We hope you are all looking forward to some well-earned R&R over the Thanksgiving holiday – it’s been a wild few weeks for biotech! As we’ve reflected on the recent data from Pfizer and Moderna, we are encouraged not only by what these results mean for our global community and the collective fight against COVID-19, but also by what they say about the tremendous power of science and innovation more broadly. We are inspired to be part of an industry that is so wholly committed to doing good in the world, and we are grateful every day for the opportunity to work with such a wide array of companies at the forefront of improving human health. Thank you for letting us be a part of your journey!
Earlier this morning, our parent company, Precision Medicine Group, announced that it has completed a major investment and recapitalization led by funds managed by Blackstone, with significant participation from Precision’s co-founders, as well as current shareholders Berkshire Partners, TPG Growth, Oak HC/FT and Vida Ventures. This investment will help fuel the expansion of PMG’s global footprint and technical capabilities to help accelerate the development, approval and commercial reach of breakthrough therapies from life science innovators. We are thrilled to welcome Blackstone to the PMG family, and look forward to their partnership! Read more here.
This week, we want to congratulate Stern IR client Jo Viney of Pandion Therapeutics who was recently recognized among FiercePharma’s Fiercest Women in Life Sciences! Read more about her tremendous accomplishments here.
SITC Recap:
Earlier this month, several Stern IR clients presented new clinical data at SITC, sharing preclinical and clinical across a number of different cancers:
- Bolt presented the trial design of its ongoing Phase ½ clinical trial, as well as preclinical data demonstrating proof-of-concept for its lead drug candidate BDC-1001. Read more here.
- Curis presented a Trial in Progress abstract for CI-8993, its first-in-class VISTA antibody. Read more here.
- Evelo Biosciences presented new preclinical data demonstrating the anti-tumor effects of EDP1908, its extracellular vesicle (EV) product candidate for the treatment of cancer. Read more here.
- Istari Oncology presented positive Phase 1 clinical data for its lead product candidate, PVSPRIO, in patients with unresectable, anti-PD-1 refractory melanoma. Read more here.
- Jounce presented new preclinical data on JTX-8064, the first tumor-associated macrophage program from its Translational Science Platform. Read more here.
- Mersana presented preclinical mechanistic data from its Immunosynthen STING-Agonist ADC platform. Read more here.
- Shattuck Labs presented preclinical proof-of-concept data from its Gamma Delta T Cell Engager (GADLEN™) platform. Read more here.
- Xencor presented updated data from the DUET-2 Phase 1 study of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in patients with advanced solid tumors, as well as new data from three preclinical-stage programs, including its IL-12-Fc cytokine program, its CD28 bispecific antibody program, and its PD-1 x TGFβR2 bispecific antibody program. Read more here and here.
- 4D pharma presented new clinical data from two trials of MRx0518, its lead immuno-oncology single strain Live Biotherapeutic candidate. Read more here.
Modernizing the Risk Factors Section of SEC Filings:
Over the summer, the SEC voted to adopt amendments to modernize the description of business, legal proceedings and risk factor disclosures that registrants are required to make pursuant to Regulation S-K (anyone who’s waded through any S-1 can attest to this). The goal was to elicit improve disclosures, tailored to reflect registrants’ particular circumstances, while also improving the readability of disclosure documents, discouraging repetition, and reducing the disclosure of information that is not material. These amendments, which can be found here, went into effect earlier this Fall. Note, in particular, the new requirement of a summary risk factor disclosure of no more than two pages if a risk factor section exceeds 15 pages!
Defining Material Non-Public Information (MNPI) in the Context of M&A:
Last month, the SEC announced that a public company had agreed to pay a $20M penalty to resolve charges related to its repurchase of stock while supposedly in possession of MNPI. As the legal team at Goodwin pointed out in a subsequent white paper, the SEC’s cease and desist order offers important lessons for assessing whether a company is in position of MNPI in the context of ongoing M&A discussions, to be determined more or less on how concrete these discussions are.
Market Update:
The markets were turbulent again, though they seem to have largely stabilized by the end of the week, with the NASDAQ, DJI and S&P 500 closing up 2%, 1% and 1% respectively. The VIX was down a substantial 9% (for the second consecutive week!), sitting at 23.11 as of market close on 11/19. The biotech markets stayed relatively flat, with the NBI, BTK, and XBI all closing down at 1%.
This week we saw continued activity on the VC side:
- Simeon George and his team at SR One completed their spinout from GlaxoSmithKline, launching their own $500 million fund. The new fund will continue building and investing in next-generation biotech companies that are translating cutting-edge science into new medicines.
- Qiming Venture Partners closed its seventh fund, raising $1.2B to back early-stage companies, with a particular focus on China market investments. As a whole, Qiming has a broader investment focus than many VCs active in biotech, backing technology players as well as healthcare startups.
This week we saw a handful of deals price, including:
- Four follow-ons: BeyondSpring ($75M), Kodiak Sciences ($560.9 M), MeiraGTx ($64.3M), Oncternal Therapeutics ($22.5M).
- One IPO: Olema Pharmaceuticals ($209M) – who priced at $19 and was trading up 157% at $49 as of market close on Thursday.
- Six privates financings: Elevation Oncology (Series B, $65M), Imago Biosciences (Series C, $80M), Nereid Therapeutics (Series A, $50M), Medable (Series C, $91M), Pharvaris (Series C, $80M), and Umoja Biopharma (Series A, $53M).