Vaxcyte Inc (PCVX)

PCVX—(-55%)—reports purportedly-positive phase-2 data for VAX-24 in infants:

https://finance.yahoo.com/news/vaxcyte-announces-positive-topline-results-110000250.html Based on these findings, the Company has selected the VAX-24 Mid dose as the basis for advancement of an optimized dose formulation to a potential Phase 3 program and, pending the VAX-31 infant Phase 2 study topline data results anticipated in mid-2026, plans to initiate an infant Phase 3 study with either VAX-24 or VAX-31 [emphasis added]. Only the middle dose of the three doses tested met the primary endpoint of non-inferiority to PFE’s Prevnar-20.

If these VAX-24 data had been stellar, PCVX would presumably have advanced the program to phase-3 now rather than possibly going to phase-3 in mid-2026.

The Peter Marks news over the weekend has undoubtedly increased the magnitude of today’s PCVX selloff.

p.s. I’ve long thought that PCVX was overvalued (#msg-175027716).

do you expect a similar pop for the infant Vax-24 data? I think the infant market is larger

PCVX over $100

PCVX sells 14.5M* shares_&prefunded_warrants @$103.00—a_7% discount to_Monday’s_closing_price:

https://www.globenewswire.com/news-release/2024/09/05/2941023/0/en/Vaxcyte-Announces-Pricing-of-1-3-Billion-Public-Offering.html

Net proceeds after underwriting fees will be ~$1.4B*. When these proceeds are added to the ~$1.4B of PCVX’s net current assets on the 6/30/24 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001649094/000164909424000052/pcvx-20240630.htm ), PCVX will have a colossal amount of liquidity.

As noted in #msg-175027716 I consider PCVX shares somewhat overvalued. The stock has some buyout vig, but the buyout vig at the current valuation is modest (IMO).

*Assuming exercise of underwriter’s option.

Vaxcyte Reports Positive Topline Data from Phase 1/2 Study of VAX-31, its 31-Valent Pneumococcal Conjugate Vaccine Candidate, in Adults Aged 50 and Older

PCVX under $100

PCVX over $30

PCVX lays_out_timelines_for VAX-24/VAX-31 programs:

https://www.globenewswire.com/news-release/2024/01/04/2804307/0/en/Vaxcyte-Provides-Clinical-and-Regulatory-Progress-Update-on-Potential-Best-in-Class-Pneumococcal-Conjugate-Vaccine-PCV-Franchise.html

Timeline info:

• In the adult VAX-24 program, the main phase-3 trial, which will seek to show non-inferiority to PFE’s Prevnar-20 on immunogenicity, is expected to start in 2H24. Other (shorter) phase-3 trials in the adult VAX-24 program will start in 2025 and 2026, so it appears that the soonest PCVX could file a BLA is 2027 and the soonest VAX-24 could receive FDA approval for adults is 2028.

• The VAX-24 program for infants is in phase-2; topline data is expected at the end of 2025.

• The VAX-31 program, which is for adults, is in phase-1/2; topline data is expected in 3Q24.

This PR also says that PCVX received “encouraging feedback” from the FDA on the CMC requirements for VAX-24, whatever that means.

I consider PCVX, which has an enterprise value of about $5B, to be somewhat overvalued.

PCVX +16% on phase-2 data for VAX-24:

https://finance.yahoo.com/news/vaxcyte-reports-positive-data-phase-103000816.html

https://investors.vaxcyte.com/static-files/90fd9df6-3990-4954-acd8-8e24690783a0

VAX-24 is a 24-valent-pneumococcal vaccine.

Please see #msg-170872992 and #msg-170868559 for background info.

PCVX gets BTD for VAX-24 in adult market—investors yawn:

https://www.globenewswire.com/news-release/2023/01/05/2583736/0/en/Vaxcyte-s-VAX-24-Granted-FDA-Breakthrough-Therapy-Designation-for-the-Prevention-of-Invasive-Pneumococcal-Disease-in-Adults.html

PCVX has around $1B(!) in cash:

https://www.globenewswire.com/news-release/2022/11/07/2550261/0/en/Vaxcyte-Reports-Third-Quarter-2022-Financial-Results-and-Provides-Business-Update.html -- $366.2 Million in Cash, Cash Equivalents and Investments as of September 30, 2022, Excluding Net Proceeds of Approximately $650.7 Million from Recent Public Offering –

Thank you DewDiligence! I'm happy for him. Larry Pickering's experience and guidance is an asset. I hope Grant's old company Mymetics can find success.

It doesn't affect options already granted. It could have an effect on insider 10b5-1 ("programmed") selling, but it probably won't affect that either.

Will this impact Grant's $1.79 options or the 10,000 + company shares he sells at market price monthly?

Correction—PCVX sells 21.6M* shares @$32.00—a 3% discount to Monday’s close—raising ~$650M* in net proceeds

https://www.globenewswire.com/news-release/2022/10/26/2541446/0/en/Vaxcyte-Announces-Pricing-of-600-Million-Public-Offering.html

*Assuming exercise of underwriter’s option.

