Cidara Therapeutics Aktie

CDTX has now reacquired CD388 from Janssen. The deal includes an $85M upfront payment to Janssen, up to $150M in developmental/regulatory milestones, up to $455M in commercial milestones and NO royalties. CDTX had to compete against other companies for re-acquiring CD388. Details are not known, but it appears that the fact that CDTX was the only one able to start a ph2b soon enough (for the 2024-2025 Northern Hemisphere flu season) played a big role (note that a delay in starting the trial in time would mean having to wait for the next flu season). Also note that Janssen (or another acquiring company) would own considerable milestones plus royalties to CDTX in a scenario where another company would acquire the rights from Janssen (in other words, the total value of the deal for Janssen is higher than the sum of the above milestones).

CDTX now plans to start a ph2b trial in 2024. Details of the design/timeline are not known yet, but it appears that a readout is possible by mid-2025 if CDTX manages to start the trial soon enough to allow full enrollment during the upcoming flu season. Details of the design/timeline of the planned ph2b will be revealed in the upcoming 1-2 weeks.

Important details to check are the following;

What is the planned timeline? Is the plan to completely enroll the ph2b in a single flu season
(meaning a readout in 2025) or will a 2nd season be necessary (meaning a readout in 2026)?

How many patients will be enrolled? This has multiple implications
(cost of the trial, timeline for completing enrollment, statistical power).

What will the comparator to CD388 be? Placebo? A flu vaccine? Will CD388 be used as an add-on to the flu vaccine? In a comparison with placebo, it will be easier to show benefit (less risky trial) but will be less compelling long term (unless efficacy is much higher than expected for flu vaccines, typically ranging between 40-60%). In a comparison with a flu vaccine, it will be harder to show benefits, but long-term commercial prospects will be much better if CD388 can show superiority over flu vaccination. I strongly believe that CD388 can show a benefit over vaccination, especially in the subset of patients that don't mount a good immune response, or even in seasons where vaccine strains are not well-matched to circulating flu strains.

What will the enrollment criteria be? Based on prior comments from CEO and expected benefit of CD388 I expect the trial to focus on high-risk (especially immunosuppressed) patients (i.e., those most likely to not mount a good enough immune response from vaccination, hence more likely to benefit from CD388).
What CDTX plans to do after the ph2b is unclear. Based on so far available data (discussed in prior coverages and the recent 10K) I expect the trial to be positive. Options for CDTX after that include:

proceeding to a ph3 alone... (which would mean need to raise considerably more cash)
or
new partnership / buyout... (which should be at much better terms following a positive ph2b).

Additional data presented on CD388

To sum up, the data presented in prior coverages (1, 2):

CD388 is safe, with only mild and transient adverse events among n=114 patients.
A single dose (either intramuscularly or subcutaneously) has a sufficient duration of action to cover the whole flu season.

CD388 was effective in reducing influenza virus replication and preventing influenza infection in a human challenge study.
The following additional pre-clinical data has been presented since my last coverages:

CD388 activity is driven by the antiviral activity of the small molecule neuraminidase inhibitor (NAI) attached to the Fc-fragment and not by the Fc-mediated effector functions. In other words, CD388 works as a long-acting antiviral and its activity is not dependent on an intact immune system (in contrast to vaccines).

CD388 is more potent in vitro compared to NAIs used in clinical practice (oseltamivir and zanamivir) and baloxavir.

CD388 retains activity against NAI-resistant strains.

In vitro activity translates to in vivo efficacy in a mouse model. Notably, CD388 was effective both prophylactically (administered before the influenza challenge) and for treatment (administered after influenza infection), even against NAI-resistant isolates. Furthermore, CD388 was more effective than currently used NAIs (oseltamivir and zanamivir). Finally, CD388 activity was preserved even at low doses and a low resistance potential was shown (both supporting the potential for prolonged protection from a single dose).

Financials
CDTX reported $35.8M in cash and cash equivalents as of December 31, 2023. Subsequently, in 2024 CDTX has received $11M and $2.8M in regulatory milestone payments associated with rezafungin. Furthermore, CDTX just raised 240M in gross proceeds from a private placement by issuing preferred stock (240,000 convertible preferred shares at a price of $1,000/share, conversion price $14.2/share). Subtracting the $85M upfront payment to Janssen, as well estimated (based on Q4 2023) $22M operating expenses (R&D $14.7M, SG&A $5.4M) during Q1 2024 CDTX should have around $180M in cash as of April 2024. Operating expenses have been relatively stable during 2022-2023, ranging from $20M-$25M per quarter. Total operating expenses were $84M in 2020, $91M in 2021, $94M in 2022 and $88M in 2023. Therefore, based on historical cash burn and above-estimated current cash balance, CDTX should have a runway of about 2 years.

