On July 25, 2024 Sanofi reported strong performance with 10% sales growth; 2024 guidance upgraded (Press release, Sanofi, JUL 25, 2024, View Source [SID1234645091]).

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Q2 sales growth of 10.2% at CER and business EPS(1) of €1.73

Dupixent sales up 29.2% to €3,303 million; target of ~€13 billion in 2024 unchanged
Pharma launches up 80.4% to €689 million, led by ALTUVIIIO, Nexviazyme, Rezurock, and Sarclisa
Vaccines sales -4.8% due to COVID-19 sales in 2023
Opella (former Sanofi Consumer Healthcare) up 9.6%, driven by the Qunol acquisition
Research and Development expenses grew 5.5%
Selling, general and administrative expenses grew 4.9%, substantially less than sales growth
Business EPS(1) of €1.73, down 0.6% reported and up 4.0% at CER
IFRS EPS of €0.89, down 22.6% reported
Q2 pipeline progress

Three regulatory approvals; Dupixent COPD (EU, July), Kevzara pJIA (US), Altuvoct hemophilia A (EU)
Four regulatory submissions, including fitusiran in hemophilia A/B and Sarclisa in multiple myeloma
Increasing pipeline news flow over 2024-2025, including 12 phase 3 data readouts

Other key updates

Sanofi ranked world’s 7th most sustainable company by TIME Magazine
Opella (Consumer Healthcare) intended separation on track with previously communicated timelines*
2024 business EPS guidance upgraded

2024 business EPS(1) to be stable at CER(2), an upgrade from a low single-digit percentage decrease previously, underpinned by accelerated delivery of Sanofi’s pipeline-driven transformation. Applying the average July 2024 exchange rates, the currency impact on 2024 business EPS is c.-5.5% to -6.5%.

Paul Hudson, Chief Executive Officer, commented:

"We are continuing our strong performance in 2024 and delivered broad-based, double-digit sales growth in the second quarter. We also made important progress in our pipeline of new medicines, including approvals for Dupixent in COPD, Kevzara in pediatric arthritis and ALTUVIIIO (EU) in hemophilia A. With the EU approval in COPD, Dupixent is the first-ever biologic medicine approved in this debilitating disease impacting hundreds of thousands of patients globally. As we accelerate our focused mid- and late-stage pipeline, we started a number of new phase 2 and phase 3 studies that will benefit patients in the future. We are well on track, delivering on our strategic priorities for Sanofi to become a development-driven, tech-powered biopharma company committed to serving patients and accelerating growth. Underpinned by accelerated delivery of Sanofi’s transformation, we upgrade our earnings per share guidance for 2024."

Q2 2024 Change Change
at CER H1 2024 Change Change
at CER
IFRS net sales reported € 10,745 m +7.8% +10.2% € 21,209 m +5.1% +8.4%
IFRS net income reported € 1,113 m -22.4% — € 2,246 m -34.5% —
IFRS EPS reported € 0.89 -22.6% — € 1.80 -34.3% —
Free cash flow(3) € 854 m -46.4% — € 545 m -82.6% —
Business operating income € 2,813 m +3.2% +8.3 % € 5,656 m -6.7% +1.4%
Business net income(1) € 2,161 m -0.7% +4.0 % € 4,380 m -10.2% -2.3%
Business EPS(1) € 1.73 -0.6% +4.0% € 3.51 -10.0% -2.3%

On July 25, 2024 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2024 (Press release, Ipsen, JUL 25, 2024, View Source [SID1234645090]).

