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康乃德生物(CNTB.US)被困在商业化前夕:创始人离场,股价7天下跌逾30%

Kangnai De Life Science (CNTB.US) is trapped on the eve of commercialization: the founder left and the stock price fell more than 30% in seven days.

Zhitong Finance ·  Jun 23 19:23

On June 21, the stock price of Kindred Biosciences (CNTB.US) fell by 3.95%, which is the seventh trading day since its Chinese founding team completely left, and also the seventh trading day of the company's new round of stock price decline. During this period, the company's stock price fell by 31.86%.

On June 21st, the stock price of Kangnaide Biotechnology (CNTB.US) fell by 3.95%. This is the seventh trading day since its Chinese founding team completely left the company, and also the seventh trading day of the company's new round of stock price decline. During this period, the company's stock price has accumulated a 31.86% decline.

According to the Wisdom Finance app, on June 12, Kindred Biosciences announced that its original CEO, Zheng Wei, and President and Chairman of the Board Pan Wubin both submitted resignation letters on June 10, which took effect on June 12. The company then announced the appointment of Barry Quart, Pharm.D as CEO and director, David Szekeres as President, and Kleanthis G. Xanthopoulos as the new chairman of the board. Thus, the original Chinese founders and technical team have completely left.

From being a 'market darling' to 'forgotten'.

Looking back at Kindred's financing history, this biotechnology enterprise that focuses on immune diseases can be said to have been favored by capital. Before its IPO on the US stock market, Kindred completed six rounds of financing. From January 2019 to August 2020, Kindred successively completed a Series B financing of 55 million US dollars and a Series C financing of 115 million US dollars. The C round of financing was led by RA Capital, with Qiming Venture Partners participating, and also with other institutions such as Lilly Asia Ventures and Boxer Capital taking part.

In March 2021, Kindred went public on NASDAQ, with an issue price of $17 per share, and the stock rose by 8.8% on its first day of trading, with a market value of nearly $1 billion. Five months after listing, the stock price reached a high of $29.27, and the market value climbed to $1.613 billion. Just when investors thought that this would be the starting point for Kindred's share price, they didn't know that it had reached the end.

Kindred's successful financing on the US stock market is closely related to the booming development of the global pharmaceutical industry from 2019 to 2021. However, in the second half of 2021, under the interference of external factors such as the Fed raising interest rates and the sharp drop in demand due to the COVID-19 pandemic, financing for global innovative drugs plummeted. In addition, due to earlier industrial speculation, excessive resources flowed in, and the input-output expectations slipped. Under the dual influence of both factors, the investment sentiment in the global biopharmaceutical market began to become rational and conservative, and the bubble burst.

Since Kindred had no commercialized products at that time, and its product development had not yet reached the key NDA stage, the company's valuation fell sharply due to the lack of expectation for hematopoiesis. In October and November 2021, the stock price of Kindred Biosciences fell by 34.63% and 72.54%, respectively.

In mid-June 2022, Kindred received a delisting warning from NASDAQ, stating that the company's trading price had been below $1 per share for 30 consecutive trading days and no longer met NASDAQ listing rules.

To maintain its NASDAQ listing status, Kindred's stock price made a 'surge' in August of the same year, rising by 16.11%, 17.86%, 23.48% and 16.20% in the four trading days of the 2nd, 5th, 8th, and 10th, respectively, pushing the company's stock price up to $1.

But this move was more like a shot of adrenaline, and since then, Kindred Biosciences' stock has been hovering around the 'life and death line' of $1 until now.

The 'dual antibody twins of IL4R' reach a turning point.

The reason for Kindred Biosciences' announcement of changes in senior management this time is 'because the company has entered the commercialization preparation stage'.

Kleanthis G. Xanthopoulos, the newly appointed chairman of the board of directors, said, 'The company's core product, rademikibart, has differentiated data for asthma and atopic dermatitis, which has made Kindred a late-stage company and entered the commercialization preparation stage.'

From the company's R&D pipeline, its core product, rademikibart, for the treatment of atopic dermatitis in China is currently in a critical Phase III clinical trial, and global trials for atopic dermatitis and asthma are in Phase II. In addition, Kindred also has another core product, CBP-307, a small-molecule modulator of the 1-phosphatidylcholine sphingosine-1 receptor (S1P1). Clinical studies for ulcerative colitis and Crohn's disease are both in Phase II.

