# PureTech Health reports strong progress across portfolio, robust shareholder returns

- Link: https://www.directorstalkinterviews.com/puretech-health-reports-strong-progress-across-portfolio-robust-shareholder-returns/4121169542
- Published: 2024-08-28T08:07:46+01:00
- Author: Amilia Stone

**PureTech Health plc** (Nasdaq/LON: PRTC), a clinical-stage biotherapeutics company
dedicated to changing the lives of patients with devastating diseases, has announced
its half-yearly results for the six months ended June 30, 2024. The following information
will be filed on Form 6-K with the United States Securities and Exchange Commission
and is also available at https://investors.puretechhealth.com/financials-filings/
reports.

> **Commenting on PureTech’s half-yearly results, Bharatt Chowrira, PhD, JD, Chief
> Executive Officer said:**
> “I am proud of the talented team at PureTech that has continued to deliver results
> with a sense of diligence and passion. PureTech made significant progress in the
> first half of 2024, advancing our mission to develop innovative therapies for 
> the patients most in need. We have also implemented strategies to drive efficient
> operations and capital allocation. This has resulted in a decrease in both our
> R&D and G&A expenses at the PureTech level.
> “Looking ahead, we are focused on several key catalysts. The highly anticipated
> FDA decision around the approval of KarXT, which is expected by Bristol Myers 
> Squibb (“BMS”) in September, would unlock the first in a series of milestone payments
> to PureTech in the coming years as well as future royalties. We are also very 
> excited about the readout of our Phase 2b trial from our Internal Program, LYT-
> 100 (deupirfenidone), which is expected by the end of 2024. We believe LYT-100
> has blockbuster potential to transform the treatment landscape for patients with
> idiopathic pulmonary fibrosis (“IPF”) as the preferred standard of care, driving
> significant value for PureTech. Additionally, we expect clinical readouts from
> both the Vor and LYT-200 programs as well as further clinical progress at Seaport
> and Vedanta.
> “With our robust hub-and-spoke drug discovery and development model and strong
> financial foundation, we believe PureTech is well-positioned to rapidly advance
> innovative therapeutic candidates to patients, and we remain committed to unlocking
> and realizing value for our shareholders.”

**Webcast and conference call details **

Members of the PureTech management team will host a conference call at 9:00am EDT/
2:00pm BST today, August 28, 2024, to discuss these results. A live webcast and 
presentation slides will be available on the investors section of PureTech’s website
under the Events and Presentations tab. To join by phone, please dial: 

**United Kingdom (Local):** +44 20 3936 2999

**United Kingdom (Toll-Free):** +44 800 358 1035

**United States (Local):** +1 646 664 1960

**United States (Toll Free):** +1 855 9796 654
**Access Code:** 808029

For those unable to listen to the call live, a replay will be available on the PureTech website.

**Key Internal Programs^(2) & Founded Entities**

| **Internal Programs ** | **Ownership ** | **Indication ** | 
| **LYT-100 ****(deupirfenidone) ** | 100%  | Being advanced for idiopathic pulmonary fibrosis and potentially other conditions involving pulmonary fibrosis  |

| **Founded Entities ** | **Ownership^(3)** | **Overview ** | 
| **Seaport Therapeutics** | 57.7% Equity   | Advancing a clinical-stage pipeline of neuropsychiatric medicines   | 
| **Karuna Therapeutics****(wholly owned subsidiary of Bristol Myers Squibb as of March 18, 2024) ** | Regulatory and commercial milestone payments from Royalty Pharma (up to $400M) and BMS, and 2% royalties on annual net sales >$2B from BMS | Advancing transformative medicines for people living with psychiatric and neurological conditions   | 
| **Gallop Oncology** | 100% Equity   | Pioneering novel therapies for the treatment of hematological malignancies, alongside treatments for locally advanced/metastatic solid tumors such as head and neck cancers    | 
| **Vedanta Biosciences** | 35.9% Equity  | Pioneering a new category of oral therapies based on defined bacterial consortia  | 
| **Vor Bio** | 3.9% Equity  | Engineering hematopoietic stem cells to enable targeted therapies for patients with blood cancers  | 
| **Sonde Health** | 34.9% Equity  | Developing a voice-based artificial intelligence platform to detect changes in health  | 
| **Entrega ** | 73.8% Equity  | Engineering hydrogels to enable the oral administration of peptide therapeutics (e.g., GLP-1 agonists)  |