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Business highlights

U.S. regulatory approvals and launches of Onivyde (irinotecan) in first-line pancreatic cancer and Iqirvo (elafibranor) in second-line primary biliary cholangitis, respectively
In-licensing of tovorafenib​ outside the U.S.: an attractive addition to our Oncology pipeline
Multiple early-stage external-innovation transactions across Oncology and Neuroscience
Financial highlights

Total-sales growth of 9.5% at CER1, or 8.0% as reported, driven by the performances of Cabometyx (cabozantinib) and Dysport (abobotulinumtoxinA), as well as contributions from Bylvay (odevixibat) and Onivyde
Core operating margin of 32.4%, a decline of 1.6% points, driven mainly by enhanced R&D investment. An unchanged IFRS operating margin of 19.2%
Upgraded 2024 financial guidance: total-sales growth greater than 7.0% at CER1
(prior guidance: greater than 6.0% at CER1); core operating margin greater than 30.0% of total sales (prior guidance: around 30%)
"Our strategic progress was illustrated by strong results in the first half, and we are well placed to deliver continued attractive growth over the medium term", commented David Loew, Chief Executive Officer, Ipsen. "Across Oncology, Rare Disease and Neuroscience, we now have a comprehensive portfolio of medicines, with additional launches in key indications this year. Onivyde and Iqirvo are now being rolled out and we are confident in our ability to deliver on their potential. I was also delighted by a further expansion of our pipeline, including the recent in-licensing of the late-stage asset, tovorafenib, in pediatric Oncology.

"Over the remainder of the year, we will remain sharply focused on the launches and commercial execution, as well as further opportunities to expand the pipeline. We have a clear and focused strategic roadmap and a culture of excellence in execution to enable us to make a real difference for patients and society."

Extract of consolidated results for H1 2024 and H1 20232:

H1 2024 H1 2023 % change
€m €m Actual CER3
Total Sales 1,659.3 1,536.6 8.0% 9.5%
Core Operating Income 538.0 523.2 2.8%
Core operating margin 32.4% 34.0% -1.6% pts
Core Consolidated Net Profit 399.4 393.0 1.6%
Core earnings per share (fully diluted) €4.78 €4.73 1.2%
IFRS Operating Income 317.8 295.6 7.5%
IFRS operating margin 19.2% 19.2% –
IFRS Consolidated Net Profit 232.3 195.1 19.1%
IFRS earnings per share (fully diluted) €2.78 €2.35 18.4%
Free Cash Flow 393.5 371.5 5.9%
Closing net debt (6.8) (272.2) n/a
Full-year 2024 guidance
We have upgraded our financial guidance for 2024:

Total-sales growth greater than 7.0%, at constant currency (prior guidance: greater than 6.0% at constant currency). Based on the average level of exchange rates in June 2024, an adverse impact on total sales of around 1% from currencies is expected
Core operating margin greater than 30.0% of total sales (prior guidance: around 30%)
Pipeline update since Q1 2024
In June 2024, we received an accelerated approval from the U.S. FDA for Iqirvo 80 mg tablets for the treatment of primary biliary cholangitis, in combination with ursodeoxycholic acid (UDCA), in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Iqirvo was, shortly thereafter, available for prescription and delivery. A decision in the E.U. is anticipated later this year.

In June 2024, we announced the expansion of our collaboration and license agreement with Exelixis, Inc. for the development of Cabometyx (cabozantinib) in advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic neuroendocrine tumors. This expansion is based on positive outcomes from the CABINET Phase III trial.

In June 2024, we announced an extension of our ongoing oncology research partnership with Marengo Therapeutics, Inc., to include TriSTAR, Marengo’s next-generation, precision T-cell engager technology. Under the terms of the agreement, we will assume responsibility for all activities, following development-candidate nomination.

In July 2024, we announced an exclusive global licensing agreement with Foreseen Biotechnology for FS001, an antibody-drug conjugate with first-in-class potential. Under the terms of the agreement, we will assume responsibility for Phase I preparation activities.

We also announced today a new global partnership outside the U.S with Day One Biopharmaceuticals for tovorafenib, an oral, once-weekly, type II RAF inhibitor for pediatric low-grade glioma. This is the most common form of childhood brain cancer. Under the terms of the agreement, we will be responsible for the regulatory and commercial activities for tovorafenib in all territories outside of the U.S.

Consolidated financial statements
The Board of Directors approved the condensed consolidated financial statements on 24 July 2024. The Company’s auditors performed a limited review of the H1 2024 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section.

Conference call
A conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here.