From the perspective of product development progress and timing, the 'commercialization preparation' mentioned by Kindred now targets the fastest-progressing rademikibart, which is the previously controversial CBP-201.

According to the Wisdom Finance app, on November 18, 2021, Kindred announced that the global Phase II clinical trial of CBP-201 for moderate-to-severe atopic dermatitis had reached its primary endpoint. However, since Kindred only announced that the 300mg Q2W group achieved a significant difference, but did not disclose the key efficacy indicators for the treatment of atopic dermatitis, namely the data for the 300mg Q4W and 150mg Q2W groups, market expectations have dropped from the previous 'me better' to 'me worse'. This also caused Kindred's stock price to plummet by 57.7% the next day.

In fact, as a targeted IL-4Rα monoclonal antibody, CBP-201 has the same mechanism of action as KinikinaCM310. But whether it is Kindred's CBP-201 or KinikinaCM310, they both target Sanofi's Dupilumab monoclonal antibody.

On November 29th, 2021, 11 days after Conaode announced the clinical results of CBP-201, the clinical data of Connoya CM310 for the treatment of moderate-to-severe specific eczema IIb was announced. The data showed that the high-dose group accounted for 73.1%, and the low-dose group accounted for 70.6%, which was significantly better than dupilumab and CBP-201. From the current perspective, it may be the difference in clinical results of the two that led the two companies to a watershed.

Due to the expected clinical results, Connoya has accelerated the market launch of CM310. At the end of April this year, Connoqua's application for listing its drug for the treatment of seasonal allergic rhinitis was accepted by the National Medical Products Administration. At the same time, the CDE website has announced that the injection of spuchebrate monoclonal antibody is planned to be included in the priority review for the indication of chronic sinusitis with nasal polyps. In fact, since the marketing application for CM310 for atopic dermatitis was submitted at the end of last year, the industry has had optimistic expectations for the product to be approved in the second half of 2024.

In terms of production and sales, it is reported that Connoya already has a production capacity of 18,600 liters, which is sufficient to support the commercial production of spiruchovsky monoclonal antibody. According to the 2023 data, the total number of employees in Connoya increased by 46.33% to 897, the highest among Hong Kong-listed innovative drug companies. Its annual report claims that it has rapidly built a core commercial team, and is expected to exceed 250 by the end of 2024.

Looking at Connaught's biological, in late November 2023, Connaught's biological announced the sale of the domestic commercial rights of Rademikibart to a domestic manufacturer, and the company currently only has the overseas rights to the product. Affected by the news of the sale of the core product CBP-201, Connaught Biological (CNTB.US) was severely hit in the secondary market, with a single-day drop of nearly 40%.

It is not difficult to see that the decline in Connaught's share price in recent years actually reflects the market sentiment changes caused by a series of negative events from the poor clinical results of CBP-201 to the sale of domestic commercial rights.

For the current Connaught biology, the overseas rights of CBP-201 are almost their only short-term reliance to achieve commercialization. However, the global market for asthma/COPD drugs is mainly occupied by GSK, AstraZeneca, and Sanofi. In 2019, GSK's product sales revenue for this area was $8.534 billion, although it fell slightly, it still accounted for 37% of the global market, firmly occupying the leading position. AstraZeneca and Sanofi achieved growth in total sales revenue in this area with their two monoclonal antibodies for asthma. Sanofi entered the top three in this field as early as 2019 with dupilumab.

Such a market competition environment means that Connaught's biology can hardly rely on its own strength to expand the overseas sales of Rademikibart. Cooperation with MNC seems to be the only path. In its previous financial report, Connaught Biological also mentioned that it has not yet built commercial and distribution capabilities, and will consider cooperation with other companies in development and commercialization.

In addition to dupilumab, many manufacturers including AstraZeneca, Akeso, Qilu Pharmaceutical and Hengrui are also focusing on the IL-4Rα target.

Moreover, Connoya CM310, which has made the fastest progress, is also facing competition pressure from dupilumab, which has a first-mover advantage in the domestic market. Therefore, turning to the overseas market with better clinical efficacy is also an option for Connoya. At that time, Connaught's biological may be besieged by competitors both at home and abroad, and its survival pressure is considerable. With its core product in such a situation, it is obviously difficult for Connaught to win market favor.

The translation is provided by third-party software.


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