However, right now, R&D expenses should be much lower, considering that CDTX has no ongoing clinical trials. On the other hand, R&D expenses will start rising again as soon as the ph2b trial starts, and will rise even more when oncology Cloudbreak assets enter the clinic. An accurate estimation of future cash burn is not possible until further guidance by CDTX on the timeline and details (e.g., number of patients) of planned clinical trials. CDTX plans to reveal more details on the ph2b within the next 1-2 weeks, which should help better inform the cash runway. What is important is that, according to CDTX, the cash runway is sufficient for the ph2b readout.

The above-mentioned $240M financing included top-tier institutional investors ("led by RA Capital Management with significant participation by Bain Capital Life Sciences as well as BVF Partners and Canaan Partners"). Although it means considerable dilution long-term (from the conversion of preferred stock to common stock), I think the overall news is very positive for CDTX. With CD388 now fully owned by CDTX, progress in the oncology pipeline and sufficient funding for the next milestones (ph2b readout and initiation of early-phase studies for CBO-421) I expect considerable upside for CDTX stock.

https://seekingalpha.com/article/4686881-cidara-therapeutics…

Concurrent with the acquisition, Cidara closed a definitive agreement for the sale of preferred stock in a private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. The private placement provides $240 million in gross proceeds that will be used by Cidara to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with a Phase 2b clinical trial in the upcoming Northern Hemisphere influenza season. The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial.

Dr. Stein continued, “This reacquisition of CD388, along with the capital to advance it through Phase 2b development, is transformational for Cidara and especially for those who could benefit from a long-acting, universal preventative against all forms of influenza. In our Phase 2b study later this year, we will evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza.
https://finance.yahoo.com/news/cidara-therapeutics-reacquire…


eine zusammenfassung vom "ablauf des deals"
https://rapport.bio/all-stories/raven-condor-cidara

...With funding from J&J, Cidara had generated compelling Phase 2a human challenge data showing
that when administered preventatively, CD388 could protect healthy volunteers
exposed to a very high dose of influenza from getting sick. ...

Accelerating the process

Shortly before the initial bid deadline, we connected with the team at Cidara, initially to learn from their experience in developing CD388 so far. However, we quickly realized that the best way to move CD388 forward quickly and efficiently would be to partner with them – after all, they were the company that originally developed the drug. The Cidara team knew the molecule inside and out, had run all of the clinical studies to date, and were the only group that we believed could get CD388 into Phase 2b in 2024 (tech transfer alone would have taken months!)....


was wird mundipharma mit den shares machen :
Mundipharma International Ltd. 4 781 408 alt
quelle https://de.marketscreener.com/kurs/aktie/CIDARA-THERAPEUTICS…

RA CAPITAL HEALTHCARE FUND, L.P.
Aggregate Purchase Price (Subscription Amount): $ 100,000,000
Number of Shares to be Acquired: 100,000

BCLS FUND III INVESTMENTS, LP
Aggregate Purchase Price (Subscription Amount): $ 100,000,000
Number of Shares to be Acquired: 100,000

CANAAN XII L.P.
Aggregate Purchase Price (Subscription Amount): $ 20,000,000
Number of Shares to be Acquired: 20,000

BIOTECHNOLOGY VALUE FUND, L.P.
By: BVF I GP LLC
Aggregate Purchase Price (Subscription Amount): $ 10,594,000
Number of Shares to be Acquired: 10,594

BIOTECHNOLOGY VALUE FUND II, L.P.
By: BVF II GP LLC
Aggregate Purchase Price (Subscription Amount): $ 8,416,000
Number of Shares to be Acquired: 8,416