On July 25, 2024 GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported the initiation of a strategic review and corporate restructuring plan (Press release, GlycoMimetics, JUL 25, 2024, View Source [SID1234645089]). GlycoMimetics has engaged Lucid Capital Markets to act as a strategic advisor in the process.

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"We are committed to acting in the best interests of patients, employees and shareholders. Given our organization’s cash resources, we plan to explore a range of potential strategic alternatives and seek to deliver value to our shareholders and find avenues that allow uproleselan and GMI-1687 to build upon their clinical promise, including in the ongoing NCI Phase 2/3 study of uproleselan in newly diagnosed AML patients," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "We believe both drug candidates have the potential to address significant unmet needs in their respective therapeutic areas and we are focused on finding organizations to advance these programs. We are proud of our team’s dedication to improving the lives of patients and are thankful for their hard work progressing uproleselan and GMI-1687."

The Company will evaluate strategic alternatives and no timetable has been set for the conclusion of the strategic review or the consummation of any such strategic transaction.

GlycoMimetics had cash and cash equivalents of approximately $31.3 million as of March 31, 2024. Based on the corporate restructuring and streamlining of operations, the Company expects to significantly reduce future operating expenses and extend its cash runway into the second quarter of 2025.

NCI Phase 2/3 Study of Uproleselan in Frontline AML

The National Cancer Institute (NCI) and the Alliance for Clinical Trials in Oncology are conducting an adaptive Phase 2/3 study of uproleselan in adults with newly diagnosed AML who are 60 years or older and fit for intensive chemotherapy. Their randomized, controlled study is evaluating the addition of uproleselan to a standard cytarabine / daunorubicin regimen (7+3) versus chemotherapy alone. The Phase 2 portion of the study completed enrollment of 267 patients in December 2021.

About AML

AML is the most common acute leukemia in adults. A cancer of the bone marrow, nearly 21,000 people in the United States are diagnosed with AML each year. Despite the availability of multiple treatments, disease prognosis is poor, and new treatment options are needed to improve outcomes. Newly diagnosed AML has the lowest 5-year survival rate of all leukemias at 31.7%. The five-year survival rate for people with relapsed/refractory disease is only 10%.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan (yoo’ pro le’se lan) is an investigational, first-in-class E-selectin antagonist. GlycoMimetics has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA) and Breakthrough Therapy designation from the Chinese National Medical Products Administration for uproleselan as a potential treatment for adult AML patients with relapsed or refractory disease. E-selectin is a leukocyte adhesion molecule constitutively expressed on endothelial cells of the vasculature and bone marrow. In AML, there is evidence that E-selectin–ligand interaction between endothelial cells in the protective niche of the Bone Marrow microEnvironment (BME) and leukemic stem cells and blasts promotes leukemic cell survival and hides them from AML therapies. Uproleselan is designed to disrupt E-selectin binding and prevent leukemic myeloid cells using the protective niche of the BME.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that is bioavailable after subcutaneous administration. This second-generation compound has potential application in oncology and inflammatory diseases, and the company’s initial clinical development has focused on sickle-cell disease (SCD). E-selectin is believed to play a major role in vaso-occlusive events (VOEs), a group of acute complications that are associated with SCD and include vaso-occlusive pain crises, acute chest syndrome (ACS), stroke, and splenic sequestration. Administration of GMI-1687 by subcutaneous injection, if successfully developed in the clinic, may enable this study drug to be approved as a patient-controlled, point-of-care treatment option.

On July 25, 2024 Ipsen (Euronext: IPN; ADR: IPSEY) and Day One Biopharmaceuticals (Nasdaq: DAWN) (Day One), reported a new global partnership outside the U.S. for tovorafenib, an oral, once-weekly, type II RAF inhibitor for pediatric low grade glioma (pLGG), the most common form of childhood brain cancer, i and any future indications developed by Day One (Press release, Day One, JUL 25, 2024, View Source [SID1234645088]).

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Tovorafenib was granted Orphan Drug Designation and received U.S. FDA approval in April 2024ii as a monotherapy treatment for patients six months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.iii These BRAF alterations account for more than half of pLGG cases worldwide and there are no approved targeted treatments for people with pLGG harboring BRAF fusions outside the U.S.i,iii,iv Day One will maintain exclusive global development and U.S. commercial rights for tovorafenib.

