MAHA report raises doubts, and Molecure has announced group layoffs. PoZdroweek

Many companies from the Polish stock exchange have sent warning signals that things are not going well for them – these include Molecure, Mabion and Pure Biologics. In the US, the discussion has not abated after the publication of the questionable quality of the MAHA (Make America Healthy Again) report. It contained references to non-existent studies on children. Eli Lilly has added another arrow to its quiver by acquiring SiteOne Therapeutics for up to $1 billion.

This time, the domestic WIGmed performed worse than its foreign counterparts. The Polish index lost 1.2%. MSCI Europe Health Care gained 0.4%, while the global MSCI World Health Care went up 0.9%.

The Warsaw Stock Exchange celebrated on Friday, as the value of trading during the session set a record (PLN 6.86 billion) – the previous maximum was on March 24, 2015 (PLN 6.02 billion). Trading on WIGmed during the last trading of the week amounted to PLN 90 million.

Source: TradingView

Among the global healthcare giants, Novo Nordisk (+6.2%) and Amgen (+6.1%) stood out. The biggest loser of the week was Sanofi , whose shares lost 5%.

Source: own study based on stooq.pl

On the Polish stock exchange, the best performing securities were Mercator Medical (+4.2%) and Voxel (+3.3%). Most of the securities fell. The hardest hit were Molecure (-17.9%) and Mabion (-5.5%). The first company announced group layoffs, and the second, apart from poor financial results for Q1 2025, has still not found financing to fill the recently identified gap – more on this later in the analysis.

Source: own study based on stooq.pl

How not to make money on healthcare stocks?

Some investors are tempted to take shortcuts. Even when they make money on stocks, after a while it turns out that the shortcut path ended in a cliff. Rouzbeh "Ross" Haghighat , a member of the board of Chinook Therapeutics, found this out. The company was acquired by Novartis for $3.2 billion in June 2023.

Haghighat has just been charged by the US Department of Justice with insider trading in connection with the acquisition. Four other people were also involved in the transaction. Earlier this week, Haghighat resigned from his position as CEO of Sernova Biotherapeutics.

According to the Justice Department, Haghighat received confidential, non-public information regarding Novartis's takeover of Chinook Therapeutics. He used that information to buy securities and also tipped off four people about the impending takeover. In total, the prosecutors calculated, the five involved in the scheme made more than $600,000.

Earnings were not hard to come by. Novartis offered Chinook Therapeutics shareholders an 83% premium over the biotech company's 60-day volume-weighted average share price.

“Ross” was charged with one count of securities fraud, 16 counts of insider trading, and two counts of conspiracy. Securities fraud is punishable by up to 25 years in prison, and each count of insider trading could mean up to 20 years in prison. The conspiracy charge carries a sentence of up to 25 years behind bars.

Eli Lilly has acquired SiteOne Therapeutics for up to $1 billion , including an undisclosed upfront payment and additional future payments based on meeting certain regulatory and sales milestones. SiteOne Therapeutics' key therapeutic asset is its non-opioid painkiller candidate, the Nav1.8 inhibitor STC-004, which is approaching Phase II development.

Lilly seems to be looking to compete with Vertex . Vertex received FDA approval for Journavx (suzetrigin) in January. Tris Pharma and Latigo Biotherapeutics are also conducting promising clinical trials in this area.

"Today's transaction adds another arrow to Lilly's growing quiver of opportunities , positioning the company as it continues to diversify and plans to grow beyond the GLP-1 segment," BMO Capital Markets analysts wrote.

Eli Lilly is already present in the area of ​​pain therapy with non-opioid drugs. It is conducting research, among others, on the preparation Mazisotine - this concerns adults with peripheral neuropathic pain in diabetics. The results of the study will be known soon, probably in July 2025.

MAHA raises doubts about quality

Last week, the White House released the Make America Healthy Again (MAHA) report. Its goal was to analyze the root causes of declining children’s health.

The study concluded that the causes of chronic disease in children are nutrition, lifestyle, overmedication and alleged pharmaceutical industry capture of regulatory agencies. According to MAHA, the pharmaceutical industry spent about $4.7 billion on federal lobbying between 1999 and 2018, more than any other industry.

In addition, the report devotes a lot of space to vaccines. The narrative is woven around the central thesis that many of them were supported by studies on small groups of participants and lacked comparative trials conducted using placebos.

The publication of the report was a contribution to the fact that it could be looked at by insightful observers of the healthcare sector. This was done by the non-profit organization NOTUS. In its opinion, MAHA refers to 7 non-existent studies.

Katherine Keyes, an epidemiologist who was listed in the MAHA report as an author of the study on adolescent anxiety, told NOTUS that the article cited in the report is not a real article she was involved with.

Ivan Oransky, co-founder of the website Retraction Watch, told the Times in a commentary that the report’s errors were typical of those created using AI, but he said he was not aware of any AI being used to prepare the report.

Karoline Leavitt, Trump’s press secretary, told reporters the misquotes were due to formatting issues and had been removed .

