Stay at the forefront of the week’s champions and runners-up among publicly traded biotech companies and the reasons behind the ups or downs of their stock price fluctuations.
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BICO Group (BICO.ST) shares plummeted 43.5% this week, to SEK 96.60 ($9.83) today, and have cratered 84% since the company reached its 52-week high closing price of SEK 611 ($58.85) on August 5, 2021 (including a 64% drop since the first trading day of the year January 3).
This week’s plunge reflects company turmoil highlighted by Executive Vice President and CFO Gusten Danielsson abruptly leaving BICO on Tuesday. The following day, Danielsson told Danish business news outlet Dagens Industri that he was forced out after expressing discontent with Gatenholm, adding that Gatenholm “is no longer the right CEO for the company.”
However, also on Wednesday, BICO’s board declared full confidence in Gatenholm and the company’s current course: “We are fully united behind the CEO, the management team and the strategy with focus on profitability. The company has great potential and is now entering an important stage for the future,” BICO board Chairman Carsten Browall said in the statement.
BICO commercialized the first bio-based ink in 2016 but has since moved far beyond bioprinting and on-demand biofabrication of human organs and tissues. Last year the company reflected that evolution by changing its name from CELLINK Life Sciences to BICO, short for “bioconvergence”—a combination of biology, engineering and computer science technologies for healthcare and life-sci applications that include robotics, artificial intelligence, advanced genomics and bioprinting.
Speaking with GEN Edge today, BICO’s Co-Founder and CEO Erik Gatenholm attributed Danielsson’s departure to differences over what BICO’s future strategic direction should be, let alone how to achieve it.
“It’s unfortunate that the former CFO chose to resign due to different views on the future,” Gatenholm said. “Historically, the finance department’s focus has mainly been on growth and acquisitions. In order to achieve our communicated goals the Board and management team now want to strengthen the finance function’s focus on profitability.”
“An increased focus on improved profitability is a necessary and natural change for the company,” Gatenholm added.
Is that profitability essential to reversing BICO’s stock plunge, Gatenholm was asked.
“I believe the stock market is currently experiencing extreme volatility due to macroeconomic effects and that the sentiment in the market has shifted a bit from growth stocks and tech to profitability. This became more clear in the beginning of the year,” Gatenholm replied. “With that being said, we are building one of the most exciting companies in the life science industry today, and we have great confidence in our people, products, and customers. Our strong mission is driving us forward, making an impact for our customers, and we believe that by reaching profitability, we can prove ourselves in the stock market as well.”
That mission has yet to be embraced by investors, who responded this week with selloffs that led to share price declines of 4.5% on Monday, 35% on Tuesday, 9% on Wednesday, and 1% today.
BICO has undertaken a buying spree in recent years that has grown the company into a family of 14 companies—most recently completing the purchase of Biosero, a San Diego developer of software solutions and services designed to enable seamless laboratory automation.
“If the right opportunity arises we are still open to add further acquisitions,” Gatenholm said. “We see no need to make changes in the bioconvergence strategy as a whole.”
For the time being, Danielsson’s duties as CFO and oversight of the company’s finance department are being handled by Tommy Niklasson, Bico’s vice president of finance.
“We are now concentrated on recruiting an experienced CFO who shares our view on BICO’s strategic direction,” Gatenholm said. “Our goal is to build a financially sustainable business that is supported by a strong finance department.”
Summing up differences with Danielsson, the CEO added “Our collected vision has always been to create the future of health, and do so by reducing the organ and tissue shortage as well as speed up drug discovery by providing accessible products that combine biology and technology, or bioconvergence. However, we had different views on the best strategy to achieve that vision. That happens.
“Having said that, I am glad that the board has full confidence in me, the management team and our current strategic direction.”
Caladrius Biosciences (CLBS)
Caladrius shares dipped 17% this week, the highlight of which was Wednesday’s announcement of the company’s planned “merger of equals” with privately-held Cend Therapeutics. Following closing of the deal expected in the third quarter, the combined company will be renamed Lisata Therapeutics, and trade on the Nasdaq under the ticker symbol LSTA.
After an initial 12% jump in premarket trading Wednesday, investors took profits, sending shares down to 61 cents from 63 cents on Tuesday. Shares fell 17% in early trading today, to 52 cents as of 11:30 a.m.
Lisata will combine Caladrius’ first-in-class autologous cell therapy products based on self-repair with Cend’s focus on treating solid tumor cancers.
Caladrius’ pipeline includes XOWNA®(CLBS16), a coronary microvascular dysfunction candidate in the Phase IIb FREEDOM trial (NCT04614467) in the U.S.; CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease; and CLBS12 (HONEDRA® in Japan), recipient of a SAKIGAKE accelerated approval designation in Japan, where it is eligible for early conditional approval to treat critical limb ischemia and Buerger’s disease.
Caladrius agreed to immediately invest $10 million in Cend “to maintain development momentum of the Cend pipeline” through a development collaboration agreement.