PCVX sells 18.75M* shares @$32.00—a 3% discount to Monday’s close—raising $600M in gross proceeds:

https://www.globenewswire.com/news-release/2022/10/26/2541446/0/en/Vaxcyte-Announces-Pricing-of-600-Million-Public-Offering.html

*Assuming exercise of underwriter’s option.

PCVX VAXCYTE INC
$34.92 +14.34 (+69.68%)
As of Oct-24-202211:29:43 AM ET

https://stockcharts.com/h-sc/ui?s=PCVX

Update: Vaxcyte's VAX-24 Investigational Pneumococcal Conjugate Vaccine Meets Standards in Phase 1/2 Study - Shares Surge
By MT Newswires — 9:53 AM ET 10/24/22

Vaxcyte (PCVX.NaE) said Monday that VAX-24, the company's investigational 24-valent pneumococcal conjugate vaccine, met the primary safety and tolerability objectives in its phase 1/2 clinical proof-of-concept study.

The study's positive topline results mean VAX-24 met or exceeded the established regulatory immunogenicity standards for all 24 serotypes at the conventional 2.2 microgram dose, which the company looks to progress into a phase 3 program.

VAX-24 showed a safety profile similar to Prevnar 20, or PCV20, for all doses studied, the company said.


Company Profile
Company LocationSan Carlos, CA
Vaxcyte, Inc., a clinical-stage biotechnology vaccine company, develops novel protein vaccines to prevent or treat bacterial infectious diseases. Its lead vaccine candidate is VAX-24, a 24-valent investigational pneumococcal conjugate vaccine that is in Phase 1/2 clinical trials to treat invasive pneumococcal disease and pneumonia

PCVX +66% on VAX-24 phase-1/2 data in adults, showing comparable efficacy/tolerability to Prevnar-20:

https://www.globenewswire.com/news-release/2022/10/24/2539776/0/en/Vaxcyte-Reports-Positive-Topline-Data-from-Phase-1-2-Proof-of-Concept-Study-of-its-24-Valent-Pneumococcal-Conjugate-Vaccine-Candidate-Being-Investigated-for-the-Prevention-of-Invas.html

The apple doesn't fall far from the tree.

https://biography.omicsonline.org/norway/optinose/larry-g-pickering-939510

https://avistacap.com/news_item/avista-capital-partners-raises-2-0-billion-inaugural-fund/

GSK to acquire clinical-stage biopharmaceutical company Affinivax, Inc.

https://affinivax.com/gsk-to-acquire-clinical-stage-biopharmaceutical-company-affinivax-inc/


GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones

Proposed acquisition provides access to next-generation 24-valent pneumococcal vaccine candidate in phase II development and highly innovative, MAPS technology

Supports development of a strong portfolio of innovative vaccines and specialty medicines

"Affinivax has developed the Multiple Antigen Presenting System (MAPS), a novel technology that supports higher valency than conventional conjugation technologies, enabling broader coverage against prevalent pneumococcal serotypes and potentially creating higher immunogenicity than current vaccines. Affinivax’s most advanced vaccine candidate (AFX3772) includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins (compared to up to 20 serotypes in currently approved vaccines). A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development."

Seems familiar...

PCVX 3/31/22 cash=$352M (including $108M raised in the Jan 2022 public offering):

https://www.globenewswire.com/news-release/2022/05/09/2439081/0/en/Vaxcyte-Reports-First-Quarter-2022-Financial-Results-and-Provides-Business-Update.html

I’m not a fan of PCVX, but I give them credit for raising cash in January (even at the steep discount to the then-current share price).

PCVX expects_to_report_data_from_phase-1/2_trial_of_(pneumococcal vaccine) VAX-24 by_year-end_2022:

https://www.globenewswire.com/news-release/2022/04/04/2415747/0/en/Vaxcyte-Doses-First-Participants-in-Phase-2-Portion-of-Ongoing-VAX-24-Phase-1-2-Clinical-Proof-of-Concept-Study-in-Adults.html

The trial is now beginning the pghase-2 portion.

Are there other companies with conjugate vaccines just as good?PFE’s Prevnar-20 is, but you probably knew that already.

“Preferred Recommendation Chances"

The success of this company seems to hinge on getting "ACIP preferred recommendation".

The vaccine seems to be very expensive and difficult to manufacture. $102,000,000 gone in the year before they even started a phase 1 trial. Seems very expensive and too hard to manufacture.

Are there other companies with conjugate vaccines just as good?

PCVX starts phase-1/2 trial of VAX-24:

https://www.globenewswire.com/news-release/2022/02/23/2390751/0/en/Vaxcyte-Doses-First-Participants-in-Phase-1-2-Clinical-Study-Evaluating-VAX-24-for-the-Prevention-of-Invasive-Pneumococcal-Disease-and-Pneumonia-in-Adults.html Vaxcyte, Inc…announced today that the first participants were dosed in the Phase 1/2 clinical study of VAX-24. This clinical proof-of-concept study will evaluate the safety, tolerability and immunogenicity of VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD) and pneumonia in adults. The Company expects to announce topline safety, tolerability and immunogenicity results from the Phase 1/2 study by the end of 2022.

