Happy December! We hope you were all able to enjoy some well-deserved downtime and a safe, healthy and delicious Thanksgiving!
Despite the holiday “break,” it’s been a very busy few weeks for Stern IR clients and we wanted to congratulate several on recent clinical, regulatory and corporate successes:
- Allena Pharmaceuticals announced initial data from its Phase 1 trial of ALLN-346 and, subsequently, a $13.0M bought deal financing. Read more here and here.
- Blueprint Medicines announced FDA approval of GAVRETO (pralsetinib) for the treatment of patients with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancer. Read more here.
- Intellia Therapeutics announced the pricing of a $175M follow-on offering. Read more here.
- Precision Biosciences announced a research collaboration and exclusive license agreement with Eli Lilly to use Precision’s proprietary ARCUS genome editing platform for the research and development of potential in vivo therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy (DMD) and two other undisclosed gene targets. Read more here.
- Precision Biosciences also announced positive interim results from its PBCAR0191 Phase 1/2a trial in r/r NHL and r/r B-ALL. Read more here.
- Rhythm Pharmaceuticals announced FDA approval of IMCIVREE (setmelanotide), the first-ever therapy for chronic weight management in patients with obesity due to POMC, PCSK1, or LEPR deficiency. Read more here.
- Sage Therapeutics announced a global collaboration and license agreement with Biogen to jointly develop and commercialize and zuranolone for major depressive disorder, postpartum depression and other psychiatric disorders, and SAGE-324 for essential tremor and other neurological disorders. Read more here.
And more excitement coming up! Many Stern IR clients will be presenting new data at the ASH and SABCS meetings this weekend and next, with several hosting webcast events, as follows:
- ADC will host a webcast event on Monday, 12/7 at 8:00am ET to discuss data from its next-generation antibody drug conjugates, including loncastuximab tesirine (Lonca) for the treatment of r/r DLBCL and camidanlumab tesirine (Cami) for Hodgkin lymphoma.
- Curis will host a webcast event on Tuesday, 12/8 at 8:00am ET to discuss data from two Phase 1 studies of CA-4948 in patients with NHL and in AML and MDS.
- Forma will host a webcast event on 12/7 at 6:00pm ET to discuss updated results from its ongoing Phase 1 trial of FT-4202 in SCD, as well as an overview of the company’s development plans for FT-4202.
- Gamida Cell will host a webcast event on Wednesday, 12/9 at 9:00am ET to discuss the company’s pipeline, including omidubicel, in Phase 3 development for patients in need of bone marrow transplant, and GDA-201, an NK cell-based cancer immunotherapy.
November: Great Month for Biotech!
As Cowen pointed out in their monthly Biotech Thermometer, November stands out as a strong month for biotech with our sector experiencing its strongest rally since the spring. The biotech indices kept pace with the broader markets – driven in large part by growing optimism for COVID vaccines, as well as increasing clarity on a more stable political environment as evidenced by the VIX decline (see below)..
Going in to December, Cowen reports that biotech specialists remain engaged and upbeat, with many benefiting from recent stock-moving data releases and now sitting on healthy returns. While generalist interest in biotech has trended somewhat down since the blistering 2Q 2020 highs, they are continuing to participate in the biotech IPOs, which continue to produce outsized returns.
New NASDAQ Listing Requirements for Board Diversity:
Earlier this week, NASDAQ submitted a proposal to the SEC seeking approval of new listing requirements for board diversity. As part of the rationale for the new requirements, NASDAQ’s proposal presents an analysis of over two dozen studies, the overwhelming majority of which found a positive association between diverse boards and improved financial performance and corporate governance.
The proposed listing rule (available in full here) would require all companies listed on NASDAQ’s U.S. exchange to:
- Publicly disclose consistent, transparent diversity statistics regarding their board of directors
- Have to have – or explain why they do not have – at least two diverse directors by a certain date based on their listing tier, including one who self-identifies as female and one who self-identifies as either an underrepresented minor or LGBTQ+.
- Smaller reporting companies could satisfy this requirement by having two female directors.
- Foreign reporting companies could satisfy this requirement by having two female directors, or one female director and one underrepresented individual in the company’s home country jurisdiction.
The markets were stable this week, with the NASDAQ, DJI and S&P 500 closing up 1%, 0.2% and 1% respectively. The VIX was also up 2%, sitting at 21.31 as of market close on 12/3. The biotech markets were similarly flat/trending positive, with the NBI, BTK, and XBI closing up 2%, 2% and 1% respectively.
This week we saw a handful of deals price, including:
- Eight follow-ons: Stern IR Client Allena ($13M), BeiGene ($340MM), Cogent Biosciences ($100M), Stern IR Client Intellia Therapeutics ($175M), Outset Medical ($212M), Progenity ($25M), Reata Pharmaceuticals ($281.7M) and Twist Bioscience ($300M).
- Four IPOs: Kinnate Biopharma ($240M), Seer ($175M), Sigilon Therapeutics ($126M), and Silverback Therapeutics ($241.5M) .
The private markets were also lively, with several deals pricing:
- Adrenomed (Series E, € 22.2M ), BioSight (Series C, $46M), Genesis (Series A, $52M), Kinaset (Series A, $40M), MaaT (Series B, €25.35 ), Noema (Series A, $59M), Proscia (Series B, $23M), and Tallac (Series A, $62M).