POLAND

Tuesday (27.5.2025)

- Grupa Diagnostyka recorded PLN 72.9 million in net profit in Q1 2025 (an increase of over 13% compared to the previous year). Operating income amounted to PLN 594.9 million (+22.5% compared to the previous year).

- The National Oncology Portal has been launched. It is available to people who are looking for reliable information about oncological diseases, prevention and treatment options. It operates at the address: onkologia.gov.pl.

- Captor Therapeutics will not appeal the NCBR decision. As a result, it will end the dispute with the institution. As a result, the company will release the reserve in the amount of PLN 7.9 million , which concerned the CT-02 project.

Wednesday (28.5.2025)

- The General Meeting of Diagnostyka has approved a dividend payment of PLN 3.31 per share. PLN 111.7 million of the net profit for 2024 will be allocated for this purpose. The rest, i.e. PLN 86.5 million, will go to the reserve capital. The right to the dividend will be established on June 4 this year , and the payment of the benefit on June 16.

The Diagnostyka Group expects to achieve a single-digit increase in the volume of tests this year and an approximately 10% increase in their average price while maintaining the level of profitability. The management of the leader of Polish laboratory diagnostics assessed that the new program "Moje Zdrowie" will have a less positive impact on financial results than "Profilaktyka 40 PLUS".

- Krzysztof Kaczmarczyk, CEO of Mabion , assessed that the process of obtaining financing is advanced and is proceeding according to schedule. According to him, the lack of adoption of the target capital in the first attempt will not hinder it.

Previously, due to the lack of quorum at the general meeting, the target capital (up to 50% of capital over a 3-year period) was not adopted. Despite this, the company will still want to use this option. For this purpose , it will convene another general meeting, at which a 33% quorum will no longer be necessary to pass a resolution.

At the same time, the company is looking for a financial or industry investor who would take over at least part of the future issue. Kaczmarczyk admitted that Mabion is in the process of raising capital based on debt, shares and a combination of both asset classes.

In Q1 2025, the company recorded a PLN 15.3 million unit net loss (compared to PLN 17.5 million profit a year earlier). Total revenues amounted to PLN 2.7 million (PLN 34 million a year earlier). Mabion's active offer pipeline as of May 27 amounted to nearly USD 188 million.

- Captor Therapeutics had PLN 65.9 million of current assets at the end of Q1 2025. The company recently started a Phase I clinical trial of its drug candidate CT-01. It assessed that once the response to the drug is observed, the time may be right to enter into a partnering agreement .

CT-01 uses targeted protein degradation technology and Captor Therapeutics believes it could revolutionize the treatment of hepatocellular carcinoma. The Phase I trial is being conducted in an open-label design - patients and doctors are aware of the use of an active drug without the use of a placebo.

"We expect that between the third and fifth cohorts we will observe a positive degradation of one of the biomarkers in response to the drug - either degradation of GSPT1/NEK7 or a reduction in the levels of markers present in the patients' blood. This does not mean a cure yet, but it will be strong evidence of the effectiveness of the molecule in accordance with the results of preclinical studies. This may also be the right time to conclude a partnering agreement," explained Michał Walczak, board member, CSO.

Thursday (29.5.2025)

- Molecure has decided to make group layoffs (up to 30 employees) , which will take place between June 10 and June 30, 2025. This is due to the need to optimize the structure of expenses in non-clinical programs, which have a more delayed commercialization perspective.

- Synthaverse had a PLN 0.5 million unit net loss in Q1 2025 (PLN 0.4 million a year earlier), operating loss amounted to PLN 0.2 million (PLN 0.3 million profit a year earlier). EBITDA profit, i.e. operating profit increased by depreciation and amortization, closed at PLN 3.4 million (PLN 1.8 million a year earlier), thanks to which the EBITDA profit margin increased to over 25% (from 13% in Q1 2024). Sales revenues reached PLN 13.4 million in Q1 2025 (PLN 13.9 million a year earlier).

"We are pleased with the rapid increase in Onko BCG sales, which results from the successively implemented development strategy. In the first quarter, our export of Onko products to EU countries increased significantly, where we recorded a 170% increase compared to last year. We are working intensively on further increasing foreign sales. On the domestic market, quarterly revenues in the Onko segment increased by almost 78%. Such significant increases bode well for the future. In accordance with the adopted strategy, we consistently focus on increasing the share of the Onko segment, which is characterized by higher profitability . In the past quarter, its share increased from 49% to 67% in total sales," explained Mieczysław Starkowicz, CEO of Synthaverse.

Friday (30.5.2025)

- Pure Biologics has terminated its agreement with Promittens Corporation due to the non-receipt of funds provided for in the agreement. Due to the termination of the agreement, the company's management has identified a risk of loss of liquidity . It intends to recommend a share issue to the general meeting. The company is obliged to repay a loan granted by the Cypriot ACRX Investments. In the event of a failure related to the rescue share issue, the management has prepared an alternative solution - it has begun preparing to file a bankruptcy petition .

