Cidara Therapeutics announced several sweeping moves on Wednesday afternoon to bring an influenza drug back in-house and raise money from investors to back the program.

The San Diego biotech said it will reacquire the flu drug candidate, CD388, from Johnson & Johnson after a deal with the drug giant three years ago. J&J bet $27 million upfront on the program, plus milestones, at a time when the pharma company was rolling out its Covid-19 vaccine and the industry was looking at treating other viruses. Cidara says it thinks that CD388 can prevent “all strains of influenza A and B.”

To get the candidate through Phase 2b, Cidara has tapped investors for $240 million in a PIPE deal, reloading a balance sheet that showed cash and equivalents of $35.8 million at the end of 2023.

Last year, J&J pulled back some of its R&D work in infectious disease, and flu has proven to be a particularly difficult area of drug development that’s led to setbacks for other attempts to prevent flu. While J&J had elected to move forward with a Phase 2b for CD388, and paid Cidara a milestone, it later decided to divest the program, CEO Jeffrey Stein told Endpoints News in an interview.

Instead of watching the drug go to another pharma company, Cidara decided to buy it back.

“It was a competitive process with a program that is potentially transformational as a universal influenza preventative that is effective against all strains and in all people,” Stein said.

RA Capital Management, a firm that has participated in multiple similar deals in recent months, led the PIPE financing that backed the deal. Stein said the company has been speaking with RA since last fall. Bain Capital Life Sciences, Biotech Value Fund and Canaan Partners also took part.

Cidara said the financing went toward the $85 million it owes upfront to J&J as part of the reacquisition. The new money will keep operations going beyond the Phase 2b topline data. Stein said the company will disclose more specifics on runway at a later date.

The Phase 2b trial will take place later this year in the Northern Hemisphere influenza season, and the money can help carry it through longer into the Southern Hemisphere influenza season if needed, Stein said in the interview.

Meanwhile, Mundipharma bought the rights to Cidara’s Rezzayo (rezafungin), which the FDA approved in March 2023. Mundipharma already had rights to the drug outside of the US and Japan, and it was approved in the EU and UK in December and January, respectively.

Cidara said the move is expected to save it $128 million thanks to reductions in CMC spending and clinical development, which includes a Phase 3 trial in China. It will also make way for Cidara’s expansion into oncology, Stein told Endpoints.

Alongside the pipeline adjustments, Cidara said board members David Gollaher and Timothy Franson will step down. RA Capital managing director Laura Tadvalkar will join the board with Ryan Spencer and James Merson, who was the previous global head of infectious disease therapeutics at J&J’s Janssen.

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The biotech sector has significantly lagged behind the performance of artificial intelligence and high-tech this year. This is because of high inflation, which in turn has made an imminent interest rate cut unlikely. Nevertheless, Germany’s economic conditions are deteriorating dramatically, particularly because of the ongoing geopolitical conflicts. It should, therefore, come as no surprise if the ECB announces an “emergency interest rate cut” in the summer. That would then be the starting signal for a major reshuffle out of the best performers of recent months and into the long-neglected biotech segment. We have selected a few interesting stocks. BioNTech and Formycon – now on sale

BioNTech’s shares (NDAQ:BNTX) have yet to gain momentum in 2024. The share price has fallen by 23% since January, and all hopes are pinned on the cancer-fighting pipeline that has been conjured up in various places. Business with COVID-19 vaccines is slowly running towards zero, meaning that the Mainz-based company will likely be in the red again this year. It is still completely unclear whether the emerging lawsuits in connection with the controversial vaccinations will come to the table at some point.

Behind the scenes, however, the company is returning to its roots and is increasingly focusing on cancer drugs. The vision is to develop new types of mRNA vaccines against cancer that can be adapted to patients as required and may even provide a cure without surgical intervention. At EUR 82.90, the share price is not far off its low for the year of EUR 78.54, giving shareholders little reason to rejoice.

The opinions of experts are also becoming increasingly skeptical, as only 8 out of 16 analysts on the Refinitiv Eikon platform are still positive and recommend the share as a “Buy”, with an average price expectation of EUR 106, which still represents a potential upside of 27%.

Munich-based biosimilar specialist Formycon will hold a conference call tomorrow, April 25, to present its figures for 2023. Revenues rose from EUR 42.5 million to EUR 77.7 million in 2023. Despite a previously formulated negative EBITDA forecast, the company reported a return to profitability with EUR 1.5 million. This was due to the pause in the development of FYB207 in 2023, resulting in unspent research funds.

The EBITDA outlook for 2024 again indicates an intensification of investments in the biosimilar pipeline. Formycon aims to achieve sales of EUR 55 to 65 million, but research expenses will again have a strong negative impact on earnings of EUR -15 to -25 million.

The share price fell back to EUR 39 Tuesday and is thus only marginally above the mid-April low of EUR 37.65. The analyst consensus on the Refinitiv Eikon platform still sees a price target of EUR 101.75. This is surprisingly far from the current share price and will likely decrease with upcoming updates.

