Q: What do you get when a biotech company is days away from uplisting to the Nasdaq Capital Market, has recently obtained funding to proceed in not one, not two, but four Phase II clinical trials with an oncology emphasis, and has collaborative partnerships with AstraZeneca (AZN), Memorial Sloan Kettering Cancer Center, and Mayo Clinic?
A: A stock primed for a major move.
The company is TapImmune Inc., and the stock is (TPIVD).
TapImmune, Inc. (web site) is a clinical-stage immune-oncology company specializing in the development of innovative technologies for the treatment of cancer and metastatic disease. The Company has made considerable clinical and financial progress over the last year, including the completion of positive Phase I clinical trials in breast and ovarian cancer at the Mayo Clinic, which showed that its TPV-100 and TPV-200 vaccines were safe and well tolerated, and demonstrated robust cellular immune responses in over 90% of evaluable patients. Since the results, TPIV has announced multiple phase 2 clinical studies – and was also granted an Orphan Drug Designation and received fast track designation from the FDA for TPIV 200 in ovarian cancer.
With a $13.3 million grant, the U.S. Department of Defense is fully funding a double-blinded, placebo controlled Phase II study of TPIV 200 in 280 patients with triple negative breast cancer to be conducted at the Mayo Clinic in Jacksonville, Florida.
Shares outstanding: 8.3 million
Closing Price 9/16/16: $5.55
Market cap: $46 million
NASDAQ Uplist Pending
As announced last week, TapImmune believes that it now meets the requirements for listing the company’s common stock on the Nasdaq Capital Market.
A number of TapImmune investors recently exercised a total of 12 million warrants, resulting in a $6 million cash infusion. Additionally, TapImmune closed on a $3 million financing through a private equity placement while certain outstanding warrants were restructured, eliminating $29 million of derivative liability. These actions successfully bolstered the Company’s balance sheet to meet Nasdaq Capital Market listing requirements, while a reverse stock split last week brought the share price above the NASDAQ listing minimum.
To be listed on the Nasdaq Capital Market, requirements include an operating history of 2 years, $5 million in shareholders equity, 1 million publicly held shares and a bid price of $4, according to the Nasdaq initial listing guide (page 9).
Having invested in many uplisting stocks over the years, I can tell you there is no grey area in this process…you either meet the requirements or you do not, and TapImmune now meets them.
The listing will open up a huge market of institutional investors that could not previously invest in TapImmune, a company with FOUR Phase II clinical trials of drugs for ovarian and breast cancer, (one with Fast Track designation and Orphan Drug status), that has collaborative partnerships with AstraZeneca, Mayo Clinic, Memorial Sloan Kettering Cancer Center.
As you read more below, it will become clear the current market cap ($46 million) does not come anywhere close to reflecting the underlying value of TPIVD. That will change with the NASDAQ listing and the resulting increased awareness of TapImmune’s world class partnerships and attractive drug pipeline by analysts and institutional investors.
Active Pipeline, Multiple Phase II Trials
TapImune’s Chairman and CEO, Glynn Wilson, Ph.D. stated earlier this month:
“Recent events have been transformative for TapImmune. We believe we are now funded to execute on the 4 Phase 2 clinical trials for our lead cancer vaccine TPIV 200, two of which have already started treating patients, with two more trials slated to commence enrollment in the coming few quarters.”
“We believe the Phase 1 data produced for both TPIV 200 and TPIV 110 in collaboration with the Mayo Clinic are the driving force behind the high-value collaborations we have been able to maintain and establish with organizations including Mayo Clinic, AstraZeneca, Sloan Kettering, and the U.S. Department of Defense. As we move forward into advancing the Phase 2 studies, some of which are represent collaboration with prestigious third party organizations, we believe this represents further independent vetting of potential of our technology.”
“Fully funded to execute on the 4 Phase II clinical trials”
Phase II Trial of TPIV 200 for Triple Negative Breast Cancer
About 15-20% of breast cancers are found to be triple-negative (meaning the breast cancer cells tested negative for estrogen receptors, progesterone receptors, and HER2. This breast cancer does not respond to hormonal therapy (such as tamoxifen or aromatase inhibitors) or therapies that target HER2 receptors, such as Herceptin (chemical name: trastuzumab). For doctors and researchers, there is intense interest in finding new medications that can treat this kind of breast cancer.
TapImmune has opened 8 clinical sites and is currently treating patients in a Phase 2 trial of the Company’s Folate Receptor Alpha cancer vaccine, TPIV 200, in the treatment of triple negative breast cancer, one of the most difficult to treat cancers representing a clear unmet medical need.
The open-label, 80 patient clinical trial is designed to evaluate dosing regimens, adjuvants, efficacy, and immune responses in women with triple negative breast cancer. Key data from the trial is expected to be included in a future New Drug Application submission to the FDA for marketing clearance.
Phase II Trial at Memorial Sloan Kettering of TPIV 200 in Ovarian Cancer in Collaboration with AstraZeneca
A Phase II study of TPIV 200 in ovarian cancer patients who are not responsive to platinum, (a commonly used chemotherapy for ovarian cancer), sponsored by Memorial Sloan Kettering Cancer Center, and in collaboration with AstraZeneca. TapImmune has begun enrollment for a 40 patient study.