…The VAX-24 Phase 1/2 clinical proof-of-concept study is a randomized, observer-blind, dose-finding, controlled study designed to evaluate the safety, tolerability and immunogenicity of VAX-24 in healthy adults. The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-24 at three dose levels and compared to Prevnar 20 in approximately 64 healthy adults 18 to 49 years of age. The Phase 2 portion will evaluate the safety, tolerability and immunogenicity of a single injection of VAX-24 at three dose levels and compared to Prevnar 20 in approximately 800 healthy adults 50 to 64 years of age.

The prespecified immunogenicity endpoints of the Phase 2 portion of the study include an assessment of the induction of antibody responses, using immunoglobulin G (IgG) and opsonophagocytic activity (OPA), at each of the three VAX-24 doses and compared to Prevnar 20 and, for the additional four serotypes contained in VAX-24 and Pneumovax 23 but not in Prevnar 20, the four-fold rise in antibody titers. The study will be conducted at approximately 13 sites in the United States.

PCVX sells 5.075M* shares/prefunded warrants @$20.00—a_15%_discount to Monday’s_closing price of $23.61:

https://www.globenewswire.com/news-release/2022/01/13/2366065/0/en/Vaxcyte-Announces-Pricing-of-100-Million-Public-Offering.html

I've long been a skeptic of this company—see, for instance #msg-163165688.

*Assuming exercise of underwriter’s option.

After listening to the Needham webcast, I’m going out on a limb and asserting that VAX-XP—the purported successor to VAX-24—will turn out to be vaporware.

PCVX -18% on VAX-24 delay reported last night (#msg-162862041).

I listened to PCVX’s CC last night and it’s clear that PCVX has a lot of work to do on the manufacturing front. PCVX is relying on Lonza for manufacturing the 24 conjugates that will comprise the VAX_24 pneumococcal vaccine, and some of these conjugates have yet to be produced. Moreover, the PCVX-Lonza relationship seems to be on the fritz insofar as PCVC executives jabbed at Lonza by implying that Lonza had moved slowly on PCVX tasks in order to serve other (higher-paying) clients.

I wouldn’t be surprised if the VAX-24 timeline slips further. VAX-24 is the kind of product candidate that belongs with a large drug/biotech company, IMO.

Adding

Vaxcyte Promotes Andrew Guggenhime to President and Chief Financial Officer

https://www.globenewswire.com/news-release/2020/12/22/2149344/0/en/Vaxcyte-Promotes-Andrew-Guggenhime-to-President-and-Chief-Financial-Officer.html

SEC Form 4. Director William Newell purchased 22,228 shares

https://www.sec.gov/Archives/edgar/data/1649094/000120919120062813/xslF345X03/doc4.xml

Vaxcyte to Present at Jefferies Virtual London Healthcare Conference

https://www.globenewswire.com/news-release/2020/11/10/2124323/0/en/Vaxcyte-to-Present-at-Jefferies-Virtual-London-Healthcare-Conference.html

Vaxcyte is hiring.

https://vaxcyte.com/careers/

Low volume but solid rise today with Q correction yesterday.

Good leadership with Mr. Pickering!

Grant Pickering, MBA -Vaxcyte, President & Chief Executive Officer, Director and Founder
Grant has nearly 30 years of experience in the pharmaceutical and biotech arena having responsibility for multiple vaccines and immunotherapeutic drug approvals and the formation and financing of multiple successful platform companies. Prior to starting Vaxcyte, Mr. Pickering was the CEO of Mymetics Corporation, a public European-based vaccine company developing a prophylactic RSV vaccine, based on a virosomal platform technology. Prior to that, he was an executive-in-residence at Kleiner, Perkins, Caufield & Byers, while serving as the CEO at Juvaris BioTherapeutics, whose immunotherapeutic and vaccine adjuvant platform yielded multiple animal health products launched by its alliance partner Bayer HealthCare, including Zelnate® and Victrio®. Prior to Juvaris, Mr. Pickering spent many years at Dendreon Corporation where he played a prominent role in the company’s IPO and led clinical development, operations and business development culminating in the launch of the therapeutic prostate cancer vaccine, Provenge®. He also led marketing and business development for the pain management platform company, Algos Pharmaceutical Corporation, which was acquired by Endo Pharmaceuticals. Mr. Pickering began his career at Glaxo and Johnson & Johnson in sales, marketing, and clinical research roles culminating in the launches of Flonase® and Floxin®. Mr. Pickering earned his BS degree in marketing from The Pennsylvania State University and his MBA from Georgetown University with high honors. Outside of Vaxcyte, Grant enjoys spending time with his wife and kids, living vicariously through their soccer triumphs, and gives back through mentoring and supporting education both domestically and in developing countries. Grant’s loyalty to his hometown of Kansas City was finally doubly rewarded as both the Royals and the Chiefs were crowned world champions since Vaxcyte got rolling.
https://vaxcyte.com/about-us/management-team/

Mymetics Corp. (otcqb: MYMX) https://www.mymetics.com/about/