Cardiol Therapeutics – Plus 100% is just the beginning

We are moving from the rather consolidating stocks to a top shooter in the biotech sector. The Canadian company Cardiol Therapeutics Inc. (TSX:CRDL) has developed a promising drug candidate called CardiolRx™ in recent years. With its pharmaceutically manufactured, oral solution formulation, the company is again making headlines because CardiolRx blocks the activation of the inflammasome signaling pathway.

After investing heavily in the product pipeline, CEO David Elsley summarizes 2023 and the aspirations for 2024 as follows: “Cardiol Therapeutics made significant progress in 2023 and early 2024 as we pursued our primary goal of providing new therapeutic options for patients with poorly treated heart disease.”

To support the ongoing clinical programs, Cardiol recently attended several scientific conferences where promising preclinical results were presented. In addition, the experts gained deep insights into the molecular and cellular mechanisms of action and benefits of the drug candidates. In February 2024, CardiolRx received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of pericarditis. With this tailwind, the company is well positioned to achieve significant milestones in 2024 and further advance their goal helping people affected by underserved debilitating heart diseases.

Significant milestones in the MAvERIC, ARCHER, and CRD-38 programs are to be achieved in the current year, which should give the company’s valuation further momentum. The Cardiol share price has risen by almost 175% in the last 12 months without consolidating significantly. With sufficient cash, there is no need to refinance at this level. This means that there is no further dilution and shareholders can continue to benefit from the success of the programs. Cardiol is likely only at the beginning of a long-term revaluation.

Novo Nordisk – What the analysts say

Novo Nordisk (OTCPK:NONOF) continues to grow and expand its product portfolio. The company is known worldwide for its innovations in the field of diabetes and obesity with leading products such as Wegovy and Ozempic. Now, the German Federal Cartel Office has approved the acquisition of Cardior Pharmaceuticals, leading the Danish pharmaceutical giant into a new era of cardiology research.

With this strategic decision, Novo Nordisk underlines its recently emphasized ambition to expand its therapeutic offering beyond its core areas and further strengthens its position as an innovation leader in the healthcare sector. The Danish company also sees the opportunity to expand its portfolio with key therapeutic approaches in the field of cardiology.

The share has taken a pause in its upward trajectory in recent weeks. At a price of DKK 884 or EUR 118.9, the market capitalization now stands at EUR 518 billion. This makes Novo Nordisk one of the largest listed stocks in Europe.

The analyst consensus on Refinitiv Eikon, with 17 recommendations out of 28 assessments, reflects high confidence in its future growth. The 12-month price targets have recently reached a consensus of DKK 945, which is around 6% higher than yesterday’s price.

Typically, experts may adjust their forecasts after new financial results, which are due to be released in a few days on May 2. It will be exciting to see whether the share price will then continue unabated or whether profit-taking will dominate the picture.

(Source: Refinitiv Eikon) Conflict of interest

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The post Takeover rumours: BioNTech, Cardiol Therapeutics and Novo Nordisk in focus appeared first on The Market Online Canada.

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CureVac, once a player in the Covid-19 vaccine race, announced that it plans to reduce costs across the company.

It said Wednesday that 150 employees have agreed to voluntarily leave the company. The news was first reported last month by German news outlet SWR. CureVac currently has more than 1,100 employees, according to the annual report.

CureVac said its reorganization will lead to savings starting in the second half of the year, and its cash runway is now set to extend into the fourth quarter of 2025. Its stock $CVAC was down about 8% on Wednesday morning.

In its fourth-quarter earnings update, the company also announced that its and GSK’s joint pandemic preparedness agreement with the German government would be terminated at the end of May. Germany had contracted the companies to supply mRNA-based vaccines in the event of a public health emergency. CureVac noted that plans to complete its vaccine manufacturing facility remain unaffected, and the site is expected to be certified in the second half of the year.

On June 1, CureVac will also be getting a new chief business officer. Thaminda Ramanayake was previously CBO at Affini-T Therapeutics.

CureVac also announced the start of a Phase 1/2 study of an H5N1 avian flu vaccine candidate as part of its collaboration with GSK to develop mRNA vaccines. There are escalating concerns about a bird flu pandemic in humans since the disease spread to dairy cows in the US. The FDA on Tuesday reported evidence of the virus in commercial pasteurized milk, but maintained that the pasteurization process is likely to inactivate the virus. The regulator said the commercial milk supply is still safe.

The avian flu vaccine study will test up to five dose levels compared to a placebo control in two groups of adults: those aged 18 to 64 years old, and adults aged 65 to 85.

CureVac’s partnership with GSK began in July 2020, and they were major players in the Covid-19 vaccine race until their vaccine failed a pivotal study and efforts flamed out. They are currently developing a seasonal mRNA flu vaccine, though the partners recently reported mixed data from a Phase 2 trial.

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