The open-label study is designed to evaluate a combination therapy which includes TapImmune’s TPIV 200 T-cell vaccine and AstraZeneca’s checkpoint inhibitor, durvalumab.
Because they are unresponsive to platinum, these patients have no real options left.
If the combination therapy proves effective, it would address a critical unmet need. TPIV 200 has received Orphan Drug designation for use in the treatment of ovarian cancer.
Multiple Near Term Positive Drivers In Addition to Nasdaq Uplisting
I love stocks with multiple near term, positive drivers…and TapImmune has them:
Enrollment to Commence in Q4 2016: Phase II Mayo Clinic-U.S. DOD Trial of TPIV 200 in Triple Negative Breast Cancer
TapImmune anticipates that this Phase 2 study of TPIV 200 in the treatment of triple negative breast cancer, conducted by the Mayo Clinic and sponsored by the U.S. Department of Defense (DOD), will begin to enroll patients in the fourth quarter of this year. The anticipated 280 patient study will be led by Dr. Keith Knutson of the Mayo Clinic in Jacksonville, Florida. Dr. Knutson is the inventor of the technology and an advisor to TapImmune.
While TapImmune is supplying doses of TPIV 200 for the trial, the remaining costs associated with conducting this study will be funded by a $13.3 million grant made by the DOD to the Mayo Clinic.
Clinical Sites to Open in Q4 2016: Phase II TPIV 200 Trial in Platinum-Sensitive Ovarian Cancer (Fast Tracked by FDA)
By the end of 2016, TapImmune expects to have at least one clinical site open in a Phase II trial of TPIV 200 in 80 ovarian cancer patients who are responsive to platinum. TPIVD received the FDA’s Fast Track designation to develop TPIV 200 as a maintenance therapy in combination with platinum, in platinum responsive ovarian cancer. This multi-center, double-blind efficacy study is sponsored and conducted by TapImmune.Dr. Glynn Wilson, Chairman and CEO of TapImmune states:
“We believe that the FDA’s decision to grant Fast Track designation to TPIV 200 for the treatment ovarian cancer significantly expedites our clinical development program. We look forward to starting Phase II trials in the near future to address this highly aggressive cancer. We believe TPIV 200 has the potential to improve outcomes for ovarian cancer patients for whom current treatment modalities offer a relative short time to recurrence and a poor overall prognosis.”
Open IND (Investigational New Drug) with FDA for TPIV 110 in Q4 2016:
TapImmune has reformulated a second cancer vaccine product, TPIV 110, following very strong safety and immune responses from a Phase 1 Mayo Clinic study.TPIV 110 targets Her2/neu, which makes it applicable to breast, ovarian and colorectal cancer. The reformulated product adds a fifth antigen which should produce an even more robust immune response activating both CD4+ and CD8+ T-cells.
TapImmune has already requested a pre-Investigational New Drug (IND) meeting with the FDA and submitted questions to the FDA related to opening the IND.
A response from the FDA is expected in September and TapImmune anticipates having an open IND by year-end pending comments from FDA.
Preclinical Pipeline Expands TapImmune’s Breast & Ovarian Cancer Killer Therapies
Also Preclinical, A Next Generation T-Cell Vaccine: PolyStart
In February of this year, TapImmune received notice of allowance on a patent for a Next Generation T-Cell Vaccine called “PolyStart.”
This unique vaccine platform antigen expression system creates a 4 (FOUR) fold or more increase in antigen presentation. The increased cell surface presentation increases activated Helper and/or long-lived Killer T-cell populations that then effectively seek out and work to destroy a patient’s cancer cells.
The below data from a current study showing the increased presentation and subsequent KILLING of the targeted cell population.
Dr. Glynn Wilson, Chairman & CEO of TapImmune explains:
“We are very excited about this technology, as we believe it marks a next generation of T-cell vaccines. PolyStart has unlimited application in oncology and infectious diseases not only within TapImmune’s own platforms but it can be applied to many others via licensing. As we move forward into Phase 2 trials for TPIV 200, which targets folate receptor alpha, and TPIV 100/110 our Her2/neu product, we fully expect to develop PolyStart as both a stand-alone therapy and as a ‘boost strategy’ to be used synergistically with our peptide-based vaccines for breast and ovarian cancer.”
I believe PolyStart is the icing on the cake of this soon-to-be-discovered, Nasdaq listed, biotech standout.
TapImmune (TPIVD) is a biotech stock that should gain solid traction with the pending NASDAQ uplisting. The company has 4 different clinical trials in Phase II for unmet needs in breast and ovarian cancers. Collaborations and partnerships with AstraZeneca, Memorial Sloan Kettering Cancer Center, and Mayo Clinic demonstrate the potential these world class organizations see in TapImmune and in the TPIV 100 & TPIV 200 clinical trials going forward.
The company has several positive forward drivers to increase momentum and share prices following the uplisting as well.
Investors can very reasonably expect increased retail and institutional awareness, increased volume, and increasing share prices in the coming weeks/months.