Cend has developed the CendR Platform™, designed to enhance drug delivery to tumors by providing enhanced tumor-targeted tissue penetration capability. The company is applying that technology to alter immunosuppression selectively within the tumor microenvironment, in order to enable a patient’s immune system and immunotherapies to fight cancer more effectively
“We believe that Cend’s technology has the potential to deliver novel and improved treatments in patients with solid tumor cancers with a lead program in pancreatic cancer that already has shown great promise based on early clinical data,” Caladrius President and CEO David J. Mazzo, PhD, stated.
Eliem Therapeutics (ELYM)
Eliem shares tumbled 56% on Monday after the company acknowledged clinical setbacks for its two lead drug candidates. Eliem acknowledged that ETX-810 failed a Phase IIa proof-of-concept trial (NCT04688671) in diabetic peripheral neuropathic pain (DPNP) by not achieving statistically significant separation from placebo on the study’s primary endpoint, assessing the change from baseline to week four in the weekly average of the daily pain score measured with the Pain Intensity Numerical Rating Scale (PI-NRS).
ETX-810 is a new chemical entity prodrug of the bioactive lipid palmitoylethanolamide (PEA). The setback does not affect another Phase IIa trial evaluating ETX-810 in patients with lumbosacral radicular pain (LSRP). That study has been fully enrolled, with topline data expected in the third quarter
Also, Eliem said it was delaying enrollment in planned Phase IIa proof-of-concepttrials assessing ETX-155 in major depressive disorder and perimenopausal depression, after reviewing interim results from a Phase Ib study of the neuroactive steroid GABAA receptor positive allosteric modulator in photosensitive epilepsy. The company said ETX-155 showed inconclusive results on the photoparoxysmal response seen after intermittent photic stimuli following the evaluation of three patients. An analysis showed that drug levels were significantly lower than expected based on the pharmacokinetic profile observed in two earlier Phase I trials of ETX-155 in healthy subjects.
“The company is currently investigating potential root causes of the observed difference in exposure from the prior studies, including evaluation of any differences between the lots of drug product used in this study and those of the prior Phase I trials,” Eliem said, adding that it will offer an update to its timelines “after the root cause is further investigated.”
Molecular Partners (MOLN)
Shares of Molecular Partners fell 37% on Wednesday, the day after the company gave investors a double dose of bad news. Molecular Partners acknowledged that Amgen will return the global rights it holds to Molecular’s MP0310 after a strategic pipeline review. MP0310 is under study in a Phase I trial, with data to be presented at an unspecified future scientific conference. No additional clinical studies are planned “at this time.”
Once the Phase I trial is completed, Molecular Partners plans to seek a new collaboration partner for MP0310, citing its mode of action. MP0310 is a dual-targeted compound designed to target both FAP and 4-1BB, with the potential to activate T-cells and other immune cells in the tumor microenvironment. Molecular aims with MP0310 to avoid systemic side effects associated with 4-1BB activation.
Separately, Molecular acknowledged without additional comment remarks made by Novartis CEO Vas Narasimhan during his company’s quarterly earnings call on April XX. Narasimhan said stated that the Emergency Use Authorization application (EUA) filed with the FDA in February by Novartis for the COVID-19 candidate ensovibep, which the pharma giant is partnering with Molecular Partners to develop, may require additional clinical data to be authorized.
Narasimhan added that Novartis is in talks with the FDA on a potential Phase III study design that could provide the additional data the agency is seeking for either an EUA or full regulatory approval of ensovibep, a Designed Ankyrin Repeat Protein (DARPin) antiviral therapeutic.
Nektar Therapeutics (NKTR)
Nektar’s shares fell 16.5% this week, starting with an 8% slide on Tuesday after the company announced it is eliminating 70% of its workforce—more than 500 jobs—in a restructuring that followed the failure of a four-year-old collaboration to develop Nektar’s lead candidate bempegaldesleukin (BEMPEG) in combination with Bristol Myers Squibb (BMS)’ cancer blockbuster Opdivo®(nivolumab) following three failed clinical trials.
Nektar said it expected to take a charge in connection with the job cuts of between $150 million and $160 million, of which a “substantial” portion will be reflected in second-quarter financial results. The company also expects to end 2022 with approximately $440 million to $450 million in cash and investments, and no debt, as a result of winding down its BEMPEG collaboration with BMS and restructuring costs.
Shares of Nektar dropped 23% on April 18, four days after the company joined BMS to announce an end to their BEMPEG-Opdivo collaboration following failures in two clinical trials—the Phase III PIVOT-09 (NCT03729245) in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC); and the Phase II PIVOT-10 trial (NCT03785925) in patients with cisplatin-ineligible, locally advanced or metastatic urothelial cancer.
In March, the combination failed the Phase III PIVOT IO-001 trial (NCT03635983), assessing BEMPEG-Opdivo as a first-line treatment for previously untreated unresectable or metastatic melanoma.
The stock slide continued into Wednesday, with a nearly 2% dip, followed today by an 8% decline in early trading today, to $3.94 as of 11:33 a.m. ET.