**Highlights **

**PureTech**

•   Completed enrollment of the Phase 2b ELEVATE IPF trial of LYT-100 (deupirfenidone)
in IPF, with topline results expected by the end of 2024. 

•   Executed $100 million tender offer, which – together with the Company’s $50 
million share buyback program that completed on February 7, 2024 – constituted $
150 million of capital returned to shareholders since May 2022.

•   Appointed key executives, including Bharatt Chowrira, PhD, JD, as Chief Executive
Officer (formerly President and Chief Business, Finance and Operating Officer), 
Eric Elenko, PhD, as President (formerly Chief Innovation Officer), Charles Sherwood
III, JD, as General Counsel, and Raju Kucherlapati, PhD as Chair of the Board of
Directors on a permanent basis.

•   Welcomed two entrepreneurs-in-residence: Sven Dethlefs, PhD, formerly Executive
Vice President and CEO of Teva North America, and Luba Greenwood, JD, Managing Partner
of the Dana-Farber Cancer Institute Venture Fund, Binney Street Capital, and former
Chief Executive Officer and Board Chair of Kojin Therapeutics.

•   Announced in the August 2024 post-period that Michele Holcomb, PhD, will join
PureTech’s Board of Directors as an independent non-executive director on September
23, 2024.

**Founded Entities**

•   **Karuna** **Therapeutics** (Karuna) was acquired by BMS in March 2024 for a
total equity value of $14 billion. PureTech received approximately $293 million 
gross proceeds from its equity position in Karuna and is eligible to receive up 
to $400 million in future milestone payments as well as royalty payments based on
KarXT regulatory and commercial successes.

•   PureTech launched **Seaport Therapeutics** (Seaport) with a $100 million oversubscribed
Series A financing to progress the development of novel neuropsychiatric therapeutic
candidates enabled by Glyph™, its novel platform that allows drugs to be absorbed
like dietary lipids so they can enter the lymphatic system directly and avoid first
pass metabolism. Seaport is led by PureTech Founder and Former CEO and Seaport Founder
and CEO Daphne Zohar, with Steven M. Paul, M.D., former CEO and Chair of Karuna,
as Founder and Chair of the Seaport Board of Directors.

•   PureTech announced that it will advance LYT-200 (anti-galectin-9 mAb) via **
Gallop Oncology** (Gallop) for the treatment of hematological malignancies, such
as acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS), and
metastatic/locally advanced solid tumors, including head and neck cancers. LYT-200
received two designations from the US Food and Drug Administration (FDA): Orphan
Drug designation for the treatment of AML and Fast Track designation for the treatment
of head and neck cancers.

•   **Vedanta Biosciences** (Vedanta) enrolled the first patient in its pivotal 
Phase 3 RESTORATiVE303 trial of VE303 for the prevention of recurrent C. difficile
infection (“rCDI”). Vedanta was also awarded $3.9 million from CARB-X to ready VE707
for a first-in-[human study](https://www.directorstalkinterviews.com/company/open-orphan-plc/orph.l)
for the prevention of multidrug-resistant infections.

•   **Vor Biopharma** (Nasdaq: VOR) (Vor) dosed the first AML patient in VBP301,
a Phase 1/2 multicenter, open-label, first-in-human study of VCAR33^(ALLO) and announced
that it expects to provide a clinical trial update in the second half of 2024.

•   **Sonde Health** (Sonde) launched Sonde Cognitive Fitness in the July post-period,
which analyzes eight vocal characteristics from 30-second voice interactions to 
provide insight into one’s cognitive state, helping people manage their mental well-
being and productivity effectively.