- The Management Board of Mercator Medical wants to distribute PLN 15 million to shareholders. This money could be used to pay a dividend (PLN 1.61 per share) or buy back its own shares from stock exchange trading.

- Urteste has the ability to cover financial needs until mid-2026. The company has financial resources of approx. PLN 4 million and unsettled subsidy refunds from PARP and NCBR in the amount of approx. PLN 7.5 million. In response to this information , the Urteste share price decreased by 10%.

WORLD

Tuesday (27.5.2025)

- GlycoEra has raised $130 million from a share issue by a consortium of investors led by Novo Holdings (which controls Novo Nordisk). The capital will be used to develop a line of extracellular protein degraders for autoimmune diseases. GlycoEra plans to begin its first human trials this year.

“Our lead program, which has demonstrated profound and rapid degradation of IgG4 preclinically, presents an opportunity to deliver transformative therapies to patients suffering from multiple autoimmune diseases,” said Ganesh Kaundinya, CEO of GlycoEra.

The money will be used specifically to develop the drug candidate GE8820. The drug targets multiple autoimmune diseases, including pemphigus, myasthenia gravis, primary membranous nephropathy and autoimmune encephalitis.

In addition to Novo Holdings, the investors include Roche Ventures, Bristol Myers Squibb, Catalio Capital Management, LifeArc Ventures, QIA, Agent Capital, Mitsubishi Tanabe Pharma subsidiary MP Healthcare Venture Management and Sixty Degree Capital.

- Boehringer Ingelheim has published results from two late-stage Phase III studies of nerandomilast in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.

The results presented showed that the studies met their primary endpoint at both doses, with nerandomilast 9 mg and 18 mg significantly reducing the decline in forced vital capacity (a measure of lung function) as measured by absolute change from baseline at week 52 compared with placebo.

Nerandomilast is an orally administered preferential phosphodiesterase 4B inhibitor. The drug candidate is under review by regulators in the US, EU, and China.

"Both diseases are devastating, with one in two people dying within five years of being diagnosed with idiopathic pulmonary fibrosis. Despite this stark reality, ongoing research can provide patients with new options as the need for additional therapies continues," said Shashank Deshpande, Head of Pharmaceuticals and Member of the Board of Management of Boehringer Ingelheim.

Wednesday (28.5.2025)

- Merck reports promising results from Phase III trial of anti-PD-1 therapy Keytruda (pembrolizumab) in ovarian cancer. The phase III KEYNOTE-B96 trial is evaluating the drug in combination with paclitaxel chemotherapy, with or without Roche's Avastin (bevacizumab), in patients with recurrent platinum-resistant ovarian cancer.

The study met its primary endpoint. Keytruda treatment also resulted in a statistically significant and clinically meaningful improvement in overall survival, a secondary endpoint.

Ovarian cancer is the seventh most common cancer in women worldwide.

Thursday (29.5.2025)

- Astellas has signed a license agreement potentially worth more than $1.3 billion with Evopoint Biosciences for the rights to an investigational antibody-drug conjugate (ADC) called XNW27011. The drug candidate is currently in Phase I/II trials for CLDN18.2-expressing solid tumors in China, including gastric, esophageal, and pancreatic cancers.

The agreement gives Astellas exclusive rights to develop and commercialize XNW27011 worldwide, except for mainland China, Hong Kong, Macau, and Taiwan. Evopoint will receive $130 million upfront, up to $70 million in short-term payments and additional milestone payments totaling up to $1.34 billion, plus royalties on sales.

Daiichi Sankyo and Merck have withdrawn their application for accelerated FDA approval of patritumab deruxtecan for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies after the HER3-targeted antibody-drug conjugate failed to improve overall survival in a confirmatory study.

- Sanofi announced it will acquire Vigil Neuroscience and its experimental Alzheimer's drug for approximately $470 million. The deal will give the French giant access to VG-3927, a once-daily, oral small-molecule TREM2 agonist currently in early clinical development for the neurodegenerative disease.

Vigil Neuroscience has already shared positive Phase I results for VG-3927, with the drug candidate demonstrating a favorable safety and tolerability profile, as well as the ability to effectively engage TREM2. A Phase II study will begin in Q3 of this year.

Friday (30.5.2025)

- Roche presented data from 93 patients with relapsing multiple sclerosis who remained in the FENopta study for at least 96 weeks. Patients treated with fenebrutinib had an annualized relapse rate (ARR) of 0.06 and showed no signs of disability progression . Fenebrutinib inhibited disease activity in the brain, as measured by MRI scans. After 96 weeks, patients who received the BTK inhibitor had no new lesions that increased gadolinium T1, a marker of active inflammation.

Roche revealed that the open-label extension study did not identify any new safety issues , and the profile of fenebrutinib is consistent with previous readings. Serious adverse events occurred in two patients.

The Company has three Phase III studies of fenebrutinib underway – the FENhance 1 and 2 studies in relapsing multiple sclerosis and the FENtrepid study in primary progressive multiple sclerosis. The first data from these studies are expected in late 2025 .