Each of these programs has the potential to expand into a treatment study for additional and broad dermatology indications beyond the initial orphan indications. Strategic allies poised to help Timber transition from a development stage to an FDA-approved product company include advisors from UCSF, Yale, and
The company has also raised
A Focus On Orphan Drug Indications Using the 505(b)(2) Regulatory Pathway
Beyond its focus on orphan drug indications,
Timber is taking advantage of those benefits in addition to the 505(b)(2) regulatory pathway, a primary means to mitigate clinical risk and time in drug development. An inherent benefit of this course is that the safety and efficacy of the original compound have already been established and can be leveraged to expedite new development. Thus, companies are often given the approval to move directly into Phase 2 clinical studies, as is the case with Timber. Mega-caps like
These orphan drugs often become the only treatment option for these rare diseases. Once approved they generally obtain better pricing and reimbursement status than drugs serving much broader populations with several competing treatment options. By focusing on orphan drugs, Timber expects to be able to target its markets with a more focused and efficient strategy that can seize substantial commercial opportunities.
The company is already developing three clinical programs, two of which are in Phase 2b clinical status.
Advancing Multiple Clinical Programs In 2020
While new to the public markets,
First, it is identifying compounds with broad and proven mechanisms of action across many dermatologic conditions. This mitigates clinical risk for each of the programs and ensures life cycle management potential. Second, it pays close attention to making sure that significant differentiation of a specific drug creates a barrier to entry. This allows Timber to maintain high earnings potential while mitigating CMC risk, which is one of the most common issues a drug will fail to get approved. Thirdly, the company is only pursuing orphan indications with no approved FDA treatments. This focus on unmet needs allows the Company to deliver truly meaningful treatments to patients, which mitigates concerns relative to pricing and reimbursement.
Currently, Timber has two assets in Phase 2b clinical trials and one preclinical stage program. The company's two late-stage products, TMB-001 in Congenital Ichthyosis and TMB-002 in Facial Angiofibromas, fit perfectly within the above-described strategy. Each one targets an orphan indication with high unmet need and no FDA approved treatments. They both also utilize the 505(b)(2) pathway by taking advantage of an established mechanism of action and well-characterized CMC and safety profiles. Finally, according to management estimates, the
In addition, both have other life cycle management opportunities to sustain growth and further maximize add-on marketing potential. Timber noted in its previous shareholder update that both trials are currently recruiting, and a top-line data readout is expected around the third quarter of 2021. Most recently, the TMB-001 CONTROL study initiated all of its 11 sites in both the
A Fortified Balance Sheet Can Push Trials Forward
One of Timber's differentiating factors is that the company came to the market with approximately
According to the company, most of its cash will go toward funding the TMB-001 and TMB-002 clinical trials. Notably, it is expected that the current cash and cash equivalent balances should be sufficient to take Timber through top-line data readout for both Phase 2b trials, expected next year. A portion of the funding will also advance the development of its earliest, preclinical asset, TMB-003. Timber plans to continue developing this asset toward an IND.
The company's management bring strong and diverse talent in the rare and orphan dermatology space that have the expertise to drive its clinical programs forward The company is led by CEO
Although investors are just learning about this newly listed company, few can argue that the company is not entering an exciting stage and period of growth from its assets. The balance sheet is strong, but Timber also has numerous potential clinical development milestones coming up over the next months. Additionally, the merger with
Creating Shareholder Value in 2020 and 2021
From a capital structure perspective, Timber has 11.9 million shares outstanding. At the time of the merger with
On the positive side of that equation, Timber can benefit from its capital structure and balance sheet by positioning itself to become one of the leading companies in the rare orphan dermatology space. It has multiple shots on goal, is supported by a robust portfolio of products that address critical unmet needs, and may be best-positioned to bring to market the first FDA-approved drug for their respective indications.
This may be a "getting to know you" period for Timber investors, who are only now learning about the value potential in the company's assets. And, while current valuations may not fairly represent an appropriate market-cap for a company with two Phase 2b programs underway, it does expose opportunity.
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