•   **Entrega** continues to advance its platform for the oral administration of
biologics, vaccines and other drugs that are otherwise not efficiently absorbed 
when taken orally. To validate its technology, Entrega generated preclinical proof-
of-concept data demonstrating administration of therapeutic peptides into the bloodstream
of large animals.

**Financial:**

•   Consolidated Cash, cash equivalents and short-term investments as of June 30,
2024, were $500.4 million^(4) (December 31, 2023: Consolidated Cash, cash equivalents
and short-term investments of $327.1 million) and PureTech Level Cash, cash equivalents
and short-term investments as of June 30, 2024, were $400.6 million^(5) (December
31, 2023: PureTech Level Cash, cash equivalents and short-term investments of $326.0
million)

•   Operating expenses for the six months ended June 30, 2024, were $66.7 million(
June 30, 2023: $79.3 million).

•   PureTech expects to have PureTech Level Cash, cash equivalents and short-term
investments of approximately $330 million^(6) at December 31, 2024, which is inclusive
of expected payments of approximately $40 million to address the Company’s tax obligations.
As of June 30, 2024, the Company maintains an expected operational runway of at 
least three years.

**Key Upcoming Milestones**

•   PureTech Health expects topline results from the Phase 2b ELEVATE IPF dose-ranging
trial of LYT-100 in patients with IPF by the end of 2024. The trial is designed 
to evaluate the efficacy, tolerability, safety and dosing regimen of LYT-100 in 
patients with IPF compared to placebo and will also assess the relative efficacy
of two doses of LYT-100. The primary endpoint is the rate of decline in Forced Vital
Capacity (“FVC”) for the combined LYT-100 arms versus placebo over the 26-week treatment
period using a prespecified Bayesian approach. Both doses of LYT-100 will be compared
to pirfenidone, though the trial is not powered to show a statistical difference
in efficacy between LYT-100 and pirfenidone. We believe LYT-100 has the potential
to have a profound impact on the way IPF is managed by allowing patients to start,
continue and fully benefit from treatment, both as monotherapy and in combination
settings with other antifibrotic therapies.

•   KarXT (formerly Karuna; now wholly owned by BMS) has a Prescription Drug User
Fee Act (“PDUFA”) date of September 26, 2024, for the treatment of schizophrenia
in adults, which means the FDA is expected to make a decision regarding the approval
of KarXT by this date. If the drug is approved, this would unlock the first in a
series of potential milestone payments to PureTech in the coming years as well as
future royalties. Pending approval, BMS also announced that KarXT is expected to
launch in late 2024.

•   LYT-200 (which will be advanced via Gallop) is being evaluated in two ongoing
Phase 1b clinical trials for the treatment of relapsed/refractory AML and MDS as
well as in combination with tislelizumab in head and neck cancers. Additional data
from the open label trials are expected in the fourth quarter of 2024 and will help
to inform future development work.

•   Vor expects to provide clinical trial updates for trem-cel and VCAR33^(ALLO)
in the second half of 2024. Trem-cel is a shielded transplant in development for
patients with AML and MDS in which healthy transplant donor cells are genetically
engineered removing CD33, with the potential to shield healthy cells and enable 
targeted therapies post-transplant such as Mylotarg and CAR-T therapy. VCAR33^(ALLO)
is a transplant donor-derived anti-CD33 CAR-T cell therapy for patients with AML
who have relapsed following a standard-of-care or trem-cel transplant.

•   Vedanta expects topline data from its Phase 3 RESTORATiVE303 trial of VE303 
for the prevention of rCDI in 2026. This trial is evaluating the efficacy and safety
of VE303 in patients with rCDI and is intended to form the basis for a Biologics
License Application (“BLA”) to be filed with the FDA. It also expects topline data
from its Phase 2 COLLECTiVE202 clinical trial of VE202 for the treatment of ulcerative
colitis (“UC”)in 2025. Vedanta also expects to initiate a Phase 1 trial of VE707
for the prevention of multidrug-resistant infections in 2025.

Share on: