Biotech ‘Thinking Several Steps Ahead with Optimizing IVR Quality Control’

August 5, 2019

By The Life Science Report

Source: Streetwise Reports   08/02/2019

The company’s latest science, presented at a recent conference, is discussed in a ROTH Capital Partners report.

In a July 31 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that Daré Bioscience Inc. (DARE:NASDAQ) presented two posters on the use of FT-Raman spectroscopy in evaluating drug stability in its intravaginal rings (IVR), on July 22 and 23 at the 2019 Controlled Release Society Annual Meeting & Exposition in Spain.

The data that Daré shared strongly validated this approach and its ability to measure a drug’s release and concentration in intravaginal ring (IVR) therapies. This is significant because both measures are key to pharmacodynamics and efficacy of Daré’s IVR therapies, currently DARE-FRT1 for pregnancy maintenance and DARE-HRT1 for menopause symptoms.


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There also is a need for measuring the stability of a drug or drugs in Daré’s IVR therapies because of a process used in developing them: hot melt extrusion (HME), which can alter a drug’s properties.

HME is used to allow delivery, through the IVR, of multiple drugs with varying molecular weights and drugs with lower solubility or bioavailability. This controlled delivery is one feature that sets apart Daré’s IVR platform from the competition.

“We view this as an important milestone assuring quality control on the road to commercialization for the two novel intravenous ring therapies,” Rahimi commented.

The first poster, “Use of FT-Raman Spectroscopy to Assess 17-Beta-Estradiol/Progesterone Ethylene Vinyl Acetate-Based Intravaginal Rings,” showed that spectroscopy effectively and reliably assayed levels of the two hormones in IVRs during manufacturing and after one and three months of storage.

The second poster, “Determination of Drug Crystallinity in Hot Melt Extruded Ethylene Vinyl Acetate Copolymer,” demonstrated that in an EVA IVR ring with 28% vinyl acetate, the contained compounds can be identified and their state determined.

“Based on these examples of strong, solid science, we are confident Daré has developed quality control steps to optimize IVR manufacturing,” noted Rahimi.

ROTH has a Buy rating and a $6 per share target price on Daré, whose current share price is around $0.76.

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Disclosures from ROTH Capital Partners, Daré Bioscience Inc., Company Note, July 31, 2019

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Daré Bioscience, Inc.

ROTH makes a market in shares of Daré Bioscience, Inc. and as such, buys and sells from customers on a principal basis.

Shares of Daré Bioscience, Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

Within the last twelve months, ROTH has managed or co-managed a public offering for Daré Bioscience, Inc.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: DARE:NASDAQ,
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