leading to superior therapeutic efficacy in multiple preclinical tumor models," an overview of data on its lead pre-clinical candidate, VET3-TGI, in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting (Press release, KaliVir Immunotherapeutics, MAY 3, 2023, View Source;cell-therapy-asgct-annual-meeting-301813498.html [SID1234630951]). The presentation is on Friday, May 19, 2023 at 5:15 PM PST.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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VET3-TGI is based on KaliVir’s unique Vaccinia Enhanced Template (VET) platform, capable of generating potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread. VET3-TGI incorporates modifications granting the expression of CXCR3, IL-12 and a TGF-β inhibitor, allowing for efficient trafficking to the tumor, activation of anti-tumor immune responses and inhibition of immunosuppressive activity.