David Loew, Chief Executive Officer, Ipsen, commented "Today’s announcement marks an exciting addition to our portfolio. Tovorafenib has the potential to make a significant impact on children living with cancer and is an excellent example of our biomarker-driven strategy as we expand our portfolio. Pediatric low-grade glioma is the most common form of childhood brain cancer, and, outside the U.S., there are still no approved targeted treatments for people with pLGG caused by BRAF alterations, including BRAF fusions or V600 in the refractory/relapsed setting. We are delighted to partner with the team at Day One as we work to bring tovorafenib to every eligible patient around the world, who may benefit from this important new treatment option."

Jeremy Bender, Ph.D., Chief Executive Officer, Day One commented, "Our collaboration with Ipsen to bring tovorafenib to patients worldwide highlights our shared commitment to bring novel therapeutics to patients who have limited treatment options. We believe Ipsen’s footprint in Europe and major regions outside of the U.S., in addition to their track record of bringing innovative medicines to market in oncology and rare pediatric diseases, will be an enormous benefit to tovorafenib and to the pediatric oncology community worldwide."

Ipsen’s deep heritage and expertise in oncology means we can accelerate the delivery of this innovation as teams focus on regulatory activities outside the U.S. pLGG is the most common brain tumor diagnosed in children, with patients suffering profound tumor- and treatment-associated morbidities that can impact their life trajectory.i Depending on the tumor’s size, location and growth rate, pLGG can present with a variety of symptoms including vision, hearing and speech problems, neurological symptoms, premature puberty, physical changes and generalized symptoms such as balance problems, fatigue and nausea.v Mortality is relatively rare, however due to the chronic nature of pLGG and potential morbidity associated with treatment, the disease can significantly affect the development, cognition, education and overall quality of life of affected children, whilst negatively impacting the mental health of parents and caregivers.

Under the terms of the agreement, Ipsen will be responsible for the regulatory and commercial activities for tovorafenib in all territories outside of the U.S. Day One will receive an upfront payment of approximately $111 million, which includes approximately $71 million in cash as well as a $40 million equity investment at a premium and up to approximately $350 million in additional launch and sales milestone payments. Day One will receive tiered double-digit royalties starting at mid-teens percentage on sales.

On July 25, 2024 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab" or the "Company"), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") that is expected to result in gross proceeds of approximately $10 million to the Company, before deducting capital market advisor fees and offering expenses (Press release, Chemomab, JUL 25, 2024, View Source [SID1234645087]).

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The PIPE included participation from both new investors, including HBM Healthcare Investments and Sphera Biotech Master Fund LP, and existing investors. Chemomab expects that the net proceeds from the PIPE will extend its cash runway to fund its operations through the beginning of 2026, an extension of approximately one year from current projections, which should fund the Company for approximately one year after the completion of two major milestones expected in early 2025.

Pursuant to the terms of the securities purchase agreement, the Company is selling to certain investors (i) 4,188,867 American Depositary Shares ("ADSs"), each representing twenty (20) ordinary shares of the Company, no par value per share, at a purchase price of $1.235 per share which reflects the average share price on the Nasdaq for the last 4 trading days and (ii), in lieu of ADSs, pre-funded warrants (the "Pre-Funded Warrants") to purchase up to 3,908,300 ADSs at a price per Pre-Funded Warrant of $1.235. The Pre-Funded Warrants have an exercise price of $0.0001 per ADS, are immediately exercisable and remain exercisable until exercised in full. The PIPE is expected to close on or about July 26, 2024, subject to satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the PIPE, together with the Company’s existing cash and cash equivalents, to fund its development programs for CM-101, and for general corporate purposes and working capital.

Oppenheimer & Co. Inc. is acting as Capital Markets Advisor to the Company for the PIPE. Other Advisors included Maxim Group and LifeSci Capital.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the ADSs, including ADSs issuable upon exercise of the Pre-Funded Warrants, purchased in the PIPE.

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