Subject to the terms and limitations contained in the Certificate of Designation,
the Series A Preferred Stock issued in the Private Placement will not become convertible until
the Company’s stockholders approve the issuance of all Common Stock issuable upon conversion of the Series A Preferred Stock (the “Conversion Shares”) and an amendment to the Company’s certificate of incorporation to increase the authorized number of shares of Common Stock to enable the issuance or reservation for issuance, as applicable, of all of the Conversion Shares (the “Stockholder Approval”). On the first Trading Day (as defined in the Certificate of Designation) following the announcement of the Stockholder Approval, each share of Series A Preferred Stock shall automatically convert into Common Stock, at the conversion price of $ 14.20 per share, rounded down to the nearest whole share, subject to the terms and limitations contained in the Certificate of Designation, including that shares of Series A Preferred Stock shall not be convertible if the conversion would result in a holder beneficially owning more than 9.99% of the Company’s outstanding shares of Common Stock as of the applicable conversion date

Financial Terms. As a condition to the effectiveness of the Janssen License Agreement,
the Company paid Janssen an upfront payment of $ 85 million.

The Company will also be obligated to pay Janssen up to $150 million in development and regulatory milestone
payments with respect to CD388 Product and up to $455 million in commercialization milestone payments
with respect to CD388 Product. The Company has no obligation to pay any royalties toJanssen on the sale
of any Product and no obligation to pay any milestone payment or other amount to Janssen with respect
to the development, registration, manufacture or commercialization of any Compound other than CD388
or any Product other than CD388 Product.

Securities Purchase Agreement

On April 23, 2024 (the “Signing Date”), the Company entered into a securities purchase agreement
(the “Securities Purchase Agreement”) with certain institutional and other accredited investors (the “Purchasers”),
pursuant to which the Company issued and sold, in a private placement (the “Private Placement”),
240,000 shares of Series A Convertible Voting Preferred Stock, par value $0.0001 per share
(the “Series A Preferred Stock”), at a purchase price of $1,000 per share. The closing
of the Private Placement took place on April 24, 2024 (the “Closing Date”)
and the Company received total gross proceeds of $240 million.

https://app.quotemedia.com/data/downloadFiling?webmasterId=9…

8 K Mundipharma Medical Company (“Mundipharma”)
https://app.quotemedia.com/data/downloadFiling?webmasterId=9…

8 K Janssen Pharmaceuticals, Inc. (“Janssen”)
https://app.quotemedia.com/data/downloadFiling?webmasterId=9…

Cidara Therapeutics erwirbt globale Entwicklungs- und kommerzielle Rechte an CD388 zurück
und gibt Privatplatzierungsfinanzierung in Höhe von 240 Millionen US-Dollar bekannt

- Privatplatzierungsfinanzierung in Höhe von 240 Millionen US-Dollar unter der Leitung von
RA Capital Management mit maßgeblicher Beteiligung von Bain Capital Life Sciences sowie BVF Partners
und Canaan Partners zur Finanzierung der klinischen Phase-2b-Studie

- CD388, das gegen alle Stämme der Influenza A und B wirksam ist,
wird für die präexpositionsprophylaktische Behandlung entwickelt

- Das Unternehmen veranstaltet heute um 16:30 Uhr ET eine
Telefonkonferenz und einen Webcast zum Update der Geschäftsstrategie

https://finance.yahoo.com/news/cidara-therapeutics-reacquire…

Cidara Therapeutics gibt Veräußerung von Rezafungin an Mundipharma* bekannt,
um sich auf die Förderung der klinischen Entwicklung der Cloudbreak DFC-Pipeline zu konzentrieren.

Durch die Transaktion ergeben sich für das Unternehmen geschätzte Kosteneinsparungen von etwa 128 Millionen US-Dollar, darunter etwa 67 Millionen US-Dollar für die klinische Entwicklung und CMC-Kosten in den nächsten drei Jahren sowie weitere etwa 61 Millionen US-Dollar an prognostizierten Verpflichtungen während der Patentlaufzeit von Rezafungin.

Mundipharma erwarb die Vermögenswerte als Gegenleistung für die Übernahme der laufenden Verpflichtung
zur Durchführung und Finanzierung der klinischen ReSPECT-Phase-3-Studie,
der Kosten des Rezafungin-Patentportfolios und der CMC sowie regulatorischer Verpflichtungen.

Gemäß den Bedingungen des Asset-Kaufvertrags werden alle zukünftigen Lizenzgebühren und Meilensteine
von Mundipharma und Melinta Therapeutics, die zuvor an Cidara zu zahlen waren, an Mundipharma übertragen.

https://finance.yahoo.com/news/cidara-therapeutics-announces…